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NSAID (Parenteral) Pregnancy: Contraindicated in pregnancy, labour and delivery, and in lactation (§4.3, §4.6). §4.6: 'In view of the known effects of NSAIDs on the foetal cardiovascular system (risk of closure of the ductus arteriosus) ketorolac is contraindicated during pregnancy, labour or delivery. The safety of ketorolac during human pregnancy has not been established.' From the 20th week of pregnancy onward ketorolac use may cause oligohydramnios resulting from foetal renal dysfunction, and ductus arteriosus constriction has been reported after second-trimester treatment. This summary may be incomplete — check the full SPC.

Ketorolac Trometamol

Brand names: Toradol

Ketorolac trometamol is a potent NSAID used for the short-term management of moderate to severe acute pain, often in the postoperative setting.

Adult dose

Dose: Acute pain in adults (the SPC's posology is written around the post-operative period): recommended initial dose 10 mg, then 10 to 30 mg every four to six hours as required. 'In the initial post-operative period, Toradol may be given as often as every two hours if needed.' 'The lowest effective dose should be given.' 'Dosage should be adjusted according to the severity of the pain and the patient response.' Reduce dosage in patients under 50 kg. SCOPE — PARENTERAL ONLY: this bundle holds the injection SPC, which contains no oral ketorolac regimen, so the page's legacy oral step-down is NOT sourced here and must not be read off this record.
Route: Intramuscular or bolus intravenous injection. §4.2 Method of administration: 'Toradol is for administration by intramuscular or bolus intravenous injection. Bolus intravenous doses should be given over no less than 15 seconds. Toradol should not be used for epidural or spinal administration.' §4.3 adds that the solution for injection 'is contraindicated for neuraxial (epidural or intrathecal) administration due to its alcohol content'.
Frequency: Every four to six hours as required; in the initial post-operative period as often as every two hours if needed.
Max: 90 mg total daily dose in non-elderly adults; 60 mg total daily dose in the elderly, in renally-impaired patients and in patients weighing less than 50 kg — §4.2: 'A total daily dose of 90 mg for non-elderly and 60 mg for the elderly, renally-impaired patients and patients less than 50 kg should not be exceeded.' Duration: 'The maximum duration of treatment should not exceed two days.' §4.2 also states 'The administration of continuous multiple daily doses of ketorolac intramuscularly or intravenously should not exceed two days because adverse events may increase with prolonged usage.'
ONSET AND DURATION (§4.2): 'The time to onset of analgesic effect following both IV and IM administration is similar and is approximately 30 minutes, with maximum analgesia occurring within one to two hours. The median duration of analgesia is generally four to six hours.' Physicians should be aware that in some patients pain relief may not occur until upwards of 30 minutes after IV or IM administration (§4.4). || ELDERLY (§4.2): 'The elderly are at increased risk of the serious consequences of adverse reactions. If an NSAID is considered necessary, the lowest effective dose should be used and for the shortest possible duration. The patient should be monitored regularly for GI bleeding during NSAID therapy. A total daily dose of 60 mg should not be exceeded.' §4.4 adds that compared to young adults the elderly have an increased plasma half-life and reduced plasma clearance of ketorolac, and 'A longer dosing interval is advisable'. The SPC states NO separate elderly per-dose figure — only the reduced 60 mg daily total above. || PAEDIATRIC (§4.2): 'Safety and efficacy in children have not been established. Therefore, Toradol is not recommended for use in children under 16 years of age.' §4.3 makes children under 16 years an outright contraindication. No paediatric dose is published. || OPIOIDS (§4.2): 'Opioid analgesics (e.g. morphine, pethidine) may be used concomitantly, and may be required for optimal analgesic effect in the early post-operative period when pain is most severe. Ketorolac does not interfere with opioid binding and does not exacerbate opioid-related respiratory depression or sedation. When used in association with Toradol IM/IV, the daily dose of opioid is usually less than that normally required.' || GI RISK AND DOSE (§4.4): 'In a non-randomised, in-hospital post-marketing surveillance study, increased rates of clinically serious GI bleeding were seen in patients < 65 years of age who received an average daily dose of > 90 mg ketorolac IM as compared to those patients receiving parenteral opioids.' 'The risk of clinically serious gastrointestinal bleeding is dose dependent.' 'Epidemiological evidence suggests that ketorolac may be associated with a high risk of serious gastrointestinal toxicity, relative to some other NSAIDs, especially when used outside the licensed indications and/or for prolonged periods.' NSAIDs including ketorolac 'may be associated with increased risk of gastro-intestinal anastomotic leak'; caution after gastro-intestinal surgery. || Neither figure exists in this SPC, which sets a TWO-day parenteral limit and no oral regimen at all. The two-day limit above is what the source states, and it is the one to follow on this record. || TRUNCATION: §4.4, §4.6 and §4.8 in this bundle end at the source-fetch limit, so the warnings, pregnancy and undesirable-effects material below is partial — do not treat it as the complete section.

Dose adjustments

Renal

§4.2: 'Contraindicated in moderate to severe renal impairment; reduce dosage in lesser impairment (not exceeding 60 mg/day IV or IM).' §4.3: contraindicated in patients with moderate or severe renal impairment (serum creatinine >160 micromol/l) or in patients at risk for renal failure due to volume depletion or dehydration, and in renal failure.

Hepatic

No hepatic dose adjustment is stated in the retrieved sections. §4.3 contraindicates ketorolac in patients with hepatic failure.

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Previously demonstrated hypersensitivity to ketorolac, any of its excipients, or other NSAIDs, and patients in whom aspirin or other prostaglandin synthesis inhibitors induce allergic reactions (asthma, rhinitis, angioedema or urticaria) — severe anaphylactic-like reactions have been observed in such patients
  • History of asthma
  • Children under 16 years of age
  • Active peptic ulcer, or any history of gastrointestinal bleeding, ulceration or perforation
  • Severe heart failure, hepatic failure and renal failure
  • Moderate or severe renal impairment (serum creatinine >160 micromol/l), or patients at risk for renal failure due to volume depletion or dehydration
  • Pregnancy, labour, delivery or lactation
  • As prophylactic analgesia before surgery (inhibition of platelet aggregation) and intra-operatively (increased risk of bleeding)
  • Suspected or confirmed cerebrovascular bleeding; operations with a high risk of haemorrhage or incomplete haemostasis; and patients at high risk of bleeding such as those with haemorrhagic diatheses, including coagulation disorders
  • Patients on anti-coagulants, including warfarin and low dose heparin (2500 - 5000 units 12 hourly)
  • Patients currently receiving ASA or other NSAIDs, including cyclooxygenase-2 selective inhibitors
  • Neuraxial (epidural or intrathecal) administration of the solution for injection, due to its alcohol content
  • Concurrent oxpentifylline; concurrent probenecid; concurrent lithium salts
  • Complete or partial syndrome of nasal polyps, angioedema or bronchospasm

Side effects

  • Gastrointestinal (the most commonly observed adverse events): peptic ulcers, ulcers, perforation or GI bleeding — sometimes fatal, particularly in the elderly; nausea, vomiting, diarrhoea, constipation, dyspepsia, abdominal pain or discomfort, melaena, haematemesis, stomatitis, ulcerative stomatitis, eructation, flatulence, oesophagitis, gastrointestinal ulceration, rectal bleeding, pancreatitis, dry mouth, fullness, exacerbation of colitis and Crohn's disease; less frequently gastritis
  • Renal and urinary: acute renal failure, increased urinary frequency, interstitial nephritis, nephrotic syndrome, urinary retention, oliguria, haemolytic uraemic syndrome, flank pain with or without haematuria or azotaemia. Signs of renal impairment such as elevations of creatinine and potassium can occur after one dose
  • Immune system: anaphylaxis and anaphylactoid reactions, which may have a fatal outcome; hypersensitivity reactions such as bronchospasm, flushing, rash, hypotension, laryngeal oedema
  • Blood and lymphatic: thrombocytopenia, purpura, neutropenia, agranulocytosis, aplastic anaemia, haemolytic anaemia
  • Infection: aseptic meningitis, especially in patients with existing auto-immune disorders such as systemic lupus erythematosus or mixed connective tissue disease (stiff neck, headache, nausea, vomiting, fever or disorientation)
  • Cardiac and vascular: palpitations, bradycardia, cardiac failure, hypertension, hypotension, haematoma, flushing, pallor, postoperative wound haemorrhage
  • Nervous system: headache, dizziness, convulsions, paraesthesia, hyperkinesias, taste abnormality
  • Psychiatric: abnormal thinking, depression, insomnia, anxiety, nervousness, psychotic reactions, abnormal dreams, hallucinations, euphoria, impaired concentration, drowsiness, confusion, stimulation
  • Metabolic: anorexia, hyperkalaemia, hyponatraemia
  • Eye: abnormal vision, visual disturbances, optic neuritis. Ear: tinnitus, hearing loss, vertigo
  • Section 4.8 in this bundle is truncated at the source-fetch limit — this list is partial and the retrieved text was ending on arterial thrombotic risk with coxibs and some NSAIDs at high doses

Monitoring

  • Monitor the patient regularly for GI bleeding during NSAID therapy, particularly in the elderly (§4.2 Elderly)
  • Patients with a history of GI toxicity, particularly when elderly, should report any unusual abdominal symptoms — especially GI bleeding (§4.4)
  • Consider combination therapy with a protective agent (e.g. misoprostol or a proton pump inhibitor) in patients at higher GI risk, in those requiring concomitant low-dose aspirin, and in those on other drugs likely to increase gastrointestinal risk (§4.4)
  • Watch for signs of renal impairment — elevations of creatinine and potassium can occur after a single dose (§4.8)
  • Close medical surveillance and caution when using ketorolac after gastro-intestinal surgery, because of the risk of gastro-intestinal anastomotic leak (§4.4)
  • Review the treatment duration actively: parenteral use must not exceed two days (§4.2)

Clinical monograph

How it works

It inhibits cyclo-oxygenase enzymes, reducing prostaglandin synthesis to produce strong analgesic and anti-inflammatory effects.

Prescribing in practice

  • Use is restricted to short-term treatment because of a high risk of serious gastrointestinal bleeding, ulceration and renal impairment, with a maximum duration of therapy specified in the SPC.
  • It is contraindicated in patients with significant renal impairment, active or previous peptic ulceration, bleeding disorders and in those at high bleeding risk.
  • Avoid combining with other NSAIDs and use caution with anticoagulants and around major surgery owing to platelet effects.

Monitoring

Monitor renal function, fluid balance and signs of gastrointestinal or operative-site bleeding throughout the short course of treatment.

Counselling the patient

  • This is a strong painkiller intended only for a short period.
  • Report any black stools, vomiting blood, reduced urine output or unusual bruising or bleeding immediately.
  • Do not take other anti-inflammatory painkillers at the same time.

Evidence & guidelines

Ketorolac's restriction to short-term use reflects its recognised risk of serious gastrointestinal and renal adverse effects.

Reference: Ketorolac SPC; Oxford Pain Group; 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.

Pathways