Pharmacologic class (EPC) · 11 drug pages

Retinoid: adverse event reports filed with FDA

65,827 reports list a drug in this class as a suspect or interacting product, 2004–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

65,827
reports across the class: 0.3% of all reports; 7,166
reports, 12 months to June 2026: 6,563 in the 12 months before; 49.6%
marked serious by the reporter: 57.4% across all reports; 11
drugs with a page: brand and generic names counted separately

Retinoid is a pharmacologic class (an FDA Established Pharmacologic Class) with 11 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 65,827 adverse event reports received by FDA, 0.3% of the database, from January 2004 to June 2026.

7,166 reports arrived in the 12 months to June 2026, close to the 6,563 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 49.6% of the class's reports are marked serious, 2.5% record death among the outcomes and 8.6% record hospitalisation, as reported.

Across the class the reactions recorded most often are depression (9.4%), inflammatory bowel disease (9.2%) and drug ineffective (8.5%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
Isotretinoin	generic	14,852	2,177	53.4%	Depression
AccutaneIsotretinoin	brand	12,317	406	77%	Inflammatory bowel disease
ZenataneIsotretinoin	brand	7,239	783	25.6%	Adverse drug reaction
ClaravisIsotretinoin	brand	7,019	217	66.4%	Unintended pregnancy
AmnesteemIsotretinoin	brand	6,035	49	45.4%	Inflammatory bowel disease
DifferinAdapalene	brand	4,892	70	3%	Dry skin
Adapalene	generic	4,720	2,964	1.7%	Drug ineffective
Tretinoin	generic	3,415	365	72.4%	Off label use
AbsoricaIsotretinoin	brand	2,518	18	37.8%	Exposure during pregnancy
Acitretin	generic	2,211	107	83.9%	Drug ineffective
TargretinBexarotene	brand	609	10	79.3%	Hypothyroidism

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Depressionlow mood9.4%6,207
Inflammatory bowel disease9.2%6,071
Drug ineffectivethe medicine did not work as expected8.5%5,624
Dry skindry skin7.4%4,896
Colitis ulcerative6.1%4,002
Acneacne3.7%2,426
Arthralgiajoint pain3.6%2,361
Headachehead pain3.5%2,288
Irritable bowel syndrome3.5%2,279
Suicidal ideationthoughts of suicide3.4%2,229
Anxietyanxiety3.2%2,136
Pregnancypregnancy3.2%2,110
Exposure during pregnancythe medicine was taken during pregnancy2.9%1,928
Unintended pregnancy2.9%1,926
Lip dry2.8%1,867
Crohn's disease2.8%1,839
Product dose omission issuea dose was missed2.6%1,716
Blood triglycerides increased2.6%1,680
Adverse drug reactiona harmful or unpleasant reaction reported to a medicine2.5%1,614
Rashskin rash2.3%1,543
Erythemaskin redness2.2%1,478
Abortion induced2.1%1,400
Off label useused for a purpose or in a way not on the label2.1%1,399
Mood altereda change in mood2.1%1,388
Skin burning sensationburning skin2%1,324

Solid bar: share of all class reports. Hollow bar: the median share across the 11 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death2.5%1,662

Life-threatening1.4%952

Hospitalisation (initial or prolonged)8.6%5,653

Disability2.1%1,359

Congenital anomaly0.9%560

Other serious43.4%28,562

Not serious50.4%33,175

Patient age

Under 20.2%138

2 to 110.7%472

12 to 1713.3%8,735

18 to 4425.6%16,843

45 to 644.2%2,746

65 to 741.4%952

75 and over0.8%513

Age not given53.8%35,428

Who reported

Physician31.5%20,729

Pharmacist1.9%1,274

Other health professional19%12,512

Lawyer9.5%6,273

Consumer or non-health professional34.4%22,634

Not given3.7%2,405

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Retinoid reports

Which drugs are in the Retinoid class on this site?

Isotretinoin, Accutane, Zenatane, Claravis, Amnesteem and Differin and 5 more. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

65,827 reports through June 2026, 7,166 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

depression (9.4%), inflammatory bowel disease (9.2%), drug ineffective (8.5%), dry skin (7.4%) and colitis ulcerative (6.1%).

Can the members table be used to rank the drugs?

No. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.