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) that is FDA-approved for the treatment of Major Depressive Disorder (MDD).
Your provider may recommend using sertraline as an off-label treatment of premature ejaculation (PE).
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
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
Family history of Bipolar Disorder or family history of suicide
Irregular heartbeat or heart problems
High blood pressure
Glaucoma or eye problems
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: Sertraline 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
Tremor or shaking
Change in sleep habits including increased sleepiness or insomnia
Sexual problems including abnormal ejaculation, erectile dysfunction, or decreased sex drive
Feeling tired or fatigued
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.