Prescription medication · Nonsteroidal Anti-Inflammatory Drug (NSAID)
indomethacin
Also sold as Indocin. Indomethacin treats moderate to severe rheumatoid arthritis, ankylosing spondylitis, and osteoarthritis.
Data updated 2026-05-15
- 12,919
- FDA reportsModerately reported
- 35
- InteractionsSeveral interactions
- 2
- Recall records
What the data shows
indomethacin (Indocin) is a prescription Nonsteroidal Anti-Inflammatory Drug (NSAID), reported less often than most tracked drugs (12,919 FDA reports), with 35 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
indomethacin (Indocin) is a prescription Nonsteroidal Anti-Inflammatory Drug (NSAID). Indomethacin treats moderate to severe rheumatoid arthritis, ankylosing spondylitis, and osteoarthritis.
Indomethacin is a drug that reduces pain and swelling. It belongs to a class of drugs called NSAIDs.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Generic Price
$0.09/unit
Generic Available
Yes (13 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Indomethacin treats moderate to severe rheumatoid arthritis, ankylosing spondylitis, and osteoarthritis.
Common side effects
Headache, Dizziness, Upset stomach
Key warnings
Indomethacin may increase your risk of serious heart problems like heart attack or stroke, which can be fatal.
The sections below are summarized in plain English from indomethacin's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Indomethacin works by blocking substances in the body that cause pain and inflammation. These substances are called prostaglandins. By blocking them, indomethacin helps to reduce swelling, pain, and stiffness.
Side Effects (from patient reports)
Based on 12,919 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for indomethacin, by number of reports
- Fatigue
Fatigue
1,102 reports
- Arthralgia
Arthralgia
1,002 reports
- Headache
Headache
990 reports
- Pain
Pain
921 reports
- Nausea
Nausea
907 reports
- Diarrhoea
Diarrhoea
878 reports
- Dizziness
Dizziness
868 reports
- Dyspnoea
Dyspnoea
744 reports
- Vomiting
Vomiting
740 reports
- Asthenia
Asthenia
643 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for indomethacin each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where indomethacin sits
indomethacin has more FDA adverse-event reports than 45% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is indomethacin; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 12,919 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 1994–2025.
Total Reports
12,919
Reports Mentioning Death
1,495
11.6% of reports — not proof of cause
Hospitalization Reports
4,370
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 2 | FATIGUE | 1,102 |
| 3 | ARTHRALGIA | 1,002 |
| 4 | HEADACHE | 990 |
| 6 | PAIN | 921 |
| 7 | NAUSEA | 907 |
| 8 | DIARRHOEA | 878 |
| 9 | DIZZINESS | 868 |
| 10 | DYSPNOEA | 744 |
| 11 | VOMITING | 740 |
| 12 | ASTHENIA | 643 |
| 13 | PYREXIA | 615 |
| 14 | PRURITUS | 606 |
| 15 | MALAISE | 590 |
| 16 | FALL | 562 |
| 17 | ABDOMINAL PAIN | 538 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Indomethacin may increase your risk of serious heart problems like heart attack or stroke, which can be fatal. This risk may occur early in treatment and may increase with longer use. You should not take this medicine before or after heart bypass surgery (CABG). Indomethacin can also increase your risk of serious stomach and intestine problems like bleeding, ulcers, and holes, which can be fatal. These problems can happen without warning. Elderly patients and those with a history of ulcers or GI bleeding are at higher risk.
Known Drug Interactions
Methotrexate Clinical Impact: Concomitant use of NSAIDs and methotrexate may increase the risk for methotrexate toxicity (e.g., neutropenia, thrombocytopenia, renal dysfunction). Intervention: During concomitant use of indomethacin capsules and methotrexate, monitor patients for methotrexate toxicity.
Mechanism: Indomethacin can cause methotrexate to build up to dangerous levels in your body, which may harm your kidneys or blood cells.
NSAIDs and Salicylates Clinical Impact: Concomitant use of indomethacin with other NSAIDs or salicylates (e.g., diflunisal, salsalate) increases the risk of GI toxicity, with little or no increase in efficacy [ see Warnings and Precautions ( 5.2 ) ] . Combined use with diflunisal may be particularly hazardous because diflunisal causes significantly higher plasma levels of indomethacin [ see Clinical Pharmacology ( 12.3 ) ]. In some patients, combined use of indomethacin and diflunisal has been associated with fatal gastrointestinal hemorrhage.
Mechanism: Diflunisal causes the body to have much higher levels of indomethacin in the blood. This increases the risk of serious stomach bleeding without making the medicine work any better.
7.2 Platelet Inhibitors Drugs such as NSAIDS (including salicylic acid, ibuprofen, indomethacin, and celecoxib), dextran, phenylbutazone, thienopyridines, dipyridamole, hydroxychloroquine, glycoprotein IIb/IIIa antagonists (including abciximab, eptifibatide, and tirofiban), and others that interfere with platelet-aggregation reactions (the main hemostatic defense of heparinized patients) may induce bleeding and should be used with caution in patients receiving heparin sodium.
Mechanism: Both drugs make it harder for your blood to clot, which increases the risk of bleeding. Indomethacin stops platelets from sticking together, while heparin thins the blood.
Use of potassium-sparing diuretics (spironolactone, amiloride, triamterene and others), potassium supplements or other drugs capable of increasing serum potassium (indomethacin, heparin, cyclosporine and others) can increase the risk of hyperkalemia.
Mechanism: Using these medicines at the same time can cause your blood potassium levels to rise too high.
Table 3: Drugs that Can Increase the Risk of Bleeding Drug Class Specific Drugs Anticoagulants argatroban, dabigatran, bivalirudin, desirudin, heparin, lepirudin Antiplatelet Agents aspirin, cilostazol, clopidogrel, dipyridamole, prasugrel, ticlopidine Non-steroidal Anti-Inflammatory Agents celecoxib, diclofenac, diflunisal, fenoprofen, ibuprofen, indomethacin, ketoprofen, ketorolac, mefenamic acid, naproxen, oxaprozin, piroxicam, sulindac Serotonin Reuptake Inhibitors citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, fluvoxamine, milnacipran, paroxetine, sertraline,...
Mechanism: Indomethacin can irritate the stomach and slow down blood clotting. When combined with warfarin, these effects add up and significantly raise your chance of bleeding.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
Common Questions
Can I take indomethacin with aspirin?
What should I do if I experience severe stomach pain while taking indomethacin?
Can indomethacin affect my blood pressure?
Is it safe to take indomethacin if I have kidney problems?
Can indomethacin cause allergic reactions?
How long does it take for indomethacin to start working?
Can I drink alcohol while taking indomethacin?
Will indomethacin interact with my other medications?
Can indomethacin cause weight gain?
What if indomethacin doesn't seem to be working for me?
What are the common side effects of indomethacin?
Does indomethacin interact with other medications?
What drug class is indomethacin?
What pregnancy or breastfeeding source fields are listed for indomethacin?
Has indomethacin been recalled?
Active Recalls
cGMP deviations
Amerisource Health Services LLC
Failed Dissolution Specifications: below specification results
Glenmark Pharmaceuticals Inc., USA
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Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for indomethacin: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 12,919.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 11.57%.
- degarelix Δ 0.00 pts · 4,979 reports · GnRH Antagonist 11.57%death share
- rabeprazole Δ 0.01 pts · 21,352 reports · Proton Pump Inhibitor (PPI) 11.58%death share
- prazosin Δ 0.03 pts · 5,825 reports · Alpha-1 Blocker 11.61%death share
- tafluprost Δ 0.11 pts · 2,845 reports · Prostaglandin Analog (Ophthalmic) 11.46%death share
Medication Guides
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Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for indomethacin
The FDA label for indomethacin (sold under brand names such as Indocin) classifies it as a prescription-only medication in the Nonsteroidal Anti-Inflammatory Drug (NSAID) class. Indomethacin treats moderate to severe rheumatoid arthritis, ankylosing spondylitis, and osteoarthritis. Official labeling lists 4 commonly reported side effects, including Headache, Dizziness, Upset stomach.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 12,919 voluntary reports. The database also lists 35 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS shows a generic unit cost of $0.09.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 2 recall records on file), and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.
Last updated: October 17, 2025
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages