Drug Safety Information for INDOMETHACIN (Indomethacin sodium)

Safety-related Labeling Changes for INDOMETHACIN (INDOMETHACIN) Rx Drug: FDA Link

Safety-related Labeling Changes for INDOCIN (INDOMETHACIN SODIUM) Rx Drug: FDA Link

Adverse Drug Reactions for INDOMETHACIN* (Indomethacin sodium)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with INDOMETHACIN
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Nausea*312
2Drug ineffective299
3Dyspnoea284
4Pain282
5Vomiting252
6Dizziness*247
7Renal failure acute239
8Arthralgia229
9Diarrhoea*224
10Pyrexia213
11Headache*210
12Asthenia206
13Fatigue204
14Anaemia173
15Renal failure170
16Hypertension170
17Anxiety*167
18Chest pain167
19Pain in extremity158
20Myocardial infarction156

* This side effect also appears in "Top 10 Side Effects of INDOMETHACIN " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking INDOMETHACIN
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Product used for unknown indication2737
2Gout*1617
3Patent ductus arteriosus1251
4Rheumatoid arthritis*962
5Pain682
6Arthritis*317
7Ankylosing spondylitis*290
8Arthralgia263
9Osteoarthritis206
10Juvenile arthritis202

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for INDOMETHACIN

Total Reports Filed with FDA: 31587


Number of FDA Adverse Event Reports by Patient Age for INDOMETHACIN

Total Reports Filed with FDA: 31587*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Indomethacin sodium (Indo-lemmon, Tivorbex, Metindol, Indomethacin er, Indocin, Indocid, Amuno, Indocin sr, Indomethacin)

Charts are based on 31587 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and INDOMETHACIN Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.