Acitretin adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Acitretin
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Generic name
Class: Retinoid
Also reported as: Acitretin Capsule, Acitretin Capsules Usp

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 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

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 2 Oct 2026.

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 2 Oct 2026.

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

Drug reports received through 30 Jun 2026. Device reports have a separate cutoff, 30 Sep 2026. Why a report count is not a rate.

Reports on file

From February 2004 to June 2026, FDA received 2,211 adverse event reports that name Acitretin. In these reports the drug is a suspect or interacting product.

In the same period, 2,767 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 107 reports in the 12 months to June 2026 and 220 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, 107 (under 0.1%) name Acitretin. Reports from consumers or other non-health professionals were 19% of the reports that name Acitretin and 45.8% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Acitretin is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

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

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

The latest update of the FDA data, recorded on 28 Oct 2026, changed no count of this page.

In April to June 2026, FDA received 16 reports that name Acitretin.
In January to March 2026, FDA received 27.
In April to June 2025, FDA received 58.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 289 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 2,182 of the 2,211 reports (98.7%).

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.

Find a reaction term

The table shows the first 50 of 289 terms.

Reaction terms in the reports that name Acitretin, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 2,211 reports
Drug ineffectivethe medicine did not work as expected	648	29.3%
Psoriasispsoriasis, a skin condition	319	14.4%
Off label useused for a purpose or in a way not on the label	269	12.2%
Treatment failurethe treatment did not work	143	6.5%
Condition aggravatedthe condition being treated got worse	138	6.2%
Diarrhoealoose or frequent stools	134	6.1%
Psoriatic arthropathy	128	5.8%
Pruritusitching	126	5.7%
Hypertensionhigh blood pressure	125	5.7%
Arthralgiajoint pain	122	5.5%
Therapeutic product effect incomplete	104	4.7%
Drug ineffective for unapproved indication	85	3.8%
Nauseafeeling sick	85	3.8%
Drug intolerancethe medicine was not tolerated	82	3.7%
Skin exfoliationpeeling skin	81	3.7%
Product use in unapproved indicationused for a purpose not on the label	78	3.5%
Fatiguetiredness	73	3.3%
Alopeciahair loss	69	3.1%
Painpain, site not specified	68	3.1%
Erythemaskin redness	65	2.9%
Drug exposure during pregnancythe medicine was taken during pregnancy	60	2.7%
Rashskin rash	59	2.7%
Hidradenitis	56	2.5%
Abdominal discomfortstomach discomfort	55	2.5%
Pregnancy	52	2.4%
Dry skin	51	2.3%
Drug-induced liver injury	49	2.2%
Astheniaweakness or lack of energy	48	2.2%
Drug interactionan interaction between medicines	48	2.2%
Urticariahives	48	2.2%
Diabetes mellitusdiabetes	47	2.1%
Crohn's disease	44	2%
Transaminases increased	42	1.9%
Erythrodermic psoriasis	40	1.8%
Infectionan infection, type not specified	38	1.7%
Myalgiamuscle pain	38	1.7%
Arthritis	36	1.6%
Gastrointestinal disorder	36	1.6%
Musculoskeletal stiffnessstiffness in muscles or joints	36	1.6%
Hepatic cirrhosis	35	1.6%
Therapeutic product effect decreased	35	1.6%
Therapy non-responderthe treatment did not work	35	1.6%
Dyspepsiaindigestion	34	1.5%
Hepatic fibrosis	34	1.5%
Squamous cell carcinoma	34	1.5%
Headachehead pain	33	1.5%
Hepatic enzyme increasedraised liver enzymes	32	1.4%
Skin plaque	32	1.4%
Hepatic steatosisfatty liver	31	1.4%
Joint swellinga swollen joint	31	1.4%

Download all 289 terms of Acitretin (CSV)

The counts add to more than 2,211 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 2 Oct 2026.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Acitretin, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2004	24	24	1	1	7	4	3	9	0
2005	46	46	5	3	15	3	1	27	0
2006	74	72	1	0	11	3	0	60	2
2007	67	66	3	2	15	3	4	45	1
2008	63	61	6	0	17	1	0	43	2
2009	55	54	4	0	13	3	0	38	1
2010	30	26	0	1	10	0	0	16	4
2011	25	22	0	0	6	0	0	17	3
2012	25	25	2	2	11	1	0	20	0
2013	30	30	0	2	8	1	0	25	0
2014	50	45	2	0	7	3	2	37	5
2015	54	37	1	1	9	1	0	29	17
2016	68	47	0	0	19	2	0	37	21
2017	81	59	6	2	15	2	0	51	22
2018	123	91	9	6	36	2	1	77	32
2019	139	113	6	3	33	2	0	95	26
2020	166	147	8	10	47	4	0	127	19
2021	135	120	5	12	20	1	0	110	15
2022	194	162	4	6	34	3	0	142	32
2023	243	148	3	6	9	2	4	143	95
2024	258	221	9	3	37	0	1	200	37
2025	198	181	9	0	37	0	0	159	17
2026	63	57	4	1	18	1	0	50	6

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. 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 2 Oct 2026.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Acitretin, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Acitretin, by the year in which FDA received them
Year	Reports
2004	18
2005	51
2006	72
2007	69
2008	59
2009	58
2010	31
2011	28
2012	26
2013	30
2014	51
2015	65
2016	73
2017	96
2018	127
2019	146
2020	162
2021	165
2022	187
2023	265
2024	226
2025	163
2026	43

Reports that name Acitretin, by month, five years to June 2026

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

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Acitretin
Age	Reports	Share
Under 2	13	0.6%
2 to 11	25	1.1%
12 to 17	20	0.9%
18 to 44	368	16.6%
45 to 64	686	31%
65 to 74	278	12.6%
75 and over	148	6.7%
Age not given	673	30.4%

Sex of the patient in the reports that name Acitretin
Sex	Reports	Share
Female	951	43%
Male	1,004	45.4%
Unknown or not given	256	11.6%

Type of reporter in the reports that name Acitretin
Reporter	Reports	Share
Physician	846	38.3%
Pharmacist	72	3.3%
Other health professional	781	35.3%
Lawyer	2	0.1%
Consumer or non-health professional	419	19%
Not given	91	4.1%

Age and sex are as the report gives them. The reporter is the primary source in the report. 24.5% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Acitretin record
Indication as recorded (MedDRA)	Reports	Share
Psoriasis	622	28.1%
Pustular psoriasis	115	5.2%
Pityriasis rubra pilaris	72	3.3%
Erythrodermic psoriasis	41	1.9%
Lichen planus	41	1.9%
Hidradenitis	39	1.8%

The reporter fills in the indication, and the field is often empty. Each share is of all 2,211 reports.

Drugs in the same reports

Other drugs that the reports of Acitretin name, in any role, in order of name
Drug	Reports that name the two
Adalimumab	304
Clobetasol	138
Cosentyx	188
Cyclosporine	410
Humira	151
Infliximab	145
Methotrexate	711
Prednisone	197
Secukinumab	160
Stelara	166

The table has the 10 drug names that these reports name most. Two names in one report says only that the report recorded the two. It says nothing about the part of a product in the event.

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 2 Oct 2026.

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 11 Mar 2026. The site read the page on 2 Oct 2026.

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These links are for navigation. No count selected them. The class page lists each drug of the class.

Official pages

DailyMed labels for AcitretinThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Acitretin: adverse event reports that FDA received. https://reportedreactions.com/drug/acitretin/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

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.

A report is in the count when it names Acitretin as a suspect or interacting product. The 2,767 reports that name it only as a concomitant medicine are not in the count. 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

Do these reports show that Acitretin was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Acitretin?

No. It is a count of what people reported to FDA: 2,211 reports from February 2004 to June 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Physician (38.3%), other health professional (35.3%) and consumer or non-health professional (19%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

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.

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