Oxaprozin

Mechanism-of-action class: Cyclooxygenase Inhibitors.

• Oxaprozin tablets are indicated: For relief of the signs and symptoms of osteoarthritis For relief of the signs and symptoms of rheumatoid arthritis For relief of the signs and symptoms of juvenile rheumatoid arthritisICD-10: M06.9, M19.90

• Oxaprozin tablets are contraindicated in the following patients: Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to oxaprozin 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

General Dosing Instructions Carefully consider the potential benefits and risks of oxaprozin tablets and other treatment options before deciding to use oxaprozin tablets. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)]. 2.2 Osteoarthritis For OA, the dosage is 1,200 mg (two 600 mg tablets) given orally once a day [see Dosage and Administration (2.5)]. 2.3 Rheumatoid Arthritis For RA, the dosage is 1,200 mg (two 600 mg tablets) given orally once a day [see Dosage and Administration (2.5)]. 2.4 Juvenile Rheumatoid Arthritis For JRA, in patients 6 to 16 years of age, the recommended dosage given orally once per day should be based on body weight of the patient as given in Table 1 [see Dosage and Administration (2.5)]. Table 1. Recommended Daily Dose of Oxaprozin by Body Weight in Pediatric Patients Body Weight Range (kg) Dose (mg) 22 to 31 600 32 to 54 900 ≥55 1200 2.5 Individualization of Dosage After observing the response to initial therapy with oxaprozin tablets, the dose and frequency should be adjusted to suit an individual patient’s needs. In osteoarthritis and rheumatoid arthritis and juvenile rheumatoid arthritis, the dosage should be individualized to the lowest effective dose of oxaprozin tablets to minimize adverse effects. The maximum recommended total daily dose of oxaprozin tablets in adults is 1,800 mg (26 mg/kg, whichever is lower) in divided doses. In children, doses greater than 1,200 mg have not been studied.

Cardiovascular Thrombotic Events Clinical trials of several cyclooxygenase-2 (COX-2) selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal. Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs. The relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CV disease. However, patients with known CV disease or risk factors had a higher absolute incidence of excess serious CV thrombotic events, due to their increased baseline rate. Some observational studies found that this increased risk of serious CV thrombotic events began as early as the first weeks of treatment. The increase in CV thrombotic risk has been observed most consistently at higher doses. To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible. Physicians and patients should remain alert for the development of such events, throughout the entire treatment course, even in the absence of previous CV symptoms. Patients should be informed about the symptoms of serious CV events and the steps to take if they occur. There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use.

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) ] 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. Adverse reaction data were derived from patients who received oxaprozin in multidose, controlled, and open-label clinical trials. Rates for events from clinical trial experience are based on 2,253 patients who took 1,200 mg to 1,800 mg oxaprozin per day in clinical trials. Of these, 1,721 patients were treated for at least 1 month, 971 patients for at least 3 months, and 366 patients for more than 1 year. Incidence Greater than 1%: : In clinical trials of oxaprozin or in patients taking other NSAIDs, the following adverse reactions occurred at an incidence greater than 1%. Cardiovascular system: edema.

Pregnancy Risk Summary Use of NSAIDs, including oxaprozin, 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 oxaprozin use between about 20 and 30 weeks of gestation, and avoid oxaprozin 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 oxaprozin, 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.

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 grams to 100 grams in adults, 1 gram 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).

• Jan 31, 2001ANDAANDA075855Dr Reddys Labs Ltd
• Sep 2, 2004ANDAANDA075987Chartwell
• May 4, 2017ANDAANDA208633Amneal Pharms Co
• Oct 20, 2023NDANDA217927Solubiomix

Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

• Daypro, Tablet, 600 mg (NDC 0025-1381-31)To be discontinued
  Sponsor: Hospira, Inc., a Pfizer Company
  Updated Jul 17, 2025

1. 1Chronic Kidney Disease829.3%
2. 2Drug Ineffective687.7%
3. 3Pain687.7%
4. 4Drug Hypersensitivity616.9%
5. 5Nausea606.8%
6. 6Renal Failure546.1%
7. 7Acute Kidney Injury515.8%
8. 8Arthralgia505.7%
9. 9Dizziness485.4%
10. 10Fatigue424.8%
11. 11Headache384.3%
12. 12Dyspnoea364.1%
13. 13Fall333.7%
14. 14Rash333.7%
15. 15Depression323.6%

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

• Anticonvulsant activity of oxaprozin in a rat model of pentylenetetrazole-induced seizure by targeting oxidative stress and SIRT1/PGC1α signaling.
  Canadian journal of physiology and pharmacology · 2022 · Khatami P, Mirazi N, Khosravi M, et al.
  PMID 35395161DOI 10.1139/cjpp-2021-0757
• Oxaprozin Analogues as Selective RXR Agonists with Superior Properties and Pharmacokinetics.
  Journal of medicinal chemistry · 2021 · Schierle S, Chaikuad A, Lillich FF, et al.
  PMID 33793232DOI 10.1021/acs.jmedchem.1c00235
• New 2-(4-(4-bromophenylsulfonyl)phenyl)-4-arylidene-oxazol-5(4H)-ones: analgesic activity and histopathological assessment.
  Romanian journal of morphology and embryology = Revue roumaine de morphologie et embryologie · 2020 · Bărbuceanu F, Roşca EV, Apostol TV, et al.
  PMID 33544801DOI 10.47162/RJME.61.2.19
• A drug-drug interaction study of a novel, selective urate reabsorption inhibitor dotinurad and the non-steroidal anti-inflammatory drug oxaprozin in healthy adult males.
  Clinical and experimental nephrology · 2020 · Furihata K, Nagasawa K, Hagino A, et al.
  PMID 32076889DOI 10.1007/s10157-020-01855-2
• Manganese(II) coordination compounds of carboxylate non-steroidal anti-inflammatory drugs.
  Journal of inorganic biochemistry · 2020 · Dimiza F, Lazou M, Papadopoulos AN, et al.
  PMID 31707332DOI 10.1016/j.jinorgbio.2019.110906
• The study of ultrasound and iontophoresis on oxaprozin transdermal penetration using surface-enhanced Raman spectroscopy.
  Drug delivery and translational research · 2020 · Liu S, Bao X, Zhang S, et al.
  PMID 31407271DOI 10.1007/s13346-019-00664-9
• Zinc-oxaprozin compounds: Synthesis, structure and biological activity.
  Journal of inorganic biochemistry · 2019 · Lazou M, Hatzidimitriou AG, Papadopoulos AN, et al.
  PMID 30939377DOI 10.1016/j.jinorgbio.2019.03.016
• Oxaprozin: A new hope in the modulation of matrix metalloproteinase 9 activity.
  Chemical biology & drug design · 2019 · Ianni A, Celenza G, Franceschini N, et al.
  PMID 30582279DOI 10.1111/cbdd.13468

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

• Drug-drug Interaction Study of FYU-981 and Oxaprozin
  Completed · Phase 1 · Interventional · 12 enrolled · Mochida Pharmaceutical Company, Ltd.
  NCT03350386updated 2022-09-14

Frequently asked questions

How does Oxaprozin work?

Mechanism-of-action class: Cyclooxygenase Inhibitors.

What is Oxaprozin used for?

According to FDA labeling, Oxaprozin carries indications including: Oxaprozin tablets are indicated: For relief of the signs and symptoms of osteoarthritis For relief of the signs and symptoms of rheumatoid arthritis For relief of the signs and symptoms of juvenile rheumatoid arthritis. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Oxaprozin?

Oxaprozin is classified as Propionic acid derivatives, Nonsteroidal Anti-inflammatory Drug, Cyclooxygenase Inhibitors, Decreased Prostaglandin Production.

What are the brand names for Oxaprozin?

Oxaprozin is marketed under brand names including Coxanto, Daypro.

What are the contraindications for Oxaprozin?

Oxaprozin labeling lists contraindications including: Oxaprozin tablets are contraindicated in the following patients: Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to oxaprozin 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.