Accutane Side Effects

As of March 31, 2024, the Food and Drug Administration (FDA) Adverse Events Reporting System recorded nearly 34,000 adverse reactions to Accutane (isotretinoin). Current FAERS information indicates that around 85% of all reported adverse reactions are serious. Death-related reports make up roughly 1.8% of all reported cases.

Disclaimer: Because of potential under-reporting as well as limitations caused by potential inaccurate, incomplete, unverified and/or untimely information FAERS data alone cannot represent all safety information on Accutane. Consult a health care professional before stopping or changing medication.

Depression, inflammatory bowel disease and ulcerative colitis are the three most reported adverse events of Accutane, making up just over 40% of all isotretinoin side effects, according to the FAERS Database.

Updated Boxed Warnings for Accutane

As of July 2024, isotretinoin has one boxed warning that patients who are or might become pregnant must not use the drug because of the possibility of major birth defects. A boxed warning is the highest safety-related warning that the FDA can assign a medication; it indicates an increased risk of serious or life-threatening side effects.

There is an extremely high risk of a fetus developing life-threatening birth defects at any stage of pregnancy if the parent takes any amount of isotretinoin, even just one dose.

According to the drug label, documented birth defects following isotretinoin exposure include abnormalities of the facial features, central nervous system, internal organs and glands. There have also been cases of IQ scores being less than 85. Reports also indicate an increased risk of spontaneous abortion (miscarriage) and premature births.

In some cases, birth defects resulting from isotretinoin use caused death. According to the black box warning, those who become pregnant while taking isotretinoin must discontinue its us immediately. Additionally, the provider should advise their patient to seek evaluation and counseling from an obstetrician-gynecologist with expertise in reproductive toxicity.

iPLEDGE Requirement for Accutane

Due to the increased risk of fetal defects with the use of Accutane, a rigorous program called iPLEDGE began in 2006 to reduce fetal exposure to isotretinoin. All patients who can become pregnant are required to sign an iPLEDGE agreement and take a monthly pregnancy test while taking Accutane.

Skin irritation, dryness and sun sensitivity are common Accutane side effects. These tend to be mild and usually resolve on their own within a few weeks.

Some common side effects, such as intestinal symptoms, joint pain and vision complications can cause long-term damage even after stopping Accutane. While it is good practice to notify your health care provider if you experience any adverse reactions, it is especially important to keep your provider informed of any symptoms that may be permanent.

Managing Common Accutane Side Effects

Moisturizing can help alleviate dryness, a common side effect of Accutane. Try applying moisture-enhancing products such as lotions, lip balms, eye drops and Vaseline as needed in areas where you experience dryness.

A diet that promotes digestive health may help alleviate gastrointestinal issues caused by Accutane. Leafy greens and probiotics are generally good for gut health, but your doctor can help you determine the best diet for your needs.

Some over-the-counter pain relievers, such as ibuprofen, may help with pain. However, not all pain relievers are appropriate. For example, it is important to limit your intake of liver-stressing substances such as acetaminophen (tylenol) and alcohol. If you consume these substances while on Accutane, you may increase your chances of liver damage.

Accutane may cause serious neurological, psychological and gastrointestinal side effects. Additional serious side effects may include decreased red or white blood cells, blood sugar problems, allergic reactions such as hives or trouble breathing, skin problems such as peeling, blistering, rash with fever and conjunctivitis (pink eye).

Report any serious side effects you experience to your doctor. You may also consider reporting to the FDA’s MedWatch Adverse Event Reporting program. Some patients who received Accutane treatment filed lawsuits against Roche, the drug’s manufacturer, in 2014. However, as of July 2024, Drugwatch is not aware of lawyers accepting these cases at this time.

Accutane and Mental Health

Depression, psychosis and suicide are possible serious side effects of Accutane.

As soon as any signs of depression or psychosis begin, contact your health care provider to determine what your next steps should be. They will likely discontinue your treatment with Accutane. You may need additional treatment beyond stopping the medication.

Serious Brain Problems with Accutane

Accutane can cause increased pressure in the brain (pseudotumor cerebri), which can lead to permanent loss of eyesight and, in rare cases, death. Severe headache, seizures, stroke, nausea and vomiting are all potential symptoms of increased brain pressure. Inform your doctor as soon as possible about these symptoms.

Accutane-Related Organ Problems

Symptoms such as severe stomach or chest pain, diarrhea, bloody stools, dark urine, difficulty swallowing and yellowing of the skin or eyes could indicate organ damage. These symptoms could indicate damage to the liver, pancreas, bowel and esophagus.

You should immediately inform your doctor of any of these symptoms. The damage might be permanent even after stopping Accutane, but swift treatment can increase your chances of recovery.

Editor Lindsay Donaldson contributed to this article.