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NSAID (preferential COX-2) Pregnancy: Contraindicated during the third trimester (risk of premature constriction/closure of the ductus arteriosus, pulmonary hypertension, renal dysfunction, prolonged bleeding time and inhibition of uterine contractions). During the first and second trimesters should not be given unless clearly necessary, at the lowest dose for the shortest duration; from the 20th week onward may cause oligohydramnios from foetal renal dysfunction - consider antenatal monitoring for oligohydramnios and ductus arteriosus constriction after several days of exposure, and discontinue if found. May impair female fertility and is not recommended in women attempting to conceive. NSAIDs appear in breast milk in very low concentrations and should if possible be avoided when breastfeeding.

Etodolac

Brand names: Lodine SR, Eccoxolac

Etodolac is a non-steroidal anti-inflammatory drug (NSAID) with relative cyclo-oxygenase-2 selectivity, used for pain and inflammation in osteoarthritis and rheumatoid arthritis.

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: 600 mg (one Etopan XL 600 mg prolonged-release tablet) once daily
Route: Oral
Frequency: Once daily
Max: The safety of doses in excess of 600 mg per day has not been established (UK SPC, Etopan XL)
UK SPC is for Etopan XL 600 mg film-coated prolonged release tablets (https://www.medicines.org.uk/emc/product/3020/smpc), which states for adults: 'One tablet daily; if a lower dose is sufficient, conventional Etodolac capsules or tablets may be used.' Etopan XL must be swallowed whole with a tumblerful of water, taken preferably with or after food. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms. No occurrence of tolerance or tachyphylaxis has been reported. ELDERLY: no change in initial dosage is generally required, but the elderly are at increased risk of the serious consequences of adverse reactions - if an NSAID is considered necessary use the lowest effective dose for the shortest possible duration and monitor regularly for GI bleeding. PAEDIATRIC: 'Not recommended' (UK SPC); US labelling states safety and effectiveness in patients below the age of 18 have not been established. Any under-18 use must be verified against a children's formulary. US LABELLING (immediate-release etodolac tablets, A-S Medication Solutions, https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5cf13771-ec53-43be-9b29-e977248fc22e) gives different regimens for the conventional formulation and is NOT the UK SPC dose - verify before use: analgesia, recommended total daily dose for acute pain is up to 1000 mg given as 200 to 400 mg every 6 to 8 hours; osteoarthritis and rheumatoid arthritis, recommended starting dose 300 mg twice or three times daily, or 400 mg twice daily, or 500 mg twice daily, with a lower dose of 600 mg/day possibly sufficing for long-term administration; doses above 1000 mg/day have not been adequately evaluated in well-controlled trials. Interactions listed below are taken from the US label because SPC section 4.5 was not retrieved in the source bundle.

Dose adjustments

Renal

US labelling: dosage adjustment is generally not required in patients with mild to moderate renal impairment, but etodolac should be used with caution as it may further decrease renal function in some patients with impaired renal function. (No renal dosing statement was present in the fetched UK SPC section 4.2; renal failure is a contraindication in SPC section 4.3.)

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; 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

  • Hypersensitivity to etodolac or to any of the excipients
  • Severe heart failure; also hepatic failure and renal failure
  • Active or history of recurrent peptic ulceration, or history of peptic ulcer disease (two or more distinct episodes of proven ulceration or bleeding)
  • History of gastrointestinal bleeding or perforation related to previous NSAID therapy
  • Previous hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or urticaria) during therapy with ibuprofen, aspirin or other NSAIDs
  • Last trimester of pregnancy
  • US label adds: in the setting of coronary artery bypass graft (CABG) surgery

Side effects

  • Gastrointestinal: nausea, epigastric pain, dyspepsia/heartburn, diarrhoea, flatulence, abdominal pain, constipation, vomiting; haematemesis, melaena, rectal bleeding, ulcerative stomatitis; gastritis less frequently; pancreatitis very rarely
  • Cardiovascular: oedema, hypertension and cardiac failure; increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke), particularly at high doses and in long-term treatment
  • Hypersensitivity: non-specific allergic reactions and anaphylaxis; asthma, aggravated asthma, bronchospasm or dyspnoea; rashes, pruritus, urticaria, purpura, angioedema, and more rarely exfoliative and bullous dermatoses including epidermal necrolysis and erythema multiforme
  • Renal and hepatic: nephrotoxicity including interstitial nephritis, nephrotic syndrome and renal failure; abnormal liver function, hepatitis and jaundice
  • Neurological/haematological: headache, dizziness, paraesthesia, drowsiness, tinnitus, vertigo, visual disturbances, optic neuritis, aseptic meningitis, confusion, depression; thrombocytopenia, neutropenia, agranulocytosis, aplastic anaemia and haemolytic anaemia

Interactions

  • ACE-inhibitors: NSAIDs may diminish the antihypertensive effect (US label)
  • Aspirin: concomitant administration is not generally recommended because of the potential for increased adverse effects; etodolac protein binding is reduced (US label)
  • Ciclosporin, digoxin, methotrexate: NSAIDs may alter elimination, leading to elevated serum levels and increased toxicity; ciclosporin nephrotoxicity may be enhanced - observe patients, particularly those with altered renal function (US label)
  • Antacids: no apparent effect on the extent of absorption, but can decrease peak concentration by 15-20% (US label)

Clinical monograph

How it works

It inhibits cyclo-oxygenase enzymes, reducing prostaglandin synthesis and thereby producing anti-inflammatory, analgesic and antipyretic effects.

Prescribing in practice

  • Like other NSAIDs it carries gastrointestinal bleeding, ulceration, cardiovascular and renal risks, so use the lowest effective dose for the shortest time and consider gastroprotection in at-risk patients.
  • Avoid in active peptic ulceration, severe heart failure and significant renal impairment, and use cautiously in older people.
  • It can interact with anticoagulants, antihypertensives, diuretics and other NSAIDs, increasing bleeding and renal risk.

Monitoring

Monitor renal function, blood pressure and for gastrointestinal symptoms, particularly with prolonged use or in higher-risk patients.

Counselling the patient

  • Take with or after food and report black stools, vomiting blood or severe indigestion.
  • Avoid combining with other anti-inflammatory painkillers such as ibuprofen.
  • Seek advice if you have swelling, breathlessness or reduced urine output.

Evidence & guidelines

MHRA and NICE advice on NSAID cardiovascular and gastrointestinal safety applies to etodolac, supporting cautious, time-limited use at the lowest effective dose.

Reference: NICE NG100 (acute pain); NICE CKS; MHRA NSAID safety; 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).

Related

Curated clinical cross-links plus same-class fallbacks.