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Health Guide / Acne

Accutane: what is it, how does it work, risks

chimene richa

Reviewed by Chimene Richa, MD, written by Michelle Konstantinovsky

Last updated: Oct 25, 2021
4 min read

table of contents

  1. What is Accutane?
  2. Accutane uses
  3. How does Accutane work?
  4. Side effects of Accutane
  5. Risks of Accutane
  6. Cost of Accutane
  7. Alternatives to Accutane for treating acne

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 struggling with pimples and can’t seem to find relief, you’re not alone. Acne affects millions of people in the United States. And while acne does mainly affect teens and young adults, plenty of older adults struggle with it as well. If you haven’t found success with any over-the-counter acne treatments, you may be curious about trying a prescription drug called Accutane. Here’s what you need to know. 

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What is Accutane?

Accutane is the brand name for the generic medication isotretinoin. It is in the retinoid class of medications (retinoids come from vitamin A) and was approved for severe treatment-resistance acne in 1982 by the U.S. Food and Drug Administration (FDA). Unlike other retinoids, which are topical (like tretinoin; see Important Safety Information), Accutane is an oral medication. It’s an effective therapy that helps with several of the main factors contributing to acne, like oil production, clogged pores, inflammation, and more (Pile, 2021). 

Accutane uses

Accutane is FDA-approved to treat a form of severe acne called recalcitrant nodular acne (which causes swollen, painful nodules on the skin) that has not been helped by other treatments, like antibiotics (Pile, 2021). 

Like many medications, Accutane also has several “off-label” uses—these are conditions that isotretinoin is not FDA-approved to treat. Still, sometimes providers may choose to prescribe it for these purposes if they see fit. Examples of off-label uses include (Pile, 2021; Landis, 2020):

  • Severe cystic acne
  • Acne that is causing scarring
  • Moderate acne
  • Cutaneous T-cell lymphomas
  • Neuroblastoma
  • Prevention of squamous cell carcinoma (a type of skin cancer) in high-risk patients 
  • Rosacea

How does Accutane work?

Accutane targets the underlying causes of acne. Acne forms due to your skin pores getting clogged with oil and dead skin cells, creating an inviting place for skin bacteria to grow and eventually leading to an inflammatory reaction and the characteristic “zit” or comedone (Leyden, 2017). 

Accutane helps treat acne by shrinking the oil glands (sebaceous glands), preventing clogged pores, decreasing the growth of skin bacteria, and anti-inflammatory effects. During treatment, Accutane also reduces oil (sebum) production. Most people continue treatment until their acne clears; however, some people have acne relapses and need to pursue a second course of Accutane (Fallah, 2021). 

It can take several weeks or more for Accutane to have its full effect, and it can make acne get worse at the beginning of treatment. Most people who take Accutane have a course of treatment that lasts for 15–20 weeks (Pile, 2021). 

Side effects of Accutane

Like all medications, Accutane carries the potential for side effects, so it’s important to talk with your healthcare provider and understand all the pros and cons before you take the medication. 

Some of the most common side effects of Accutane include (Pile, 2021): 

  • Chapped or dry lips (cheilitis)–occurs in approximately 90% of users
  • Dry skin
  • Itchy skin
  • Dry eyes  
  • Dry nose

Accutane also commonly raises your triglycerides, a type of fat or lipid in your blood. Your healthcare provider may want to monitor your labwork while on treatment (Pile, 2021).

Other side effects include sun sensitivity (more susceptible to sunburns), thinning hair, and decreased night vision, nausea, vomiting, headaches, joint pain, and mental health issues (may cause depression or suicidal thoughts) (DailyMed, 2020). 

Risks of Accutane

One serious complication of Accutane is its potential to cause severe pregnancy and birth problems. You should not take Accutane if you are pregnant or may become pregnant because there is a high risk that it can result in loss of the pregnancy or harm to the baby. 

This potential compilation is so significant that the FDA has issued a black box warning (its most serious warning). The FDA classifies this drug as Pregnancy Category X, meaning that it has been shown to cause harm to the developing fetus and is contraindicated in people who are pregnant or who may become pregnant.

If you’re thinking of taking Accutane for acne, you will need to first take a pregnancy test. The iPLEDGE program has been established to ensure that people who are pregnant don’t take Accutane. This program also strives to prevent people from becoming pregnant while taking the medication. You can only get a prescription for Accutane if you’re registered with iPLEDGE, have a prescription from a prescriber registered with iPLEDGE, and get the medication from a registered pharmacy iPLEDGE. You’ll also need to be on two forms of birth control while taking Accutane (Pile, 2021).

Cost of Accutane

Check with your insurance provider as many plans cover Accutane. Out-of-pocket, generic isotretinoin costs around $105. Brand name Accutane ranges from $88–$185 for a one-month supply (GoodRx, n.d.). 

Alternatives to Accutane for treating acne

While Accutane is a highly effective acne therapy, it’s usually considered a last resort treatment because of its potential to cause serious side effects. Most medical professionals will recommend that you try a variety of other acne treatments before trying Accutane. 

Accutane is a very strong oral retinoid, but many topical retinoids are also considered effective acne treatments. Examples of topical retinoids include adapalene (brand name Differin), tazarotene (brand name Tazorac), and tretinoin (brand name Retin-A) (Leyden, 2017). 

Benzoyl peroxide is a safe and effective treatment for acne, often used as first-line therapy. It works by attacking the skin bacteria (C. acnes) that can lead to acne. You can get benzoyl peroxide over-the-counter in washes, creams, and gels. It can improve your acne in as little as five days after starting it. Depending on the severity of your acne, you may want to combine it with other treatments (Zaenglein, 2018). 

Many topical antibiotics inhibit the growth of the bacteria C. acnes, and they also reduce inflammation. Some of the most popular topical antibiotics used to target acne are erythromycin and clindamycin. Providers sometimes use oral antibiotics like doxycycline to help with acne. Birth control pills and spironolactone have also been shown to effectively treat acne in some people (Zaenglein, 2018).

References

  1. DailyMed. (2020). Isotretinoin capsules. Retrieved on Oct 22, 2021 from https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1cf11710-f966-4529-8e08-02175f588bca
  2. Fallah, H., & Rademaker, M. (2021). Isotretinoin in the management of acne vulgaris: practical prescribing. International Journal of Dermatology, 60(4), 451–460. doi: 10.1111/ijd.15089. Retrieved from https://pubmed.ncbi.nlm.nih.gov/32860434/
  3. GoodRx.com. (n.d.). Accutane. Retrieved on Oct 22, 2021 from https://www.goodrx.com/accutane
  4. Landis M. N. (2020). Optimizing isotretinoin treatment of acne: update on current recommendations for monitoring, dosing, safety, adverse effects, compliance, and outcomes. American Journal of Clinical Dermatology, 21(3), 411–419. doi:10.1007/s40257-020-00508-0. Retrieved from https://pubmed.ncbi.nlm.nih.gov/32107726/
  5. Leyden, J., Stein-Gold, L., & Weiss, J. (2017). Why topical retinoids are mainstay of therapy for acne. Dermatology and therapy, 7(3), 293–304. doi: 10.1007/s13555-017-0185-2.  Retrieved from https://pubmed.ncbi.nlm.nih.gov/28585191/
  6. Pile, H. D. & Sadiq, N. M. (2021). Isotretinoin. [Updated 2021 May 10]. In: StatPearls [Internet]. Retrieved on Oct 22, 2021 from https://www.ncbi.nlm.nih.gov/books/NBK525949/
  7. Zaenglein, A. L. (2018). Acne vulgaris. The New England Journal of Medicine, 379(14), 1343–1352. doi: 10.1056/NEJMcp1702493. Retrieved from https://pubmed.ncbi.nlm.nih.gov/30281982/
chimene richa
Chimene Richa, MD

Dr. Chimene Richa is a board-certified Ophthalmologist and Senior Medical Writer/Reviewer at Ro.

Related articles

Important Safety Information for Tretinoin

What is the FDA-approved use of tretinoin?

Tretinoin is a topical medication that is used to treat acne and to reduce the appearance of fine lines and wrinkles and other signs of photoaging on the face. 

Who should not use tretinoin?

Do not use tretinoin if:

  • You are allergic to tretinoin.
  • You are pregnant or breastfeeding, you are trying to get pregnant, or you are unsure whether you are pregnant. When prescribed as an oral medication, tretinoin was associated with miscarriage and birth defects. While there is inconclusive evidence that tretinoin applied topically can cause miscarriage or birth defects, it is best to be cautious. Tretinoin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

How should I use tretinoin?

  • Unless directed otherwise by your provider, use the formula at nighttime before bed (UV light in sun degrades tretinoin). Wash your face using a gentle cleanser and pat dry. Let the skin dry completely before applying the medication. Apply a thin layer to the entire face. Avoid direct contact with your eyes and eyelids (under the eyes is ok). Wash your hands after applying.
  • Repeat 2–3 times a week as tolerated to begin with, then gradually increase to nightly use, or as directed by your provider.
  • Avoid exposure to the eyes, including eyelids, mouth, angles of the nose, and mucous membranes. If contact with the eyes occurs, rinse thoroughly with large amounts of water.
  • People using tretinoin should have an aggressive sun protection regimen including sunscreen (at least SPF 15 for daily wear and at least SPF 30 when spending time in direct sunlight), protective clothing, and sun avoidance whenever possible.

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

  • It’s important to tell your Ro Derm-affiliated provider all of the topical as well as oral medications you are currently using, including prescription, over-the-counter medications, vitamins, and herbal and dietary supplements, even if you think they are unrelated to the skin condition being treated. 
  • Tretinoin can make your skin more sensitive to the sun and can cause drying and peeling. 
    • Using tretinoin with other topical drying agents can increase the drying effects of tretinoin. Some topical medications to watch out for include salicylic acid, sulfur, and resorcinol
    • Some common oral medications that can make your skin more sensitive to the sun, including certain antibiotics and blood pressure medications, might exacerbate any sun sensitivity resulting from tretinoin use.
  • It’s important to share your entire medical history with your provider. In particular, tell your provider if you have a history of:
    • Eczema
    • Sensitivity to the sun or are easily sunburned
    • Conditions that may increase sensitivity to sunlight. These include systemic lupus erythematosus, cutaneous lupus erythematosus, albinism, and porphyria
  • Tell your provider if you are pregnant, planning to become pregnant, or 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 should monitor for when using tretinoin?

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

These serious side effects are rare, but may occur with tretinoin.

  • Skin discoloration
  • Inflammatory reaction with blistering

What are the most common side effects of tretinoin?

There may be some discomfort or peeling during the early days of treatment while your skin is adjusting to tretinoin. If side effects don’t subside within 2 to 4 weeks, or you are not seeing improvement, reach out to your Ro Derm-affiliated provider for guidance. 

  • Dryness
  • Itching
  • Burning
  • Redness
  • Peeling

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.