Fenoprofen is a nonsteroidal anti-inflammatory drug indicated for relief of mild to moderate pain in adults, among other approved uses. It is available as capsules for oral use. MedsAcross supplies Fenoprofen for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
1. INDICATIONS AND USAGE FENOPROFEN CALCIUM is indicated for: • Relief of mild to moderate pain in adults • Relief of the signs and symptoms of rheumatoid arthritis • Relief of the signs and symptoms of osteoarthritis FENOPROFEN CALCIUM is a nonsteroidal anti-inflammatory drug indicated for: Relief of mild to moderate pain in adults. Relief of the signs and symptoms of rheumatoid arthritis. Relief of the signs and symptoms of osteoarthritis.
Source: US FDA prescribing information
Fenoprofen has analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of FENOPROFEN CALCIUM, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2). Fenoprofen is a potent inhibitor of prostaglandin synthesis in vitro. Fenoprofen concentrations reached during therapy have produced in vivo effects. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models. Prostaglandins are mediators of inflammation. Because fenoprofen is an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues.
Source: US FDA prescribing information
2. DOSAGE AND ADMINISTRATION Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals. Analgesia: For the treatment of mild to moderate pain, the recommended dosage is 200 mg given orally every 4 to 6 hours, as needed. Rheumatoid Arthritis and Osteoarthritis: For the relief of signs and symptoms of rheumatoid arthritis or osteoarthritis the recommended dose is 400 to 600 mg given orally, 3 or 4 times a day. The dose should be tailored to the needs of the patient and may be increased or decreased depending on the severity of the symptoms. Dosage adjustments may be made after initiation of drug therapy or during exacerbations of the disease. Total daily dosage should not exceed 3,200 mg.
Source: US FDA prescribing information
4. CONTRAINDICATIONS FENOPROFEN CALCIUM is contraindicated in the following patients: Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to fenoprofen or any components of the drug product History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients In the setting of coronary artery bypass graft (CABG) surgery • Known hypersensitivity to fenoprofen or any components of the drug product. • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. • In the setting of (CABG) surgery
Source: US FDA prescribing information
Boxed warning (risk of serious cardiovascular and gastrointestinal events): Cardiovascular Thrombic Events Non-Steroidal 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. 5. WARNINGS AND PRECAUTIONS Warning and Precautions • Hepatotoxicity: Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop. • Hypertension: Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure.
Source: US FDA prescribing information
6. ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: • Cardiovascular Thrombotic Events • GI Bleeding, Ulceration and Perforation • Hepatotoxicity • Hypertension • Heart Failure and Edema • Renal Toxicity and Hyperkalemia • Anaphylactic Reactions • Serious Skin Reactions • Hematologic Toxicity Most common adverse reactions (incidence ≥ 5%) are Dyspepsia, headache, somnolence, nausea, dizziness, constipation, nervousness, asthenia, and peripheral edema.
Source: US FDA prescribing information
7. DRUG INTERACTIONS See Table 1 for clinically significant drug interactions with fenoprophen. Table 1: Clinically Significant Drug Interactions with Fenoprofen Drugs That Interfere with Hemostasis Clinical Impact: Fenoprofen and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of fenoprofen and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone. Serotonin release by platelets plays an important role in hemostasis. Case-control and cohort epidemiological studies showed that concomitant use of drugs that interfere with serotonin reuptake and an NSAID may potentiate the risk of bleeding more than an NSAID alone.
Source: US FDA prescribing information
Store at room temperature 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
4 presentations of Fenoprofen, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Fenoprofen 400 mg capsuleOralGeneric name | — | US FDA | Available on request |
| Fenoprofen 200 mg capsuleOralGeneric name | — | US FDA | Available on request |
| Fenoprofen 300 mg capsuleOralGeneric name | — | US FDA | Available on request |
| Fenopron TM 300 mg capsuleOral | Galt Pharmaceuticals | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 16 March 1976 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions linked to Fenoprofen in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 4 presentations of Fenoprofen and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Fenoprofen, including Fenopron TM.
Yes. The US FDA first approved Fenoprofen on 16 March 1976, according to Drugs@FDA.
No listed presentation of Fenoprofen is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Fenoprofen is classified under ATC code M01AE04 (Fenoprofen).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.