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Accutane Side Effects

Accutane (isotretinoin) is prescribed to treat severe, difficult to control acne. Common side effects can include dry skin, chapped lips, vision issues, and joint pain. The more serious, severe side effects of isotretinoin include birth defects, mental health problems, and stomach issues.

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

Women of childbearing potential must enroll in a special pregnancy prevention program (iPLEDGE) before being prescribed isotretinoin because of the drug’s risks. Men and women without reproductive potential who use isotretinoin must also participate in the iPLEDGE program.

Side effects of the medication have led to more than 7,000 lawsuits against the manufacturer of Accutane.

Common side effects of Accutane (isotretinoin) include:
  • Dry skin, rash
  • Itching
  • Chapped, dry lips
  • Dry nose, nosebleeds
  • Dry eyes
  • Vision problems
  • Back pain, joint pain
Serious side effects of Accutane (isotretinoin) include:
  • Birth defects, premature birth
  • Miscarriage, infant death
  • Depression, suicidal thoughts or behavior
  • Inflammatory bowel disease
  • Crohn’s Disease
  • Ulcerative Colitis

Birth Defects

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

Since 1985, isotretinoin’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 isotretinoin.

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

Birth defects from isotretinoin can also affect the central nervous system, immune system (thymus gland), certain hormones (parathyroid), and heart.

Isotretinoin 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 a pregnancy prevention program (iPLEDGE).

Fact
Women of child-bearing potential taking isotretninoin must undergo monthly blood tests to check for pregnancy.

The iPLEDGE program is required for isotretinoin users. This program requires women to take monthly pregnancy tests at a doctor’s office. Men and women without reproductive potential who use isotretinoin must also participate in the iPLEDGE program.The iPLEDGE program has decreased, but not completely stopped, birth defects from isotretinoin.

Results of one study showed an average of three pregnancies for every 1,000 patients taking isotretinoin.

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. Both conditions can be managed with medications.

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 UC than patients who don’t take the drug.

Conflicting Research

Studies published since 2013 refute a link between isotretinoin and IBD. Some authors have instead proposed 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 isotretinoin may be coincidental based on the person’s age. IBD usually begins around 19 years of age. This is around the same age that a patient might experience severe acne and start taking isotretinoin.

Still, isotretinoin’s most recent drug label includes a warning about the possibility of developing IBD.

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 isotretinoin users over an 18-year time period.

Isotretinoin 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 isotretinoin could cause mental health disorders.

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

Researchers still don’t understand how isotretinoin causes mental health events. Definitive proof of an association between depression and isotretinoin 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 isotretinoin 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 up to Sept. 30, 2016.

Results showed no apparent association between isotretinoin and an increased risk for depression. This study, and others, have shown that treating acne could actually reduce symptoms of depression.

Accutane pills
Accutane Side Effect Facts
  1. Inflammatory Bowel Disease Accutane users may be at more than twice the risk for developing serious bowel diseases as non-users.
  2. Birth Defects Isotretinoin’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 mental health history.

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

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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
Emily Miller
Emily Miller Managing Editor
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16 Cited Research Articles

Drugwatch.com writers follow rigorous sourcing guidelines and cite only trustworthy sources of information, including peer-reviewed journals, court records, academic organizations, highly regarded nonprofit organizations, government reports and interviews with qualified experts. Review our editorial policy to learn more about our process for producing accurate, current and balanced content.

  1. 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
  2. Medline Plus. (2019, December 2). Crohn disease. U.S. National Library of Medicine. Retrieved from https://medlineplus.gov/ency/article/000249.htm
  3. Medline Plus. (2019, December 2). Ulcerative colitis. U.S. National Library of Medicine. Retrieved from https://medlineplus.gov/ency/article/000250.htm
  4. 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
  5. U.S. Food and Drug Administration. (2019, October). Sun Pharmaceutical Industries: Absorica and Absorica LD (isotretinoin). Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021951s013lbl.pdf
  6. Roan, S. (2009, November 7). Acne drug risks may create a void. Los Angeles Times. Retrieved from https://www.latimes.com/archives/la-xpm-2009-nov-07-sci-accutane7-story.html
  7. 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
  8. 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
  9. 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
  10. U. S. National Library of Medicine. (2019, November 26). Crohn’s disease. Retrieved from https://medlineplus.gov/crohnsdisease.html
  11. Crohn's and Colitis Foundation of America. (n.d.) What is Crohn's Disease? Retrieved from https://www.crohnscolitisfoundation.org/what-is-crohns-disease
  12. Crohn's and Colitis Foundation of America. (n.d.). What is Ulcerative Colitis? Retrieved from https://www.crohnscolitisfoundation.org/what-is-ulcerative-colitis
  13. U. S. National Library of Medicine. (2019, November 26). Ulcerative Colitis. Retrieved from https://medlineplus.gov/ulcerativecolitis.html
  14. Li, C. et al. (2019, Jan). Use of isotretinoin and risk of depression in patients with acne: a systematic review and meta-analysis. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6347928/
  15. Lee, S. et al. (2016, Feb) Does exposure to isotretinoin increase the risk for the development of inflammatory bowel disease? A meta-analysis. Retrieved from https://journals.lww.com/eurojgh/Abstract/2016/02000/Does_exposure_to_isotretinoin_increase_the_risk.14.aspx
  16. Tkachenko, E. et al. (2019, Jul 17) US Food and Drug Administration reports of pregnancy and pregnancy-related adverse events associated with isotretinoin. Retrieved from https://jamanetwork.com/journals/jamadermatology/fullarticle/2738261
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