Generic Medicine Info
Indications and Dosage
Ankylosing spondylitis, Osteoarthritis, Rheumatoid arthritis
Adult: 300-600 mg 3-4 times daily. Max: 3-3.2 g daily. Use the lowest effective dose for the shortest possible duration consistent with the individual patient treatment goals.

Mild to moderate pain
Adult: 300-600 mg 3-4 times daily. Max: 3 g daily. Alternatively, 200 mg 4-6 hourly as needed. Max: 3.2 g daily. Use the lowest effective dose for the shortest possible duration consistent with the individual patient treatment goals.
Renal Impairment
Severe: Contraindicated.
Should be taken with food.
Hypersensitivity to fenoprofen; history of asthma, urticaria, or allergic-type reaction to aspirin or other NSAIDs; active, or history of peptic ulcer/haemorrhage (2 or more distinct episodes of proven ulceration or bleeding); history of gastrointestinal bleeding or perforation related to previous NSAIDs therapy; in the setting of CABG surgery. Severe renal impairment. Pregnancy (3rd trimester).
Special Precautions
Patient with known CV disease or risk factors for CV disease, uncontrolled hypertension, CHF, established ischaemic heart disease, peripheral arterial disease; history of upper gastrointestinal disease (e.g. ulcerative colitis, Crohn’s disease). Hepatic and mild to moderate renal impairment. Elderly. Pregnancy (1st and 2nd trimester) and lactation.
Adverse Reactions
Significant: Anaphylactoid reactions, CNS effects (e.g. drowsiness, dizziness), visual disturbances (e.g. blurred vision), haematological effects (e.g. decreased platelet adhesion and aggregation, anaemia), increased transaminase, increased risk of hyperkalaemia; dysuria, cystitis, haematuria, interstitial nephritis, nephrotic syndrome.
Cardiac disorders: Palpitation.
Ear and labyrinth disorders: Tinnitus.
Gastrointestinal disorders: Dyspepsia, nausea, abdominal pain, diarrhoea, vomiting, constipation.
General disorders and administration site conditions: Asthenia.
Metabolism and nutrition disorders: Peripheral oedema.
Nervous system disorders: Headache, somnolence.
Psychiatric disorders: Nervousness.
Skin and subcutaneous tissue disorders: Increased sweating, pruritus, rash.
Potentially Fatal: Serious CV thrombotic events (e.g. MI, stroke), drug reaction with eosinophilia and systemic symptoms (DRESS); gastrointestinal inflammation, ulceration, bleeding, and perforation. Rarely, severe hepatic reactions (e.g. fulminant hepatitis, hepatic necrosis, hepatic failure), serious skin reactions (e.g. exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis).
PO: Z (NSAIDs caused foetal ductus arteriosus premature closure, foetal renal impairment and persistent pulmonary hypertension. Avoid near term, else use lowest dose for shortest time.)
Patient Counseling Information
This drug may cause drowsiness, dizziness, fatigue, or visual disturbances, if affected, do not drive or operate machinery.
Monitoring Parameters
Obtain LFT, renal function (e.g. urine output, BUN, creatinine); CBC and chemistry profile periodically during long-term therapy. Monitor blood pressure at initiation and during therapy; signs and symptoms of bleeding, fluid retention, hepatotoxicity, or ototoxicity.
Symptoms: Lethargy, drowsiness, nausea, vomiting, epigastric pain, gastrointestinal bleeding. Rarely, hypertension, acute renal failure, respiratory depression, coma. Management: Supportive and symptomatic treatment. Consider emesis, activated charcoal, and/or osmotic catharsis within 4 hours of ingestion or in case of large overdosage.
Drug Interactions
Increased risk of adverse effects (e.g. gastrointestinal toxicity, bleeding) with other NSAIDs, anticoagulants (e.g. warfarin), antiplatelets (e.g. aspirin), SSRIs, and corticosteroids. May reduce antihypertensive effects of ACE inhibitors, angiotensin II receptor antagonists, and β blockers (e.g. propranolol). May reduce the natriuretic effects of loop and thiazide diuretics. May increase plasma concentration and toxicity of digoxin. May increase toxicity of lithium and methotrexate. May increase nephrotoxic effect of ciclosporin. May increase the risk of pemetrexed-associated myelosuppression, renal and gastrointestinal toxicity. Decreased plasma half-life with phenobarbital. May increase the risk of convulsions with quinolone antibiotics. Increased risk of haematological toxicity with zidovudine.
Food Interaction
Rate and extent of absorption may be reduced when taken with food or milk. Increased risk of gastrointestinal bleeding with alcohol.
Lab Interference
May interfere with Amerlex-M kit assay values and may give false elevations in both free and total serum triiodothyronine. May lead to false positive aldosterone/renin ratio.
Mechanism of Action: Fenoprofen is a propionic acid derivative which reversibly inhibits cyclooxygenase-1 and 2 (COX-1 and 2) enzymes resulting in decreased formation of prostaglandin precursors. It also has antipyretic, analgesic, and anti-inflammatory actions.
Onset: Full effect: Up to 2-3 weeks.
Absorption: Rapidly and almost completely absorbed from the gastrointestinal tract. Food and milk may reduce the rate and extent of absorption. Bioavailability: Approx 85%. Time to peak plasma concentration: 1-2 hours.
Distribution: Enters breast milk. Plasma protein binding: 99%.
Metabolism: Extensively metabolised in the liver.
Excretion: Via urine (approx 90% as metabolite). Elimination half-life: Approx 3 hours.
Chemical Structure

Chemical Structure Image

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 3342, Fenoprofen. https://pubchem.ncbi.nlm.nih.gov/compound/Fenoprofen. Accessed Sept. 27, 2022.

Store between 20-25°C.
MIMS Class
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
ATC Classification
M01AE04 - fenoprofen ; Belongs to the class of propionic acid derivatives of non-steroidal antiinflammatory and antirheumatic products.
Anon. Fenoprofen. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 12/09/2022.

Anon. Fenoprofen. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 12/07/2022.

Buckingham R (ed). Fenoprofen Calcium. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 12/07/2022.

Fenoprofen 300 (Typharm Ltd). MHRA. https://products.mhra.gov.uk. Accessed 12/07/2022.

Nalfon Capsule (Xspire Pharma). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 12/07/2022.

Disclaimer: This information is independently developed by MIMS based on Fenoprofen from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2024 MIMS. All rights reserved. Powered by MIMS.com
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