Fenoprofen

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 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. ( 1 ) • Relief of the signs and symptoms of rheumatoid arthritis.ICD-10: M06.9, M19.90

• 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 [ see Warnings and Precautions ( 5.7 , 5.9 ) ] • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.contraindicated

• Use the lowest effective dosage for shortest duration consistent with individual patient treatment goals ( 2.1 ) • Analgesia: For the treatment of mild to moderate pain, the recommended dosage is 200 mg given orally every 4 to 6 hours, as needed ( 2.1 ) • 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. 2.1 General Dosing Instructions Carefully consider the potential benefits and risks of fenoprofen calcium and other treatment options before deciding to use fenoprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. Use lowest effective dosage for the shortest duration consistent with individual patient treatment goals [ see Warnings and Precautions ( 5 ) ]. Fenoprofen calcium may be administered with meals or with milk. Although the total amount absorbed is not affected, peak blood levels are delayed and diminished. Patients with rheumatoid arthritis generally seem to require larger doses of fenoprofen calcium than do those with osteoarthritis. The smallest dose that yields acceptable control should be employed.

• 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 ( 5.3 ) • Hypertension: Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure ( 5.4 , 7 ) • Heart Failure and Edema: Avoid use of fenoprofen calcium in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure ( 5.5 ) • Renal Toxicity: Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of fenoprofen calcium in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function ( 5.6 ) • Anaphylactic Reactions: Seek emergency help if an anaphylactic reaction occurs ( 5.7 ) • Exacerbation of Asthma Related to Aspirin Sensitivity: Fenoprofen calcium is contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity) ( 5.8 ) • Serious Skin Reactions: Discontinue fenoprofen calcium at first appearance of skin rash or other signs of hypersensitivity ( 5.9 ) • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): Discontinue and evaluate clinically ( 5.10 ) • Fetal Toxicity; Limit use of NSAIDs, including fenoprofen calcium, between about 20 to 30 weeks in pregnancy due to the risk of oligohydramnios/fetal renal dysfunction.

The following adverse reactions are discussed in greater detail in other sections of the labeling: •Cardiovascular Thrombotic Events [ see Warnings and Precautions ( 5.1 ) ] •GI Bleeding, Ulceration and Perforation [ see Warnings and Precautions ( 5.2 ) ] •Hepatotoxicity [ see Warnings and Precautions ( 5.3 ) ] •Hypertension [ see Warnings and Precautions ( 5.4 ) ] •Heart Failure and Edema [ see Warnings and Precautions ( 5.5 ) ] •Renal Toxicity and Hyperkalemia [ see Warnings and Precautions ( 5.6 ) ] •Anaphylactic Reactions [ see Warnings and Precautions ( 5.7 ) ] •Serious Skin Reactions [ see Warnings and Precautions ( 5.9 ) ] •Hematologic Toxicity [ see Warnings and Precautions ( 5.12 ) ] Most common adverse reactions (incidence ≥ 5%) are Dyspepsia, headache, somnolence, nausea, dizziness, constipation, nervousness, asthenia, and peripheral edema.( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch ( 6 ) 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. During clinical studies for rheumatoid arthritis, osteoarthritis, or mild to moderate pain and studies of pharmacokinetics, complaints were compiled from a checklist of potential adverse reactions, and the following data emerged.

Infertility: NSAIDs are associated with reversible infertility. Consider withdrawal of fenoprofen calcium in women who have difficulties conceiving ( 8.3 ) 8.1 Pregnancy Risk Summary Use of NSAIDs, including fenoprofen calcium, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. Because of these risks, limit dose and duration of fenoprofen calcium use between about 20 and 30 weeks of gestation, and avoid fenoprofen calcium use at about 30 weeks of gestation and later in pregnancy ( see Clinical Considerations, Data) Premature Closure of Fetal Ductus Arteriosus Use of NSAIDs, including fenoprofen calcium, at about 30 weeks gestation or later in pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Oligohydramnios/Neonatal Renal Impairment Use of NSAIDs at about 20 weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment. Data from observational studies regarding other potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive.

Metabolism

Absorption Under fasting conditions, fenoprofen is rapidly absorbed, and peak plasma levels of 50 mcg/L are achieved within 2 hours after oral administration of 600 mg doses. Good dose proportionality was observed between 200 and 600 mg doses in fasting male volunteers.

Symptoms following acute NSAID overdosages have been typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which have been generally reversible with supportive care. Gastrointestinal bleeding has occurred. Hypertension, acute renal failure, respiratory depression, and coma have occurred, but were rare [ see Warnings and Precautions ( 5.1 , 5.2 , 5.4, 5.6) ]. Manage patients with symptomatic and supportive care following an NSAID overdosage. There are no specific antidotes. Consider emesis and/or activated charcoal (60 to 100 grams in adults, 1 to 2 grams per kg of body weight in pediatric patients) and/or osmotic cathartic in symptomatic patients seen within four hours of ingestion or in patients with a large overdosage (5 to 10 times the recommended dosage). Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding. For additional information about overdosage treatment contact a poison control center (1-800-222-1222).

• Mar 16, 1976NDANDA017604Pharmaco
• Jul 18, 2022ANDAANDA214475Rising

1. 1Diarrhoea510%
2. 2Drug Hypersensitivity510%
3. 3Headache510%
4. 4Myocardial Infarction48.3%
5. 5Pain In Extremity48.3%
6. 6Decreased Appetite36.3%
7. 7Drug Interaction36.3%
8. 8Intestinal Diaphragm Disease36.3%
9. 9Pneumonia36.3%
10. 10Vomiting36.3%
11. 11Weight Decreased36.3%
12. 12Asthenia24.2%
13. 13Burning Sensation24.2%
14. 14Cardiac Disorder24.2%
15. 15Cardiomyopathy24.2%

Recent PubMed references pinned to Fenoprofen as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• nido-carborane conjugates with ibuprofen, flurbiprofen and fenoprofen: synthesis, characterization, COX inhibition potential and anticancer activity.
  Journal of inorganic biochemistry · 2026 · Sonam S, Mojić M, Laube M, et al.
  PMID 41844461DOI 10.1016/j.jinorgbio.2026.113282
• Sustainable Microextraction Using Switchable Solubility Solvent for the Liquid Chromatographic Determination of Three Profenoid Drugs in Urine Samples.
  Journal of separation science · 2025 · Patakidou C, Ntorkou M, Zacharis CK, et al.
  PMID 40650458DOI 10.1002/jssc.70223
• The Anticonvulsant Effect of Nonsteroidal Anti-Inflammatory Drug, Fenoprofen, in Pentylenetetrazole-Induced Epileptic Rats: Behavioral, Histological, and Biochemical Evidence.
  Pharmacology research & perspectives · 2025 · Rahimi-Tesiye M, Rajabi-Maham H, Azizi V, et al.
  PMID 39907374DOI 10.1002/prp2.70072
• Insights into the electronic structure of non-steroidal anti-inflammatory drugs: soft X-ray study of fenoprofen, ketoprofen and methyl salicylate in the gas phase.
  Physical chemistry chemical physics : PCCP · 2024 · Sa'adeh H, Maris A, Prince KC, et al.
  PMID 39555791DOI 10.1039/d4cp03600j
• Carborane Conjugates with Ibuprofen, Fenoprofen and Flurbiprofen: Synthesis, Characterization, COX Inhibition Potential and In Vitro Activity.
  ChemMedChem · 2025 · Sonam S, Jelača S, Laube M, et al.
  PMID 38844420DOI 10.1002/cmdc.202400018
• Unusual human serum albumin fibrillation inhibition by ketoprofen and fenoprofen: Mechanistic insights.
  Journal of molecular recognition : JMR · 2021 · Prasanthan P, Kishore N
  PMID 34505308DOI 10.1002/jmr.2937
• Overloading behavior of fenoprofen and naproxen as two model compounds on a non-porous silicon pillar array column.
  Journal of chromatography. A · 2021 · Naghdi E, De Malsche W
  PMID 34153737DOI 10.1016/j.chroma.2021.462332
• Quantification of fenoprofen in human plasma using UHPLC-tandem mass spectrometry for pharmacokinetic study in healthy subjects.
  Biomedical chromatography : BMC · 2020 · Bharwad KD, Shah PA, Shrivastav PS, et al.
  PMID 31630419DOI 10.1002/bmc.4708

The 1 most recently updated of 1 ClinicalTrials.gov registrations naming Fenoprofen as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Comparison Between Two Different Doses of Nulbuphine _bupivacaine in TAP Block in Cancer Abdominal Surgeries
  Unknown · Interventional · 30 enrolled · Assiut University
  NCT05090579updated 2021-10-25

Frequently asked questions

How does Fenoprofen work?

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).

What is Fenoprofen used for?

According to FDA labeling, Fenoprofen carries indications including: 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. ( 1 ) • Relief of the signs and symptoms of rheumatoid arthritis.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Fenoprofen?

Fenoprofen is classified as Propionic acid derivatives, Nonsteroidal Anti-inflammatory Drug, Cyclooxygenase Inhibitors, Decreased Prostaglandin Production, Increased Immunologic Activity.

What are the brand names for Fenoprofen?

Fenoprofen is marketed under brand names including Fenopron, Nalfon.

What are the contraindications for Fenoprofen?

Fenoprofen labeling lists contraindications including: 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 [ see Warnings and Precautions ( 5.7 , 5.9 ) ] • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.. Always consult the full prescribing information and a clinician.