Adapalene

Name: ADAPALENE () — FDA Adverse Event Reports
Creator: PillSignal
License: https://open.fda.gov/license/

According to the FDA label: USE For the treatment of acne

5,024 adverse event reports submitted to the FDA (2004–2026)

This data reflects voluntary reports submitted to the FDA's Adverse Event Monitoring System (AEMS), formerly the FDA Adverse Event Reporting System (FAERS). A report does not mean the medication caused the event. Data may be incomplete or contain errors. Learn more about AEMS. New to this data? Read our guide on how to interpret FDA adverse event reports →

New to FDA adverse event data? Here's how to read these reports →

Top Reported Adverse Events

The most frequently reported events in association with Adapalene 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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Drug Ineffective 2,386 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 →
Dry Skin 797 reports
Skin that lacks moisture, which can feel rough, tight, or flaky.
Full definition in the glossary → See all drugs reporting this event →
Skin Burning Sensation 491 reports
Skin Irritation 482 reports
Acne 450 reports
A skin condition causing pimples, usually on the face, chest, or back.
Full definition in the glossary → See all drugs reporting this event →
Condition Aggravated 406 reports
A report that the person's existing health condition got worse. This describes a worsening of something the person already had, not necessarily a new problem caused by the drug.
Full definition in the glossary →
Erythema 401 reports
Redness of the skin.
Full definition in the glossary →
Rash 321 reports
An area of irritated, red, or bumpy skin.
Full definition in the glossary → See all drugs reporting this event →
Skin Exfoliation 270 reports
Peeling or shedding of the outer layer of skin.
Full definition in the glossary →
Therapy Cessation 227 reports
Hypersensitivity 164 reports
An exaggerated reaction by the immune system, similar to an allergic reaction.
Full definition in the glossary →
Pruritus 140 reports
Itching of the skin.
Full definition in the glossary → See all drugs reporting this event →
Pain Of Skin 91 reports
Therapeutic Product Effect Incomplete 76 reports
A report that the medication only partly worked. Similar to drug ineffective, it reflects that someone felt the treatment did not fully help.
Full definition in the glossary →
Therapeutic Response Decreased 76 reports
A report that a treatment seemed to work less well than before. Similar to drug ineffective and therapeutic product effect decreased.
Full definition in the glossary →

Browse the full glossary →

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

Adapalene adverse event reports by reporter sex
Sex	Reports
Female	1,830
Male	920
Unknown	2

By Age Group

View age group data as a table

Adapalene adverse event reports by reporter age group
Age group	Reports
0-17	425
18-34	324
35-49	164
50-64	67
65-74	25
75+	8

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 Adapalene. 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

Adapalene adverse event reports by reported outcome
Outcome	Reports
Non-Serious	4,661
Other Serious	284
Hospitalization	103
Life-Threatening	17
Death	12
Disability	10

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 Adapalene. 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

Adapalene adverse event reports by year
Year	Reports
2004	1
2006	2
2007	2
2008	2
2009	3
2010	5
2011	8
2012	18
2013	12
2014	16
2015	37
2016	40
2017	29
2018	36
2019	68
2020	52
2021	51
2022	92
2023	168
2024	810
2025	851
2026 (partial)	2,721

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 Adapalene

In FDA adverse event reports that mention Adapalene, these medications appeared most often in the same report.

Clindamycin (110 reports)
Doxycycline Hyclate (90 reports)
Doxycycline (88 reports)
Albuterol (81 reports)
Ergocalciferol (78 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.

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