Last reviewed 2026-04-20 · How we verify

Indocin Sr (INDOMETHACIN)

Indomethacin works by blocking the production of prostaglandins, which are hormone-like substances that cause pain and inflammation.

Indocin Sr (Indomethacin) is a nonsteroidal anti-inflammatory drug (NSAID) that targets the prostaglandin E2 receptor EP2 subtype. Originally developed in the 1960s, it is now owned by Zyla Life Sciences and is used to treat various conditions such as ankylosing spondylitis, osteoarthritis, and rheumatoid arthritis. Indocin Sr is a small molecule modality with a bioavailability of 99% and a half-life of 1.4 hours. It is off-patent and has multiple generic manufacturers. Key safety considerations include gastrointestinal side effects and potential kidney damage.

At a glance

Mechanism of action

Mechanism of ction Indomethacin has analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of TIVORBEX, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2).Indomethacin is potent inhibitor of prostaglandin synthesis in vitro. Indomethacin concentrations reached during therapy have produced in vivo effects. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models. Prostaglandins are mediators of inflammation. Because indomethacin is an inhibitor of prostaglandin synthesis, its mode of action may be due to decrease of prostaglandins in peripheral tissues.

Approved indications

• Ankylosing spondylitis
• Bursitis
• Bursitis of shoulder
• Gout
• Osteoarthritis
• Patent ductus arteriosus
• Rheumatoid arthritis
• Shoulder Tendonitis
• Synovitis
• Tendinitis
• Tenosynovitis

Boxed warnings

• WARNING: 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) ]. Indomethacin capsules are contraindicated in the setting of coronary artery bypass graft (CABG) surgery [ see Contraindications (4) and Warnings and Precautions (5.1) ] . Gastrointestinal Bleeding, Ulceration, and Perforation 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 [ see Warnings and Precautions (5.2) ].

Common side effects

• Nausea
• Dyspepsia
• Diarrhea
• Abdominal distress or pain
• Constipation
• Anorexia
• Bloating
• Flatulence
• Peptic ulcer
• Gastroenteritis
• Rectal bleeding
• Proctitis

Drug interactions

• irbesartan
• labetalol
• lisinopril
• lithium
• losartan
• methotrexate
• metoprolol
• moexipril
• nadolol
• penbutolol
• phenprocoumon
• pindolol

Key clinical trials

• Drug Repurposing in Thyroid Carcinoma: a Feasibility Trial (PHASE1)
• Prophylactic PS Placement to Prevent Pancreatitis After Endoscopic Transpapillary GPC for Cholelithiasis With Concomitant Choledocholithiasis (NA)
• Paracervical Block With Combined Ketorolac and Lidocaine for Osmotic Dilator Placement (PHASE2)
• Study Comparing Transobturator Cystocele vs. Anterior Vaginal RepairS (NA)
• Nonopioid Analgesia After Anterior Cruciate Ligament Reconstruction (PHASE2,PHASE3)
• The Efficiency of Periarticular Multimodal Drug Injection in Pain Management Following Primary Unilateral TKA (NA)
• Rectal Indomethacin vs Intravenous Ketorolac (PHASE4)
• E7 TCR T Cells for Human Papillomavirus-Associated Cancers (PHASE1,PHASE2)

Patents

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.