Accutane Side Effects

The most common side effects from Accutane are chapped lips (90% of users), dry skin and itching (80%) and dry nasal pages or mild nosebleeds (80%). Only 15% of users have joint and muscle pain. These issues start between two to four weeks after starting the medication.

The prescribed dosage may determine the severity of any effects. People who take lower doses may not experience any issues, while those on higher doses may have more effects — and more serious ones.

When you start taking isotretinoin, your acne may worsen temporarily before it gets better.

Most side effects from Accutane go away in a few days or weeks after you stop taking the drug. In some people, the effects lessen in the first few months of treatment, while in others they last the duration of treatment. If your side effects last more than a few weeks after you stop taking isotretinoin, talk to your doctor.

The medication also has some severe side effects. Left untreated, they can cause permanent problems.

Serious side effects from Accutane are far less common. Only 1 in 500 people report being affected severely after taking the medication.

Though rare, increased pressure in the brain, gastrointestinal disorders and other potentially life-threatening maladies have been reported. Accutane can cause permanent damage even if someone stops taking it.

Prolonged buildup of pressure on the brain can lead to long-term vision and hearing problems. In rare cases, permanent loss of eyesight and even death have been reported.

Other long-term issues from taking Accutane include erectile dysfunction, loss of libido, mental health problems, problems with bones, muscles and joints, blood sugar irregularity and diabetes. Babies whose mothers took Accutane while pregnant women have an increased risk of birth defects.

Serious side effects have led people to file Accutane lawsuits against the drug’s manufacturer.

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

Birth defects resulting from isotretinoin can range from miscarriages to physical defects at birth. Statistically, 3% – 5% of pregnancies result in a birth defect. Accutane causes birth defects in at least 35% of infants who were exposed to the drug during pregnancy — even if the medication was only taken briefly.

Hearing and vision issues have occured, as have issues with babies being born with small ears. Other less common, but life-threatening, defects include heart deformities and fluid around the brain. Some infants have been born with a small or abnormally formed head, small jaw, cleft palate, while some will be born with a small or missing thymus gland.

Isotretinoin in Pregnancy

About 50% of people who take Accutane are females of child-bearing age. This makes birth defects associated with Accutane use a significant concern.

From 1982 to 2006, more than 2,000 pregnant women had pregnancies that resulted in many spontaneous or elective abortions. As a result, Roche started a pregnancy prevention program (iPLEDGE).

The iPLEDGE program is required for isotretinoin users. The 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 Accutane.

Some studies linked Accutane to two gastrointestinal disorders: Crohn’s disease and ulcerative colitis (UC). A 2020 study published in the Journal of the American Academy of Dermatology showed a higher incidence of irritable bowel diseases (IBD), the umbrella term for conditions like Crohn’s disease ulcerative colitis, among people who took isotretinoin. The risk, however, was low and there was not a statistically significant difference in risk for those who did not take isotretinoin.

The U.S. Food and Drug Administration (FDA) has not connected Accutane to Crohn’s disease. Instead, it warns against digestive issues that may develop while taking the medication.

Accutane And Inflammatory Bowel Diseases (IBD)

A University of North Carolina study found that people taking isotretinoin had a 1.68 times higher risk of developing IBD than people who did not use the medication. That rate rose to 2.67 for people who filled four or more prescriptions of Accutane.

A more recent comprehensive study published in the European Journal of Gastroenterology & Hepatology found the rate of IBD was the same among people who took isotretinoin as it was for those who did not take it. Researchers did not find an increased risk for developing IBD or Crohn’s disease after taking Accutane.

Isotretinoin’s most recent drug label does include a warning about the possibility of developing IBD.

Multiple medical studies that investigated Accutane for a link to mental health disorders, including depression, psychosis and suicidal thoughts, provide mixed results. Research remains ongoing about whether the medication increases patients’ risk of depression.

The FDA from 1982 to mid-2000 records 37 reports of suicide, 110 hospitalizations for depression or suicidal behavior and 284 cases of depression that required no hospitalization among people taking Accutane. In 1998, drugmaker Roche added a warning to Accutane’s label, stating that isotretinoin could potentially cause mental health disorders.

A 2017 study published in the Journal of the American Academy of Dermatology found little to no evidence of any increased risk of depression linked to Accutane. And a 2019 study published in the British Medical Journal showed that people with acne who took Accutane reported improved depression symptoms.