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Health Guide / Antidepressant medications

Antidepressants that cause weight loss

steve silvestro

Reviewed by Steve Silvestro, MD, written by Michael Martin

Last updated: Dec 10, 2021
5 min read

table of contents

  1. Do some antidepressants cause weight loss?
  2. Why do antidepressants affect weight?
  3. What types of antidepressants are available?
  4. Additional treatments for depression
  5. Seek the help you need 

Disclaimer

If you have any medical questions or concerns, please talk to your healthcare provider. The articles on Health Guide are underpinned by peer-reviewed research and information drawn from medical societies and governmental agencies. However, they are not a substitute for professional medical advice, diagnosis, or treatment.

If you’ve been prescribed an antidepressant, you may be curious about its potential effect on weight, particularly if it causes weight gain or weight loss. While many antidepressants have been shown to potentially cause weight gain, there’s only one that is known to cause weight loss in the long run. Here’s what the research says about how antidepressant use can affect what you see on the scale.

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Do some antidepressants cause weight loss?

There are more than a dozen antidepressant drugs that are popularly prescribed. But only one has been consistently associated with weight loss in studies: bupropion (brand name Wellbutrin; see Important Safety Information).

A 2019 meta-analysis of 27 studies on antidepressants and weight gain found that taking antidepressants can increase body weight by an average of 5%—except bupropion, which was associated with weight loss (Alonso-Pedrero, 2019).

Another study from 2016 looked at the long-term weight loss effect of various antidepressants and found that non-smokers who took bupropion lost 7.1 pounds over two years. (This effect was not seen in smokers.) Users of the other antidepressants in the study gained weight (Arterburn, 2016).

Bupropion also seems to help with weight loss maintenance. A 2012 study found that adults with obesity who took bupropion SR (standard release) in 300mg or 400mg doses lost 7.2% and 10% of their body weight, respectively, over 24 weeks and maintained much of that weight loss at 48 weeks (Anderson, 2012). 

In fact, bupropion is part of the popular weight loss drug naltrexone-bupropion (brand name Contrave), which is FDA approved for treatment of overweight or obesity. 

Why do antidepressants affect weight?

Experts aren’t exactly sure why weight changes occur with antidepressants. Antidepressant medications’ effect on weight is, in the words of one study, “only partially understood” and “poorly described” (Gafoor, 2018). 

In very broad terms, antidepressants act on a variety of chemicals, neurotransmitters, and receptors in the brain. This changes the level of the impact of these neurotransmitters in the brain. Ideally, that improves mental health issues like depression and anxiety. In some cases, these effects seem to cause metabolic changes that lead to weight gain.

For example: Bupropion is a medication known as an NDRI (norepinephrine-dopamine reuptake inhibitor). This means that it prevents the brain from absorbing free-floating norepinephrine and dopamine (two types of neurotransmitters). When they aren’t reabsorbed quickly, adrenaline and dopamine stick around and act on the brain longer. This may affect metabolism and appetite, resulting in weight loss. 

Some antidepressants affect histamine and serotonin, which regulate appetite (Gill, 2020). Others act on neurotransmitters and receptors connected to weight gain (David, 2016). Some of these medications, mainly the early first-generation tricyclic antidepressants, may change the way the body metabolizes lipids (fats) and glucose (blood sugar)  (Hasnain, 2012; David, 2016). 

Of course, weight gain or weight loss is far from guaranteed when you take antidepressants.

Fear of weight gain shouldn’t keep you from taking antidepressants if you need them. Talk with your healthcare provider if you’re bothered by weight changes—adjusting your diet, increasing exercise, or, in some cases, switching medications can be effective solutions.

What types of antidepressants are available?

There are many different types of antidepressants available.

The most common antidepressant medications are selective serotonin reuptake inhibitors (SSRIs), which include fluoxetine (brand name Prozac; see Important Safety Information), sertraline (brand name Zoloft; see Important Safety Information), paroxetine (brand name Paxil or Brisdelle; see Important Safety Information), and escitalopram (brand name Lexapro; see Important Safety Information). 

Serotonin-norepinephrine reuptake inhibitors (SNRIs) are also frequently prescribed, including venlafaxine (brand name Effexor; see Important Safety Information), duloxetine (brand name Cymbalta; see Important Safety Information), and desvenlafaxine (brand name Pristiq).

Bupropion, as we’ve discussed, is an NDRI, so it works a little differently than the more standard SSRIs and SNRIs.  

Other types of antidepressants include tricyclic antidepressants (TCAs) and monoamine oxidase inhibitors. These tend to cause worse side effects, so they’re not generally the first treatment your provider will try. 

Additional treatments for depression

In some cases, depression can have a medical cause, such as hypothyroidism, vitamin B12 deficiency, low testosterone, or side effects of medication. A healthcare provider can diagnose and treat these.

Unfortunately, most cases of depression aren’t caused by medical issues. For depression that doesn’t have a medical cause, the main treatments are antidepressant medication and psychotherapy.

Therapy

Research shows that antidepressants and cognitive behavioral therapy (CBT) are about equally effective for the treatment of depression. However, CBT may have more long-lasting effects and prevent relapse (Hollon, 2005). During CBT, therapists encourage patients to replace negative, unhelpful thoughts with more positive ones. 

Diet and exercise

Both aerobic and resistance exercises have been found to be effective at relieving depression (Craft, 2004). Some studies indicate that the Mediterranean diet is associated with a lower rate of depression (Sánchez-Villegas, 2009). 

Other things that might improve depression include getting better sleep, increasing social interaction, and avoiding excessive alcohol and tobacco use. 

Seek the help you need 

If you are feeling anxious or depressed, it’s important to seek out the help you need. Speak with your healthcare provider or a mental health professional to figure out whether antidepressants, therapy, or a combination thereof are right for you. If you are concerned about weight gain or weight loss on antidepressants, be sure to discuss that with your healthcare provider as well. Together, you can determine a treatment approach that’s best for you.

References

  1. Alonso‐Pedrero, L., Bes‐Rastrollo, M., & Marti, A. (2019). Effects of antidepressant and antipsychotic use on weight gain: A systematic review. Obesity Reviews : An Official Journal of the International Association for the Study of Obesity, 20(12), 1680–1690. doi: 10.1111/obr.12934. Retrieved from https://pubmed.ncbi.nlm.nih.gov/31524318/
  2. Anderson, J. W., Greenway, F. L., Fujioka, K., Gadde, K. M., McKenney, J., O’Neil, P. M. (2012). Bupropion SR Enhances Weight Loss: A 48-Week Double-Blind, Placebo- Controlled Trial. Obesity Society, 10(7), 633-641. https://doi.org/10.1038/oby.2002.86. Retrieved from https://onlinelibrary.wiley.com/doi/full/10.1038/oby.2002.86
  3. Arteburn, D., Sofer, T., Boudreau, D. M., Bogart, A., Westbrook, E. O., Theis, M. K., et al. (2016). Long-term weight changes after initiating second-generation antidepressants. Journal of Clinical Medicine, 5(4):48. doi: 10.3390/jcm5040048. Retrieved from https://pubmed.ncbi.nlm.nih.gov/27089374/
  4. Craft, L. L., & Perna, F. M. (2004). The Benefits of Exercise for the Clinically Depressed. The Primary Care Companion to The Journal of Clinical Psychiatry, 06(03), 104–111. doi: 10.4088/pcc.v06n0301. Retrieved from https://pubmed.ncbi.nlm.nih.gov/15361924/
  5. David, D. J., & Gourion, D. (2016). Antidépresseurs et tolérance : déterminants et prise en charge des principaux effets indésirables [Antidepressant and tolerance: Determinants and management of major side effects]. L’Encephale, 42(6), 553–561. https://doi.org/10.1016/j.encep.2016.05.006. Retrieved from https://pubmed.ncbi.nlm.nih.gov/27423475/
  6. DSM-5 (2013). Depressive disorders. Diagnostic and Statistical Manual of Mental Disorders. doi:10.1176/appi.books.9780890425596.dsm04. Retrieved from https://dsm.psychiatryonline.org/doi/book/10.1176/appi.books.9780890425596
  7. Gafoor, R., Booth, H. P., & Gulliford, M. C. (2018). Antidepressant utilisation and incidence of weight gain during 10 years’ follow-up: population based cohort study. BMJ (Clinical Research Ed.), 361, k1951. https://doi.org/10.1136/bmj.k1951. Retrieved from https://pubmed.ncbi.nlm.nih.gov/29793997/
  8. Gill, H., Gill, B., El-Halabi, S., Chen-Li, D., Lipsitz, O., Rosenblat, J. D., et al. (2020). Antidepressant Medications and Weight Change: A Narrative Review. Obesity, 28(11), 2064–2072. doi: 10.1002/oby.22969. Retrieved from https://onlinelibrary.wiley.com/doi/abs/10.1002/oby.22969
  9. Hasnain, M., Vieweg, W. V., & Hollett, B. (2012). Weight gain and glucose dysregulation with second-generation antipsychotics and antidepressants: a review for primary care physicians. Postgraduate Medicine, 124(4), 154–167. https://doi.org/10.3810/pgm.2012.07.2577. Retrieved from https://pubmed.ncbi.nlm.nih.gov/22913904/
  10. Hollon, S. D., Derubeis, R. J., Shelton, R. C., Amsterdam, J. D., Salomon, R. M., O’Reardon, J. P., et al. (2005). Prevention of Relapse Following Cognitive Therapy vs Medications in Moderate to Severe Depression. Archives of General Psychiatry, 62(4), 417. doi: 10.1001/archpsyc.62.4.417. Retrieved from https://pubmed.ncbi.nlm.nih.gov/15809409/
steve silvestro
Steve Silvestro, MD

Dr. Steve Silvestro is a board-certified pediatrician and Senior Manager, Medical Content & Education at Ro.

Related articles

Important Safety Information for Bupropion Sustained-Release (SR)

Warning: Suicidal Thoughts and Behaviors

Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. In short-term studies, antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults under age 24. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk in patients 65 and older.

Patients of all ages being treated with antidepressants should be observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially early during antidepressant treatment and when the dose is adjusted up or down. Families and caregivers of patients should look for the emergence of symptoms on a day-to-day basis, since changes may be abrupt.

Call your healthcare provider right away or 911 in an an emergency if you observe any of the following behaviors, especially if they are new, worse, unusual, or worry you: emergence of suicidality, worsening of depression, emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, inability to sit still or restlessness, racing thoughts that you can’t fully control, or becoming easily distracted.

What are the FDA-approved uses of bupropion SR?

Bupropion SR is an aminoketone antidepressant used to treat Major Depressive Disorder (MDD). It is also categorized as a norepinephrine-dopamine reuptake inhibitor (NDRI).

Who should not use bupropion SR?

Do not use bupropion SR if:

  • You have had seizures in the past or have been diagnosed with a seizure disorder.
  • You have a current or prior diagnosis of bulimia or anorexia nervosa. 
  • You have abruptly discontinued alcohol, benzodiazepines, barbiturates, or antiepileptic drugs.
  • You are taking a class of medications called monoamine oxidase inhibitors (MAOIs). Examples of MAOIs include isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Emsam), and tranylcypromine (Parnate), linezolid, or intravenous methylene blue. When MAOIs are used at the same time as bupropion, there is an increased risk of very high blood pressure levels which can lead to a medical emergency. 
  • You have a known allergic reaction to bupropion hydrochloride.

How should I take bupropion SR?

You can take bupropion SR with or without food. The tablet should be swallowed whole and not crushed, split, or chewed.

You should take bupropion SR exactly as prescribed, and continue to take bupropion SR as prescribed even after your symptoms improve. You should not change your dosing regimen or stop taking bupropion SR without discussing with your provider first. A gradual reduction in dosage rather than abruptly stopping is recommended whenever possible.

If your symptoms are not improving or you have any questions about changing or stopping medication, reach out to your Ro-affiliated provider for guidance.

What should I tell my Ro-affiliated provider before using bupropion SR?

  • Bupropion SR contains the active ingredient bupropion. It is the same active ingredient that is found in medications called Wellbutrin, Wellbutrin SR, Wellbutrin XL, Aplenzin, Zyban, or Forfivo XL. Tell your provider if you are taking one of these medications.
  • Bupropion SR has many drug interactions. It’s important to tell your Ro-affiliated provider all of the medications you are currently taking, including prescription, over-the-counter medications, vitamins, and herbal and dietary supplements. Some medications to watch out for include:
    • Monoamine oxidase inhibitors (MAOIs), including the antibiotic linezolid (Zyvox) and intravenous methylene blue (rare)
    • Antipsychotics, such as risperidone (Risperdal) and haloperidol (Haldol)
    • Other antidepressants, including SSRIs and SNRIs
    • Theophylline (Elixophyllin)
    • Corticosteroids, such as prednisone
    • Drugs used to treat Parkinson’s Disease called levodopa and amantadine
    • Digoxin (Digox)
    • Tamoxifen
  • It’s important to share your entire medical history with your provider. In particular, tell your provider if you have a past history of:
    • Suicidal thoughts or attempted suicide
    • Bipolar Disorder
    • Family history of Bipolar Disorder or family history of suicide
    • Seizures
    • Liver problems
    • Kidney problems
    • If you are a smoker and/or you’re trying to quit smoking
    • Alcohol or opiate abuse
    • Diabetes
    • Eating disorders
  • Tell your provider if you are pregnant, planning to become pregnant, or breastfeeding. You should discuss with your provider if bupropion SR should be used during pregnancy and while breastfeeding.

Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death.

What are the most serious side effects that I or a caregiver should monitor for when taking bupropion SR?

If you are experiencing a medical emergency, call 911 or seek immediate medical attention.

These serious side effects are rare, but can occur with bupropion SR. You or a caregiver should carefully monitor for these side effects, especially in the beginning of treatment and with dose changes.

  • Smoking Cessation: Some people have had serious side effects while taking bupropion to help them quit smoking (known as the brand name drug Zyban). These side effects include new or worse mental health problems, such as changes in behavior or thinking, aggression, hostility, agitation, depression, or suicidal thoughts or actions. If you are thinking of quitting smoking, talk to your provider before you start taking bupropion.
  • Risk of seizure: Bupropion SR can cause seizure and the chance of seizure is related to too high of a dose of bupropion SR. Tell your provider about any past history of seizure, all medical history, and any other medications you are taking.
  • Increase in blood pressure: Bupropion SR can increase blood pressure. Your blood pressure should be well controlled prior to starting treatment. The chance of high blood pressure may be higher if you also use nicotine replacement therapy (such as a nicotine patch) to help you stop smoking. Your provider will monitor your blood pressure regularly. Consider monitoring your blood pressure at home.
  • Activation of Mania/Hypomania: Especially at the beginning of treatment, monitor for changes in behavior such as an unusually elevated mood, feeling unusually irritable, a big increase in energy, being more talkative than usual, racing thoughts, or engaging in risky behaviors. These changes in behavior could be signs of undiagnosed Bipolar Disorder.
  • Psychosis and other neuropsychiatric reactions: Depressed patients treated with bupropion SR have had a variety of neuropsychiatric signs and symptoms, including delusions, hallucinations, psychosis, concentration disturbance, paranoia, and confusion. Some of these patients had a diagnosis of bipolar disorder. Monitor for these signs and symptoms and tell your provider right away if these reactions occur.
  • Eye Effects: In rare instances, antidepressants may cause a certain type of eye problem called acute angle-closure glaucoma. Monitor for eye pain, changes in your vision, or swelling or redness in or around the eye.
  • Allergic Reactions, some severe: Discontinue bupropion SR if you develop an allergic or anaphylactic reaction including skin rash, itching, hives, chest pain, swelling, and shortness of breath.
  • Cognitive and Motor Impairment: Bupropion SR may impair judgment, thinking, and motor skills. Avoid driving a car or operating hazardous machinery until you know that your performance is not affected.
  • Alcohol Use: Limit or avoid using alcohol while taking bupropion SR. If you usually drink a lot of alcohol, talk with your provider first before suddenly stopping. If you suddenly stop drinking alcohol, you may increase your chance of having seizures.

What are the most common side effects of bupropion SR?

  • Agitation
  • Insomnia, trouble sleeping
  • Headache
  • Dizziness
  • Nausea, vomiting
  • Constipation
  • Tremor
  • Sweating
  • A rapid or irregular heartbeat
  • Dry mouth
  • Loss of appetite, weight loss
  • Sore throat

You are encouraged to report negative side effects of prescription products to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

This information is not comprehensive. Please see the full Prescribing Information for complete safety information. 

Important Safety Information for Fluoxetine

Warning: Suicidal Thoughts and Behaviors

Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. In short-term studies, antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults under age 24. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk in patients 65 and older.

Patients of all ages being treated with antidepressants should be observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially early during antidepressant treatment and when the dose is adjusted up or down. Families and caregivers of patients should look for the emergence of symptoms on a day-to-day basis, since changes may be abrupt.

Call your healthcare provider right away or 911 in an an emergency if you observe any of the following behaviors, especially if they are new, worse, unusual, or worry you: emergence of suicidality, worsening of depression, emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, inability to sit still or restlessness, racing thoughts that you can’t fully control, or becoming easily distracted.

What is the FDA-approved use of fluoxetine?

Fluoxetine is a selective serotonin reuptake inhibitor (SSRI) used for acute and maintenance treatment of Major Depressive Disorder (MDD).

Who should not use fluoxetine?

Do not use fluoxetine if:

  • You are taking a class of medications called monoamine oxidase inhibitors (MAOIs). Examples of MAOIs include isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Emsam), and tranylcypromine (Parnate), linezolid, or intravenous methylene blue. MAOIs may increase the risk of serotonin syndrome.
  • You are taking a medication called pimozide or thioridazine. Taking these medications with fluoxetine can increase the risk of prolonged QT interval, which is a potentially dangerous change to the electrical signals that make your heart beat.

How should I take fluoxetine?

You can take fluoxetine with or without food. 

You should take fluoxetine exactly as prescribed, and continue to take fluoxetine as prescribed even after your symptoms improve. You should not change your dosing regimen or stop taking fluoxetine without discussing with your provider first. A gradual reduction in dosage rather than abruptly stopping is recommended whenever possible.

If your symptoms are not improving or you have any questions about changing or stopping medication, reach out to your Ro-affiliated provider for guidance.

What should I tell my Ro-affiliated provider before using fluoxetine?

  • Fluoxetine has many drug interactions. It’s important to tell your Ro-affiliated provider all of the medications you are currently taking, including prescription, over-the-counter medications, vitamins, and herbal and dietary supplements. Some medications to watch out for include:
    • Monoamine oxidase inhibitors (MAOIs), including the antibiotic linezolid (Zyvox) and intravenous methylene blue (rare)
    • NSAIDs, such as ibuprofen or naproxen
    • Aspirin
    • Blood thinners, such as warfarin (Coumadin)
    • Migraine medications called triptans, such as sumatriptan (Imitrex)
    • Benzodiazepines, such as diazepam and alprazolam
    • Other or SSRIs or SNRIs, such as sertraline (Zoloft)
    • Tamoxifen
    • St. John’s Wort
  • It’s important to share your entire medical history with your provider. In particular, tell your provider if you have a past history of:
    • Suicidal thoughts or attempted suicide
    • Family history of Bipolar Disorder or family history of suicide
    • Seizures
    • Irregular heartbeat or heart issues
    • Bipolar Disorder
    • Glaucoma or eye problems
    • Diabetes
  • Tell your provider if you are pregnant, planning to become pregnant, or breastfeeding. SSRI use, particularly later in pregnancy, may increase risk of complications in the newborn. You should discuss with your provider if fluoxetine should be used during pregnancy. There have been reports of fluoxetine passing into breast milk. Talk to your provider about the best way to feed your baby while taking fluoxetine.

Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death.

What are the most serious side effects that I or a caregiver should monitor for when taking fluoxetine?

If you are experiencing a medical emergency, call 911 or seek immediate medical attention.

These serious side effects are rare, but can occur with fluoxetine. You or a caregiver should carefully monitor for these side effects, especially in the beginning of treatment and with dose changes.

  • Serotonin Syndrome: Serotonin syndrome is an uncommon, potentially life-threatening condition that occurs when taking too much of an SSRI or SNRI at once or when fluoxetine is taken along with other drugs that increase the activity of serotonin in the central nervous system. These medications may include MAOIs, triptans (a class of drugs used to treat migraines), tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John’s Wort. Monitor for symptoms of elevated body temperature, flushing, sweating, abdominal pain, diarrhea, agitation, and a racing heartbeat.
  • Allergic Reactions and Rash: Tell your provider if you develop a rash or hives. Discontinue use of fluoxetine and seek emergency care immediately if you have a severe allergic reaction. Signs and symptoms of a severe allergic reaction include swelling of the face, eyes, or mouth, or having trouble breathing. 
  • Activation of Mania/Hypomania: Especially at the beginning of treatment, monitor for changes in behavior such as an unusually elevated mood, feeling unusually irritable, a big increase in energy, being more talkative than usual, racing thoughts, or engaging in risky behaviors. These changes in behavior could be signs of undiagnosed Bipolar Disorder.
  • Abnormal Bleeding: Tell your provider if you experience any increased or unusual bruising, bleeding, or nose bleed. Fluoxetine may increase the risk of bleeding when taken with NSAIDs (such as ibuprofen or naproxen), aspirin, or blood thinners such as warfarin (Coumadin).
  • QT Prolongation: Tell your provider right away if you experience fast, slow, or irregular heart rate, shortness of breath, fainting, or dizziness, which may indicate serious cardiac arrhythmia.
  • Cognitive and Motor Impairment: Fluoxetine may impair judgment, thinking, and motor skills. Avoid driving a car or operating hazardous machinery until you know that your performance is not affected. Do not drink alcohol while you take fluoxetine.
  • Eye Effects: In rare instances, antidepressants may cause a certain type of eye problem called acute angle-closure glaucoma. Monitor for eye pain, changes in your vision, or swelling or redness in or around the eye.
  • Low Sodium in the Blood (Hyponatremia): Elderly people may be at greater risk for this condition. Symptoms may include headache, weakness or feeling unsteady, confusion, problems concentrating or thinking, and memory problems.

What are the most common side effects of fluoxetine?

  • Nausea, diarrhea
  • Lack of appetite, weight loss
  • Dry mouth
  • Headache
  • Sexual problems, including decreased sex drive, erectile dysfunction, or trouble ejaculating
  • Change in sleep habits, including insomnia or increased sleepiness
  • Nervousness, anxiety
  • Lack of energy, or feeling generally weak
  • Tremor
  • Sweating

You are encouraged to report negative side effects of prescription products to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

This information is not comprehensive. Please see the full Prescribing Information for complete safety information. 

Important Safety Information for Sertraline

Warning: Suicidal Thoughts and Behaviors

Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. In short-term studies, antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults under age 24. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk in patients 65 and older.

Patients of all ages being treated with antidepressants should be observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially early during antidepressant treatment and when the dose is adjusted up or down. Families and caregivers of patients should look for the emergence of symptoms on a day-to-day basis, since changes may be abrupt.

Call your healthcare provider right away or 911 in an an emergency if you observe any of the following behaviors, especially if they are new, worse, unusual, or worry you: emergence of suicidality, worsening of depression, emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, inability to sit still or restlessness, racing thoughts that you can’t fully control, or becoming easily distracted. 

What is the FDA-approved use of sertraline?

Sertraline is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of Major Depressive Disorder (MDD).

Who should not use sertraline?

Do not use sertraline if:

  • You are taking a class of medications called monoamine oxidase inhibitors (MAOIs). Examples of MAOIs include isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Emsam), and tranylcypromine (Parnate), linezolid, or intravenous methylene blue. MAOIs may increase the risk of serotonin syndrome.
  • You are taking a medication called pimozide. Taking this medication with sertraline can increase the risk of prolonged QT interval, which is a potentially dangerous change to the electrical signals that make your heart beat.
  • You have a known allergic reaction to sertraline.

How should I take sertraline?

You can take sertraline with or without food. 

You should take sertraline exactly as prescribed, and continue to take sertraline as prescribed even after your symptoms improve. You should not change your dosing regimen or stop taking sertraline without discussing with your provider first. A gradual reduction in dosage rather than abruptly stopping is recommended whenever possible.

If your symptoms are not improving or you have any questions about changing or stopping medication, reach out to your Ro-affiliated provider for guidance.

What should I tell my Ro-affiliated provider before using sertraline?

  • Sertraline has many drug interactions. It’s important to tell your Ro-affiliated provider all of the medications you are currently taking, including prescription, over-the-counter medications, vitamins, and herbal and dietary supplements. Some medications to watch out for include:
    • Monoamine oxidase inhibitors (MAOIs), including the antibiotic linezolid (Zyvox) and intravenous methylene blue (rare)
    • NSAIDs, such as ibuprofen or naproxen
    • Aspirin
    • Blood thinners, such as warfarin (Coumadin)
    • Migraine medications called triptans, such as sumatriptan (Imitrex)
    • Other SSRIs or SNRIs, such as fluoxetine (Prozac)
    • St. John’s Wort
  • It’s important to share your entire medical history with your provider. In particular, tell your provider if you have a past history of:
    • Suicidal thoughts or attempted suicide
    • Bipolar Disorder
    • Family history of Bipolar Disorder or family history of suicide
    • Liver problems
    • Irregular heartbeat or heart problems
    • Stroke
    • High blood pressure
    • Seizures
    • Glaucoma or eye problems
  • Tell your provider if you are pregnant, planning to become pregnant, or breastfeeding. SSRI use, particularly later in pregnancy, may increase risk of complications in the newborn. You should discuss with your provider if sertraline should be used during pregnancy or while breastfeeding.

Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death.

What are the most serious side effects that I or a caregiver should monitor for when taking sertraline?

If you are experiencing a medical emergency, call 911 or seek immediate medical attention.

These serious side effects are rare, but can occur with sertraline. You or a caregiver should carefully monitor for these side effects, especially in the beginning of treatment and with dose changes.

  • Serotonin Syndrome: Serotonin syndrome is an uncommon, potentially life-threatening condition that occurs when taking too much of an SSRI or SNRI at once or when sertraline is taken along with other drugs that increase the activity of serotonin in the central nervous system. These medications may include MAOIs, triptans (a class of drugs used to treat migraines), tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John’s Wort. Monitor for symptoms of elevated body temperature, flushing, sweating, abdominal pain, diarrhea, agitation, and a racing heartbeat.
  • Increased risk of bleeding: Tell your provider if you experience any increased or unusual bruising, bleeding, or nose bleed. Sertraline may increase the risk of bleeding when taken with NSAIDs (such as ibuprofen or naproxen), aspirin, or blood thinners such as warfarin (Coumadin).
  • Activation of Mania/Hypomania: Especially at the beginning of treatment, monitor for changes in behavior such as an unusually elevated mood, feeling unusually irritable, a big increase in energy, being more talkative than usual, racing thoughts, or engaging in risky behaviors. These changes in behavior could be signs of undiagnosed Bipolar Disorder.
  • Eye Effects: In rare instances, antidepressants may cause a certain type of eye problem called acute angle-closure glaucoma. Monitor for eye pain, changes in your vision, or swelling or redness in or around the eye.
  • Low Sodium in the Blood (Hyponatremia): Elderly people may be at greater risk for this condition. Symptoms may include headache, weakness or feeling unsteady, confusion, problems concentrating or thinking, and memory problems.
  • QT Prolongation: Tell your provider right away if you experience fast, slow, or irregular heart rate, shortness of breath, fainting, or dizziness, which may indicate serious cardiac arrhythmia.
  • Cognitive and Motor Impairment: Fluoxetine may impair judgment, thinking, and motor skills. Avoid driving a car or operating hazardous machinery until you know that your performance is not affected. Do not drink alcohol while you take sertraline.

What are the most common side effects of sertraline?

  • Nausea, loss of appetite, diarrhea, or indigestion
  • Increased sweating
  • Tremor or shaking
  • Agitation
  • Change in sleep habits including increased sleepiness or insomnia
  • Sexual problems including abnormal ejaculation, erectile dysfunction, or decreased sex drive
  • Feeling tired or fatigued
  • Anxiety

You are encouraged to report negative side effects of prescription products to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

This information is not comprehensive. Please see the full Prescribing Information for complete safety information. 

Important Safety Information for Paroxetine (Brisdelle®)

This Important Safety Information has been adapted from the Prescribing Information for BRISDELLE®. 

What is the most important information I should know about paroxetine? 

  • BOXED WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
  • SUICIDALITY AND ANTIDEPRESSANT DRUGS
    • Paroxetine and other antidepressant medicines may increase suicidal thoughts or actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. Watch for these changes and call your healthcare provider right away if you notice new or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe. Pay particular attention to such changes when sertraline is started or when the dose is changed.
  • You should not drive, operate heavy machinery, or do other dangerous activities until you know how paroxetine affects you. 

Who should not take paroxetine? 

Do not take paroxetine if you: 

  • Take a Monoamine Oxidase Inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid. Do not take an MAOI within 14 days of stopping paroxetine unless directed to do so by your healthcare provider. Do not start paroxetine if you stopped taking an MAOI in the last 14 days unless directed to do so by your healthcare provider. People who take paroxetine close in time to an MAOI may have serious or life-threatening side effects. Get medical help right away if you have any of these symptoms: 
    • high fever
    • uncontrolled muscle spasms
    • stiff muscles
    • rapid changes in heart rate or blood pressure
    • confusion
    • loss of consciousness (pass out). 
  • Take thioridazine or pimozide. Do not take thioridazine or pimozide together with paroxetine because this can cause serious heart problems or sudden death. 
  • Are allergic to paroxetine. 
  • Are pregnant. paroxetine is not for pregnant women. Paroxetine can harm your unborn baby. 

When should I call my primary provider? 

Call your healthcare provider right away if you have any of the following symptoms:

  • Suicidal thoughts or actions: paroxetine, and related antidepressant medicines, may increase suicidal thoughts or actions within the first few months of treatment. Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions. Watch for these changes and call your healthcare provider right away if you notice: New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe. Pay particular attention to such changes when paroxetine is started. Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms. Call your healthcare provider right away or go to the nearest emergency room if you have any of the following symptoms, especially if they are new, worse, or worry you: Attempts to commit suicide; acting on dangerous impulses; acting aggressive or violent; thoughts about suicide or dying; new or worse depression; new or worse anxiety or panic attacks; feeling agitated, restless, angry, or irritable; trouble sleeping; an increase in activity or talking more than what is normal for you or other unusual changes in behavior or mood. 
  • Serotonin Syndrome. This condition can be life-threatening and may include: Nervousness, hallucinations, coma, or other changes in mental status; coordination problems or small movements of the muscles that you cannot control; racing heartbeat, high or low blood pressure; sweating or fever; nausea, vomiting, or diarrhea; muscle rigidity; dizziness; flushing; tremors; seizures.
  • Reduced effectiveness of tamoxifen: Tamoxifen (a medicine used to treat breast cancer) may not work as well if it is taken at the same time as paroxetine. If you are taking tamoxifen, tell your healthcare provider before starting paroxetine. 
  • Abnormal bleeding: paroxetine may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin, or non-steroidal anti-inflammatory drugs (NSAIDs), like ibuprofen, naproxen, or aspirin. 
  • Visual symptoms. 
  • Low salt (sodium) levels in the blood: Elderly people may be at greater risk for this. Symptoms may include: headache; weakness or feeling unsteady; confusion, problems concentrating or thinking or memory problems. 
  • Bone Fractures: Women who take paroxetine may have a higher risk of bone fractures. 
  • Manic episodes: Greatly increased energy; severe trouble sleeping; racing thoughts; reckless behavior; unusually grand ideas; excessive happiness or irritability; talking more or faster than usual. 
  • Seizures or convulsions. 
  • Restlessness: Women who take paroxetine may feel an inner restlessness, nervousness, or be unable to sit still or stand still especially when they start taking paroxetine. 

If you are experiencing a medical emergency, call 911 or seek immediate medical attention.

What is the FDA-approved use of paroxetine?

Paroxetine (10 mg, 20 mg, 30 mg, 40 mg) is approved by the FDA for treatment of Major Depressive Disorder (MDD), Obsessive-Compulsive Disorder (OCD), Panic Disorder, Social Anxiety Disorder, Generalized Anxiety Order, and Posttraumatic Stress Disorder (PTSD). Paroxetine (7.5 mg) is approved by the FDA under the brand name Brisdelle® for the treatment of moderate to severe vasomotor symptoms associated with menopause, and is not approved for the treatment of any psychiatric condition. 

What should I tell my Rory-affiliated provider before starting paroxetine? 

Before starting paroxetine, tell your healthcare provider if you have:

  • liver or kidney problems
  • bipolar disorder or mania
  • low sodium levels in your blood
  • glaucoma (high pressure in the eye)
  • have or had seizures, convulsions, or bleeding problems
  • have any other medical conditions
  • are breastfeeding or plan to breastfeed. 

Tell your healthcare provider about all the medicines that you take, including prescription and non-prescription medicines such as migraine headache medication (triptans), other antidepressants and antipsychotics, vitamins, and herbal supplements. If you take paroxetine, you should not take any other medicines that contain paroxetine, including Paxil® , Paxil CR® , and Pexeva® . 

Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death.

What are the most common side effects of paroxetine? 

The most common possible side effects of paroxetine include: 

  • Headache
  • tiredness
  • nausea 
  • and vomiting

Tell your healthcare provider if you have any side effect that bothers you or does not go away. 

These are not all the possible side effects of paroxetine. Please read the Medication Guide within the full Prescribing Information, including information about the BOXED WARNING, before taking paroxetine. 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088.

Product names referenced herein are trademarks of their respective owners.

Important Safety Information for Escitalopram

Warning: Suicidal Thoughts and Behaviors

Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. In short-term studies, antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults under age 24. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk in patients 65 and older.

Patients of all ages being treated with antidepressants should be observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially early during antidepressant treatment and when the dose is adjusted up or down. Families and caregivers of patients should look for the emergence of symptoms on a day-to-day basis, since changes may be abrupt.

Call your healthcare provider right away or 911 in an an emergency if you observe any of the following behaviors, especially if they are new, worse, unusual, or worry you: emergence of suicidality, worsening of depression, emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, inability to sit still or restlessness, racing thoughts that you can’t fully control, or becoming easily distracted.

What are the FDA-approved uses of escitalopram?

Escitalopram is a selective serotonin reuptake inhibitor (SSRI) used for:

  • Acute and Maintenance Treatment of Major Depressive Disorder (MDD) 
  • Acute Treatment of Generalized Anxiety Disorder (GAD)

Who should not use escitalopram?

Do not use escitalopram if:

  • You are taking a class of medications called monoamine oxidase inhibitors (MAOIs). Examples of MAOIs include isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Emsam), and tranylcypromine (Parnate), linezolid, or intravenous methylene blue. MAOIs may increase the risk of serotonin syndrome.
  • You are taking a medication called pimozide. Taking this medication with escitalopram can increase the risk of prolonged QT interval, which is a potentially dangerous change to the electrical signals that make your heart beat.
  • You have a known allergic reaction to escitalopram.

How should I take escitalopram?

You can take escitalopram with or without food.

You should take escitalopram exactly as prescribed, and continue to take escitalopram as prescribed even after your symptoms improve. You should not change your dosing regimen or stop taking escitalopram without discussing with your provider first. A gradual reduction in dosage rather than abruptly stopping is recommended whenever possible.

If your symptoms are not improving or you have any questions about changing or stopping medication, reach out to your Ro-affiliated provider for guidance.

What should I tell my Ro-affiliated provider before using escitalopram?

  • Escitalopram has many drug interactions. It’s important to tell your Ro-affiliated provider all of the medications you are currently taking, including prescription, over-the-counter medications, vitamins, and herbal and dietary supplements. Some medications to watch out for include:
    • Monoamine oxidase inhibitors (MAOIs), including the antibiotic linezolid (Zyvox) and intravenous methylene blue (rare)
    • NSAIDs, such as ibuprofen or naproxen
    • Aspirin
    • Blood thinners, such as warfarin (Coumadin)
    • Migraine medications called triptans, such as sumatriptan (Imitrex)
    • Other antidepressants, including SSRIs or SNRIs such as sertraline (Zoloft) or citalopram (Celexa)
    • St. John’s Wort
  • It’s important to share your entire medical history with your provider. In particular, tell your provider if you have a past history of:
    • Suicidal thoughts or attempted suicide
    • Bipolar Disorder
    • Family history of Bipolar Disorder or family history of suicide
    • Seizures
    • Heart problems
    • Glaucoma or eye problems
    • Liver problems
  • Tell your provider if you are pregnant, planning to become pregnant, or breastfeeding. SSRI use, particularly later in pregnancy, may increase risk of complications in the newborn. You should discuss with your provider if escitalopram should be used during pregnancy. There have been reports of escitalopram passing into breast milk. Talk to your provider about the best way to feed your baby while taking escitalopram.

Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death.

What are the most serious side effects that I or a caregiver should monitor for when taking escitalopram?

If you are experiencing a medical emergency, call 911 or seek immediate medical attention.

These serious side effects are rare, but can occur with escitalopram. You or a caregiver should carefully monitor for these side effects, especially in the beginning of treatment and with dose changes.

  • Serotonin Syndrome: Serotonin syndrome is an uncommon, potentially life-threatening condition that occurs when taking too much of an SSRI or SNRI at once or when escitalopram is taken along with other drugs that increase the activity of serotonin in the central nervous system. These medications may include MAOIs, triptans (a class of drugs used to treat migraines), tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John’s Wort. Monitor for symptoms of elevated body temperature, flushing, sweating, abdominal pain, diarrhea, agitation, and a racing heartbeat.
  • Activation of Mania/Hypomania: Especially at the beginning of treatment, monitor for changes in behavior such as an unusually elevated mood, feeling unusually irritable, a big increase in energy, being more talkative than usual, racing thoughts, or engaging in risky behaviors. These changes in behavior could be signs of undiagnosed Bipolar Disorder.
  • Low Sodium in the Blood (Hyponatremia): Elderly people may be at greater risk for this condition. Symptoms may include headache, weakness or feeling unsteady, confusion, problems concentrating or thinking, and memory problems.
  • Abnormal Bleeding: Tell your provider if you experience any increased or unusual bruising, bleeding, or nose bleed. Escitalopram may increase the risk of bleeding when taken with NSAIDs (such as ibuprofen or naproxen), aspirin, or blood thinners such as warfarin (Coumadin).
  • Cognitive and Motor Impairment: escitalopram may impair judgment, thinking, and motor skills. Avoid driving a car or operating hazardous machinery until you know that your performance is not affected. Do not drink alcohol while taking escitalopram.
  • Eye Effects: In rare instances, antidepressants may cause a certain type of eye problem called acute angle-closure glaucoma. Monitor for eye pain, changes in your vision, or swelling or redness in or around the eye.

What are the most common side effects of escitalopram?

  • Insomnia
  • Nausea, diarrhea
  • Increased sweating
  • Fatigue and drowsiness
  • Difficulty sleeping, insomnia
  • Headache
  • Decreased libido
  • Difficulty reaching orgasm, or abnormal ejaculation

You are encouraged to report negative side effects of prescription products to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

This information is not comprehensive. Please see the full Prescribing Information for complete safety information.

Important Safety Information for Venlafaxine Extended-Release

Warning: Suicidal Thoughts and Behaviors

Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. In short-term studies, antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults under age 24. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk in patients 65 and older.

Patients of all ages being treated with antidepressants should be observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially early during antidepressant treatment and when the dose is adjusted up or down. Families and caregivers of patients should look for the emergence of symptoms on a day-to-day basis, since changes may be abrupt.

Call your healthcare provider right away or 911 in an an emergency if you observe any of the following behaviors, especially if they are new, worse, unusual, or worry you: emergence of suicidality, worsening of depression, emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, inability to sit still or restlessness, racing thoughts that you can’t fully control, or becoming easily distracted.

What are the FDA-approved uses of venlafaxine extended-release?

Venlafaxine extended-release is a serotonin and norepinephrine reuptake inhibitor (SNRI) for the treatment of:

  • Major Depressive Disorder (MDD)
  • Generalized Anxiety Disorder (GAD)

Who should not use venlafaxine extended-release?

Do not use venlafaxine extended-release if:

  • You are taking a class of medications called monoamine oxidase inhibitors (MAOIs). Examples of MAOIs include isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Emsam), and tranylcypromine (Parnate), linezolid, or intravenous methylene blue. MAOIs may increase the risk of serotonin syndrome.
  • You have a known allergic reaction to venlafaxine hydrochloride or desvenlafaxine succinate.

How should I take venlafaxine extended-release?

You should take venlafaxine extended-release with food.

You should take venlafaxine extended-release exactly as prescribed, and continue to take venlafaxine extended-release as prescribed even after your symptoms improve. You should not change your dosing regimen or stop taking venlafaxine extended-release without discussing with your provider first. A gradual reduction in dosage rather than abruptly stopping is recommended whenever possible.

If your symptoms are not improving or you have any questions about changing or stopping medication, reach out to your Ro-affiliated provider for guidance.

What should I tell my Ro-affiliated provider before using venlafaxine extended-release?

  • Venlafaxine extended-release has many drug interactions. It’s important to tell your Ro-affiliated provider all of the medications you are currently taking, including prescription, over-the-counter medications, vitamins, and herbal and dietary supplements. Some medications to watch out for include:
    • Monoamine oxidase inhibitors (MAOIs)
    • Tricyclic Antidepressants (TCAs)
    • NSAIDs, such as ibuprofen or naproxen
    • Aspirin
    • Blood thinners, such as warfarin (Coumadin)
    • Migraine medications called triptans, such as sumatriptan (Imitrex)
    • Other antidepressants, including SSRIs or SNRIs such as sertraline (Zoloft)
    • St. John’s Wort
  • It’s important to share your entire medical history with your provider. In particular, tell your provider if you have a past history of:
    • Suicidal thoughts or attempted suicide
    • Bipolar Disorder
    • Family history of Bipolar Disorder or family history of suicide
    • Seizures
    • High blood pressure
    • High cholesterol
    • Heart problems
  • Tell your provider if you are pregnant, planning to become pregnant, or breastfeeding. SSRI or SNRI use, particularly later in pregnancy, may increase risk of complications in the newborn. You should discuss with your provider if venlafaxine extended-release should be used during pregnancy. Some venlafaxine extended-release may pass into breast milk. Talk to your provider about the best way to feed your baby while taking venlafaxine extended-release.

Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death.

What are the most serious side effects that I or a caregiver should monitor for when taking venlafaxine extended-release?

If you are experiencing a medical emergency, call 911 or seek immediate medical attention.

These serious side effects are rare, but can occur with venlafaxine extended-release. You or a caregiver should carefully monitor for these side effects, especially in the beginning of treatment and with dose changes.

  • Serotonin Syndrome: Serotonin syndrome is an uncommon, potentially life-threatening condition that occurs when taking too much of an SSRI or SNRI at once or when venlafaxine extended-release is taken along with other drugs that increase the activity of serotonin in the central nervous system. These medications may include MAOIs, triptans (a class of drugs used to treat migraines), tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John’s Wort. Monitor for symptoms of elevated body temperature, flushing, sweating, abdominal pain, diarrhea, agitation, and a racing heartbeat.
  • Increases in blood pressure: Your blood pressure should be well controlled prior to starting treatment. Your provider will monitor your blood pressure regularly. Consider monitoring your blood pressure at home.
  • Abnormal Bleeding: Tell your provider if you experience any increased or unusual bruising, bleeding, or nose bleed. Venlafaxine extended-release may increase the risk of bleeding when taken with NSAIDs (such as ibuprofen or naproxen), aspirin, warfarin, and other anticoagulants.
  • Eye Effects: In rare instances, antidepressants may cause a certain type of eye problem called acute angle-closure glaucoma. Monitor for eye pain, changes in your vision, or swelling or redness in or around the eye.
  • Activation of Mania/Hypomania: Especially at the beginning of treatment, monitor for changes in behavior such as an unusually elevated mood, feeling unusually irritable, a big increase in energy, being more talkative than usual, racing thoughts, or engaging in risky behaviors. These changes in behavior could be signs of undiagnosed Bipolar Disorder.
  • Low Sodium in the Blood (Hyponatremia): Elderly people may be at greater risk for this condition. Symptoms may include headache, weakness or feeling unsteady, confusion, problems concentrating or thinking, and memory problems.
  • Cognitive and Motor Impairment: Venlafaxine extended-release may impair judgment, thinking, and motor skills. Avoid driving a car or operating hazardous machinery until you know that your performance is not affected. Do not drink alcohol while you take venlafaxine extended-release.
  • Lung Disease and Inflammation (Pneumonitis): Venlafaxine extended-release may cause rare lung problems. Monitor for symptoms such as worsening shortness of breath, cough, or chest discomfort.

What are the most common side effects of venlafaxine extended-release?

  • Nausea, vomiting
  • Change in sleep habits including increased sleepiness or insomnia
  • Dry mouth
  • Sweating
  • Sexual problems including abnormal ejaculation, erectile dysfunction, or decreased sex drive
  • Decreased appetite, weight loss
  • Constipation
  • Abnormal dreams
  • Headache
  • Dizziness
  • Nervousness
  • Tremor

You are encouraged to report negative side effects of prescription products to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

This information is not comprehensive. Please see the full Prescribing Information for complete safety information. 

Important Safety Information for Duloxetine

Warning: Suicidal Thoughts and Behaviors

Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. In short-term studies, antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults under age 24. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk in patients 65 and older.

Patients of all ages being treated with antidepressants should be observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially early during antidepressant treatment and when the dose is adjusted up or down. Families and caregivers of patients should look for the emergence of symptoms on a day-to-day basis, since changes may be abrupt.

Call your healthcare provider right away or 911 in an an emergency if you observe any of the following behaviors, especially if they are new, worse, unusual, or worry you: emergence of suicidality, worsening of depression, emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, inability to sit still or restlessness, racing thoughts that you can’t fully control, or becoming easily distracted.

What are the FDA-approved uses of duloxetine?

Duloxetine is a serotonin and norepinephrine reuptake inhibitor (SSRI) used for:

  • Acute and Maintenance Treatment of Major Depressive Disorder (MDD)
  • Generalized Anxiety Disorder (GAD)

Who should not use duloxetine?

Do not use duloxetine if:

  • You are taking a class of medications called monoamine oxidase inhibitors (MAOIs). Examples of MAOIs include isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Emsam), and tranylcypromine (Parnate), linezolid, or intravenous methylene blue. Taking an MAOI at the same time as duloxetine may increase the risk of serotonin syndrome.

How should I take duloxetine?

You can take duloxetine with or without food.

You should take duloxetine exactly as prescribed, and continue to take duloxetine as prescribed even after your symptoms improve. You should not change your dosing regimen or stop taking duloxetine without discussing with your provider first. A gradual reduction in dosage rather than abruptly stopping is recommended whenever possible.

If your symptoms are not improving or you have any questions about changing or stopping medication, reach out to your Ro-affiliated provider for guidance.

What should I tell my Ro-affiliated provider before using duloxetine?

  • Duloxetine has many drug interactions. It’s important to tell your Ro-affiliated provider all of the medications you are currently taking, including prescription, over-the-counter medications, vitamins, and herbal and dietary supplements. Some medications to watch out for include:
    • Monoamine oxidase inhibitors (MAOIs)
    • NSAIDs, such as ibuprofen or naproxen
    • Aspirin
    • Blood thinners, such as warfarin (Coumadin)
    • Migraine medications called triptans, such as sumatriptan (Imitrex)
    • Other antidepressants, including SSRIs or SNRIs such as sertraline (Zoloft) or citalopram (Celexa)
    • St. John’s Wort
  • It’s important to share your entire medical history with your provider. In particular, tell your provider if you have a past history of:
    • Suicidal thoughts or attempted suicide
    • Bipolar Disorder
    • Family history of Bipolar Disorder or family history of suicide
    • Liver problems
    • Heavy alcohol use
    • Kidney problems
    • Seizures
    • Heart problems
    • Glaucoma or eye problems
    • Diabetes
  • Tell your provider if you are pregnant, planning to become pregnant, or breastfeeding. SSRI use, particularly later in pregnancy, may increase risk of complications in the newborn. Use of duloxetine during the month before delivery may lead to an increased risk for postpartum hemorrhage. You should discuss with your provider if duloxetine should be used during pregnancy. There have been reports of duloxetine passing into breast milk. Talk to your provider about the best way to feed your baby while taking duloxetine.
    • There is a pregnancy exposure registry that monitors the pregnancy outcomes in women exposed to duloxetine during pregnancy. To enroll, contact the Cymbalta (duloxetine) Pregnancy Registry at 1-866-814-6975 or https://lillypregnancyregistry.com/ 

Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death.

What are the most serious side effects that I or a caregiver should monitor for when taking duloxetine?

If you are experiencing a medical emergency, call 911 or seek immediate medical attention.

These serious side effects are rare, but can occur with duloxetine. You or a caregiver should carefully monitor for these side effects, especially in the beginning of treatment and with dose changes.

  • Liver Failure: Severe liver problems, sometimes fatal, have been reported with duloxetine. Talk to your provider if you develop itching, right upper belly pain, dark urine, or yellow skin/eyes, which may be signs of liver problems. Heavy alcohol consumption may be associated with severe liver injury.
  • Decrease in blood pressure when standing up, falls, and fainting: Monitor especially during the beginning of treatment and with any dose increases. Your provider may consider lowering your dosage.
  • Serotonin Syndrome: Serotonin syndrome is an uncommon, potentially life-threatening condition that occurs when taking too much of an SSRI or SNRI at once or when duloxetine is taken along with other drugs that increase the activity of serotonin in the central nervous system. These medications may include MAOIs, triptans (a class of drugs used to treat migraines), tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John’s Wort. Monitor for symptoms of elevated body temperature, flushing, sweating, abdominal pain, diarrhea, agitation, and a racing heartbeat.
  • Abnormal Bleeding: Tell your provider if you experience any increased or unusual bruising, bleeding, or nose bleed. Duloxetine may increase the risk of bleeding when taken with NSAIDs (such as ibuprofen or naproxen), aspirin, and warfarin. A post-marketing study showed a higher incidence of postpartum hemorrhage in mothers taking duloxetine.
  • Severe Skin Reactions: These skin reactions may need to be treated in a hospital and may be life-threatening. Call your provider right away or get emergency help if you have skin blisters, peeling rash, sores in your mouth, hives, or any other allergic reactions.
  • Activation of Mania/Hypomania: Especially at the beginning of treatment, monitor for changes in behavior such as an unusually elevated mood, feeling unusually irritable, a big increase in energy, being more talkative than usual, racing thoughts, or engaging in risky behaviors. These changes in behavior could be signs of undiagnosed Bipolar Disorder.
  • Eye Effects: In rare instances, antidepressants may cause a certain type of eye problem called acute angle-closure glaucoma. Monitor for eye pain, changes in your vision, or swelling or redness in or around the eye.
  • Low Sodium in the Blood (Hyponatremia): Elderly people may be at greater risk for this condition. Symptoms may include headache, weakness or feeling unsteady, confusion, problems concentrating or thinking, and memory problems.

What are the most common side effects of duloxetine?

  • Nausea, vomiting
  • Dry mouth
  • Change in sleep habits including increased sleepiness or insomnia
  • Constipation, diarrhea
  • Decreased appetite, weight loss
  • Increased sweating
  • Fast heartbeat
  • Agitation
  • Headache
  • Sexual problems including abnormal ejaculation, erectile dysfunction, or decreased sex drive

You are encouraged to report negative side effects of prescription products to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

This information is not comprehensive. Please see the full Prescribing Information for complete safety information.