Retin-Atretinoin
According to the FDA label: Tretinoin capsules are indicated for the induction of remission in adults and pediatric patients 1 year of age and older with acute promyelocytic leukemia (APL) characterized by the presence of the t(15;17) translocation or PML/RARα gene expression, and who are refractory to or who have relapsed from anthracycline chemotherapy or for whom anthracycline-based chemotherapy is contraindicated.
7,439 adverse event reports submitted to the FDA (2004–2026)
Top Reported Adverse Events
The most frequently reported events in association with Retin-A 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.
Show these terms with plain-language definitions
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Off Label Use 900 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Drug Ineffective 768 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 →Pain 536 reports
A general report of physical discomfort, used when no more specific location is given.
Full definition in the glossary →Product Use in Unapproved Indication 472 reports
Using a medication for a condition it is not officially approved to treat. Like off label use, this is a reporting category and does not by itself mean harm occurred.
Full definition in the glossary →Vomiting 470 reports
Throwing up the contents of the stomach.
Full definition in the glossary → See all drugs reporting this event →Nausea 413 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Rash 390 reports
An area of irritated, red, or bumpy skin.
Full definition in the glossary → See all drugs reporting this event →Headache 388 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Diarrhoea 372 reports
Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.
Full definition in the glossary → See all drugs reporting this event →Paraesthesia 363 reports
An abnormal skin sensation such as tingling, prickling, or a pins and needles feeling. Also spelled paresthesia in American English.
Full definition in the glossary → See all drugs reporting this event →Abdominal Pain Upper 348 reports
Pain in the upper part of the belly, above the navel.
Full definition in the glossary →Fatigue 332 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Hypoaesthesia 332 reports
Reduced sense of touch or numbness in part of the body. Also spelled hypoesthesia in American English.
Full definition in the glossary → See all drugs reporting this event →Drug Intolerance 328 reports
A report that the person could not tolerate a medication, often due to uncomfortable effects.
Full definition in the glossary →Gastrooesophageal Reflux Disease 314 reports
A condition, often called acid reflux or GERD, where stomach acid flows back into the food pipe, causing heartburn. Also spelled gastroesophageal in American English.
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 | 4,830 |
| Male | 1,546 |
| Unknown | 41 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 504 |
| 18-34 | 1,082 |
| 35-49 | 1,254 |
| 50-64 | 926 |
| 65-74 | 587 |
| 75+ | 272 |
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 Retin-A. 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 | 3,362 |
| Non-Serious | 2,867 |
| Hospitalization | 1,543 |
| Death | 825 |
| Life-Threatening | 466 |
| Disability | 314 |
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 Retin-A. 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 | 47 |
| 2005 | 47 |
| 2006 | 36 |
| 2007 | 52 |
| 2008 | 135 |
| 2009 | 99 |
| 2010 | 110 |
| 2011 | 159 |
| 2012 | 198 |
| 2013 | 117 |
| 2014 | 175 |
| 2015 | 312 |
| 2016 | 528 |
| 2017 | 478 |
| 2018 | 532 |
| 2019 | 455 |
| 2020 | 445 |
| 2021 | 453 |
| 2022 | 576 |
| 2023 | 643 |
| 2024 | 758 |
| 2025 | 877 |
| 2026 (partial) | 207 |
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 Retin-A
In FDA adverse event reports that mention Retin-A, these medications appeared most often in the same report.
- Ergocalciferol (1,237 reports)
- Acetaminophen (796 reports)
- Cetirizine (762 reports)
- Prednisone (734 reports)
- Arsenic Trioxide (697 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