Reported Reactions

Adverse event reports that FDA received

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Retinoid adverse event reports that FDA received for the drugs of this class

Kind of class
Pharmacologic class (FDA Established Pharmacologic Class)
Drug pages
11

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

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.

Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on . The data have the reports that FDA received through .

FDA also says:

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 has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.

Source: openFDA, Drug Adverse Event Overview. The site read the page on .

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.

Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on .

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

Reports on file

Retinoid is a pharmacologic class: an FDA Established Pharmacologic Class. The class has 11 drug pages on this site.

From January 2004 to June 2026, FDA received 65,827 adverse event reports that name a drug of the class. In these reports the drug is a suspect or interacting product. A report that names two drugs of the class counts one time for each.

FDA received 7,166 reports in the 12 months to June 2026 and 6,563 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 7,166 (0.5%) name a drug of the class. Reports for patients aged 45 to 64 were 4.2% of the reports that name a drug of the class and 20% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate.

Pharmacologic class

The Established Pharmacologic Class (EPC) of FDA is the class on the label of a drug. The site puts a drug in the class that its reports have most often.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Drugs of the class

The rows are in order of name. A brand name and its generic name are separate rows, because reporters name them separately.

FDA says:

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.

Source: openFDA, Drug Adverse Event Overview. The site read the page on .

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.

Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of . The site read the page on .

Drug pages of the class Retinoid, in order of name
DrugName typeReportsReports, 12 months to June 2026
AbsoricaIsotretinoinBrand name2,51818
AccutaneIsotretinoinBrand name12,317406
AcitretinGeneric name2,211107
AdapaleneGeneric name4,7202,964
AmnesteemIsotretinoinBrand name6,03549
ClaravisIsotretinoinBrand name7,019217
DifferinAdapaleneBrand name4,89270
IsotretinoinGeneric name14,8522,177
TargretinBexaroteneBrand name60910
TretinoinGeneric name3,415365
ZenataneIsotretinoinBrand name7,239783

Reaction lookup

These are the reaction terms that the reports of the class record. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 1,336 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for 65,662 of the 65,827 reports (99.7%).

The reports of the other years are not in the counts.

So a count in the table can be lower than the count of FDA.

The table shows the first 50 of 1,336 terms.

Reaction terms in the reports that name a retinoid drug, most reports first
Reaction term (MedDRA) and plain meaningReportsShare of the 65,827 reports
Depressionlow mood6,2079.4%
Inflammatory bowel disease6,0719.2%
Drug ineffectivethe medicine did not work as expected5,6248.5%
Dry skin4,8967.4%
Colitis ulcerative4,0026.1%
Acne2,4263.7%
Arthralgiajoint pain2,3613.6%
Headachehead pain2,2883.5%
Irritable bowel syndrome2,2793.5%
Suicidal ideationthoughts of suicide2,2293.4%
Anxiety2,1363.2%
Pregnancy2,1103.2%
Exposure during pregnancythe medicine was taken during pregnancy1,9282.9%
Unintended pregnancy1,9262.9%
Lip dry1,8672.8%
Crohn's disease1,8392.8%
Product dose omission issuea dose was missed1,7162.6%
Blood triglycerides increased1,6802.6%
Adverse drug reactiona harmful or unpleasant reaction (the term names a medicine)1,6142.5%
Rashskin rash1,5432.3%
Erythemaskin redness1,4782.2%
Abortion induced1,4002.1%
Off label useused for a purpose or in a way not on the label1,3992.1%
Mood altereda change in mood1,3882.1%
Skin burning sensationburning skin1,3242%
Skin exfoliationpeeling skin1,3082%
Gastrointestinal injury1,2791.9%
Drug exposure during pregnancythe medicine was taken during pregnancy1,2701.9%
Condition aggravatedthe condition being treated got worse1,2631.9%
Crohn's diseaseCrohn's disease, an inflammatory bowel disease1,2071.8%
Treatment noncompliancethe treatment was not taken as directed1,1801.8%
Nauseafeeling sick1,0691.6%
Abdominal painstomach or belly pain1,0641.6%
Epistaxisnosebleed1,0501.6%
Maternal exposure during pregnancythe mother took the medicine during pregnancy1,0251.6%
Product use in unapproved indicationused for a purpose not on the label1,0161.5%
Blood cholesterol increasedraised cholesterol1,0091.5%
Skin irritationirritated skin1,0041.5%
Back pain9861.5%
Fatiguetiredness9851.5%
Myalgiamuscle pain9431.4%
Rectal haemorrhage9331.4%
Painpain, site not specified9301.4%
No adverse effect9241.4%
Therapy cessation8991.4%
Diarrhoealoose or frequent stools8971.4%
Injurya physical injury8931.4%
Intestinal obstructiona blocked bowel8891.4%
Alopeciahair loss8691.3%
Pruritusitching8651.3%

Download all 1,336 terms of the class (CSV)

The counts add to more than 65,827 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.

Source: openFDA, Drug Adverse Event Overview. The site read the page on .

Reports by month

Reports that name a retinoid drug, by month, five years to June 2026
02,5005,00020222023202420252026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Outcomes, patients and reporters

Outcomes in the reports of the class Retinoid
OutcomeReportsShareShare as a bar
Death1,6622.5%
Life-threatening9521.4%
Hospitalization (initial or prolonged)5,6538.6%
Disability or Permanent Damage1,3592.1%
Congenital Anomaly/Birth Defect5600.9%
Other Serious (Important Medical Events)28,56243.4%
Not serious33,17550.4%

An outcome in a report is not proof that a drug was the cause. The reporter gives the outcome, and FDA does not verify it. A report can have more than one outcome. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.

Source: openFDA, Drug Adverse Event Overview. The site read the page on .

Age of the patient in the reports of the class Retinoid
AgeReportsShareShare as a bar
Under 21380.2%
2 to 114720.7%
12 to 178,73513.3%
18 to 4416,84325.6%
45 to 642,7464.2%
65 to 749521.4%
75 and over5130.8%
Age not given35,42853.8%
Type of reporter in the reports of the class Retinoid
ReporterReportsShareShare as a bar
Physician20,72931.5%
Pharmacist1,2741.9%
Other health professional12,51219%
Lawyer6,2739.5%
Consumer or non-health professional22,63434.4%
Not given2,4053.7%

Official pages

The site checked these addresses on . The links open in a new tab.

Cite this page

Reported Reactions. Retinoid: adverse event reports that FDA received. https://reportedreactions.com/class/retinoid/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of . Reports received through .

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

The class of a drug is the Established Pharmacologic Class that openFDA attaches to its reports most often. When the reports have none, it is the class in the NDC Directory. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Which drugs are in the Retinoid class on this site?

Absorica, Accutane, Acitretin, Adapalene, Amnesteem, Claravis and 5 more, in order of name. The class of a drug comes from the pharmacologic class (EPC) on its FDA label.

Can the table of drugs rank the drugs?

No. FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product.

Source: openFDA, Drug Adverse Event Overview. The site read the page on .

Common products may have a higher number of adverse events due to the higher total number of people using the product.

Source: openFDA, Drug Adverse Event Overview. The site read the page on .

Drugs also differ in the conditions that they treat and in their time on the market.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.