indomethacin
Brand names: Indocin
Indomethacin is a drug that reduces pain and swelling. It belongs to a class of drugs called NSAIDs.
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.
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.
How to Take It
Take indomethacin capsules as directed by your doctor. For arthritis, the usual dose is 25 mg two or three times a day. For painful shoulder, the dose is 75 to 150 mg daily, divided into 3 or 4 doses. For gout, the dose is 50 mg three times a day.
Pregnancy & Breastfeeding
Using indomethacin during the later stages of pregnancy may harm your unborn baby. Limit use between 20 and 30 weeks of pregnancy, and avoid use after 30 weeks. Talk to your doctor if you are pregnant or plan to become pregnant.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule.
Storage
Store indomethacin capsules at room temperature (68°F to 77°F) and protect them from light.
Side Effects (from patient reports)
Based on 9,720 FDA adverse event reports.
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
Death-Related Reports
1,495
Hospitalization Reports
4,370
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | DRUG INEFFECTIVE | 1,371 |
| 2 | FATIGUE | 1,102 |
| 3 | ARTHRALGIA | 1,002 |
| 4 | HEADACHE | 990 |
| 5 | OFF LABEL USE | 939 |
| 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 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) 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.
What to do: Your doctor should monitor you closely for signs of drug toxicity while you are using both medications.
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.
What to do: Avoid taking these two medicines together. This combination is dangerous and has been linked to fatal bleeding in the stomach.
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.
What to do: Use this combination with caution. Your doctor should watch closely for any signs of bleeding.
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.
What to do: Your doctor may need to adjust your doses and will likely order regular blood tests to check your potassium.
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, venlafa...
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.
What to do: Monitor yourself closely for any unusual bleeding or bruising. Your healthcare provider should perform regular blood tests to ensure your blood does not become too thin.
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?
Is indomethacin safe during pregnancy?
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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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 9,720 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 further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.
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. Always consult a healthcare professional before making medication decisions.
Last updated: October 17, 2025
Read our methodology — how this data is sourced, computed, and verified.
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