Accutane: Side Effects, Safety Risks and What to Watch For

Accutane was the brand name for isotretinoin, a prescription medicine for those with any type of acne, including cystic, nodular or severe acne that other treatments couldn’t manage. Roche manufactured Accutane but discontinued it in 2009.

The medication is still available in the U.S. under brand names like Absorica, Amnesteem, Claravis, Myorisan and Zenatane, and as a generic drug. Though the original brand name is no longer available, some people still refer to any isotretinoin option as Accutane.

Isotretinoin is a retinoid and a natural component of vitamin A. The only treatment for all four acne causes, it works by shrinking the sebaceous glands, preventing clogged pores, lowering the amount of acne-causing bacteria on your skin and reducing inflammation. Most people take Accutane for four to six months, though some continue to use it for as long as a year.

While isotretinoin is the most effective medication for severe, treatment-resistant acne, it also comes with several side effects. Some severe gastrointestinal side effects led people to file Accutane lawsuits.

The most common Accutane side effects include dry skin, chapped lips or nose irritation. These don’t usually require medical attention.

The most common side effect is chapped lips, and about 90% of people experience dryness around the lips and mouth.

Dermatologists recommend using lip and skin moisturizers to help with dryness. Nasal gels can help prevent nosebleeds, and eye drops can help with eye irritation.

If any of these side effects become bothersome or aren’t manageable, speak to your medical provider.

While side effects are usually mild, Accutane may rarely cause more severe side effects such as depression, birth defects and inflammatory bowel disease.

Because of the seriousness of some side effects, doctors can only prescribe Accutane for 30 days at a time. You need to check in with your dermatologist before you can get a refill.

These are not all of the serious potential side effects of Accutane use.

Make sure to discuss the risks and benefits of taking Accutane with your medical provider. If you experience mood changes, digestive problems or other concerning symptoms, talk to your doctor right away.

Yes, Accutane can affect mental health. Accutane’s prescribing information warns that its use may cause psychosis, depression, aggression and suicidal thoughts or actions.

The FDA required manufacturers to add a warning about this fact to the label in 2005 and said it would continue to monitor reports of suicide or suicide attempts linked to isotretinoin.

In one study published in JAMA Dermatology, researchers found 17,829 reports of adverse psychiatric events associated with isotretinoin from 1997 through 2017. Depressive disorders made up 43% of all the reports, emotional instability made up 16.6% and anxiety disorders made up 13.5%. They also uncovered nearly 2,300 reports of suicidal ideation and almost 1,000 suicide attempts or completions.

Researchers think isotretinoin may contribute to psychiatric disorders by altering the levels of serotonin, dopamine and norepinephrine — neurotransmitters that affect mood. However, researchers haven’t definitively found the cause.

Accutane may cause birth defects because it is a derivative of vitamin A. Too much vitamin A exposure in utero can affect fetal development.

Though exposure is more likely if the pregnant person is on Accutane, semen may also carry small amounts of isotretinoin. This could result in fetal exposure as well, so it’s important to tell your doctor if you or your partner gets pregnant (or hopes to do so) while you’re on Accutane so they can advise you both.

Exposing a baby to isotretinoin even in small amounts during the first trimester could lead to babies being born with birth defects. Increased instances of stillbirths, miscarriages and fetal disintegration have also been associated with Accutane use.

These are not all the birth defects associated with Accutane use.

In order to reduce the chances of babies being born with birth defects, Accutane can only be prescribed by medical providers who enroll in and comply with the iPLEDGE program.

iPLEDGE providers need to make sure patients on Accutane are not pregnant when they start treatment. They must also run a pregnancy test through a CLIA-certified lab each month during treatment and a month after treatment is completed, and report any Accutane patient pregnancies during this window.

Your prescriber must also enroll you in the iPLEDGE REMS, regardless of whether you can get pregnant. This is to help monitor isotretinoin distribution.

After you get your iPLEDGE REMS log-in credentials, you need to change your password and answer comprehension questions (if required). The iPEDS REMS will let you know if you qualify to receive the medication and let you know the date by which you must fill the prescription. You may need to continue answering comprehension questions each month.

During and for one month following treatment, people who can get pregnant need to use at least two effective forms of birth control and take pregnancy tests at least once a month. Not all types of birth control are iPledge-approved; talk to your doctor about options and consult the downloadable Patient Guide on the iPledge website.

If someone becomes pregnant while taking isotretinoin, it’s essential to contact the doctor immediately. One study found that any level of exposure to Accutane can cause malformation or other issues. If a patient continues the pregnancy, careful monitoring is necessary.

Accutane has not been recalled or banned for safety reasons. Roche decided to discontinue it in 2009 because the brand name couldn’t compete with generics.

The company also faced high costs of defending itself from personal injury lawsuits claiming Accutane caused irritable bowel diseases such as Crohn’s and ulcerative colitis.

Generic isotretinoin is still available in the U.S. While it has not been banned, its use is heavily restricted because of the risk of birth defects.

Mild side effects like chapped lips often don’t require medical treatment, though you can talk to your provider about any concerns you have. If you experience mood changes, develop severe gastrointestinal symptoms like rectal bleeding, have changes in your hearing, become pregnant while taking Accutane or notice other worrying side effects, stop treatment and seek medical care right away.

Make sure to keep all your medical records, prescription receipts or packaging just in case you need to provide them to any of your treating physicians. Your medical provider will suggest the right treatment based on the symptoms you report.

You can also report adverse effects to the FDA through MedWatch.

People filed Accutane lawsuits for side effects such as IBS and psychiatric problems. The primary claim in these lawsuits was that Roche and generic drug makers failed to warn about these risks.

The bulk of the lawsuits claimed Accutane caused people to develop Crohn’s disease and ulcerative colitis, two types of IBD. At one point, there were close to 8,000 lawsuits for Crohn’s disease pending in New Jersey.

Plaintiffs initially won millions in jury verdicts. However, several verdicts were reversed on appeal.