Prescription medicine
Indomethacin Brand names: Indocin
Indomethacin (Indocin) is a prescription medicine with an FDA approval on record since 1965. FDA's NDC Directory lists it from 31 generic labelers, and pharmacies paid $0.210 per indomethacin ER 75 mg capsule in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the indomethacin FDA label on DailyMed (effective December 19, 2025, Glenmark Pharmaceuticals Inc., USA); the NDA 16059 record on Drugs@FDA; every indomethacin label on DailyMed.
Highlights of the record
FDA label of December 19, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS.
See full prescribing information for complete boxed warning.
Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use ( 5.1 )
Indomethacin capsules are contraindicated in the setting of coronary artery bypass graft (CABG) surgery ( 4 , 5.1 )
NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events ( 5.2 ) Cardiovascular Thrombotic Events
Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use [ see Warnings and Precautions (5.1) ]. […]
Used for
From the label: indications and usageIndomethacin capsules are indicated for:
Moderate to severe rheumatoid arthritis including acute flares of chronic disease
Moderate to severe ankylosing spondylitis
Moderate to severe osteoarthritis
Acute painful shoulder (bursitis and/or tendinitis)
Acute gouty arthritis Indomethacin capsules are nonsteroidal anti-inflammatory drug indicated for:
Moderate to severe rheumatoid arthritis including acute fl
Forms and strengths
- 25 mg
- 50 mg
- 75 mg
- 1 mg/ml
- 25 mg/5ml
Capsule; extended-release capsule; suppository; injection (powder) (lyophilized) for solution; suspension.
On the market
- Earliest approval on file
- June 10, 1965 Indocin, Zyla Life Sciences; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 51 first September 4, 1985; 19 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 33 of which 31 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- April 23, 2030 Tivorbex capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.210 per capsule Indomethacin ER 75 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 9 since 2014 0 Class I among all firms' recalls; latest May 15, 2025
- FAERS reports
- 13,174 through July 30, 2026
What is indomethacin used for?
From the label: indications and usageIndomethacin capsules are indicated for:
Moderate to severe rheumatoid arthritis including acute flares of chronic disease
Moderate to severe ankylosing spondylitis
Moderate to severe osteoarthritis
Acute painful shoulder (bursitis and/or tendinitis)
Acute gouty arthritis Indomethacin capsules are nonsteroidal anti-inflammatory drug indicated for:
Moderate to severe rheumatoid arthritis including acute flares of chronic disease
Moderate to severe ankylosing spondylitis
Moderate to severe osteoarthritis
Acute painful shoulder (bursitis and/or tendinitis)
Acute gouty arthritis
Conditions named in the indications of indomethacin's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Nonsteroidal Anti-inflammatory Drug.
Source: FDA drug label (Indomethacin), 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 patient leaflet for indomethacin say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAIDs can cause serious side effects, including: • Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase: o with increasing doses of NSAIDs o with longer use of NSAIDs Do not take NSAIDs right before or after a heart surgery called a “coronary artery bypass graft (CABG).” Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack. • Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines: o anytime during use o without warning symptoms o that may cause death The risk of getting an ulcer or bleeding increases with: • past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs • taking medicines called “corticosteroids”, “anticoagulants”, “SSRIs”, or “SNRIs” • increasing doses of NSAIDs • older age • longer use of NSAIDs • poor health • smoking • advanced liver disease • drinking alcohol • bleeding problems NSAIDs should only be used: • exactly as prescribed • at the lowest dose possible for your treatment • for the shortest time needed
Source: FDA drug label (Indomethacin), Glenmark Pharmaceuticals Inc., USA, effective December 19, 2025 (SPL set f7ed39e2-5431-4e47-935c-c7441d058f94), via openFDA; the full label on DailyMed
Is there a generic for indomethacin (Indocin)?
The FDA approved the first generic indomethacin on September 4, 1985. 51 generic applications are approved; 19 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists indomethacin from 31 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Indocin oral suspension; a patent listed only for Tivorbex capsules runs to April 23, 2030. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1965 earliest approval on file
- 1985 first generic approved
- 2030 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for indomethacin (Indocin)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.210 per Indomethacin ER 75 mg capsule, down 1% from $0.212 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Indomethacin ER 75 mg capsule (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Indomethacin 25 mg capsule | Generic | $0.0934 per capsule | $2.80 | -11% |
| Indomethacin 50 mg capsule | Generic | $0.130 per capsule | $3.90 | -5% |
| Indomethacin ER 75 mg capsule | Generic | $0.210 per capsule | $6.30 | -1% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has indomethacin been recalled?
The FDA's Enforcement Report lists 9 recalls naming indomethacin since 2014: 0 Class I (the most serious), 8 Class II, 1 Class III; 5 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| May 15, 2025 | Class II | Amerisource Health Services LLC | cGMP deviations |
| May 9, 2025 | Class II | KVK Tech, Inc. | cGMP deviations |
| March 13, 2025 | Class II | Glenmark Pharmaceuticals Inc., USA | CGMP Deviations |
| July 31, 2024 | Class II | Glenmark Pharmaceuticals Inc., USA | Failed Dissolution Specifications: below specification results |
| November 7, 2023 | Class II | Glenmark Pharmaceuticals Inc., USA | Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen |
| July 18, 2018 | Class II | Hetero Labs, Ltd. - Unit III | Failed Tablet/Capsule Specifications: customer complaints of deformed, clumped, misshaped, melted or stuck together capsules. |
| March 19, 2018 | Class III | Glenmark Pharmaceuticals Inc., USA | Labeling: Incorrect Instructions: bottles incorrectly labeled with the usual adult dosage of "One or two capsules 2 or 3 times a day." rather than the correct … |
| March 24, 2014 | Class II | Teva Pharmaceuticals USA | CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the indomethacin label say about other medicines?
The indomethacin label names 19 other medicines in its interaction, contraindication or warning sections. The labels of 48 other medicines name indomethacin. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Amikacin | drug interactions | In one study of premature infants treated with Indomethacin for Injection and also receiving either gentamicin or amikacin, both peak and trough levels of these aminoglycosides were significantly elevated. |
| Aspirin | contraindications | History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. |
| Captopril | drug interactions | Indomethacin can reduce the antihypertensive effects of captopril and losartan. |
| Cyclosporine | drug interactions | Clinical Impact: Concomitant use of indomethacin capsules and cyclosporine may increase cyclosporine’s nephrotoxicity. Intervention: During concomitant use of indomethacin capsules and cyclosporine, monitor patients for signs of worsening renal function. NSAIDs and Salicylates |
| Dexamethasone | drug interactions | False-negative results in the dexamethasone suppression test (DST) in patients being treated with indomethacin have been reported. |
| Diflunisal | drug interactions | NSAIDs and Salicylates Clinical Impact: Concomitant use of indomethacin with other NSAIDs or salicylates (…) increases the risk of GI toxicity, with little or no increase in efficacy [ see Warnings and Precautions () ]. … Intervention: The concomitant use of indomethacin with other NSAIDs or salicylates, especially diflunisal, is not recommended. |
| Digoxin | drug interactions | Clinical Impact: The concomitant use of indomethacin with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin. Intervention: During concomitant use of indomethacin capsules and digoxin, monitor serum digoxin levels. |
| Furosemide | drug interactions | Diuretics Clinical Impact: Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients. … Intervention: Indomethacin and triamterene should not be administered together. During concomitant use of indomethacin capsules with diuretics, observe patients for signs of worsening renal function, in addition to … |
| Gentamicin | drug interactions | In one study of premature infants treated with Indomethacin for Injection and also receiving either gentamicin or amikacin, both peak and trough levels of these aminoglycosides were significantly elevated. |
| Lithium | drug interactions | Clinical Impact: NSAIDs have produced elevations in plasma lithium levels and reductions in renal lithium clearance. The mean minimum lithium concentration increased 15%, and the renal clearance decreased by approximately 20%. … Intervention: During concomitant use of indomethacin capsules and lithium, monitor patients for signs of lithium toxicity. |
| Losartan | drug interactions | Indomethacin can reduce the antihypertensive effects of captopril and losartan. |
| Meloxicam | drug interactions | Pemetrexed Clinical Impact: Concomitant use of indomethacin capsules and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (…). … potential interaction between pemetrexed and NSAIDs with longer half-lives (e.g., meloxicam, nabumetone), patients taking these NSAIDs should interrupt dosing for at least five days before, the day of, and two days … |
| Methotrexate | drug interactions | Methotrexate Clinical Impact: Concomitant use of NSAIDs and methotrexate may increase the risk for methotrexate toxicity (…). Intervention: During concomitant use of indomethacin capsules and methotrexate, monitor patients for methotrexate toxicity. |
| Nabumetone | drug interactions | Pemetrexed Clinical Impact: Concomitant use of indomethacin capsules and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (…). … interaction between pemetrexed and NSAIDs with longer half-lives (e.g., meloxicam, nabumetone), patients taking these NSAIDs should interrupt dosing for at least five days before, the day of, and two days following … |
Every other medicine the indomethacin label names
| Medicine named | Section | What the label says |
|---|---|---|
| Pemetrexed | drug interactions | Pemetrexed Clinical Impact: Concomitant use of indomethacin capsules and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (…). Intervention: During concomitant use of indomethacin capsules and pemetrexed, in patients with renal impairment whose creatinine clearance ranges from 45 to 79 mL/min, monitor for myelosuppression, renal and GI … |
| Probenecid | drug interactions | Clinical Impact: When indomethacin is given to patients receiving probenecid, the plasma levels of indomethacin are likely to be increased. Intervention: During the concomitant use of indomethacin capsules and probenecid, a lower total daily dosage of indomethacin may produce a satisfactory therapeutic effect. … |
| Propranolol | drug interactions | ACE Inhibitors, Angiotensin Receptor Blockers, and Beta-Blockers Clinical Impact: • NSAIDs may diminish the antihypertensive effect of angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or beta-blockers (including propranolol). … Intervention: • During concomitant use of indomethacin capsules and ACE-inhibitors, ARBs, or beta-blockers, monitor blood pressure to ensure that the desired blood pressure is obtained. … |
| Triamterene | drug interactions | Diuretics Clinical Impact: Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients. … Intervention: Indomethacin and triamterene should not be administered together. During concomitant use of indomethacin capsules with diuretics, observe patients for signs of worsening renal function, in addition to … |
| Warfarin | drug interactions | Drugs That Interfere with Hemostasis Clinical Impact: • Indomethacin and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of indomethacin and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone. … Intervention: Monitor patients with concomitant use of indomethacin capsules with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), selective serotonin reuptake inhibitors (SSRIs), and serotonin … |
Other labels that name indomethacin
Source: FDA drug label (Indomethacin), 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 for indomethacin?
The FDA Adverse Event Reporting System holds 13,174 reports that list indomethacin among the medicines taken, through July 30, 2026, 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.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as indomethacin?
25 other medicines are given the same way (oral) and in the same FDA class as indomethacin or labeled mainly for the same use (rheumatoid arthritis), the same class first. Rheumatoid arthritis lists all 46 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Ibuprofen | Osteoarthritis, Rheumatoid arthritis | 273 labelers | $0.0573 per tablet 800 mg tablet | No current entry |
| Naproxen | Osteoarthritis, Rheumatoid arthritis | 146 labelers | $0.0565 per tablet 500 mg tablet | No current entry |
| Celecoxib | Osteoarthritis, Rheumatoid arthritis | 65 labelers | $0.0762 per capsule 200 mg capsule | No current entry |
| Diclofenac | Osteoarthritis, Rheumatoid arthritis | 67 labelers | $0.0619 per tablet 75 mg tablet | A presentation being discontinued |
| Meloxicam | Osteoarthritis, Rheumatoid arthritis | 43 labelers | $0.0166 per tablet 7.5 mg tablet | No current entry |
| Etodolac | Osteoarthritis, Rheumatoid arthritis | 30 labelers | $0.262 per tablet 400 mg tablet | No current entry |
| Nabumetone | Osteoarthritis, Rheumatoid arthritis | 28 labelers | $0.128 per tablet 500 mg tablet | No current entry |
| Diclofenac and misoprostol | Osteoarthritis, Rheumatoid arthritis | 10 labelers | $0.665 per tablet 50-0.2 mg tablet | No current entry |
Every medicine labeled for the same conditions as indomethacin
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does indomethacin compare with medicines for the same use?
9 side-by-side pages set indomethacin beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to indomethacin
- 25 medicines for the same use
- Other NSAIDs
- the pharmacologic class, with prices and generics
- Indomethacin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other