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Indomethacin

Indomethacin is a nonsteroidal anti-inflammatory drug (NSAID) used for arthritis, gout, and shoulder pain in oral and rectal forms, and to close a patent ductus arteriosus in premature infants in its intravenous form.

Brand names IndocinTivorbex
Drug class Nonsteroidal Anti-inflammatory Drug
Rx Forms 5
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 73 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 7, 2026 🚨Recall on record · 5
Other forms & routes:
Rectal
Indomethacin at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Indomethacin is a strong, older NSAID (nonsteroidal anti-inflammatory drug), on the market since about 1965 and available generically, that cuts the chemicals driving pain and swelling; it is a common pick for gout flares and also treats rheumatoid arthritis, ankylosing spondylitis, osteoarthritis and acute shoulder pain. It works well but is harder on many people than other NSAIDs, with headache and dizziness standing out beside heartburn and nausea, so see how it affects you before driving. Its boxed warning covers serious, sometimes fatal heart attack, stroke and stomach bleeding, so use the lowest dose for the shortest time and get help for chest pain, black stools or vomiting blood.

Clinical pearls

  • Take the extended-release capsules with food, right after a meal, or with an antacid to ease stomach irritation.
  • Skip over-the-counter ibuprofen, naproxen and aspirin while on it, since stacking NSAIDs raises the risk of stomach bleeding.
  • If you take lithium, methotrexate or digoxin, make sure that prescriber knows, since indomethacin can push those levels too high.
  • The IV form is a separate hospital-only use, closing an open heart vessel (patent ductus arteriosus) in premature infants.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Indomethacin, like other NSAIDs, raises the risk of serious and sometimes fatal heart attacks, strokes, and stomach or intestinal bleeding. The heart risk can begin early and may grow the longer you take it. Indomethacin extended-release capsules must not be used around CABG surgery.

Stomach bleeding, ulcers, and perforation (a hole in the stomach or intestine) can happen at any time and often without warning symptoms. Older adults and people with a past ulcer or GI bleeding are at greatest risk. Watch for chest pain, shortness of breath, weakness on one side, black stools, or vomiting blood.

Read the full warning on DailyMed →
How you get itPrescription only
Comes asCapsule, Extended-release capsule, Rectal suppository +2
Earliest FDA record1965
Companies listing it with the FDA32
FDA label last updatedMar 26, 2025
FDA’s strongest warning (boxed)Yes, read the warning

Patient information guide A plain-language walkthrough of Indomethacin, written from its FDA label.

What Indomethacin is used for

▾

Indomethacin is used for different conditions depending on the product.

  • Indocin oral suspension and Indocin suppositories: moderate to severe rheumatoid arthritis, including acute flares
  • Indocin oral suspension and Indocin suppositories: moderate to severe ankylosing spondylitis
  • Indocin oral suspension and Indocin suppositories: moderate to severe osteoarthritis
  • Indocin oral suspension and Indocin suppositories: acute painful shoulder (bursitis and/or tendinitis)
  • Indocin oral suspension and Indocin suppositories: acute gouty arthritis
  • Indomethacin for Injection (intravenous): closing a hemodynamically significant patent ductus arteriosus in premature infants weighing 500 to 1,750 g, when 48 hours of usual medical management has not worked

How Indomethacin works

▾

Indomethacin blocks cyclooxygenase (COX-1 and COX-2) enzymes and is a potent inhibitor of prostaglandin synthesis. Prostaglandins make nerves more sensitive to pain and drive inflammation. Lowering them helps reduce pain, swelling, and fever.

The exact mechanism is not completely understood.

Indomethacin dosage

▾

Indomethacin comes as capsules, extended-release capsules, an oral suspension, and rectal suppositories. A healthcare team gives the intravenous injection. Doses and how often you take it depend on the condition, and your prescriber may adjust it based on how you respond.

  • Use the lowest effective dose for the shortest time.
  • Extended-release capsules are taken with food, right after meals, or with antacids.
  • Suppositories are not for oral or vaginal use.
  • Follow your prescriber’s directions and your product label.

Dosing details from the FDA-approved label

From the Indomethacin prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Moderate to severe rheumatoid arthritis including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis
    • Indomethacin capsules, USP 25 mg twice a day or three times a day
    • If well tolerated, increase the daily dosage by 25 mg or by 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150-200 mg is reached
    • Oral suspension: INDOCIN 25 mg (5 mL) twice a day or three times a day
    • Maximum: The total daily dose should not exceed 200 mg (40 mL for suspension)
    • Use with greater care in the elderly; up to a maximum of 100 mg of the total daily dose may be given at bedtime for persistent night pain/morning stiffness
  • Acute painful shoulder (bursitis and/or tendinitis)
    • Indomethacin capsules, USP 75-150 mg daily in 3 or 4 divided doses (suspension: 75-150 mg (15-30 mL) daily in 3 or 4 divided doses)
    • The usual course of therapy is 7-14 days
    • Discontinue after signs and symptoms of inflammation have been controlled for several days
  • Acute gouty arthritis
    • Indomethacin capsules, USP 50 mg three times a day until pain is tolerable, then rapidly reduced to complete cessation of the drug (suspension: 50 mg (10 mL) three times a day)
  • Indomethacin extended-release capsules (all indications of indomethacin capsules except acute gouty arthritis)
    • 75 mg once a day can be substituted for indomethacin 25 mg capsules t.i.d
    • 75 mg b.i.d. can be substituted for indomethacin 50 mg capsules t.i.d
    • Always give with food, immediately after meals or with antacids
  • Pediatric use
    • Indomethacin ordinarily should not be prescribed for children 14 years of age and under
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION • Use the lowest effective dosage for shortest duration consistent with individual patient treatment goals ( 2.1 ) • The dosage for moderate to severe rheumatoid arthritis including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis is one indomethacin extended-release 75 mg capsule daily ( 2.2 ) • The dosage for acute painful shoulder (bursitis and/or tendinitis) is one indomethacin extended-release 75 mg capsule once or twice daily ( 2.3 ) 2.1 General Dosing Instructions Carefully consider the potential benefits and risks of indomethacin extended-release and other treatment options before deciding to use indomethacin extended-release capsules. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [ see Warnings and Precautions ( 5 ) ]. After observing the response to initial therapy with indomethacin, the dose and frequency should be adjusted to suit an individual patient’s needs. Adverse reactions generally appear to correlate with the dose of indomethacin. Therefore, every effort should be made to determine the lowest effective dosage for the individual patient. THIS SECTION PREDOMINANTLY REFERENCES THE INDOMETHACIN IMMEDIATE-RELEASE CAPSULE ORAL DOSAGE AND IS INTENDED TO PROVIDE GUIDANCE IN USING INDOMETHACIN EXTENDED-RELEASE CAPSULES, 75 MG. Indomethacin extended-release capsules, 75 mg once a day can be substituted for indomethacin immediate-release capsules, 25 mg three times a day. However, there will be significant differences between the two dosage regimens in indomethacin blood levels, especially after 12 hours [ see Clinical Pharmacology ( 12 ) ]. In addition, indomethacin extended-release capsules, 75 mg twice a day can be substituted for indomethacin immediate-release capsules, USP 50 mg three times a day. Indomethacin extended-release capsules may be substituted for all the indications for indomethacin immediate-release capsules, USP except acute gouty arthritis. Dosage Recommendations for Active Stages of the Following: 2.2 Moderate to severe rheumatoid arthritis including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis Indomethacin immediate-release capsules, 25 mg twice a day or three times a day.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Indomethacin side effects

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The most common side effects are:

Common side effects

  • Headache
  • Dizziness
  • Indigestion or heartburn
  • Nausea, with or without vomiting
  • Diarrhea
  • Abdominal pain or discomfort
  • Constipation

When to get medical help

  • Chest pain, shortness of breath, weakness on one side of the body, or slurred speech can signal a heart attack or stroke. Get emergency help.
  • Black or bloody stools, vomiting blood, or severe stomach pain can signal bleeding or an ulcer. Stomach problems can happen without warning.
  • Yellow skin or eyes, severe fatigue, nausea, or flu-like symptoms may signal liver problems. Call your doctor.
  • Stop the drug and call right away for a skin rash, blisters, fever, or facial swelling. These can be serious skin or allergic reactions.
  • Swelling, rapid weight gain, or worsening heart failure symptoms need prompt medical attention.
  • Seek emergency help for signs of a severe allergic reaction, such as trouble breathing or swelling of the face or throat.
  • Blurred vision or other vision changes need a prompt eye exam.
  • Rectal bleeding or rectal irritation should be reported to your doctor.

Indomethacin warnings and precautions

▾
  • Heart attack and stroke: The risk can start early and rises with longer use or higher doses. Do not use around CABG surgery.
  • Stomach and intestinal bleeding: Ulcers and perforation can happen without warning, especially in older adults and people with past ulcers or bleeding.
  • Blood pressure and heart failure: It can raise blood pressure and cause fluid retention or worsen heart failure.
  • Kidneys and liver: It can cause kidney injury, raise potassium, and affect liver tests.
  • Skin and allergic reactions: Stop at the first rash or sign of hypersensitivity.
  • Eyes and nervous system: Long-term use can cause corneal deposits and retinal changes. It can cause drowsiness and may worsen depression, epilepsy, or parkinsonism.

Indomethacin interactions

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Indomethacin can interact with several types of medicine.

  • Warfarin, aspirin, SSRIs, and SNRIs: higher bleeding risk
  • Other NSAIDs and salicylates, especially diflunisal: more stomach toxicity
  • ACE inhibitors, ARBs, beta-blockers, and diuretics: weaker blood pressure control and possible kidney effects
  • Triamterene: should not be taken together, due to risk of kidney failure
  • Digoxin, lithium, methotrexate, cyclosporine, and pemetrexed: higher levels or toxicity
  • Probenecid: raises indomethacin levels
  • Alcohol and smoking: raise the risk of stomach bleeding

Interactions listed in the FDA-approved label

From the Indomethacin prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Anticoagulants (e.g., warfarin), antiplatelet agents, SSRIs, SNRIs (drugs that interfere with hemostasis): Synergistic effect on bleeding, with increased risk of serious bleeding compared to either drug alone. Monitor patients for signs of bleeding.
  • Aspirin: No greater therapeutic effect than the NSAID alone, and a significantly increased incidence of GI adverse reactions. Concomitant use with analgesic doses of aspirin is not generally recommended; indomethacin is not a substitute for low dose aspirin for cardiovascular protection.
  • ACE inhibitors, angiotensin receptor blockers, beta-blockers: NSAIDs may diminish the antihypertensive effect; in elderly, volume-depleted or renally impaired patients, ACE inhibitor/ARB co-administration may deteriorate renal function, including possible acute renal failure. Monitor blood pressure; monitor renal function in high-risk patients; ensure adequate hydration.
  • Diuretics (loop, thiazide, triamterene, potassium-sparing): NSAIDs reduced the natriuretic effect of loop and thiazide diuretics; triamterene with indomethacin resulted in reversible acute renal failure in two of four healthy volunteers; potassium levels may increase. Indomethacin and triamterene should not be administered together; observe for worsening renal function and diuretic efficacy.
  • Digoxin: Reported to increase serum concentration and prolong the half-life of digoxin. Monitor serum digoxin levels.
  • Lithium: Elevated plasma lithium levels and reduced renal lithium clearance; mean minimum lithium concentration increased 15% and renal clearance decreased by approximately 20%. Monitor patients for signs of lithium toxicity.
  • Methotrexate: May increase the risk for methotrexate toxicity (e.g., neutropenia, thrombocytopenia, renal dysfunction). Monitor patients for methotrexate toxicity.
  • Cyclosporine: May increase cyclosporine's nephrotoxicity. Monitor for signs of worsening renal function.
  • Other NSAIDs and salicylates (e.g., diflunisal, salsalate): Increases the risk of GI toxicity with little or no increase in efficacy; diflunisal raises indomethacin plasma levels and combined use has been associated with fatal GI hemorrhage. Concomitant use, especially with diflunisal, is not recommended.
  • Pemetrexed: May increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity. With creatinine clearance 45 to 79 mL/min, monitor for toxicity; avoid indomethacin for two days before, the day of, and two days following pemetrexed administration.
Read the label’s full interactions text

7 DRUG INTERACTIONS See Table 2 for clinically significant drug interactions with indomethacin. Table 2 Clinically Significant Drug Interactions with Indomethacin Dr ugs That Interfere with Hemostasis C linica l 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. Serotonin release by platelets plays an important role in hemostasis. Case-control and cohort epidemiological studies showed that concomitant use of drugs that interfere with serotonin reuptake and an NSAID may potentiate the risk of bleeding more than an NSAID alone. Intervention: Monitor patients with concomitant use of indomethacin extended-release capsules with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs) for signs of bleeding [ see Warnings and Precautions (5.12) ]. Aspirin C linica l Impact: Controlled clinical studies showed that the concomitant use of NSAIDs and analgesic doses of aspirin does not produce any greater therapeutic effect than the use of NSAIDs alone. In a clinical study, the concomitant use of an NSAID and aspirin was associated with a significantly increased incidence of GI adverse reactions as compared to use of the NSAID alone [ see Warnings and Precautions (5.2) ]. Intervention: Concomitant use of indomethacin extended-release capsules and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding [ see Warnings and Precautions (5.12) ]. Indomethacin extended-release capsules are not a substitute for low dose aspirin for cardiovascular protection.

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

🌿100 supplements and herbs with documented Indomethacin interactions, ranked by severity Check Indomethacin against a supplement or herb →

Before taking Indomethacin

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  • Do not use if you are allergic to indomethacin, or if aspirin or NSAIDs have caused asthma, hives, or allergic reactions.
  • Do not use around CABG surgery.
  • Suppositories should not be used with a history of proctitis or recent rectal bleeding.
  • Tell your doctor about ulcers, GI bleeding, heart disease, high blood pressure, heart failure, kidney or liver disease, or dehydration.
  • Pregnancy: avoid at about 30 weeks and later; limit use between about 20 and 30 weeks.
  • Breastfeeding: it may be present in breast milk, so discuss with your doctor.
  • Children: safety in those 14 and younger has not been established for the extended-release capsules.
  • Older adults are at higher risk for serious stomach bleeding.

Indomethacin overdose

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Overdose can cause lethargy, drowsiness, nausea, vomiting, and stomach pain. Bleeding in the stomach or intestines can occur. Rarely it causes high blood pressure, acute kidney failure, slowed breathing, or coma. There is no specific antidote, and treatment is supportive. Call a poison control center at 1-800-222-1222 or seek emergency care.

What Indomethacin does in the body

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Indomethacin has pain-relieving, anti-inflammatory, and fever-reducing effects. It strongly inhibits prostaglandin synthesis, which lowers prostaglandins in tissues. It also reduces plasma renin activity.

How your body processes Indomethacin

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Oral indomethacin is absorbed quickly and almost completely, with peak levels at about 2 hours. Extended-release capsules release some drug right away and the rest over about 12 hours. It is about 99% bound to plasma proteins, crosses the placenta, and appears in breast milk. It is cleared by the kidneys, liver metabolism, and bile, with a half-life of about 4.5 hours.

How to store Indomethacin

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Store at 20° to 25°C (68° to 77°F) . Protect from moisture

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

100

Supplements & herbs that interact with Indomethacin

100 supplements and herbal products have documented interactions with Indomethacin in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 5
  • Moderate · 68
  • Minor · 27
ACTIVATED CHARCOAL Major ASARABACCA Major BEER Major SIBERIAN COCKLEBUR Major WINE Major ADRAFINIL Moderate AFRICAN WILD POTATO Moderate ARISTOLOCHIA Moderate +92 more
Every supplement checked against Indomethacin — ranked by severity The full interaction hub: 5 major · 68 moderate · 27 minor · every one linked to its full report. Check Indomethacin against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

1

Nutrient depletion considerations

Indomethacin has been associated with lower levels of 1 nutrient in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.

FOLIC ACID Insufficient Evidence
See the full Indomethacin nutrient depletion report

Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.

Indomethacin: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Indomethacin — the kind of thing our pharmacy team would talk through with you at the counter.

What is indomethacin used for?

▾
Oral and rectal Indocin products treat arthritis conditions like rheumatoid arthritis, ankylosing spondylitis, and osteoarthritis. They also treat acute gouty arthritis and acute painful shoulder. The IV form is a different use: it closes a patent ductus arteriosus in premature infants.

How should I take it?

▾
Take it exactly as prescribed, using the lowest dose that works for the shortest time. Extended-release capsules should be taken with food, right after a meal, or with antacids to protect your stomach. Suppositories are only for rectal use, never by mouth or vaginally.

What side effects should I expect?

▾
The most common ones are headache, dizziness, indigestion or heartburn, and nausea. Many people also get diarrhea, stomach pain, or constipation. Tell me if these bother you or don’t go away.

When should I call my doctor right away?

▾
Get help for chest pain, shortness of breath, weakness on one side, or slurred speech. Also call for black or bloody stools, vomiting blood, severe stomach pain, yellow skin or eyes, a skin rash, or swelling of the face. Stomach bleeding can happen without warning, so don’t wait.

Can I take it with other medicines?

▾
Check with me first. It can raise bleeding risk with warfarin, aspirin, and SSRIs. It can also weaken blood pressure medicines and diuretics, and it should not be combined with triamterene. Avoid other NSAIDs unless your doctor says otherwise.

Is it safe in pregnancy?

▾
It should be avoided at about 30 weeks of pregnancy and later because it can harm the baby’s heart vessel and kidneys. Between about 20 and 30 weeks, it should be limited to the lowest dose for the shortest time. Tell your doctor if you are pregnant or trying to conceive.

Is Indomethacin available over the counter?

▾
No. Indomethacin is a prescription medicine: every Indomethacin product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Indomethacin first available?

▾
The earliest FDA record we hold for Indomethacin is from 1965: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Indomethacin was first used.

Who makes Indomethacin?

▾
32 companies currently list Indomethacin products in the FDA's NDC Directory, including Bryant Ranch Prepack, A-S Medication Solutions, PD-Rx Pharmaceuticals, Inc.. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Indomethacin on HelloPharmacist

📊Indomethacin supplement interactions100 checked — ranked by severity 🌿Drug & Supplement CheckerIndomethacin vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Indomethacin NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Indomethacin Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Indomethacin forms and strengths (how it comes)

Indomethacin is available in 5 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Indomethacin inactive ingredients by manufacturer.

Capsule

By mouth
How this form is used
What it may be used for
  • Indomethacin capsules are used for moderate to severe rheumatoid arthritis, ankylosing spondylitis, and osteoarthritis.
  • Indomethacin capsules are also used for acute painful shoulder and acute gouty arthritis.
Important instructions
  • Indomethacin capsules are taken by mouth, generally two to four times a day depending on the condition.
  • Indomethacin capsules should be used at the lowest effective dose for the shortest time.
Available strengths 2 strengths
25 mg 50 mg
142 FDA-listed product records ⓘ

Extended-release capsule

By mouth
How this form is used
What it may be used for
  • Indomethacin extended-release capsules may be substituted for the uses of indomethacin capsules except acute gouty arthritis.
Important instructions
  • Indomethacin extended-release capsules can be taken once a day in place of three daily doses of regular capsules, but blood levels differ between the two.
  • Always take indomethacin extended-release capsules with food, right after meals, or with antacids to reduce stomach irritation.
Available strengths 1 strength
75 mg
38 FDA-listed product records ⓘ

Rectal suppository

Rectal
Brands Indocin
How this form is used
What it may be used for
  • Indocin suppositories are used for moderate to severe rheumatoid arthritis, ankylosing spondylitis, and osteoarthritis.
  • Indocin suppositories are also used for acute painful shoulder and acute gouty arthritis.
Important instructions
  • Indocin suppositories are not for oral or vaginal use.
  • Indocin suppositories can be substituted for indomethacin capsules, but blood levels differ between the two.
  • Indocin suppositories should not be used if you have a history of proctitis or recent rectal bleeding.
Available strengths 1 strength
50 mg
11 FDA-listed product records ⓘ

Injection

Into a vein
How this form is used
What it may be used for
  • Indomethacin for Injection is used to close a hemodynamically significant patent ductus arteriosus in premature infants weighing 500 to 1,750 g when 48 hours of usual medical management is ineffective.
Important instructions
  • Indomethacin for Injection is for intravenous use only.
  • Indomethacin for Injection is given as a course of three intravenous doses 12 to 24 hours apart, with the dose based on the infant’s age.
  • With Indomethacin for Injection, urinary output is watched closely during treatment.
Available strengths 1 strength
1 mg/mL
7 FDA-listed product records ⓘ

Oral suspension

By mouth
Brands Indocin
How this form is used
What it may be used for
  • Indocin oral suspension is used for moderate to severe rheumatoid arthritis, ankylosing spondylitis, and osteoarthritis.
  • Indocin oral suspension is also used for acute painful shoulder (bursitis and/or tendinitis) and acute gouty arthritis.
Important instructions
  • Indocin oral suspension is taken by mouth, generally two to four times a day depending on the condition.
  • Indocin oral suspension should be used at the lowest effective dose for the shortest time.
Available strengths 1 strength
25 mg/5 mL
4 FDA-listed product records ⓘ

Indomethacin on the U.S. market: products, makers and brands

How Indomethacin appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

32 companies list 83 Indomethacin product records with the FDA, mostly as capsule, extended-release capsule, rectal suppository; the earliest marketing or approval year on record is 1965. Brand names on the directory include Indocin, Tivorbex; the rest are generics.

5
Dose forms ⓘ
32
Labelers (makers, repackagers, distributors)
3
Brand names
83
FDA-listed product records ⓘ
1965
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (10) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Bryant Ranch Prepack18%
A-S Medication Solutions8%
PD-Rx Pharmaceuticals, Inc.7%
Proficient Rx LP6%
Camber Pharmaceuticals, Inc.5%
Northwind Health Company, LLC5%
Other makers51%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Indomethacin is used (Medicaid data)

A general measure of how commonly Indomethacin is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Indomethacin is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

142,731
Medicaid prescriptions filled (Q1–Q4 2025)
$2.4M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Indomethacin prescribed? Of the 1,601 medications we measure, Indomethacin ranks #445 by Medicaid prescriptions — more than 72% of them.

Where Indomethacin ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #445 of 1,601
#440 Vancomycin 145,157 Rx #441 Levodopa and Carbidopa 143,727 Rx #442 Roflumilast 143,447 Rx #443 Scopolamine Transderma... 143,028 Rx #444 Somatropin 142,879 Rx #445 Indomethacin 142,731 Rx #446 Lovastatin 141,955 Rx #447 Regadenoson 141,955 Rx #448 Dexlansoprazole 141,938 Rx #449 Levocarnitine 141,917 Rx #450 Acetazolamide 141,794 Rx

Utilization by Indomethacin product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 50 mg oral capsule is the most-dispensed Indomethacin product — about 65% of these Medicaid prescriptions.

indomethacin 50 MG Oral Capsule Most dispensed

93,086 Medicaid prescriptions (Q1–Q4 2025) 65% of Indomethacin prescriptions shown $1.2M gross reimbursement (before rebates) ≈ $13 per prescription (gross)

Summed across the 3 of 136 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 197818

indomethacin 25 MG Oral Capsule

43,755 Medicaid prescriptions (Q1–Q4 2025) 31% of Indomethacin prescriptions shown $523,339 gross reimbursement (before rebates) ≈ $12 per prescription (gross)

Summed across the 4 of 127 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 197817

indomethacin 75 MG Extended Release Oral Capsule

5,455 Medicaid prescriptions (Q1–Q4 2025) 4% of Indomethacin prescriptions shown $95,881 gross reimbursement (before rebates) ≈ $18 per prescription (gross)

Summed across the 6 of 127 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 310992

indomethacin 5 MG/ML Oral Suspension

369 Medicaid prescriptions (Q1–Q4 2025) <1% of Indomethacin prescriptions shown $541,024 gross reimbursement (before rebates) ≈ $1,466 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 310991

indomethacin 50 MG Rectal Suppository

66 Medicaid prescriptions (Q1–Q4 2025) <1% of Indomethacin prescriptions shown $38,266 gross reimbursement (before rebates) ≈ $580 per prescription (gross)

Summed across the 1 of 14 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 197819

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Indomethacin, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 15 of 407 listed Indomethacin NDCs with Medicaid activity.

Compare Indomethacin products

A representative set of FDA-listed product records for Indomethacin — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 83 of 83 products — FDA National Drug Code Directory. See every product, package size and price: browse all 83 Indomethacin NDCs →

Indomethacin recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list 5 Indomethacin recalls since July 2021. All of them are still ongoing or began in the last six months. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Ongoing Class II May 15, 2025 · Amerisource Health Services LLC
cGMP deviations
  • Indomethacin Extended-Release Capsules, USP, 75 mg, 30 capsules (3 x 10 blister cards) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-411-21 (carton),… Lots: Lot #: 1021950, Exp. 11/30/2026 FDA record D-0454-2025 →
Ongoing Class II May 9, 2025 · KVK Tech, Inc.
cGMP deviations
  • Indomethacin Extended-Release Capsules USP, 75 mg, 100-count bottle, Rx only, Mfd. By: KVK-Tech, Inc., Newtown, PA, 18940, Made in USA, NDC 10702-016-01. Lots: Lot#: 18400A, Exp 7/31/2027 FDA record D-0445-2025 →
Ongoing Class II Mar 13, 2025 · Glenmark Pharmaceuticals Inc., USA
CGMP Deviations
  • Indomethacin Extended-Release Capsules, 75mg, 60-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals… Lots: Lot # 17232323, exp. date Oct-25 17232335, exp. date Oct-25 17232323, exp. date Oct-25 FDA record D-0329-2025 →
Ongoing Class II Jul 31, 2024 · Glenmark Pharmaceuticals Inc., USA
Failed Dissolution Specifications: below specification results
  • Indomethacin Extended-Release Capsules, USP, 75 mg, packaged in a) 60-count bottle (NDC 68462-325-60) and b) 90-count bottle (NDC 68462-325-90), Rx Only, Manufactured by: Glenmark Pharmaceuticals Lim… Lots: Lot#: 17240105, Exp 12/31/2025 FDA record D-0643-2024 →
Ongoing Class II Nov 7, 2023 · Glenmark Pharmaceuticals Inc., USA
Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen
  • Indomethacin 25mg Capsules, USP, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahw… Lots: Lot# 19231903; Exp 4/2025 Lot# 19231858; Exp 4/2025 Lot# 19231881; Exp 4/2025 Lot# 19233484; Exp 8/2025 Lot# 19233490; Exp 8/2025 FDA record D-0123-2024 →

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Indomethacin RxCUI 5781 5 dose forms · 11 strengths
  1. Dose form (SCDF) Extended Release Oral Capsule RxCUI 370689 In current FDA listings
    Clinical drug / strength (SCD) 25 MG RxCUI 251255 75 MG RxCUI 310992
  2. Dose form (SCDF) Injection RxCUI 1863327 In current FDA listings
    Clinical drug / strength (SCD) 1 MG RxCUI 346508
  3. Dose form (SCDF) Oral Capsule RxCUI 370687 In current FDA listings
    Clinical drug / strength (SCD) 20 MG RxCUI 1490727 25 MG RxCUI 197817 40 MG RxCUI 1491529 50 MG RxCUI 197818 75 MG RxCUI 392073
  4. Dose form (SCDF) Oral Suspension RxCUI 370686 In current FDA listings
    Clinical drug / strength (SCD) 5 MG/ML RxCUI 310991
  5. Dose form (SCDF) Rectal Suppository RxCUI 370688 In current FDA listings
    Clinical drug / strength (SCD) 50 MG RxCUI 197819 100 MG RxCUI 199549

Look up RxCUI 5781 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Indomethacin costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Capsule · Oral 50 mg $0.130 per capsule NDC details & price history
Capsule · Oral 25 mg $0.093 per capsule NDC details & price history
Capsule, Extended Release · Oral 75 mg $0.210 per capsule NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Indomethacin brand names

Indomethacin is sold under 2 brand names in the FDA directory — Indocin, Tivorbex. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Indocin Tivorbex

Who makes Indomethacin: manufacturers and labelers

32 companies list Indomethacin products with the FDA. By number of product records, the largest are Bryant Ranch Prepack, A-S Medication Solutions, PD-Rx Pharmaceuticals, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Bryant Ranch Prepack 15 A-S Medication Solutions 7 PD-Rx Pharmaceuticals, Inc. 6 Proficient Rx LP 5 Camber Pharmaceuticals, Inc. 4 Northwind Health Company, LLC 4 Direct Rx 3 Glenmark Pharmaceuticals Inc., USA 3 NuCare Pharmaceuticals, Inc. 3 Preferred Pharmaceuticals Inc. 3 Remedyrepack Inc. 3 Asclemed USA, Inc. 2 AvPAK 2 Chartwell RX, LLC 2 St. Mary's Medical Park Pharmacy 2 XLCare Pharmaceuticals Inc. 2 Zydus Pharmaceuticals USA Inc. 2 ANI Pharmaceuticals, Inc. 1 Advanced Rx Pharmacy of Tennessee, LLC 1 American Health Packaging 1 Amneal Pharmaceuticals LLC 1 Amneal Pharmaceuticals NY LLC 1 Coupler LLC 1 Fresenius Kabi USA, LLC 1

…and 8 more on the FDA NDC directory.

Indomethacin drug class (RxNorm)

Indomethacin belongs to the Nonsteroidal Anti-inflammatory Drug class.

Pharmacologic class Nonsteroidal Anti-inflammatory Drug
Drug family (ATC) Other cardiac preparations, Acetic acid derivatives and related substances, Antiinflammatory preparations, non-steroids for topical use
How it works Cyclooxygenase Inhibitors

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Indomethacin page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Mar 26, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Indomethacin.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Indomethacin after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
73
Finished products in the current FDA directory
83
Companies listing them (makers, repackagers, distributors)
32
FDA labeler codes behind them ⓘ
36
Linked representative label ⓘ
Chartwell RX, LLC
Linked label effective
Mar 26, 2025
Composite sections available
24
Linked SPL Set ID
9607920c-4d25-40b9-957e-87e9ca5574e8
Linked SPL Document ID
3143c8a1-9d17-9eb6-e063-6394a90ab16b
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Chartwell RX, LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →