Active Ingredient History
Indometacin (INN and BAN) or indomethacin (AAN, USAN, and former BAN) is a nonsteroidal anti-inflammatory drug (NSAID) commonly used as a prescription medication to reduce fever, pain, stiffness, and swelling from inflammation. Indomethacin has analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of Indometacin, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2). Indomethacin is a 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 a decrease of prostaglandins in peripheral tissues. Indometacin is 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. In general, adverse effects seen with indomethacin are similar to all other NSAIDs. For instance, indometacin inhibits both cyclooxygenase-1 and cyclooxygenase-2, it inhibits the production of prostaglandins in the stomach and intestines, which maintain the mucous lining of the gastrointestinal tract. Indometacin, therefore, like other non-selective COX inhibitors can cause peptic ulcers. These ulcers can result in serious bleeding and/or perforation requiring hospitalization of the patient. To reduce the possibility of peptic ulcers, indomethacin should be prescribed at the lowest dosage needed to achieve a therapeutic effect, usually between 50–200 mg/day. It should always be taken with food. Nearly all patients benefit from an ulcer protective drug (e.g. highly dosed antacids, ranitidine 150 mg at bedtime, or omeprazole 20 mg at bedtime). Other common gastrointestinal complaints, including dyspepsia, heartburn and mild diarrhea are less serious and rarely require discontinuation of indomethacin. NCATS
Drug Pricing (per unit)
Note: This drug pricing data is preliminary, incomplete, and may contain errors.
| Organization | Org Type | FDA approvals | Clinical Trials involvement | Org ID | Force Sort |
|---|
| Organization | Org Type | FDA approvals | Clinical Trials involvement | Org ID | Force Sort |
|---|
Arthritis (approved 1965)
Arthritis, Rheumatoid (approved 1965)
Acute Pain (Phase 3)
Adenocarcinoma (Phase 1/Phase 2)
Alzheimer Disease (Phase 3)
Ankle Injuries (Phase 4)
Anti-Bacterial Agents (Phase 4)
Arthralgia (Phase 2)
Arthritis, Gouty (Phase 3)
Asthma (Phase 2)
Axial Spondyloarthritis (Phase 4)
Azithromycin (Phase 4)
Brain Injuries (Phase 1/Phase 2)
Breast Neoplasms (Phase 2)
Breast Neoplasms, Male (Phase 1)
Carcinoma, Squamous Cell (Phase 2)
Cardiovascular Diseases (Phase 3)
Cataract (Phase 4)
Cefazolin (Phase 4)
Cerebral Intraventricular Hemorrhage (Phase 3)
Cerebrovascular Circulation (Early Phase 1)
Colitis, Ulcerative (Phase 1)
Colonic Neoplasms (Phase 1/Phase 2)
Colorectal Neoplasms (Phase 4)
Cough (Phase 3)
COVID-19 (Phase 3)
Drug Interactions (Phase 1)
Ductus Arteriosus, Patent (Phase 4)
Electroencephalography (Phase 2)
Enuresis (Phase 4)
Esophageal Neoplasms (Phase 1)
Family Planning Services (Phase 4)
Fatty Acids (Phase 2)
Fertilization in Vitro (Phase 3)
Gastrointestinal Diseases (Phase 4)
Gout (Phase 4)
Healthy Volunteers (Phase 4)
Heart Defects, Congenital (Phase 3)
Heart Diseases (Phase 3)
Hemorrhage (Phase 4)
Histiocytosis, Langerhans-Cell (Phase 2/Phase 3)
Hypertension (Phase 1/Phase 2)
Hypotension, Orthostatic (Phase 1)
Infant, Premature (Phase 3)
Infant, Premature, Diseases (Phase 3)
Infant, Very Low Birth Weight (Phase 3)
Inflammation (Phase 4)
Intestinal Neoplasms (Phase 1)
Kidney Diseases (Phase 1/Phase 2)
Labor, Obstetric (Phase 2)
Leukomalacia, Periventricular (Phase 1/Phase 2)
Live Birth (Phase 4)
Macular Edema (Phase 4)
Melanoma (Phase 2)
Neuromuscular Junction (Phase 4)
Obstetric Labor Complications (Phase 4)
Obstetric Labor, Premature (Phase 4)
Orthostatic Intolerance (Phase 1/Phase 2)
Osteoarthritis (Phase 4)
Ovarian Neoplasms (Phase 1)
Pain (Phase 3)
Pain, Postoperative (Phase 4)
Pancreatectomy (Phase 2)
Pancreatitis (Phase 4)
Pancreatitis, Chronic (Phase 2)
Physiological Effects of Drugs (Phase 4)
Pregnancy Complications (Phase 4)
Premature Birth (Phase 4)
Prostatic Neoplasms (Phase 2)
Pure Autonomic Failure (Phase 1)
Regional Blood Flow (Phase 2)
Renal Colic (Phase 3)
Sleep Apnea, Obstructive (Phase 1/Phase 2)
Squamous Cell Carcinoma of Head and Neck (Phase 2)
Stroke (Phase 1/Phase 2)
Tachycardia (Phase 1/Phase 2)
Triple Negative Breast Neoplasms (Phase 1)
Uterine Cervical Incompetence (Phase 4)
Uterine Cervical Neoplasms (Phase 2)
Vulvar Neoplasms (Phase 2)
| Trial | Phase | Start Date | Organizations | Indications |
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