Isotretinoin

Is isotretinoin safe?

For people with severe acne who use it under the rules, mostly yes, but it is one of the most tightly controlled medicines in routine use. Isotretinoin, first sold in the US as Accutane in 1982 and in the UK as Roaccutane, clears acne that has not responded to antibiotics and often keeps it away. A typical course lasts 15 to 20 weeks.

Its central risk is pregnancy. Any amount, even for a short time, carries what the US label calls an "extremely high risk" of life-threatening birth defects of the face, ears, eyes, heart and brain. That is why it has a boxed warningBoxed warningThe strongest safety warning the US FDA puts on a medicine's label, printed inside a black border at the top.More in the glossary and is only available through the iPLEDGE programme. We score it 67, below montelukast (78) and finasteride (81), two other medicines watched for mood or sexual effects, because the pregnancy risk and side-effect list are heavier.

The pregnancy rules

In the US, everyone who takes isotretinoin is registered in iPLEDGE, and so are prescribers and pharmacies. For people who can get pregnant, the label requires:

• Two forms of contraception at the same time, at least one of them a primary method, from 1 month before starting until 1 month after the last dose (or a commitment to abstinence).
• A screening and a confirmatory negative pregnancy test before the first prescription.
• A test before every prescription, at the end of the course, and 1 month after stopping.
• Collecting each prescription within 7 days of the test; pharmacies supply at most 30 days and no refills.

The FDA approved changes in February 2026 that let prescribers allow home pregnancy tests during and after treatment, with the first tests still done in a clinic. The start date has been moved to 15 November 2026. Earlier changes removed the 19-day lockout for people who missed their window.

Everyone, regardless of sex, must not share capsules or donate blood during treatment and for 1 month after.

Mood, mental health and sexual side effects

The label warns of depression, psychosis, aggression and, rarely, suicidal thoughts, suicide attempts and suicide. Evidence on cause is mixed. A 2024 meta-analysis in JAMA Dermatology, pooling 25 studies with about 1.6 million people, found the one-year risk of suicide attempts, suicidal thoughts and self-harm was each below 0.5%. Users were not more likely to attempt suicide than non-users at two years. Depression was reported by 3.83% in the first year.

UK regulators took a cautious line anyway. In October 2023 the MHRA required mental health and sexual function checks before and during treatment and two prescribers for under-18s. In January 2026 it dropped the second-prescriber rule but kept the checks, added a new risk form and patient video, and started a national audit. Sexual dysfunction (erectile problems, low libido, vaginal dryness) is on the US label as something that may continue after treatment.

The physical side effects

Dry lips, skin, eyes and nose affect almost everyone, and lip inflammation is dose-related. Beyond that, the label lists:

• Raised triglycerides in about 25% of patients, which is why fasting lipid tests are done before and during treatment.
• Muscle and joint pain; CPK, a muscle enzyme, was markedly raised in about 24% of people in one trial, often after hard exercise.
• Raised pressure in the skull (headache, vision changes), especially with tetracycline antibiotics.
• Rarer serious problems: pancreatitis, hepatitis, inflammatory bowel disease, severe skin reactions (SJS and TEN), hearing loss and reduced night vision.

Interactions

The list is short. Avoid vitamin A supplements, including high-dose multivitamins, because isotretinoin is a form of vitamin A; see our vitamin A page for the upper limits. Avoid tetracycline antibiotics such as doxycycline and minocycline, which many people take for acne before switching. In a study with a standard combined pill, isotretinoin did not change hormone levels, but whether it affects other contraceptives is not known.

How to take it safely

Take the capsules with a full glass of liquid, whole, in two doses a day. Absorica LD is a different formulation and is not interchangeable milligram for milligram. Use lip balm and eye drops, avoid waxing, dermabrasion and laser treatments during the course and for at least 6 months after (the label warns of scarring), and use sunscreen. If a dose is missed, skip it rather than doubling up. If your mood changes or you get severe stomach pain, headache with vision changes or bloody diarrhoea, stop and contact your prescriber straight away. Talk to your doctor or pharmacist about any other medicine or supplement before starting.

How we scored it

Track record (90), dependence (95) and overdose marginOverdose marginHow far a normal dose is from a harmful one. A wide margin means an accidental extra dose is unlikely to cause serious harm.More in the glossary (85) are strong. Regulatory warnings (15) is the weakest factor, reflecting the boxed warningBoxed warningThe strongest safety warning the US FDA puts on a medicine's label, printed inside a black border at the top.More in the glossary, iPLEDGE and the UK measures. Serious side effects (45) is held down by the birth defect risk and a long list of uncommon but serious effects.