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Accutane and depression: the label and the studies

Accutane's label warns of depression, psychosis and, rarely, suicide. What studies found, the warning signs, and where to get help now: call or text 988.

A potted green plant, a glass of water and a stack of folded white towels on a painted windowsill looking out on a garden

By Nick, Founder of Skinli. Not a doctor. General education only.

Part of the Accutane (isotretinoin), which puts every step in order.

If you are thinking about suicide or harming yourself, get help now. In the US, call or text 988 to reach the 988 Suicide and Crisis Lifeline, which answers 24 hours a day. If you are in danger right now, call 911. If you take isotretinoin, stop taking it and tell your prescriber today.

Isotretinoin, the drug many people still call Accutane, carries a warning on its FDA label about depression, psychosis and suicide. Researchers have studied the question for decades and still disagree about whether the drug itself causes these problems. This guide reports what the label says, what the main studies found, and what to do if your mood changes. For the drug itself, see the Accutane guide.

Skinli gives general education and is not a doctor. Isotretinoin is prescribed and monitored by a doctor, who checks your mood at every monthly visit. Your prescriber is the first person to call about any change in how you feel.

What the FDA label says

The August 2026 label for one generic isotretinoin capsule states that the drug "may cause depression, psychosis and, rarely, suicidal ideation, suicide attempts, suicide, and aggressive and/or violent behaviors." Suicidal ideation means thoughts of suicide.

The label tells prescribers to ask patients and family members about any history of mental health problems before starting, and to check for symptoms of depression, mood problems, psychosis or aggression at every visit. If any of these develop, it says the patient should stop isotretinoin immediately and promptly contact the prescriber. It adds that stopping "may be insufficient" and that a referral to a mental health professional may be needed.

The older Accutane label, still on DailyMed, adds three statements in its patient section:

  • Some patients became depressed or developed other serious mental problems while taking the drug or soon after stopping it.
  • There were reports that some people with these problems did not appear depressed.
  • "No one knows if isotretinoin caused these behaviors or if they would have happened even if the person did not take" the drug.

The label also reports that in some patients, depression went away after stopping and returned when the drug was started again.

The warning signs

The Medication Guide asks you, or a family member, to watch for these signs and to stop the drug and call your prescriber right away if they appear:

  • Feeling sad or having crying spells
  • Losing interest in activities you once enjoyed
  • Sleeping too much or having trouble sleeping
  • Being more irritable, angry or aggressive than usual, including temper outbursts or thoughts of violence
  • A change in appetite or body weight
  • Trouble concentrating
  • Pulling away from friends or family
  • Feeling you have no energy
  • Feelings of worthlessness or guilt
  • Thoughts about hurting yourself or taking your own life
  • Acting on dangerous impulses
  • Seeing or hearing things that are not real

MedlinePlus adds anxiety, poor performance at school or work, and trouble falling or staying asleep, and asks family members to learn these signs so they can call the doctor if you cannot.

What to do if your mood changes

  1. In a crisis, call or text 988 in the US, or call 911 if you are in danger. MedlinePlus, from the US National Library of Medicine, lists calling or texting 988 as a way to reach help.
  2. Stop taking isotretinoin, as the label directs, and contact your prescriber the same day. Do not wait for the next monthly visit.
  3. Tell someone you trust what you are feeling, and ask them to stay in touch.
  4. Ask about follow-up care. The older label's Medication Guide says people who had these symptoms may need mental health care after stopping.

What the studies found

The studies below looked at large groups of people. None of them can show what will happen to one person.

StudyWhat it found
2024 review in JAMA Dermatology, 25 studies with 1,625,891 peopleWithin one year, the pooled risk of depression among users was 3.83 percent, and the risks of suicide, suicide attempt, suicidal thoughts and self-harm were each below 0.5 percent. Users were no more likely than non-users to have psychiatric conditions overall, and were less likely to attempt suicide 2 to 4 years after treatment
2019 review in BMJ Open, 20 studiesDepression symptoms improved from before treatment. No link with depressive disorders overall. Retrospective studies, which look back at records, did show a link; prospective studies, which follow people forward, did not
2021 US insurance study in the Journal of the American Academy of Dermatology, 72,555 patientsIsotretinoin users were more likely to have a psychiatric diagnosis than acne patients taking antibiotic pills or the general population. The general population was 1.47 times as likely as isotretinoin users to have a record of suicidal thoughts or attempts. Suicidal behavior was 0.10 percent during treatment, 0.22 percent in the year before and 0.34 percent in the year after. The rise after treatment was unlikely to be due to chance; the drop during treatment could have been
2010 Swedish study in the BMJ, 5,756 patientsThe rate of suicide attempts was higher during treatment and up to six months after, and was already rising in the year before treatment. From three years after, it matched the expected rate

The authors of the 2024 review called their results reassuring and still told doctors to keep watching patients for signs of distress. The Swedish authors wrote that an extra risk caused by the drug could not be established, because the risk was already rising before treatment, and they advised close watch for up to a year after treatment ends. The authors of the 2021 study called for more research into the rise in suicidal behavior in the year after treatment.

Each of these studies has limits. The 2021 and 2010 studies used health records, which depend on how diagnoses were coded, and the 2021 study left out people with public insurance or none.

Why this is hard to settle

Severe acne itself affects mood. The American Academy of Dermatology (AAD) says research shows that people with severe acne often become depressed, whether or not they take isotretinoin. The UK NICE guideline says acne of any severity can cause psychological distress and mental health disorders. So a study has to separate the effect of the acne from the effect of the drug, and that is difficult to do.

The AAD says some studies link isotretinoin with a lower risk of mood changes, and stresses that such a link does not prove the drug improves mood. It says dermatologists agree more studies are needed to know who is most at risk. A 2020 study in JAMA Dermatology followed 57 patients on isotretinoin with a questionnaire on how their skin affected their lives. Their scores for the emotional burden of acne improved by more than half by the second month of treatment.

Before you start

The label and the guidelines ask for a mental health check before the first prescription:

  • Tell your prescriber about any past depression, anxiety, psychosis, suicide attempt or self-harm, and any medicine you take for it.
  • Tell your prescriber about mental health problems in your family.
  • NICE says doctors should take a person's psychological wellbeing into account and refer them to mental health services before starting treatment when that is appropriate.
  • The Swedish authors wrote that patients with severe acne should not automatically be refused isotretinoin because of a past suicide attempt. The label leaves the decision to the prescriber and says that for some patients the risks may outweigh the benefits.

If isotretinoin is not the right choice for you, a dermatologist has other options for severe acne. When to see a dermatologist for severe acne lists them.

During and after treatment

Write down how your mood has been each week, and bring the list to the monthly visit. Ask someone close to you to tell you if they see a change. After the last dose, keep watching your mood; the Swedish authors advised close watch for up to a year. The side effects guide covers the other warning signs to report, and the how to get Accutane guide explains the monthly check-ins where your prescriber asks about mood.

If you ever feel you cannot keep yourself safe, call or text 988 in the US, or call 911.

Frequently asked questions

Does accutane cause depression?

The FDA label says Accutane may cause depression, psychosis and, rarely, suicidal thoughts, suicide attempts and suicide, and an older label adds that no one knows whether the drug caused these events. Studies disagree: a 2024 JAMA Dermatology review of 25 studies found no higher risk of psychiatric conditions overall among users. The label still says to stop the drug and contact your prescriber if depression develops. In a crisis in the US, call or text 988.

Can accutane cause depression years later?

The FDA label describes depression while taking Accutane or soon after stopping it. A 2010 BMJ study of 5,756 Swedish patients found a higher rate of suicide attempts during treatment and up to six months after it; from three years after treatment, the rate matched what was expected, through 15 years of follow-up. The authors advised close watch for up to a year after treatment. Tell your doctor about any lasting low mood.

Does accutane depression go away?

Depression linked to Accutane went away after stopping the drug in some patients, according to the FDA label, which says it came back in some of them when the drug was restarted. The label also warns that stopping may not be enough and that further care, such as a referral to a mental health professional, may be needed. Contact your prescriber instead of waiting for it to pass.

When does accutane depression start?

The FDA label says depression and other serious mental problems have started in some patients while taking Accutane and in others soon after stopping it. For that reason, the label asks prescribers to check for symptoms of depression at every visit, and asks patients and family members to watch for warning signs the whole time. The Swedish BMJ study found the higher rate of suicide attempts during treatment and up to six months after.

What does accutane depression feel like?

Depression on Accutane can feel like the signs the Medication Guide lists: feeling sad or having crying spells, losing interest in things you enjoyed, sleeping too much or too little, being more irritable, angry or aggressive, changes in appetite or weight, trouble concentrating, pulling away from friends and family, low energy, feelings of worthlessness or guilt, and thoughts of hurting yourself. Seeing or hearing things that are not real is a sign of psychosis.

Can you take accutane with depression?

A history of depression does not by itself rule out Accutane, and the decision rests with the prescriber. The FDA label asks prescribers to ask about past mental health problems in the patient and family before starting, and says that for some patients the risks may outweigh the benefits. The UK NICE guideline says to consider referral to mental health services before starting, where appropriate. Tell your prescriber your full history.

Does accutane interact with antidepressants?

The FDA label's drug interaction section names vitamin A supplements, tetracycline antibiotics and some forms of birth control, and antidepressant medicines are absent from that list. MedlinePlus and other isotretinoin labels warn against St. John's wort, an herbal remedy some people take for low mood, because it can make hormonal birth control fail. Tell your prescriber and pharmacist about every medicine and supplement you take, including antidepressants, so they can check the whole plan.

Does accutane cause depression and anxiety?

The FDA label lists anxiety and panic attacks among the psychiatric side effects reported with isotretinoin, along with depression, irritability, anger and emotional instability. It says many of these come from voluntary reports, so it is not always possible to know how often they happen or whether the drug caused them. MedlinePlus lists anxiety among the symptoms to report to your doctor right away. In a crisis in the US, call or text 988.

Can stopping accutane cause depression?

The FDA label reports depression in some patients soon after they stopped Accutane, as well as during treatment, without saying whether stopping was the cause. The Swedish BMJ study of 5,756 patients found a higher rate of suicide attempts in the six months after treatment and recommended close monitoring for up to a year. The older label's Medication Guide says some people may need mental health care after stopping.

How to avoid accutane depression?

The FDA label's plan for mood on Accutane has three parts: tell your prescriber about past mental health problems in you and your family before starting, get checked for mood changes at every visit, and stop the drug and contact your prescriber as soon as warning signs appear. The label asks family members to watch as well. The American Academy of Dermatology says dermatologists screen for depression before prescribing.

Sources

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A doctor can tell you what this is.

Skin that hurts, spreads, bleeds, weeps or does not get better needs a doctor or a dermatologist. They can confirm what it is and offer treatment that needs a prescription.

Skinli gives general education about isotretinoin and prescribes nothing. Isotretinoin is prescribed and monitored by a doctor. If you take it and might be pregnant, stop and call your prescriber today. If you have thoughts of suicide or self-harm, call or text 988 in the US, or call 911 if you are in danger.