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Orudis (KETOPROFEN)
Orudis (Ketoprofen) is a nonsteroidal anti-inflammatory drug (NSAID) developed by a predecessor of Wyeth Pharms Inc. It targets prostaglandin G/H synthase 1 to treat conditions such as osteoarthritis, rheumatoid arthritis, and dysmenorrhea. Orudis is a small molecule with a 90% bioavailability and a half-life of 2.1 hours. It was FDA-approved in 1986 and is now off-patent with multiple generic manufacturers. As an NSAID, Orudis carries key safety considerations related to gastrointestinal and renal toxicity.
At a glance
| Generic name | KETOPROFEN |
|---|---|
| Sponsor | Wyeth Pharms Inc |
| Drug class | Nonsteroidal Anti-inflammatory Drug [EPC] |
| Target | Prostaglandin G/H synthase 1 |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 1986 |
Approved indications
- Dysmenorrhea
- Osteoarthritis
- Pain
- Rheumatoid arthritis
Boxed warnings
- 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 extended-release capsules are 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 ).
Common side effects
- Dyspepsia
- Peptic ulcer or GI bleeding
- Gastrointestinal perforation
- Hematemesis
- Intestinal ulceration
- Hepatic dysfunction
- Hepatitis
- Jaundice
- Gastrointestinal bleeding
- Nausea
- Abdominal pain
- Diarrhea
Drug interactions
- lithium
- methotrexate
- phenprocoumon
- warfarin
Key clinical trials
- Paracetamol With or Without Ketoprofen in the Management of Pain for Patients Receiving Brachytherapy (KETOCOL-1304) (PHASE2)
- Study of Analgesics Drug and Human Milk Transfer in Mature Milk, to Avoid Breastfeeding Cessation Without Scientific Probes
- Ketamine Administration for Postoperative Pain Management in Patients Undergoing Knee Arthroplasty (NA)
- Helping Osteoarthritis Patients to Walk With NSAID (PHASE4)
- Effect of Phonophoresis on Trigger Points (NA)
- Reversing External-beam Radiotherapy-associated Fibrosis Syndrome: an Interventional Bayesian Adaptive Randomized-controlled Orphan Drug Platform Trial for Orodental Sequelae (Reverse-fibrose) (PHASE2)
- Multiprofen-CC to Reduce Pain in Hand Arthritis (PHASE3)
- Novel Transdermal Ketoprofen Gel Formulation for Knee Osteoarthritis (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Orudis CI brief — competitive landscape report
- Orudis updates RSS · CI watch RSS