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Indomethacin Side Effects

The most commonly reported side effects of indomethacin include fatigue, off label use, and arthralgia, based on 15,054 FDA adverse event reports from 2004 to 2025. 10.1% of reports found the drug to be ineffective.

Indomethacin side effects

Percentages show how often each reaction appears relative to total reports for indomethacin.

1
Drug Ineffective10.1%1,525
2
Fatigue7.8%1,173
3
Off Label Use7.0%1,050
4
Arthralgia6.5%986
5
Headache6.3%942
6
Diarrhoea6.0%899
7
Pain5.9%881
8
Dizziness5.6%843
9
Nausea5.5%826
10
Vomiting4.6%686
11
Malaise4.3%653
12
Pruritus4.2%631
13
Dyspnoea4.1%619
14
Chronic Kidney Disease3.9%587
15
Abdominal Pain3.8%568

These are voluntary reports and do not establish that indomethacin caused these reactions.

Report severity

78.5%Serious11,815 reports
32.7%Hospitalizations4,922 reports
11.0%Fatal1,661 reports

Seriousness is determined by the reporter, not by OpenClaim.

Indomethacin drug interactions

Other drugs that appear in adverse event reports alongside indomethacin. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Adalimumab8.9%1,343
2
Acetaminophen8.1%1,214
3
Etanercept7.8%1,169
4
Methotrexate6.9%1,043
5
Omeprazole6.5%981
6
Prednisone5.0%749
7
Esomeprazole4.8%725
8
Celecoxib4.5%675
9
Tocilizumab4.5%675
10
Pantoprazole-sodium4.3%646
11
Infliximab4.2%634
12
Diclofenac4.2%632
13
Tramadol-hydrochloride3.9%582
14
Naproxen3.8%577
15
Aspirin3.8%574

Taken alongside

1
Acetaminophen15.7%2,365
2
Prednisone11.0%1,662
3
Aspirin10.8%1,623
4
Allopurinol9.9%1,493
5
Ibuprofen9.1%1,372
6
Lisinopril8.9%1,347
7
Omeprazole8.5%1,286
8
Ergocalciferol8.4%1,266
9
Furosemide8.2%1,241
10
Naproxen8.2%1,229
11
Gabapentin7.7%1,164
12
Amlodipine7.4%1,111
13
Albuterol7.2%1,088
14
Pantoprazole-sodium7.2%1,077
15
Folic-acid6.7%1,012

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports indomethacin side effects

45.1% of indomethacin adverse event reports involve female patients and 40.8% involve male patients. The largest age group is adult at 62%. These figures reflect who reports side effects, not underlying risk.

Sex

Female45.1%
Male40.8%
Unknown14.1%

Age group

< 25.2%
2–112.0%
12–172.2%
18–6462.1%
65+28.5%

What is indomethacin used for

Conditions and purposes for which patients were taking indomethacin when the adverse event was reported.

Abdominal PainAbdominal Pain LowerAbdominal Pain UpperAbortion ThreatenedAcute Kidney InjuryAdverse EventAmniotic Fluid Volume IncreasedAnalgesic EffectAnalgesic Intervention Supportive TherapyAnalgesic TherapyAnkle FractureAnkylosing SpondylitisAntibiotic ProphylaxisAntibiotic TherapyAnticoagulant Therapy

Showing 15 of 576 indications

Indomethacin brand names and reporting trend

Indomethacin is sold under brand names including Tivorbex, Indocin.

Brand names

Tivorbex17,447
Indocin1,137

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking indomethacin with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.