Ketoprofen

Overview

Ketoprofen, a propionic acid derivative, is a nonsteroidal anti-inflammatory agent (NSAIA) with analgesic and antipyretic properties.

Indication

For symptomatic treatment of acute and chronic rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, primary dysmenorrhea and mild to moderate pain associated with musculotendinous trauma (sprains and strains), postoperative (including dental surgery) or postpartum pain.

Associated Conditions

Ankylosing Spondylitis (AS)
Migraine
Mild pain
Osteoarthritis (OA)
Post Partum Pain
Postoperative pain
Primary Dysmenorrhoea
Rheumatoid Arthritis
Moderate Pain

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Reversing External-beam Radiotherapy-associated Fibrosis Syndrome: an Interventional Bayesian Adaptive Randomized-controlled Orphan Drug Platform Trial for Orodental Sequelae (Reverse-fibrose)	2025/04/06	NCT06912763	Phase 2	Not yet recruiting	M.D. Anderson Cancer Center
Non-steroidal Anti-inflammatory in Cardiac Surgery	2024/04/24	NCT06381063	Phase 3	Recruiting	Centre Hospitalier Universitaire, Amiens
PET Imaging of Cyclooxygenase in Multiple Sclerosis	2021/09/30	NCT05062083	Phase 2	Terminated	National Institute of Mental Health (NIMH)
A Study on Ketoprofen Lysine Salt (KLS) + Gabapentin (GABA) vs KLS to Investigate Their Pharmacodynamic in Healthy Males	2021/03/17	NCT04802967	Phase 1	Completed	Dompé Farmaceutici S.p.A
Efficacy of CLORazepate for the Treatment of MIGraine Attack in the Emergency Room	2021/01/27	NCT04726592	Phase 3	Terminated	Assistance Publique - Hôpitaux de Paris
Bioequivalence of Ketoprofen Oral Gel vs Ketoprofen Lysine Salt as Granules for Oral Solution	2020/12/21	NCT04678076	Phase 1	Completed	Aziende Chimiche Riunite Angelini Francesco S.p.A
Ketoprofen With or Without Vaginal Isonicotinic Acid Hydrazide Prior to Hysterosalpingography	2020/08/05	NCT04500470	Not Applicable	Completed	Aswan University Hospital
A Study to Assess Efficacy and Safety of the Ketoprofen vs Diclofenac	2020/06/09	NCT04421911	Phase 3	Completed	Handok Inc.
Lymphedema Treatment Registry	2020/02/17	NCT04272372	N/A	Not yet recruiting	Ege University
Sphenopalatine Blockade Versus Clinical Treatment	2019/11/04	NCT04148846	Not Applicable	UNKNOWN	University of Sao Paulo General Hospital

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Draxxin KP	Zoetis Inc.	54771-2155	SUBCUTANEOUS	120 mg in 1 mL	5/23/2025
Ketoprofen	Misemer Pharmaceuticals, Inc.	0276-0507	ORAL	75 mg in 1 1	5/26/2025
Ketoprofen	Misemer Pharmaceuticals, Inc.	0276-0506	ORAL	50 mg in 1 1	2/1/2024
Ketoprofen	Misemer Pharmaceuticals, Inc.	0276-0504	ORAL	25 mg in 1 1	2/1/2024

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
FASTUM GEL 2.5%	A. MENARINI MANUFACTURING LOGISTICS AND SERVICES S.R.L.	SIN06755P	GEL	2.5 g/100 g	1/4/1992
PRONALGES 50 TABLET 50 mg	PT DEXA MEDICA	SIN12115P	ENTERIC COATED TABLET	50 mg	10/31/2002
PRONALGES 100 TABLET 100 mg	PT DEXA MEDICA	SIN12153P	ENTERIC COATED TABLET	100 mg	12/23/2002
HARUFEN PLASTER 30MG	SINIL Pharmaceutical Co., Ltd.	SIN16447P	PLASTER	30 mg	3/21/2022
KEFENTECH PLASTER 30 mg/sheet	JEIL HEALTH SCIENCE	SIN10768P	PLASTER	30 mg/sheet	2/25/1999
KETOFEN GEL 2.5% w/w	Hovid Bhd	SIN15748P	GEL	2.50%w/w	7/18/2019
KEFENTECH AIR 30 MG/SHEET	JEIL HEALTH SCIENCE	SIN15212P	PLASTER	30 MG/SHEET	4/18/2017
KENHANCER PLASTER 30 mg/sheet	GC BIOPHARMA CORP.	SIN10769P	PLASTER	30 mg/sheet	2/25/1999
KETOTOP PAIN RELIEF PLASTER 30MG	HANDOK INC	SIN15832P	PLASTER	30mg	10/17/2019
ALKETO PLASTER 30 MG	Sinil Pharmaceutical Co., Ltd.	SIN14989P	PLASTER	30.000 mg	4/15/2016

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
PAINKILL PATCH 30MG	N/A	EUGENPHARM INTERNATIONAL LIMITED	N/A	N/A	12/24/2010
HOHOTAPE MEDICAL PLASTER 30MG	N/A	BEST UNITED MARKETING LIMITED	N/A	N/A	3/6/2025
TON PE JING PLASTER 30MG	N/A	BEST UNITED MARKETING LIMITED	N/A	N/A	4/30/2021
TARFEN MEDICAL PLASTER 30MG	N/A	BEST UNITED MARKETING LIMITED	N/A	N/A	3/6/2025
KETOFEN CAP 50MG	N/A	WILCOME PHARMACEUTICAL COMPANY LIMITED	N/A	N/A	11/12/1982

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
ORUDIS SR ketoprofen 200mg capsule blister pack	27535	Sanofi-Aventis Australia Pty Ltd	Medicine	A	10/21/1991
ORUVAIL SR ketoprofen 200mg capsule blister pack	42422	Sanofi-Aventis Australia Pty Ltd	Medicine	A	1/7/1993

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
PMS-KETOPROFEN E-50 - ECT 50MG	Pharmascience Inc	02150816	Tablet (Enteric-Coated) - Oral	50 MG / ECT	12/31/1995
RHODIS CAP 50MG	rhodiapharm inc	00761664	Capsule - Oral	50 MG / CAP	12/31/1988
KETOPROFEN-SR - SRT 200MG	PRO DOC LIMITEE	02210487	Tablet (Extended-Release) - Oral	200 MG / TAB	9/18/1997
KETOPROFEN	aa pharma inc	00790427	Capsule - Oral	50 MG	12/31/1989
PMS-KETOPROFEN	Pharmascience Inc	02148773	Suppository - Rectal	50 MG	12/31/1995
NOVO-KETO-EC TAB 100MG	novopharm limited	01981536	Tablet (Enteric-Coated) - Oral	100 MG / TAB	12/31/1992
KETOPROFEN-E ECT 100MG	PRO DOC LIMITEE	02084198	Tablet (Enteric-Coated) - Oral	100 MG / ECT	12/31/1996
NOVO-KETO SUPPOSITORIES 100MG	novopharm limited	02156083	Suppository - Rectal	100 MG / SUP	12/31/1996
ORUVAIL 150	aventis pharma inc	01913050	Capsule (Sustained-Release) - Oral	150 MG / CAP	12/31/1991
RHODIS SR 200MG	rhodiapharm inc	02031175	Tablet (Extended-Release) - Oral	200 MG / SRT	12/31/1995

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
ORUDIS RETARD 200 mg COMPRIMIDOS DE LIBERACION PROLONGADA	Sanofi Aventis S.A.	57128	COMPRIMIDO DE LIBERACIÓN PROLONGADA	Medicamento Sujeto A Prescripción Médica	Not Commercialized
FASTUM 25 mg/g GEL	Laboratorios Menarini S.A.	56387	GEL	Medicamento Sujeto A Prescripción Médica	Commercialized
ORUDIS 50 mg CAPSULAS	Sanofi Aventis S.A.	52097	CÁPSULA DURA	Medicamento Sujeto A Prescripción Médica	Not Commercialized
FASTUM 50 MG CÁPSULAS DURAS	Laboratorios Menarini S.A.	54445	CÁPSULA DURA	Medicamento Sujeto A Prescripción Médica	Commercialized
ORUDIS 100 mg SOLUCION INYECTABLE	Sanofi Aventis S.A.	55857	SOLUCIÓN INYECTABLE	Medicamento Sujeto A Prescripción Médica	Not Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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