Amnesteemisotretinoin
According to the FDA label: Severe Recalcitrant Nodular Acne Isotretinoin capsules are 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.
19,891 adverse event reports submitted to the FDA (2004–2026)
Top Reported Adverse Events
The most frequently reported events in association with Amnesteem 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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Depression 1,427 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 →- Pregnancy 1,227 reports
- Abortion Induced 832 reports
Dry Skin 811 reports
Skin that lacks moisture, which can feel rough, tight, or flaky.
Full definition in the glossary → See all drugs reporting this event →Headache 809 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Arthralgia 797 reports
Exposure During Pregnancy 789 reports
A report noting that a person was exposed to a medication during pregnancy. This is a tracking category for monitoring, not a description of harm by itself.
Full definition in the glossary →Suicidal Ideation 725 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 →- Inflammatory Bowel Disease 692 reports
Drug Exposure During Pregnancy 645 reports
A report noting that a person was exposed to a medication during pregnancy. This is a tracking category for monitoring, not a description of harm by itself.
Full definition in the glossary →Adverse Drug Reaction 611 reports
A general report of a harmful or unintended response to a medication, used when no more specific reaction is named.
Full definition in the glossary →Anxiety 600 reports
A feeling of worry, nervousness, or unease.
Full definition in the glossary → See all drugs reporting this event →Product Dose Omission Issue 587 reports
A report that a dose of the medication was missed or skipped.
Full definition in the glossary →Drug Ineffective 581 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →- Mood Altered 557 reports
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 | 9,747 |
| Male | 5,231 |
| Unknown | 153 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 3,121 |
| 18-34 | 4,464 |
| 35-49 | 988 |
| 50-64 | 282 |
| 65-74 | 86 |
| 75+ | 48 |
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 Amnesteem. 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 |
|---|---|
| Non-Serious | 9,229 |
| Other Serious | 9,081 |
| Hospitalization | 1,624 |
| Death | 510 |
| Disability | 395 |
| Life-Threatening | 331 |
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 Amnesteem. 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 |
|---|---|
| 2004 | 149 |
| 2005 | 301 |
| 2006 | 510 |
| 2007 | 689 |
| 2008 | 962 |
| 2009 | 611 |
| 2010 | 657 |
| 2011 | 1,533 |
| 2012 | 1,246 |
| 2013 | 303 |
| 2014 | 267 |
| 2015 | 969 |
| 2016 | 317 |
| 2017 | 298 |
| 2018 | 456 |
| 2019 | 485 |
| 2020 | 791 |
| 2021 | 1,111 |
| 2022 | 1,569 |
| 2023 | 1,751 |
| 2024 | 2,134 |
| 2025 | 2,348 |
| 2026 (partial) | 434 |
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 Amnesteem
In FDA adverse event reports that mention Amnesteem, these medications appeared most often in the same report.
- Doxycycline (294 reports)
- Doxycycline Hyclate (294 reports)
- Clindamycin (218 reports)
- Prednisone (200 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