Non-selective NSAID Pregnancy: Use of NSAIDs, including indomethacin, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. Limit dose and duration of use between about 20 and 30 weeks of gestation, and avoid use at about 30 weeks of gestation and later in pregnancy. Data from observational studies on other potential embryofetal risks of NSAID use in the first or second trimesters are inconclusive. (US labelling — verify against the UK SPC.)

Indomethacin

Brand names: Indocid

Indomethacin is a potent indole NSAID used in orthopaedics for acute gout, ankylosing spondylitis, acute musculoskeletal inflammation and sometimes for prophylaxis of heterotopic ossification.

Adult dose

Dose: 25 mg two or three times a day (moderate to severe rheumatoid arthritis including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis)

Route: Oral (capsules — 25 mg and 50 mg strengths)

Frequency: Two or three times a day

Max: The total daily dose should not exceed 200 mg; doses above a total daily dose of 150 to 200 mg generally do not increase the effectiveness of the drug

SOURCE: no eMC/UK SPC was present in this bundle (providers.emc is null) — this draft is distilled from US FDA prescribing information for indomethacin capsules and must be verified against the UK SPC before use. TITRATION: if 25 mg two or three times a day is 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 a total daily dose of 150 to 200 mg is reached. In patients with persistent night pain and/or morning stiffness, giving a large portion of the total daily dose — up to a maximum of 100 mg — at bedtime may help. In acute flares of chronic rheumatoid arthritis it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily. If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and observe closely; stop the drug if severe adverse reactions occur. After the acute phase is controlled, reduce the daily dose repeatedly to the smallest effective dose or discontinue. OTHER INDICATIONS on the same label: acute painful shoulder (bursitis and/or tendinitis) 75 to 150 mg daily in 3 or 4 divided doses, discontinued after signs and symptoms of inflammation have been controlled for several days, usual course 7 to 14 days; acute gouty arthritis 50 mg three times a day until pain is tolerable, then reduce the dose rapidly to complete cessation. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals. ELDERLY: at greater risk of NSAID-associated serious cardiovascular, gastrointestinal and/or renal adverse reactions — start dosing at the low end of the dosing range and monitor; indomethacin may cause confusion or rarely psychosis. Some sections of the product information we used were incomplete — check the full SPC.

Paediatric dose

Route: oral

Frequency: total daily dose given in divided doses

Max: Maximum daily dosage should not exceed 3 mg/kg/day or 150 to 200 mg/day, whichever is less (limited data are available to support a maximum daily dosage of 4 mg/kg/day or 150 to 200 mg/day, whichever is less)

US labelling: safety and effectiveness in paediatric patients 14 years of age and younger has not been established, and indomethacin capsules should not be prescribed for them unless toxicity or lack of efficacy associated with other drugs warrants the risk. If a decision is made to use indomethacin for paediatric patients two years of age or older, they should be monitored closely with periodic assessment of liver function — cases of hepatotoxicity, including fatalities, have been reported in paediatric patients with juvenile rheumatoid arthritis. If treatment is instituted, the suggested starting dose is 1 to 2 mg/kg/day given in divided doses (a range, so no single per-kg value is given). As symptoms subside the total daily dosage should be reduced. Verify against a children's formulary and against the UK SPC before prescribing. Source: US FDA labelling (openFDA/DailyMed) — no UK SPC paediatric text was fetched.

Dose adjustments

Renal

No numeric renal dose adjustment is stated. Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration or hypovolemia. Avoid use of indomethacin in patients with advanced renal disease unless the benefits are expected to outweigh the risk of worsening renal function. Indomethacin and its metabolites are substantially excreted by the kidneys and the risk of adverse reactions may be greater in patients with impaired renal function, including the elderly.

Dose independently re-sourced from US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Known hypersensitivity (e.g. anaphylactic reactions and serious skin reactions) to indomethacin or any components of the drug product
History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs — severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients
In the setting of coronary artery bypass graft (CABG) surgery

Side effects

Headache, dizziness, dyspepsia and nausea (most common adverse reactions, incidence 3% or greater)
Gastrointestinal bleeding, ulceration and perforation
Cardiovascular thrombotic events
Hepatotoxicity — discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop
Hypertension, heart failure and oedema
Renal toxicity and hyperkalaemia; anaphylactic reactions; serious skin reactions and DRESS; haematologic toxicity

Interactions

Anticoagulants such as warfarin — synergistic effect on bleeding; concomitant use carries an increased risk of serious bleeding compared with either drug alone; monitor for signs of bleeding
Antiplatelet agents (e.g. aspirin), SSRIs and SNRIs — drugs that interfere with haemostasis or serotonin reuptake may potentiate bleeding risk more than an NSAID alone; monitor for signs of bleeding
Aspirin — concomitant use with NSAIDs produces no greater therapeutic effect but was associated with a significantly increased incidence of gastrointestinal adverse reactions
Antihypertensive medications — patients may have an impaired response to these therapies when taking NSAIDs; monitor blood pressure
The Drug Interactions table was truncated at the source-fetch limit and further interactions (including those in the UK SPC) were not retrieved

Clinical monograph

How it works

It is a strong non-selective cyclo-oxygenase inhibitor, markedly reducing prostaglandin synthesis to control inflammation and pain.

Prescribing in practice

It has a high rate of gastrointestinal and central nervous system adverse effects (notably headache, dizziness and confusion, especially in the elderly), so reserve it and use the lowest effective dose for the shortest time.
Avoid in active peptic ulceration, significant renal or hepatic impairment, heart failure and the third trimester of pregnancy.
Caution with anticoagulants, antiplatelets, diuretics, ACE inhibitors and lithium owing to bleeding, renal and drug-level interactions.

Monitoring

Monitor renal function, blood pressure and for gastrointestinal and CNS adverse effects, particularly in older patients.

Counselling the patient

Take with food; report stomach pain, black stools or vomiting blood.
Tell your prescriber about headaches, dizziness or confusion.
Use only for the short course prescribed.

Evidence & guidelines

MHRA advice on NSAIDs supports lowest-effective-dose, shortest-duration use, with indomethacin recognised for a higher adverse-effect burden than many alternatives.

Reference: NICE CG177 (Gout); BOA/BSSH HO prevention guidelines; SPC Indocid; Cochrane Review (NSAIDs for HO prevention); Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

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