NSAID (prodrug) Pregnancy: Use of NSAIDs including sulindac 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. There are no adequate and well-controlled studies in pregnant women; sulindac should be used in pregnancy only if the potential benefit justifies the potential risk.

Sulindac

Brand names: Clinoril

Sulindac is a non-steroidal anti-inflammatory drug (NSAID) used for the relief of pain and inflammation in musculoskeletal and joint disorders.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 150 mg twice a day (recommended starting dosage in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis); the dosage may be lowered or raised depending on the response

Route: Oral — administered with food

Frequency: Twice a day

Max: 400 mg per day. Dosages above 400 mg per day are not recommended.

Carefully consider the potential benefits and risks before use, and use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. After observing the response to initial therapy, the dose and frequency should be adjusted to suit the individual patient's needs. OTHER INDICATIONS: in acute painful shoulder (acute subacromial bursitis / supraspinatus tendinitis) and in acute gouty arthritis the recommended dosage is 200 mg twice a day, reduced according to response once a satisfactory response has been achieved — therapy for 7-14 days is usually adequate in acute painful shoulder, and 7 days is usually adequate in acute gouty arthritis. A prompt response (within one week) can be expected in about one-half of patients with osteoarthritis, ankylosing spondylitis and rheumatoid arthritis; others may require longer to respond. Elderly (65 years and older): caution should be exercised as advancing age appears to increase the possibility of adverse reactions, and elderly patients tolerate ulceration or bleeding less well. Paediatric: safety and effectiveness in paediatric patients have not been established. CLINICIAN CHECK: this draft is from the US FDA prescribing information (SULINDAC tablets, PuraCap Laboratories LLC dba Blu Pharmaceuticals, label date 2025-12-11) — no UK SPC posology was fetched; verify against the UK SPC.

Dose adjustments

Renal

No numeric renal dose adjustment is stated. The US label notes (Geriatric Use) that sulindac is known to be substantially excreted by the kidney and that the risk of toxic reactions may be greater in patients with impaired renal function; because elderly patients are more likely to have decreased renal function, care should be taken in dose selection and it may be useful to monitor renal function.

Dose auto-extracted from US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Known hypersensitivity to sulindac or the excipients
Patients who have experienced asthma, urticaria or allergic-type reactions after taking aspirin or other NSAIDs (severe, rarely fatal, anaphylactic/anaphylactoid reactions have been reported in such patients)
In the setting of coronary artery bypass graft (CABG) surgery

Side effects

Gastrointestinal pain (10%), dyspepsia, nausea with or without vomiting, diarrhoea, constipation, flatulence, anorexia and gastrointestinal cramps
Rash and pruritus
Dizziness, headache and nervousness
Tinnitus
Oedema
Less than 1 in 100: gastritis, gastroenteritis or colitis; peptic ulcer and gastrointestinal bleeding; rarely GI perforation and intestinal strictures; liver function abnormalities, jaundice, cholestasis, hepatitis, hepatic failure; pancreatitis

Interactions

ACE inhibitors and angiotensin II antagonists — NSAIDs may diminish their antihypertensive effect; in patients with compromised renal function (e.g. elderly or volume-depleted patients, including those on diuretics) co-administration may cause further deterioration of renal function including possible acute renal failure, usually reversible. Monitor renal function periodically in combination therapy
Aspirin — concomitant administration significantly depressed the plasma levels of the active sulindac sulfide metabolite; adding aspirin did not alter the types of clinical or laboratory adverse experiences for sulindac
Acetaminophen (paracetamol) — had no effect on plasma levels of sulindac or its sulfide metabolite
Note: the US label's Drug Interactions section was truncated at the source-fetch limit, so further interactions were not retrieved — clinician to source

Clinical monograph

How it works

It is a prodrug converted to an active sulphide metabolite that inhibits cyclo-oxygenase enzymes, reducing prostaglandin synthesis and thereby pain and inflammation.

Prescribing in practice

Like other NSAIDs it carries gastrointestinal bleeding and ulceration risk; use the lowest effective dose for the shortest time and consider gastroprotection in those at risk.
It can cause fluid retention and raise blood pressure, and may impair renal function, so caution applies in cardiovascular, renal or hepatic impairment and in the elderly.
Avoid combining with other NSAIDs and use caution with anticoagulants and other drugs affecting bleeding or renal function.

Monitoring

Monitor blood pressure and renal function in those at risk with longer-term use, and review for gastrointestinal symptoms.

Counselling the patient

Take with or after food and report indigestion, black stools or vomiting blood.
Seek advice about other painkillers, as combining NSAIDs increases risk.
Report swelling, breathlessness or reduced urine output.

Evidence & guidelines

NSAID class risks for gastrointestinal, cardiovascular and renal harm are well established and reflected in MHRA advice and NICE guidance.

Reference: NICE; 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.

Pathways