Accutane® (isotretinoin) Side Effects

Stueve Siegel Hanson is investigating Accutane. Patients have experienced serious adverse reactions following Accutane acne treatment and have filed Accutane lawsuits seeking compensation for medical expenses, pain and suffering caused by these side effects.

Accutane is a drug that was developed by Hoffmann-La Roche Inc. and approved by the U.S. Food & Drug Administration (FDA) in 1982 as a treatment for severe acne. The active ingredient in Accutane is isotretionoin, which is derived from Vitamin A. The treatment works by drying up sebum, an oily substance produced by skin glands. Accutane was taken orally in pill form twice a day for approximately 15 to 20 days. Though Roche Pharmaceuticals took Accutane off the market on June 29, 2009 the generic form may still be available under different brand names such as Isotretinoin, Sotret,  Claravix and Amnesteem.

A Congressional investigation found that while Accutane was only approved for severe acne, many dermatologists were prescribing it to patients that were experiencing only mild acne. In fact, the findings showed that 90 percent of women, and half of the teens that were prescribed the drug only had mild acne. That is one of the causes of the controversy about Accutane.

Accutane has long been associated with a number of very serious side effects. A current Black Box warning, required by the FDA since 2003 on the defective drug cautions consumers about its potential to harm unborn children. A Black Box warning is the strongest warning that the FDA requires.  The warning indicates that studies have found that the drug carries a significant risk of serious or even life-threatening adverse effects. The FDA required Hoffman-La Roche to place a black box warning on the labeling and in literature describing it to help patients avoid serious adverse events.  In addition, the FDA now has stricter rules regarding the dispensation of Accutane. 

There are many side effects reported by people who have taken Accutane. They include:

  • pain and swelling of lips,
  • alopecia,
  • vision problems,
  • conjunctivitis,
  • dry mouth,
  • peeling of the skin,
  • severe itching,
  • and even nose bleeds.

Other more severe side effects may include depression, violent behavior, suicide attempts, major birth defects, stroke, or seizures.

Accutane has also been linked to Inflammatory Bowel Disease (IBD). Inflammatory bowel disease (IBD) actually refers to two chronic diseases, ulcerative colitis and Crohn's disease.  These diseases both cause inflammation of the patient's intestines, although the area affected differs between the two conditions. These can be serious diseases if not detected early. Early detection can mean that the diseases can be managed with medications. Otherwise, the disease can result in surgery and long-term ongoing treatment. Some warning symptoms include:

  • severe abdominal pain
  • pain in the joints
  • sudden weight loss
  • loss of appetite
  • skin conditions
  • rectal bleeding & bloody diarrhea
  • fever

Ulcerative colitis often causes ulcers and inflammation in the large intestine. In most cases, it begins in the rectum and works its way up the colon.

Crohn's disease usually affects the small intestine, but can occur in all portions of the digestive tract, including the mouth, stomach, and colon. Ulcers as one of the Crohn disease symptoms may go away without treatment, but they often recur in the same or other spots over and over again.

Problems often develop among individuals with no prior history of intestinal problems and the adverse effects of taking Accutane® can take up to several years to show up despite the medication remaining in the blood for only four to seven days. They can also range in severity.

If you experience any severe side effects when taking isotretinoin, whether Accutane or a generic form of the drug, you should seek medical advice immediately.

Many critics of the drug Accutane believe that the manufacturer did not do enough to adequately warn patients about these potentially fatal side effects, and did not complete adequate testing.  Because of this, there have been a number of personal injury lawsuits filed against the manufacturer. 

If you have experienced serious side effects outlined above caused by Accutane and wish to receive additional information about your legal options, please call 1-888-756-6494 or fill out the form on this page.


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