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indomethacin

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Brand names: Indocin

Nonsteroidal Anti-Inflammatory Drug (NSAID) Rx

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.

The medicine is not working
1,369
Feeling tired
1,102
Joint pain
1,002
Head pain
990
Using the medicine for a different purpose than approved
939
Aches or soreness
921
Feeling sick to your stomach
907
Loose or watery stools
878
Feeling lightheaded
868
Difficulty breathing
744

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

Female 5,939 (52%)
Male 5,321 (47%)

Age Distribution

0–17 521
18–44 2,062
45–64 3,260
65–74 1,407
75+ 848

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

DYSPNOEA 315
DIARRHOEA 296
DIZZINESS 281
ARTHRALGIA 279
ASTHENIA 272
SEPSIS 270
PRURITUS 268
FATIGUE 262
INSOMNIA 262
CARDIO-RESPIRATORY ARREST 255

Reactions in Hospitalization Reports

PAIN 346
DYSPNOEA 322
DRUG INEFFECTIVE 315
ARTHRALGIA 297
PYREXIA 293
DIARRHOEA 290
FATIGUE 290
HEADACHE 267
DIZZINESS 263
VOMITING 262

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.

moderate diflunisal

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.

moderate heparin

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.

moderate perindopril

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.

moderate warfarin

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.

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Common Questions

Can I take indomethacin with aspirin?
It is generally not recommended to take indomethacin with aspirin due to the increased risk of bleeding.
What should I do if I experience severe stomach pain while taking indomethacin?
Stop taking indomethacin and contact your doctor immediately, as this could be a sign of a serious stomach problem.
Can indomethacin affect my blood pressure?
Yes, indomethacin can increase blood pressure. Your doctor may monitor your blood pressure while you are taking this medication.
Is it safe to take indomethacin if I have kidney problems?
Indomethacin can affect your kidneys. Talk to your doctor before taking this medicine if you have kidney problems.
Can indomethacin cause allergic reactions?
Yes, some people may experience allergic reactions to indomethacin. Seek emergency help if you have signs of a severe allergic reaction.
How long does it take for indomethacin to start working?
It may take a few days to a week to feel the full effects of indomethacin. Talk to your doctor if your symptoms do not improve.
Can I drink alcohol while taking indomethacin?
It is best to avoid alcohol while taking indomethacin, as it can increase the risk of stomach problems.
Will indomethacin interact with my other medications?
Indomethacin can interact with other medications. Tell your doctor about all the medicines you are taking.
Can indomethacin cause weight gain?
Weight gain is not a common side effect of indomethacin, but it can cause fluid retention in some people.
What if indomethacin doesn't seem to be working for me?
Talk to your doctor if indomethacin does not seem to be working. They may adjust your dose or suggest a different treatment.
What are the common side effects of indomethacin?
The most commonly reported side effects of indomethacin include Headache, Dizziness, Upset stomach, Nausea. Based on 9,720 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does indomethacin interact with other medications?
Yes, indomethacin has 35 known drug interactions. Notable interactions include methotrexate, diflunisal, heparin. Always inform your doctor about all medications you are taking.
What drug class is indomethacin?
indomethacin belongs to the Nonsteroidal Anti-Inflammatory Drug (NSAID) drug class. It requires a prescription (Rx). Indomethacin treats moderate to severe rheumatoid arthritis, ankylosing spondylitis, and osteoarthritis.
Is indomethacin safe during pregnancy?
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. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.
Has indomethacin been recalled?
There are 2 recalls associated with indomethacin products. cGMP deviations. Check the recalls section below for full details and affected products.

Active Recalls

Class II May 15, 2025

cGMP deviations

Amerisource Health Services LLC

Class II July 31, 2024

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

All federal data sources used on this page