Accutaneisotretinoin
According to the FDA label: Severe Recalcitrant Nodular Acne Accutane is indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. “Severe,” by definition, 2 means “many” as opposed to “few or several” nodules.
28,656 adverse event reports submitted to the FDA (2000–2026)
Top Reported Adverse Events
The most frequently reported events in association with Accutane in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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- Inflammatory Bowel Disease 5,091 reports
Depression 4,188 reports
A persistent low mood, loss of interest, or feelings of sadness. If you are struggling, the 988 Suicide and Crisis Lifeline (call or text 988 in the US) is available 24 hours a day.
Full definition in the glossary → See all drugs reporting this event →Colitis Ulcerative 3,757 reports
A long-term condition, usually called ulcerative colitis, that causes inflammation and sores in the lining of the large intestine. It often appears in reports as a condition being treated.
Full definition in the glossary →- Irritable Bowel Syndrome 2,000 reports
- Pregnancy 1,854 reports
Crohn's Disease 1,661 reports
A long-term condition that causes inflammation of the digestive tract. It often appears in reports as a condition being treated.
Full definition in the glossary →Dry Skin 1,655 reports
Skin that lacks moisture, which can feel rough, tight, or flaky.
Full definition in the glossary → See all drugs reporting this event →Anxiety 1,399 reports
A feeling of worry, nervousness, or unease.
Full definition in the glossary → See all drugs reporting this event →Suicidal Ideation 1,350 reports
Thoughts of suicide. This term records that such thoughts were reported, and its presence does not establish that a medication was the cause. If you or someone you know is struggling, the 988 Suicide and Crisis Lifeline (call or text 988 in the US) is available 24 hours a day.
Full definition in the glossary →Product Dose Omission Issue 1,281 reports
A report that a dose of the medication was missed or skipped.
Full definition in the glossary →- Gastrointestinal Injury 1,260 reports
Arthralgia 1,146 reports
- Lip Dry 1,140 reports
- Crohn's Disease 1,131 reports
Headache 1,094 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 13,343 |
| Male | 8,521 |
| Unknown | 362 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 4,217 |
| 18-34 | 6,474 |
| 35-49 | 1,486 |
| 50-64 | 448 |
| 65-74 | 115 |
| 75+ | 55 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Accutane. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Other Serious | 16,164 |
| Non-Serious | 10,048 |
| Hospitalization | 3,694 |
| Disability | 954 |
| Death | 698 |
| Life-Threatening | 481 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Accutane. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2000 | 1 |
| 2001 | 1 |
| 2003 | 1 |
| 2004 | 963 |
| 2005 | 974 |
| 2006 | 1,036 |
| 2007 | 868 |
| 2008 | 1,200 |
| 2009 | 861 |
| 2010 | 1,238 |
| 2011 | 2,278 |
| 2012 | 2,379 |
| 2013 | 777 |
| 2014 | 201 |
| 2015 | 268 |
| 2016 | 309 |
| 2017 | 1,247 |
| 2018 | 445 |
| 2019 | 481 |
| 2020 | 818 |
| 2021 | 1,240 |
| 2022 | 2,311 |
| 2023 | 2,436 |
| 2024 | 3,019 |
| 2025 | 2,791 |
| 2026 (partial) | 513 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Accutane
In FDA adverse event reports that mention Accutane, these medications appeared most often in the same report.
- Doxycycline (370 reports)
- Doxycycline Hyclate (370 reports)
- Prednisone (349 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026