Amnesteem (isotretinoin) adverse event reports that FDA received

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

Name type: Brand name
Generic name: Isotretinoin
Class: Retinoid
Also reported as: Amnesteem 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 6,035 adverse event reports that name Amnesteem. In these reports the drug is a suspect or interacting product.

In the same period, 127 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 49 reports in the 12 months to June 2026 and 44 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, 49 (under 0.1%) name Amnesteem. Reports for patients aged 18 to 44 were 38.5% of the reports that name Amnesteem and 12.3% 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 Amnesteem 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 Amnesteem.
In January to March 2026, FDA received 17.
In April to June 2025, FDA received 16.

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 221 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 6,028 of the 6,035 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 221 terms.

Reaction terms in the reports that name Amnesteem, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 6,035 reports
Inflammatory bowel disease	664	11%
Depressionlow mood	556	9.2%
Blood triglycerides increased	374	6.2%
Headachehead pain	365	6%
Arthralgiajoint pain	350	5.8%
Drug exposure during pregnancythe medicine was taken during pregnancy	345	5.7%
Dry skin	342	5.7%
Suicidal ideationthoughts of suicide	252	4.2%
Lip dry	251	4.2%
Anxiety	228	3.8%
Pregnancy	213	3.5%
Maternal exposure during pregnancythe mother took the medicine during pregnancy	210	3.5%
Mood altereda change in mood	199	3.3%
Abortion induced	192	3.2%
Blood cholesterol increasedraised cholesterol	162	2.7%
Colitis ulcerative	158	2.6%
Exposure during pregnancythe medicine was taken during pregnancy	155	2.6%
Myalgiamuscle pain	155	2.6%
Aspartate aminotransferase increasedraised liver enzyme (AST)	152	2.5%
Back pain	146	2.4%
Alanine aminotransferase increasedraised liver enzyme (ALT)	137	2.3%
Abdominal painstomach or belly pain	136	2.3%
Epistaxisnosebleed	134	2.2%
Acne	121	2%
Mood swings	116	1.9%
Nauseafeeling sick	115	1.9%
Fatiguetiredness	114	1.9%
Diarrhoealoose or frequent stools	111	1.8%
Treatment noncompliancethe treatment was not taken as directed	106	1.8%
Drug ineffectivethe medicine did not work as expected	102	1.7%
Rectal haemorrhage	92	1.5%
Dry eye	90	1.5%
Irritable bowel syndrome	88	1.5%
Rashskin rash	85	1.4%
Chapped lips	78	1.3%
Depressed moodlow mood	77	1.3%
Crohn's disease	75	1.2%
Alopeciahair loss	74	1.2%
Abortion spontaneousmiscarriage	73	1.2%
Irritability	73	1.2%
Vision blurredblurred vision	70	1.2%
Anger	68	1.1%
Dizzinesslight-headedness or unsteadiness	68	1.1%
Liver function test abnormal	62	1%
Hepatic enzyme increasedraised liver enzymes	58	1%
Aggressionaggressive behaviour	55	0.9%
Haematocheziablood in the stool	55	0.9%
Crohn's diseaseCrohn's disease, an inflammatory bowel disease	54	0.9%
Insomniadifficulty sleeping	50	0.8%
Abdominal discomfortstomach discomfort	49	0.8%

Download all 221 terms of Amnesteem (CSV)

The counts add to more than 6,035 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	Generic name	14,852
Absorica	Brand name	2,518
Absorica LD	Brand name	219
Accutane	Brand name	12,317
Amnesteem (this page)	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 Amnesteem, 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	32	30	2	5	10	0	0	18	2
2005	109	101	6	5	11	3	2	79	8
2006	184	163	12	6	12	3	3	134	21
2007	273	267	10	0	19	2	0	241	6
2008	109	100	6	3	18	6	0	85	9
2009	139	134	2	2	25	4	2	120	5
2010	1,150	273	7	4	41	7	3	245	877
2011	977	390	6	3	33	6	0	375	587
2012	120	106	5	1	27	3	0	94	14
2013	639	271	6	4	25	2	2	255	368
2014	759	146	2	1	29	2	1	134	613
2015	779	170	6	0	20	1	2	150	609
2016	99	67	3	1	4	2	0	63	32
2017	53	31	0	0	9	0	1	31	22
2018	61	42	1	1	3	0	0	41	19
2019	89	61	4	0	2	0	0	55	28
2020	99	78	3	0	6	1	0	74	21
2021	117	97	2	0	7	0	0	90	20
2022	54	43	0	0	2	0	0	42	11
2023	68	61	2	0	6	0	0	56	7
2024	41	37	1	0	1	0	0	36	4
2025	47	40	2	0	1	0	0	37	7
2026	37	30	0	0	1	0	0	30	7

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 Amnesteem, 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 Amnesteem, by the year in which FDA received them
Year	Reports
2004	21
2005	93
2006	152
2007	199
2008	211
2009	138
2010	197
2011	1,258
2012	899
2013	614
2014	740
2015	773
2016	81
2017	51
2018	64
2019	93
2020	103
2021	111
2022	58
2023	67
2024	34
2025	45
2026	33

Reports that name Amnesteem, 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 Amnesteem
Age	Reports	Share
Under 2	9	0.1%
2 to 11	26	0.4%
12 to 17	1,395	23.1%
18 to 44	2,323	38.5%
45 to 64	210	3.5%
65 to 74	18	0.3%
75 and over	5	0.1%
Age not given	2,049	34%

Sex of the patient in the reports that name Amnesteem
Sex	Reports	Share
Female	3,320	55%
Male	2,462	40.8%
Unknown or not given	253	4.2%

Type of reporter in the reports that name Amnesteem
Reporter	Reports	Share
Physician	2,526	41.9%
Pharmacist	70	1.2%
Other health professional	1,723	28.6%
Lawyer	295	4.9%
Consumer or non-health professional	1,208	20%
Not given	213	3.5%

Age and sex are as the report gives them. The reporter is the primary source in the report. 98.6% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Amnesteem record
Indication as recorded (MedDRA)	Reports	Share
Acne	2,960	49%
Acne cystic	600	9.9%
Rosacea	15	0.2%
Hidradenitis	12	0.2%
Off label use	9	0.1%
Acne conglobata	7	0.1%

The reporter fills in the indication, and the field is often empty. Each share is of all 6,035 reports.

Drugs in the same reports

Other drugs that the reports of Amnesteem name, in any role, in order of name
Drug	Reports that name the two
Absorica	47
Accutane	511
Celexa	19
Claravis	775
Ibuprofen	25
Isotretinoin	180
Myorisan	127
Zenatane	33
Zoloft	24
Zyrtec	31

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

Isotretinoin same ingredient
Absorica same ingredient
Absorica LD same ingredient
Accutane same ingredient
Claravis same ingredient
Zenatane same ingredient
Adapalene same class
Bexarotene same class
Acitretin same class
Differin same class
Amn107 next in the A to Z list
Amoksiklav 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 AmnesteemThe 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. Amnesteem: adverse event reports that FDA received. https://reportedreactions.com/drug/amnesteem/ 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 Amnesteem as a suspect or interacting product. The 127 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 Amnesteem 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 Amnesteem?

No. It is a count of what people reported to FDA: 6,035 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 (28.6%) and consumer or non-health professional (20%). 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.

To the top of the page