Indomethacin adverse event reports that FDA received

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

Name type: Generic name
Class: Nonsteroidal anti-inflammatory drug
Also reported as: Indomethacin 25mg Cap, Indomethacin 50mg Cap, Indomethacin /00003801/

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 4,531 adverse event reports that name Indomethacin. In these reports the drug is a suspect or interacting product.

In the same period, 7,186 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 275 reports in the 12 months to June 2026 and 506 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, 275 (under 0.1%) name Indomethacin. Reports from consumers or other non-health professionals were 16.2% of the reports that name Indomethacin 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 Indomethacin 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 50 reports that name Indomethacin.
In January to March 2026, FDA received 32.
In April to June 2025, FDA received 88.

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 625 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 4,444 of the 4,531 reports (98.1%).

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 625 terms.

Reaction terms in the reports that name Indomethacin, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 4,531 reports
Drug ineffectivethe medicine did not work as expected	719	15.9%
Off label useused for a purpose or in a way not on the label	619	13.7%
Headachehead pain	614	13.6%
Fatiguetiredness	554	12.2%
Dizzinesslight-headedness or unsteadiness	518	11.4%
Arthralgiajoint pain	514	11.3%
Diarrhoealoose or frequent stools	498	11%
Pruritusitching	421	9.3%
Vomitingbeing sick	418	9.2%
Drug intolerancethe medicine was not tolerated	402	8.9%
Nauseafeeling sick	386	8.5%
Abdominal pain upperupper stomach pain	379	8.4%
Foetal exposure during pregnancythe unborn baby was exposed to the medicine	379	8.4%
Malaisegeneral feeling of being unwell	376	8.3%
Dyspnoeashortness of breath	370	8.2%
Astheniaweakness or lack of energy	364	8%
Abdominal painstomach or belly pain	344	7.6%
Hypersensitivityan allergic-type reaction	331	7.3%
Insomniadifficulty sleeping	327	7.2%
Pyrexiafever	317	7%
Painpain, site not specified	316	7%
Product use in unapproved indicationused for a purpose not on the label	279	6.2%
Decreased appetitereduced appetite	278	6.1%
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	278	6.1%
Falla fall	276	6.1%
Tinnitusringing in the ears	272	6%
Vision blurredblurred vision	266	5.9%
Sepsisa severe body-wide response to infection	261	5.8%
Haemorrhagic stroke	248	5.5%
Somnolencedrowsiness	246	5.4%
Drug interactionan interaction between medicines	245	5.4%
Tachycardiafast heart rate	242	5.3%
Chillschills or shivering	241	5.3%
Angioedemadeep swelling of skin or mucous membranes	236	5.2%
Drug ineffective for unapproved indication	236	5.2%
Joint swellinga swollen joint	236	5.2%
Eye pain	234	5.2%
Cardio-respiratory arrestthe heart and breathing stopped	233	5.1%
Cough	233	5.1%
Maternal exposure during pregnancythe mother took the medicine during pregnancy	232	5.1%
Rashskin rash	231	5.1%
Haematemesis	229	5.1%
Blindnessloss of sight	227	5%
Altered state of consciousness	224	4.9%
Coma	220	4.9%
Head discomfortdiscomfort in the head	220	4.9%
Swelling facea swollen face	219	4.8%
Blood pressure increaseda raised blood pressure reading	216	4.8%
Ocular discomfort	216	4.8%
Premature babya baby born early	215	4.7%

Download all 625 terms of Indomethacin (CSV)

The counts add to more than 4,531 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 Indomethacin with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Indomethacin (this page)	Generic name	4,531
Indomethacin sodium	Generic name	336
Indocin	Brand name	1,021

Sum of the separately reported names: 5,888. 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 Indomethacin, 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	61	57	8	9	42	0	0	12	4
2005	49	47	6	7	32	1	0	16	2
2006	101	81	8	5	42	5	0	35	20
2007	72	69	5	8	36	2	1	32	3
2008	91	82	13	4	56	4	0	27	9
2009	102	97	22	9	56	3	0	31	5
2010	78	74	14	7	51	2	1	30	4
2011	97	92	10	9	49	1	1	37	5
2012	76	70	5	4	30	2	4	39	6
2013	101	81	15	4	32	3	0	48	20
2014	82	68	10	4	32	2	0	42	14
2015	93	69	6	5	38	4	0	40	24
2016	135	96	5	11	39	2	5	60	39
2017	151	108	17	10	46	4	6	72	43
2018	227	167	11	6	30	6	1	145	60
2019	242	162	9	11	37	5	2	137	80
2020	227	190	15	7	44	10	14	152	37
2021	323	310	41	14	63	5	4	272	13
2022	522	505	83	21	96	11	16	437	17
2023	457	420	69	32	104	27	12	368	37
2024	522	497	173	52	134	48	46	447	25
2025	534	516	144	80	182	65	47	469	18
2026	188	180	53	31	60	26	22	168	8

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 Indomethacin, 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 Indomethacin, by the year in which FDA received them
Year	Reports
2004	54
2005	54
2006	99
2007	74
2008	90
2009	102
2010	77
2011	102
2012	85
2013	102
2014	84
2015	100
2016	150
2017	165
2018	264
2019	254
2020	272
2021	368
2022	563
2023	444
2024	544
2025	402
2026	82

Reports that name Indomethacin, 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 Indomethacin
Age	Reports	Share
Under 2	82	1.8%
2 to 11	71	1.6%
12 to 17	88	1.9%
18 to 44	931	20.5%
45 to 64	940	20.7%
65 to 74	400	8.8%
75 and over	249	5.5%
Age not given	1,770	39.1%

Sex of the patient in the reports that name Indomethacin
Sex	Reports	Share
Female	2,037	45%
Male	1,388	30.6%
Unknown or not given	1,106	24.4%

Type of reporter in the reports that name Indomethacin
Reporter	Reports	Share
Physician	1,103	24.3%
Pharmacist	277	6.1%
Other health professional	2,209	48.8%
Lawyer	14	0.3%
Consumer or non-health professional	734	16.2%
Not given	194	4.3%

Age and sex are as the report gives them. The reporter is the primary source in the report. 34.7% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Indomethacin record
Indication as recorded (MedDRA)	Reports	Share
Migraine	216	4.8%
Gout	208	4.6%
Patent ductus arteriosus	120	2.6%
Headache	117	2.6%
Tocolysis	107	2.4%
Foetal exposure during pregnancy	83	1.8%

The reporter fills in the indication, and the field is often empty. Each share is of all 4,531 reports.

Drugs in the same reports

Other drugs that the reports of Indomethacin name, in any role, in order of name
Drug	Reports that name the two
Acetaminophen	914
Aspirin	451
Ibuprofen	462
Naproxen	467
Prednisone	688
Pregabalin	412
Propranolol	449
Tocilizumab	416
Tramadol hydrochloride	410
Venlafaxine hydrochloride	444

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

Indomethacin sodium same ingredient
Indocin same ingredient
Junior Strength Advil same class
Ilevro same class
Ketoprofen same class
Ibuprofen tablets same class
Mefenamic acid same class
Indometacin next in the A to Z list
Inegy next in the A to Z list
Indinavir Sulfate next in the A to Z list
Inexium next in the A to Z list
Indinavir 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 IndomethacinThe 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. Indomethacin: adverse event reports that FDA received. https://reportedreactions.com/drug/indomethacin/ 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 Indomethacin as a suspect or interacting product. The 7,186 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 Indomethacin 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 Indomethacin?

No. It is a count of what people reported to FDA: 4,531 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?

Other health professional (48.8%), physician (24.3%) and consumer or non-health professional (16.2%). 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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