Accutane Side Effects

Accutane’s manufacturer, Roche, stopped selling the powerful acne medication in the United States, but you can still find generic versions. Isotretinoin can cause severe birth defects, mental health problems and stomach issues. The common, less serious side effects include chapped lips, dry skin and nosebleeds.

Accutane pills
Accutane Side Effect Facts
  1. Inflammatory Bowel Disease Accutane users may be at twice the risk for developing serious bowel diseases as non-users.
  2. Birth Defects Accutane's label features a black box warning about “extremely high risk” of “severe birth defects.”
  3. Depression and Suicide Accutane use is linked to suicidal thoughts and behaviors in patients with no prior psychiatric history.

Birth defects are among the most serious side effects of Accutane (isotretinoin). Taking isotretinoin during pregnancy may also result in miscarriage, premature birth and infant death.

Women of childbearing age had to enroll in a special pregnancy prevention program before being prescribed Accutane because of the drug’s risks. Side effects of the medication led to more than 7,000 Accutane lawsuits.

Accutane (Isotretinoin) Side Effects
  • Birth defects
  • Miscarriage
  • Premature birth
  • Infant death
  • Depression
  • Psychosis
  • Suicidal thoughts or behavior
  • Aggressive or violent behavior
  • Increased brain pressure (pseudotumor cerebri)
  • Serious skin reactions
  • Acute pancreatitis
  • Lipid abnormalities
  • Hearing impairment
  • Liver toxicity
  • Inflammatory bowel disease
  • Skeletal abnormalities
  • Vision impairment

Roche stopped making Accutane in 2009. But Americans could still buy generic versions as of 2019. Roche’s current version of isotretinoin is branded as Roaccutane and is sold outside the United States.

Birth Defects

Birth defects from Accutane can range from miscarriages to babies born with slits where ears should be.

Since 1985, Accutane’s label has contained a black box warning detailing its “extremely high risk” of “severe birth defects.” The label warns female patients who are or may become pregnant to avoid taking Accutane.

The boxed warning also lists possible birth defects that can happen with Accutane. These birth defects include anything from ear, eye and other face-related abnormalities to abnormal skull development.

Birth defects from Accutane can also affect the central nervous system, thymus gland, parathyroid hormone and heart.

Accutane and Pregnancy

About half of Accutane users are women of childbearing age. This makes birth defects associated with Accutane-use a significant concern.


From 1982 to 2006, more than 2,000 isotretinoin-users became pregnant. These pregnancies resulted in many spontaneous or elective abortions.

As a result, Roche initiated pregnancy prevention programs.

Fact
Women of child-bearing age taking Accutane had to undergo monthly blood tests to check for pregnancy.

The iPledge program became the program of choice for Accutane users. This program required women to take monthly pregnancy tests at a doctor’s office. Patient also had to register by computer.

The programs did not completely stop incidents of birth defects from Accutane.

Results of one study on the effectiveness of the programs showed an average of three fetal exposures for every 1,000 patients.

Gastrointestinal Disorders: Crohn’s Disease and Ulcerative Colitis

Studies link Accutane to two types of gastrointestinal disorders: Crohn’s disease and ulcerative colitis (UC).

Both Crohn’s and UC are inflammatory bowel diseases (IBD), but the conditions affect patients in different ways.

Crohn’s can occur anywhere in the digestive tract but most often affects the lower end of the small intestine. UC more commonly affects the lining of the large intestine (colon) and the rectum.

Symptoms common with both conditions include abdominal pain and cramping, weight loss, diarrhea, fever, fatigue, mouth sores, joint pain and swelling, and blood in the stool.

Crohn’s cannot be cured. UC can only be cured with surgery to remove the large intestine.

Accutane and Inflammatory Bowel Diseases (IBD)

A study released in 2009 found Accutane users had almost double the chance of developing a serious bowel disorder than those who never took Accutane.

Researchers at the University of North Carolina Chapel Hill presented evidence confirming that a link exists between isotretinoin and IBD.

They compared 8,189 cases of IBD with 21, 832 healthy individuals. The results of the study showed people taking isotretinoin had a 1.68 times higher risk of developing IBD than people who did not use the drug.

This number increased to 2.67 times the risk among patients who filled four or more prescriptions of Accutane.

Patients who use isotretinoin are 4.36 times more likely to develop ulcerative colitis than patients who don’t take the drug.

Conflicting Research

Studies published in 2013 refute a link between isotretinoin and IBD, according to the American Academy of Dermatology . The findings instead propose a link between severe acne and a predisposition to IBD. Both conditions involve inflammation.

The studies also conclude that the occurrence of IBD in patients taking Accutane may be coincidental based on the person’s age. IBD usually begins around age 19. This is around the same age that a patient might suffer from severe acne and start taking Accutane.

Still, Accutane’s most recent drug label included an IBD warning.

Depression and Suicide

Studies also linked Accutane to psychiatric disorders.

From 1982 to May 2000, the FDA received hundreds of reports linking isotretinoin use to depression.

These reports included 37 suicides, 110 hospitalizations for depression or suicidal behavior, and 284 cases of non-hospitalized depression.

Fact
Reports received by the FDA showed 37 suicides among Accutane users over an 18-year span.

Accutane and Depression

Roche responded to the reports of depression and suicide in 1998, by adding a warning to the medication’s label. The warning stated that Accutane could cause psychiatric disorders.


Before 2005, reports of depression and suicide linked to the use of Accutane accounted for the fourth-highest number of adverse reactions occurring in the U.S.


Researchers still don’t understand how Accutane causes psychiatric events. Definitive proof of an association between depression and Accutane is still lacking.

Ongoing Research

A 2017 study in the Journal of the American Academy of Dermatology concluded that there may not be an association between Accutane and depression at all.

The study was a meta-analysis, or evidence-based examination, of published literature. It included all literature regarding the relationship between isotretinoin and depression from its inception up to Sept. 30, 2016. It did not review randomized controlled trials.

Results showed no apparent association between isotretinoin and an increased risk for depression. The study showed treating acne could actually reduce symptoms of depression in patients.

Please seek the advice of a medical professional before making health care decisions.

Related Pages
Kristin Compton
Written By Kristin Compton Writer

Kristin Compton's background is in legal studies. She worked as a paralegal before joining Drugwatch as a writer and researcher. She was also a member of the National Association of Legal Assistants. A mother and longtime patient, she has firsthand experience of the harmful effects prescription drugs can have on women and their children. Some of her qualifications include:

  • Bachelor of Arts in Legal Studies | Pre-Law from University of West Florida
  • Past employment with The Health Law Firm and Kerrigan, Estess, Rankin, McLeod & Thompson LLC
  • Personal experience battling severe food allergies, asthma and high-risk pregnancies
Edited By

16 Cited Research Articles

  1. U.S. National Library of Medicine. (2018, February 1). Isotretinoin (By Mouth). https://www.ncbi.nlm.nih.gov/pubmedhealth/PMHT0010802/?report=details
  2. Huang, MD, Y. & Cheng, MD, Y. (2016, December 28). Isotretinoin treatment for acne and risk of depression: A systemic review and meta-analysis. Journal of the American Academy of Dermatology. Retrieved from http://www.jaad.org/article/S0190-9622(16)31289-0/fulltext
  3. Medline Plus. (2016, January 28). Crohn disease. U.S. National Library of Medicine. Retrieved from https://medlineplus.gov/ency/article/000249.htm
  4. Medline Plus. (2015, August 14). Ulcerative colitis. U.S. National Library of Medicine. Retrieved from https://medlineplus.gov/ency/article/000250.htm
  5. American Academy of Dermatology (AAD). (2014, March 21). Dermatologist evaluates latest isotretinoin developments for treatment of severe acne. Retrieved from https://www.aad.org/media/news-releases/dermatologist-evaluates-latest-isotretinoin-developments-for-treatment-of-severe-acne
  6. Shin, J. et al. (2011 December). The impact of the iPLEDGE program on isotretinoin fetal exposure in an integrated health care system. Journal of the American Academy of Dermatology. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/21565419
  7. U.S. Food and Drug Administration. (2010, May 21). Roche: Accutane. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18662s051lbl.pdf
  8. DailyMed. (2009 May). Accutane. Retrieved from https://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm?archiveid=10663
  9. Roan, S. (2009, November 7). New Study may deal final blow to acne drug Accutane. Los Angeles Times. Retrieved from https://www.latimes.com/archives/la-xpm-2009-nov-07-sci-accutane7-story.html
  10. Reddy, D. et al. (2006 July). Possible Association Between Isotretinoin and Inflammatory Bowel Disease. The American Journal of Gastroenterology, 101. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/16863562
  11. Abroms, L. et al. (2006, November 21). What is the best approach to reducing birth defects associated with isotretinoin? PLOS Medicine. Retrieved from https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.0030483
  12. Wysowski, D. et al. (2001, May 21). An analysis of reports of depression and suicide in patients treated with isotretinoin. Journal of the American Academy of Dermatology, 45:4. Retrieved from https://www.jaad.org/article/S0190-9622%2801%2928089-X/abstract
  13. U. S. National Library of Medicine. (n.d.). Crohn’s disease. Retrieved from https://medlineplus.gov/crohnsdisease.html
  14. Crohn's and Colitis Foundation of America. (n.d.) What is Crohn's Disease? Retrieved from https://www.crohnscolitisfoundation.org/what-are-crohns-and-colitis/what-is-crohns-disease/
  15. Crohn's and Colitis Foundation of America. (n.d.). What is Ulcerative Colitis? Retrieved from https://www.crohnscolitisfoundation.org/what-are-crohns-and-colitis/what-is-ulcerative-colitis/
  16. U. S. National Library of Medicine. (n.d.). Ulcerative Colitis. Retrieved from https://medlineplus.gov/ulcerativecolitis.html
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