What the label lists and what reports show
Indomethacin side effects
Indomethacin's FDA label: “Most common adverse reactions (incidence ≥ 3%) are headache, dizziness, dyspepsia and nausea.” FAERS holds 13,174 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is fatigue (1,142 reports).
- Generic listed
- Boxed warning
Check it at the source: the indomethacin FDA label on DailyMed (effective December 19, 2025, Glenmark Pharmaceuticals Inc., USA); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of NSAIDs?NSAIDs can cause serious side effects, including: See “What is the most important information I should know about medicines called Non-Steroidal Anti-inflammatory Drugs (NSAIDs)?” • new or worse high blood pressure • heart failure • liver problems including liver failure • kidney problems including kidney failure • low red blood cells (anemia) • life-threatening skin reactions • life-threatening allergic reactions • Other side effects of NSAIDs include: stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, and dizziness. […]
Source: FDA drug label, Glenmark Pharmaceuticals Inc., USA, effective December 19, 2025 (SPL set f7ed39e2-5431-4e47-935c-c7441d058f94), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence ≥ 3%) are headache, dizziness, dyspepsia and nausea.
From the label: adverse reactions, continuedThe following adverse reactions are discussed in greater detail in other sections of the labeling: • Cardiovascular Thrombotic Events [see Warnings and Precautions ( 5.1 )] • GI Bleeding, Ulceration and Perforation [see Warnings and Precautions ( 5.2 )] • Hepatotoxicity [see Warnings and Precautions ( 5.3 )] • Hypertension [see Warnings and Precautions ( 5.4 )] • Heart Failure and Edema [see Warnings and Precautions ( 5.5 )] • Renal Toxicity and Hyperkalemia [see Warnings and Precautions ( 5.6 )] • Anaphylactic Reactions [see Warnings and Precautions ( 5.7 )] • Serious Skin Reactions [see Warnings and Precautions ( 5.9 )] • Hematologic Toxicity [see Warnings and Precautions ( 5.12 )] • Most common adverse reactions (incidence ≥ 3%) are headache, dizziness, dyspepsia and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Glenmark Pharmaceuticals Inc., USA at 1 (888) 721-7115 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. …
Source: FDA drug label, Glenmark Pharmaceuticals Inc., USA, effective December 19, 2025 (SPL set f7ed39e2-5431-4e47-935c-c7441d058f94), via openFDA; the full label on DailyMed
What do FAERS reports show?
13,174 reports list indomethacin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,524 are coded as a death and 4,449 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 23 reactions below, 11 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Indomethacin: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions