Section 02 · Monograph
Indomethacin
Reviewed Nov 2026FDA label
IndocinNSAID
- Forms
- Cap: 25, 50mg | ER cap: 75mg | Supp: 50mg | Susp: 25mg/5mL
- Dose
- Start 25mg TID, titrate to response (indomethacin-responsive headaches: paroxysmal hemicrania, hemicrania continua)
- MOA
- COX inhibition
Black Box Warning
- Risk of serious cardiovascular thrombotic events; contraindicated in CABG surgery
- Risk of serious GI bleeding, ulceration and perforation, which can be fatal
Indications
- Moderate to severe rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, acute gouty arthritis and bursitis/tendinitisFDA-labeled
- Patent ductus arteriosus closure (IV, neonates)FDA-labeled
Off-Label Uses
- Indomethacin-responsive headaches: paroxysmal hemicrania, hemicrania continuaOff-label
- Primary cough, exertional and sex headache; hypnic headacheOff-label
Mechanism of Action
- Potent non-selective COX inhibitor; additional effects on nitric oxide/trigeminal pathways thought to explain its unique efficacy in indomethacin-responsive headaches
Full Dosing
Adult / usual
- Headache syndromes: start 25mg TID with food; increase by 25mg/day steps toward 150-225mg/day until response (clinical response within 1-3 days is part of the diagnostic criteria for paroxysmal hemicrania and hemicrania continua)
- Use the lowest effective maintenance dose; consider PPI gastroprotection
- Available as capsules, extended-release capsules, suppositories and oral suspension
Contraindications
- Asthma, urticaria or allergic reaction to aspirin or NSAIDs
- Perioperative CABG pain
- Active GI bleeding or ulcer
Drug Interactions
- Raises lithium levels
- Warfarin and aspirin: bleeding risk
- ACE inhibitors and diuretics: reduced effect and renal risk
- Raises methotrexate levels
Adverse Effects
- GI upset, ulcer and bleeding
- Headache, dizziness, confusion
- Renal impairment and fluid retention; hypertension
- Cardiovascular thrombotic events
Monitoring Parameters
- Renal function, blood pressure and CBC with long-term use
- GI symptoms
Pregnancy & Lactation
- Avoid at 20 weeks gestation and later; avoid in the third trimester
- Present in milk; use caution