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Ketoprofen

Fastum, Ketospray, Profenid · ATC code M01AE03

Brand names: Fastum, Ketospray, Profenid, Alrheumun, Effekton, Gabrilen N, Artrocol, Bi-Profenid, Catoxfen, Ketofen, Mivelin PR, Nevrozz, Proflam, Teknazol, Orudis

Key facts
Active substance
Ketoprofen
ATC code
M01AE03
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-29

Boxed warning

Cardiovascular Thrombotic Events

  • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. [see WARNINGS and PRECAUTIONS].
  • Ketoprofen Capsules, USP is contraindicated in the setting of coronary artery bypass graft (CABG) surgery. [see CONTRAINDICATIONS and WARNINGS].

Gastrointestinal Risk

  • NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal (GI) events (see WARNINGS).

¹ Throughout this package insert, the term NSAID refers to a non-aspirin non-steroidal anti-inflammatory drug.

Key facts

Ketoprofen is a nonsteroidal anti-inflammatory drug (NSAID). Per the US prescribing information, it is used for rheumatoid arthritis, osteoarthritis, pain and primary dysmenorrhea.

What it is used for

  • Signs and symptoms of rheumatoid arthritis and osteoarthritis
  • Management of pain
  • Primary dysmenorrhea

Dosing

  • Use the lowest effective dose for the shortest duration
  • Rheumatoid arthritis and osteoarthritis: start with 75 mg three times or 50 mg four times a day; maximum 300 mg/day
  • Pain and dysmenorrhea: 25 to 50 mg every 6 to 8 hours as necessary; doses above 75 mg give no added analgesia
  • Mild renal impairment: maximum 150 mg daily; more severe impairment (GFR less than 25 mL/min/1.73 m2): maximum 100 mg daily
  • Impaired liver function with serum albumin below 3.5 g/dL: maximum initial daily dose 100 mg; over 75 years, reduce the initial dose
  • Taking it with food or milk may minimize gastrointestinal effects

Contraindications

  • Hypersensitivity to ketoprofen
  • Asthma, urticaria or allergic-type reactions after aspirin or other NSAIDs
  • Setting of coronary artery bypass graft (CABG) surgery

Important warnings

  • Boxed warning: increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal and may occur early in treatment
  • Boxed warning: serious gastrointestinal bleeding, ulceration and perforation, at any time and without warning; elderly patients at greater risk
  • Hypertension, heart failure and edema; avoid in severe heart failure
  • Renal toxicity, especially with impaired renal or liver function, heart failure, diuretics or ACE inhibitors
  • Anaphylactic reactions and DRESS, sometimes fatal

Side effects

  • Mainly gastrointestinal: dyspepsia (11%), nausea, abdominal pain, diarrhea, constipation, flatulence
  • Headache, dizziness, somnolence or insomnia
  • Tinnitus, visual disturbance
  • Peptic ulcer or GI bleeding

Interactions

  • Oral corticosteroids and anticoagulants: increased risk of GI bleeding
  • Diuretics, ACE inhibitors, ARBs: blunted effect and risk of renal toxicity
  • Concomitant use with ketoprofen extended-release capsules not recommended

Pregnancy and breastfeeding

  • Avoid from about 30 weeks gestation: risk of premature closure of the fetal ductus arteriosus
  • From about 20 weeks: possible fetal renal dysfunction with oligohydramnios

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Patient information (US)

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

Austria

  • FastumA. Menarini - Industrie Farmaceutiche Riunite - S.R.L. · 1 register entry
  • KetosprayCyathus Exquirere Pharmaforschungsgmbh · 1 register entry
  • ProfenidSanofi-Aventis Gmbh Osterreich · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Germany

  • AlrheumunTeofarma S.R.L. · 1 register entry
  • EffektonTeofarma S.R.L. · 1 register entry
  • Gabrilen NTrommsdorff Gmbh & Co. Kg · 2 register entries

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Turkey

  • ArtrocolWORLD MEDICINE İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
  • Bi-ProfenidSANOFİ SAĞLIK ÜRÜNLERİ LTD. ŞTİ., GM BAY SAĞLIK ÜRÜNLERİ İTH. İHR. VE TİC. LTD. ŞTİ. · 3 register entries
  • CatoxfenRİBO GEN İLAÇ SAĞLIK HİZMETLERİ İTHALAT İHRACAT SANAYİ TİCARET A.Ş. · 1 register entry
  • KetofenNOBEL İLAÇ SAN. VE TİC. A.Ş. · 7 register entries
  • Mivelin PRWORLD MEDICINE İLAÇ SAN. VE TİC. A.Ş. · 4 register entries
  • NevrozzFARMALAS İLAÇ SAN. VE TİC. LTD. ŞTİ. · 1 register entry
  • ProfenidGM BAY SAĞLIK ÜRÜNLERİ İTH. İHR. VE TİC. LTD. ŞTİ. · 1 register entry
  • ProflamABDİ İBRAHİM İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • TeknazolNOBEL İLAÇ SAN. VE TİC. A.Ş. · 3 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

USA

  • OrudisAllegis Pharmaceuticals, Inc. · 1 register entry

Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-29

Brand names in 23 more European countries
Belgium
Fastum
Bulgaria
Ketospray, Артрокол, Кетонал, Кетопрофен Абр, Кетопрофен Софарма, Кетофлекс, Фастум
Croatia
Fastum, Ketonal, Knavon
Cyprus
Fastum
Czechia
Fastum, Keplat, Ketonal, Prontoflex
Estonia
Fastum, Keto, Ketonal
Finland
Keto, Ketorin, Orudis
France
Bi Profenid Lp, Ketoprofene Aguettant, Ketoprofene Benta, Ketoprofene Biogaran, Ketoprofene Cristers, Ketoprofene Eg, Ketoprofene Lp Arrow, Ketoprofene Lp Biogaran, Ketoprofene Lp Cristers, Ketoprofene Lp Sandoz, Ketoprofene Lp Viatris, Ketoprofene Lp Zentiva, Ketoprofene Medisol, Ketoprofene Pharmy Ii, Ketoprofene Teva, Ketum, Profemigr, Profenid, Toprec
Greece
Drastirel
Hungary
Fastum, Keplat, Ketospray
Ireland
Fastum
Italy
Alket, Dolgosin, Fastum, Ibifen, Isofenal, Keplat, Ketodipil, Ketoplus, Ketoprofene Eg, Momenactcompi’, Orudis, Steofen
Latvia
Fastum, Keto, Ketonal
Lithuania
Fastum, Ketonal
Luxembourg
Fastum, Ketoprofene Aguettant
Malta
Fastum, Ketokaps Max
Poland
Fastum, Febrofen, Ketoflix, Ketokaps, Ketolek, Ketonal, Ketoprex Forte, Ketoprex Max, Ketoprofen Apteo Med, Ketoprofen Lgo, Ketoprofen Sf, Ketoprofen Ziaja, Ketospray Forte, Opokan-Keto, Refastin
Portugal
Kepin, Keplat, Profenid
Romania
Fastum, Ketomag, Ketonal, Ketoprofen Rompharm, Ketoprofen Slavia, Ketoprofen Terapia, Ketoprofen Tis, Ketoproxin, Ketospray
Slovakia
Fastum, Ketonal, Ketospray
Slovenia
Ketonal, Ketoprofen Vitabalans
Spain
Fastum
Sweden
Siduro

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Sources

  1. U.S. Food and Drug Administration. Ketoprofen (Marnel Pharmaceuticals, Inc.) – Prescribing Information, 2026-04-02. DailyMed (NLM), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=4e7bceb6-dcb5-c5e0-e063-6294a90a101e
  2. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  5. U.S. FDA – Drug labels (openFDA/DailyMed), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/

Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error

Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.