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Non-selective NSAID Pregnancy: UK gel SPC §4.6, verbatim: 'There are no clinical data from the use of topical forms of ketoprofen during pregnancy. Even if systemic exposure is lower compared with oral administration, it is not known if the systemic ketoprofen exposure reached after topical administration can be harmful to an embryo/foetus. During the first and second trimester of pregnancy, ketoprofen should not be used unless clearly necessary. If used, the dose should be kept as low as possible. During the third trimester of pregnancy, all prostaglandin synthetase inhibitors including ketoprofen may induce cardiopulmonary and renal toxicity in the foetus. At the end of the pregnancy, prolonged bleeding time in both mother and child may occur, and labour can be delayed. Therefore, ketoprofen is contraindicated during the last trimester of pregnancy.' LACTATION (§4.6): 'Trace amounts of ketoprofen are excreted in breast milk following oral administration, therefore the gel should not be used during breast feeding.' US oral label (Pregnancy Risk Summary): 'Use of NSAIDs, including ketoprofen extended-release capsules, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. Because of these risks, limit dose and duration of ketoprofen extended-release capsules use between about 20 and 30 weeks of gestation, and avoid ketoprofen extended-release capsules use at about 30 weeks of gestation and later in pregnancy.' This summary may be incomplete — check the full SPC.

Ketoprofen

Brand names: Oruvail, Powergel

Ketoprofen is a propionic acid NSAID used for pain and inflammation in musculoskeletal, rheumatic and other painful conditions.

Adult dose

Dose: Oral (US extended-release capsule labelling), rheumatoid arthritis and osteoarthritis: 200 mg once a day. Topical (UK SPC, ketoprofen 2.5% w/w gel), painful or inflamed musculoskeletal surface: approximately 2 to 4 g of gel (representing approximately 5 to 10 cm of gel) per application, two to four applications daily, for up to seven days.
Route: Oral (extended-release capsules) and topical cutaneous gel 2.5% w/w. UK gel SPC: 'For cutaneous use' / 'For topical use only'; the gel is not to be applied to mucous membranes, anal or genital areas, or the eyes, and is not to be used with occlusive dressings.
Frequency: Oral extended-release: once a day. Topical gel: two to four applications daily, for up to seven days.
Max: Maximum 200 mg per day by mouth (US extended-release capsule label, verbatim: 'The recommended maximum daily dose of ketoprofen is 200 mg/day for ketoprofen extended-release capsules. Dosages higher than 200 mg/day of ketoprofen extended-release capsules are not recommended because they have not been studied.'). A separate ceiling applies to the topical gel (UK SPC, verbatim): 'The usual maximum dose is 15 g per day.' Lower oral ceilings apply in renal and hepatic impairment — see renalAdjustment and hepaticAdjustment.
SCOPE: both of the page's routes are covered, but from two different regulators — the oral figures are US extended-release-capsule labelling (no UK oral SPC was in the bundle) and the topical figures are the UK SPC. || ORAL, verbatim (US DOSAGE AND ADMINISTRATION, 'Rheumatoid Arthritis and Osteoarthritis'): 'The recommended starting dose of ketoprofen in otherwise healthy patients is for ketoprofen extended-release capsules 200 mg administered once a day. Smaller doses of ketoprofen extended-release capsules should be utilized initially in small individuals, or in debilitated or elderly patients.' Also: 'Concomitant use of ketoprofen extended-release capsules is not recommended.' and 'Relatively smaller people may need smaller doses.' ACUTE PAIN — the same label states: 'Ketoprofen extended-release capsules are not recommended for use in treating acute pain because of its extended-release characteristics.' ADMINISTRATION: 'physicians may wish to prescribe that ketoprofen extended-release capsules be taken with antacids, food, or milk.' ELDERLY: 'It is recommended that the initial dosage of ketoprofen extended-release capsules should be reduced for patients over 75 years of age.' A higher 300 mg/day figure appears in the label only as an observation, not a recommendation: 'Individual patients may show a better response to 300 mg of ketoprofen capsules daily as compared to 200 mg, although in well-controlled clinical trials patients on 300 mg did not show greater mean effectiveness. They did, however, show an increased frequency of upper- and lower-GI distress and headaches' — it is NOT published above and is above the label's own stated maximum. || TOPICAL, verbatim (UK SPC §4.2): 'For cutaneous use. Penetration of the gel by gentle and prolonged massage on the painful or inflamed surface for up to seven days. Two to four daily applications of approximately 2 to 4 g gel, representing approximately 5 to 10 cm. The usual maximum dose is 15 g per day. The lowest effective dose should be used for the shortest duration necessary to relieve symptoms.' || PHOTOSENSITIVITY (UK SPC §4.4, verbatim): 'Areas of skin treated with Ketoprofen 2.5 % Gel should not be exposed to direct sunlight, or solarium ultraviolet light, either during treatment or for two weeks following treatment discontinuation, in order to avoid phototoxicity reactions and photoallergy.' Hands should be washed thoroughly before and immediately after each application unless they are the area being treated.

Dose adjustments

Renal

Oral (US extended-release capsule label, verbatim): 'In patients with mildly impaired renal function, the maximum recommended total daily dose of ketoprofen extended-release capsules is 150 mg. In patients with a more severe renal impairment (GFR less than 25 mL/min/1.73 m 2 or end-stage renal impairment), the maximum total daily dose of ketoprofen extended-release capsules should not exceed 100 mg.' The same section adds: 'All patients with metabolic impairment, particularly those with both hypoalbuminemia and reduced renal function, may have increased levels of free (biologically active) ketoprofen and should be closely monitored... it is recommended that such patients also be started on lower doses of ketoprofen extended-release capsules and closely monitored.' Elderly: 'In elderly patients, renal function may be reduced with apparently normal serum creatinine and/or BUN levels. Therefore, it is recommended that the initial dosage of ketoprofen extended-release capsules should be reduced for patients over 75 years of age.' TOPICAL: the UK gel SPC gives no dose reduction for renal impairment; it states only (§4.4) 'Although systemic effects are minimal, the gel should be used with caution in patients with reduced heart, liver or renal function: isolated cases of systemic adverse reactions consisting of renal affections have been reported.'

Hepatic

Oral (US extended-release capsule label, verbatim): 'It is recommended that for patients with impaired liver function and serum albumin concentration less than 3.5 g/dL, the maximum initial total daily dose of ketoprofen extended-release capsules should be 100 mg... The dosage may be increased to the range recommended for the general population, if necessary, only after good individual tolerance has been ascertained.' TOPICAL: no hepatic dose adjustment appears in the fetched UK gel SPC — only the §4.4 caution that 'the gel should be used with caution in patients with reduced heart, liver or renal function'.

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC; 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 allergy to ketoprofen, or to substances of similar activity to aspirin (UK gel SPC §4.3)
  • History of hypersensitivity to any of the excipients (UK gel SPC §4.3)
  • History of any photosensitivity reactions (UK gel SPC §4.3)
  • Known hypersensitivity reactions, such as symptoms of asthma or allergic rhinitis, to ketoprofen, fenofibrate, tiaprofenic acid, acetylsalicylic acid, or to other NSAIDs — including when taken by mouth (UK gel SPC §4.3)
  • History of skin allergy to ketoprofen, tiaprofenic acid, fenofibrate, or to a UV blocker or perfumes (UK gel SPC §4.3)
  • Sun exposure, even in the case of hazy sun, including UV light from a solarium, during treatment and for 2 weeks after its discontinuation (UK gel SPC §4.3)
  • Third trimester of pregnancy (UK gel SPC §4.3 and §4.6)
  • Pathological skin changes such as dermatosis, eczema or acne, infected skin lesions, or open wounds (UK gel SPC §4.3)
  • Topical route only — not to be applied to mucous membranes, anal or genital areas, nor on the eyes; not to be used with occlusive dressings (UK gel SPC §4.3)
  • Treatment should be discontinued immediately upon development of any skin reaction, including cutaneous reactions after co-application of octocrylene-containing products (UK gel SPC §4.3)
  • ORAL (US label): hypersensitivity to ketoprofen; and 'should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs'
  • ORAL (US label): 'contraindicated in the setting of coronary artery bypass graft (CABG) surgery'

Side effects

  • Topical, uncommon (UK gel SPC §4.8): local skin reactions such as rash, erythema, eczema, pruritus and burning sensation; application site burn
  • Topical, rare (§4.8): photosensitisation, urticaria, bullous/contact/exfoliative/vesicular dermatitis, phlyctenular eczema, blister, photosensitivity reaction, allergic reaction, skin exfoliation, skin oedema
  • Topical, not known (§4.8): Stevens-Johnson syndrome; secondary impetigo; eosinophilia; anaphylactic shock, angioedema, hypersensitivity reactions; eyelid oedema; vasculitis; peptic ulcer, gastrointestinal bleeding, diarrhoea, lip oedema; pyrexia; wound complication
  • Topical, very rare (§4.8): aggravation of previous renal insufficiency, acute renal failure
  • Oral (US label ADVERSE REACTIONS): 'Minor gastrointestinal side effects predominated; upper gastrointestinal symptoms were more common than lower gastrointestinal symptoms.'
  • Oral (US label): 'Peptic ulcer or GI bleeding occurred in controlled clinical trials in less than 1% of 1,076 patients; however, in open label continuation studies in 1,292 patients the rate was greater than 2%.'
  • Oral (US label): 'Gastrointestinal reactions were followed in frequency by central nervous system side effects, such as headache, dizziness, or drowsiness.'
  • Systemic effects from topical use (UK gel SPC §4.4): 'Topical application of large amounts may result in systemic effects including hypersensitivity and asthma (renal disease has also been reported).'
  • This side-effect list may be incomplete — check the full SPC.

Monitoring

  • Infection (UK gel SPC §4.4, verbatim): 'Ketoprofen can mask symptoms of infection, which may lead to delayed initiation of appropriate treatment... When ketoprofen is administered for fever or pain relief in relation to infection, monitoring of infection is advised.'
  • Skin (UK gel SPC §4.4): stop at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity; 'Should a skin rash occur after gel application, treatment must be stopped.'
  • Duration (UK gel SPC §4.4): 'The recommended length of treatment should not be exceeded... due to the risk of developing contact dermatitis and photosensitivity reactions which increases over time.'
  • Oral, renal function (US label, Geriatric Use): 'it may be useful to monitor renal function' in patients over 75 years of age
  • Oral, patients with metabolic impairment (US label): patients with both hypoalbuminaemia and reduced renal function 'should be closely monitored'

Clinical monograph

How it works

It inhibits cyclo-oxygenase enzymes to reduce prostaglandin production, giving analgesic, anti-inflammatory and antipyretic effects.

Prescribing in practice

  • As an NSAID it carries gastrointestinal, cardiovascular and renal risks, so use the lowest effective dose for the shortest period, especially in the elderly.
  • Topical ketoprofen can cause photosensitivity reactions, so treated skin should be protected from sunlight during and after use as directed in the SPC.
  • Consider gastroprotection in high-risk patients and review concurrent anticoagulant, antiplatelet and nephrotoxic therapy.

Monitoring

Monitor renal function and blood pressure in at-risk patients and watch for gastrointestinal symptoms during treatment.

Counselling the patient

  • Take oral preparations with or after food and report black stools or vomiting blood.
  • If using the gel, keep treated skin covered and out of sunlight, and wash your hands after application.
  • Avoid other anti-inflammatory painkillers unless advised.

Evidence & guidelines

NSAID class risks are well established, and MHRA has advised on the risk of photosensitivity with topical ketoprofen.

Reference: MHRA Drug Safety Update; 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.

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