Isotretinoin adverse event reports that FDA received

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

Name type: Generic name
Class: Retinoid
Also reported as: Isotretinoin Capsules

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 January 2004 to June 2026, FDA received 14,852 adverse event reports that name Isotretinoin. In these reports the drug is a suspect or interacting product.

In the same period, 732 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 2,177 reports in the 12 months to June 2026 and 2,554 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, 2,177 (0.2%) name Isotretinoin. Reports from consumers or other non-health professionals were 23.1% of the reports that name Isotretinoin 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 Isotretinoin 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 405 reports that name Isotretinoin.
In January to March 2026, FDA received 405.
In April to June 2025, FDA received 368.

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 554 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 14,845 of the 14,852 reports (99.9%).

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 554 terms.

Reaction terms in the reports that name Isotretinoin, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 14,852 reports
Depressionlow mood	1,001	6.7%
Pregnancy	998	6.7%
Exposure during pregnancythe medicine was taken during pregnancy	710	4.8%
Abortion induced	658	4.4%
Adverse drug reactiona harmful or unpleasant reaction (the term names a medicine)	627	4.2%
Product dose omission issuea dose was missed	570	3.8%
Dry skin	554	3.7%
Headachehead pain	533	3.6%
Arthralgiajoint pain	523	3.5%
Suicidal ideationthoughts of suicide	499	3.4%
Drug ineffectivethe medicine did not work as expected	442	3%
Mood altereda change in mood	440	3%
Anxiety	385	2.6%
Lip dry	308	2.1%
Myalgiamuscle pain	303	2%
Drug exposure during pregnancythe medicine was taken during pregnancy	296	2%
Off label useused for a purpose or in a way not on the label	291	2%
Maternal exposure during pregnancythe mother took the medicine during pregnancy	283	1.9%
No adverse effect	266	1.8%
No adverse eventno adverse event was reported	250	1.7%
Abdominal painstomach or belly pain	244	1.6%
Epistaxisnosebleed	242	1.6%
Blood triglycerides increased	233	1.6%
Dry eye	233	1.6%
Product use issuea problem in how the product was used	232	1.6%
Back pain	224	1.5%
Diarrhoealoose or frequent stools	222	1.5%
Acne	218	1.5%
Abortion spontaneousmiscarriage	215	1.4%
Fatiguetiredness	211	1.4%
Painpain, site not specified	211	1.4%
Therapy cessation	209	1.4%
Condition aggravatedthe condition being treated got worse	204	1.4%
Rashskin rash	202	1.4%
Rectal haemorrhage	196	1.3%
Cheilitis	194	1.3%
Treatment noncompliancethe treatment was not taken as directed	189	1.3%
Nauseafeeling sick	188	1.3%
Alopeciahair loss	184	1.2%
Inflammatory bowel disease	175	1.2%
Suicide attempta suicide attempt	171	1.2%
Depressed moodlow mood	169	1.1%
Mood swings	161	1.1%
Foetal exposure during pregnancythe unborn baby was exposed to the medicine	155	1%
Sacroiliitis	136	0.9%
Xerosis	134	0.9%
Erectile dysfunctiondifficulty getting or keeping an erection	132	0.9%
Drug intolerancethe medicine was not tolerated	129	0.9%
Pyrexiafever	128	0.9%
Vision blurredblurred vision	127	0.9%

Download all 554 terms of Isotretinoin (CSV)

The counts add to more than 14,852 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.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Isotretinoin with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Isotretinoin (this page)	Generic name	14,852
Absorica	Brand name	2,518
Absorica LD	Brand name	219
Accutane	Brand name	12,317
Amnesteem	Brand name	6,035
Claravis	Brand name	7,019
Zenatane	Brand name	7,239

Sum of the separately reported names: 50,199. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

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.

Outcomes by year

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

Outcomes in the reports that name Isotretinoin, 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	180	180	2	2	8	2	0	169	0
2005	237	233	9	4	11	0	7	212	4
2006	266	255	9	14	29	2	6	217	11
2007	434	430	28	7	61	7	6	367	4
2008	714	677	27	10	75	6	9	598	37
2009	553	523	90	6	61	8	7	421	30
2010	416	277	7	6	94	11	11	218	139
2011	251	200	14	15	38	8	5	150	51
2012	290	268	15	11	85	20	5	214	22
2013	245	165	22	11	38	10	8	114	80
2014	213	206	15	10	69	33	8	141	7
2015	184	134	5	4	21	10	6	115	50
2016	182	158	3	15	39	18	4	111	24
2017	195	170	6	7	42	9	6	138	25
2018	357	250	8	8	43	15	27	209	107
2019	367	290	6	17	71	36	11	217	77
2020	617	335	14	13	67	21	8	262	282
2021	945	417	31	32	67	23	6	338	528
2022	1,431	436	13	17	53	27	14	380	995
2023	1,543	549	20	12	62	16	7	491	994
2024	2,112	684	11	20	81	22	16	623	1,428
2025	2,241	700	14	18	69	24	9	638	1,541
2026	879	388	9	4	38	16	5	355	491

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 Isotretinoin, 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 Isotretinoin, by the year in which FDA received them
Year	Reports
2004	48
2005	204
2006	344
2007	480
2008	739
2009	500
2010	479
2011	258
2012	374
2013	254
2014	160
2015	178
2016	191
2017	182
2018	371
2019	372
2020	650
2021	943
2022	1,461
2023	1,614
2024	2,027
2025	2,213
2026	810

Reports that name Isotretinoin, 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 Isotretinoin
Age	Reports	Share
Under 2	58	0.4%
2 to 11	216	1.5%
12 to 17	1,701	11.5%
18 to 44	3,307	22.3%
45 to 64	283	1.9%
65 to 74	56	0.4%
75 and over	26	0.2%
Age not given	9,205	62%

Sex of the patient in the reports that name Isotretinoin
Sex	Reports	Share
Female	6,869	46.2%
Male	3,195	21.5%
Unknown or not given	4,788	32.2%

Type of reporter in the reports that name Isotretinoin
Reporter	Reports	Share
Physician	6,224	41.9%
Pharmacist	391	2.6%
Other health professional	4,145	27.9%
Lawyer	177	1.2%
Consumer or non-health professional	3,425	23.1%
Not given	490	3.3%

Age and sex are as the report gives them. The reporter is the primary source in the report. 70.5% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Isotretinoin record
Indication as recorded (MedDRA)	Reports	Share
Acne	3,868	26%
Acne cystic	355	2.4%
Neuroblastoma	207	1.4%
Hidradenitis	119	0.8%
Acne conglobata	76	0.5%
Acne fulminans	42	0.3%

The reporter fills in the indication, and the field is often empty. Each share is of all 14,852 reports.

Drugs in the same reports

Other drugs that the reports of Isotretinoin name, in any role, in order of name
Drug	Reports that name the two
Accutane	199
Amnesteem	187
Cisplatin	114
Claravis	305
Clindamycin	156
Cyclophosphamide	120
Doxycycline	236
Etoposide	140
Prednisone	130
Zenatane	117

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.

Pages near this one

Absorica same ingredient
Absorica LD same ingredient
Accutane same ingredient
Amnesteem same ingredient
Claravis same ingredient
Zenatane same ingredient
Epiduo Forte same class
Retin-A same class
Differin same class
Targretin same class
Tazorac same class
Isosorbide mononitrate next in the A to Z list

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

Official pages

DailyMed labels for IsotretinoinThe 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.

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Reported Reactions. Isotretinoin: adverse event reports that FDA received. https://reportedreactions.com/drug/isotretinoin/ 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 Isotretinoin as a suspect or interacting product. The 732 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 Isotretinoin 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 Isotretinoin?

No. It is a count of what people reported to FDA: 14,852 reports from January 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 (41.9%), other health professional (27.9%) and consumer or non-health professional (23.1%). 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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