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Oxaprozin

Also known as: Oxaprozin

Nonsteroidal Anti-inflammatory DrugCyclooxygenase Inhibitors

Route: Oral

4 interactions on record⛔ Black Box Warning

Oxaprozin has 4 known drug interactions based on U.S. FDA drug labeling data. 2 are classified as major interactions requiring close medical supervision. Notable interactions include combinations with Acetylsalicylic Acid, Warfarin, Furosemide. Patients taking Oxaprozin should inform their healthcare provider of all current medications — including over-the-counter drugs and supplements — to avoid potentially harmful combinations. Data sourced from OpenFDA and the NIH National Library of Medicine.

Total: 4
Major: 2
Moderate: 2

Major (2)

Oxaprozin + Acetylsalicylic Acid— Concomitant use associated with significantly increased incidence of GI adverse reactions and increased risk of bleeding…
Oxaprozin + Warfarin— Synergistic effect on bleeding with increased risk of serious bleeding compared to either drug alone.

Moderate (2)

Oxaprozin + Furosemide— Diuretics Clinical Impact: Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the natr…
Oxaprozin + Propranolol— NSAIDs may diminish the antihypertensive effect of beta-blockers; may result in deterioration of renal function in elder…

Oxaprozin + Acetylsalicylic Acid⚠️Major

Concomitant use associated with significantly increased incidence of GI adverse reactions and increased risk of bleeding.

Oxaprozin + Warfarin⚠️Major

Synergistic effect on bleeding with increased risk of serious bleeding compared to either drug alone.

Oxaprozin + Furosemide🟡Moderate

Diuretics Clinical Impact: Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients. In such high risk patients, monitor for signs of worsening renal function (7) Diuretics: NSAIDs can reduce natriuretic effect of furosemide and thiazide diuretics.

Oxaprozin + Propranolol🟡Moderate

NSAIDs may diminish the antihypertensive effect of beta-blockers; may result in deterioration of renal function in elderly, volume-depleted, or renally impaired patients.

⛔ FDA Black Box Warning

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS 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 (5.1)]. Oxaprozin is contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see Contraindications (4) and Warnings and Precautions (5.1) ]. Gastrointestinal Bleeding, Ulceration, and Perforation NSAIDs cause an increased risk of serious gastrointestinal (GI) 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 and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events [see Warnings and Precautions (5.2) ]. See full prescribing information for complete boxed warning. 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 (5.1) Oxaprozin is contraindicated in the setting of coronary artery bypass graft (CABG) surgery ( 4 , 5.1 ) NSAIDs cause an increased risk of serious gastrointestinal (GI) 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 and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events ( 5.2 )

Contraindications

4 CONTRAINDICATIONS Oxaprozin is 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. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients [see Warnings and Precautions ( 5.7 , 5.8 ) ] In the setting of coronary artery bypass graft (CABG) surgery [see Warnings and Precautions ( 5.1 )] Known hypersensitivity to oxaprozin or any components of the drug product ( 4) History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs ( 4) In the setting of CABG surgery ( 4)

Pregnancy & Breastfeeding

8.1 Pregnancy Risk Summary Use of NSAIDs, including oxaprozin, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs, including oxaprozin, in pregnant women starting at 30 weeks of gestation (third trimester). There are no adequate and well-controlled studies of oxaprozin in pregnant women. Data from observational studies regarding potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive. In the general U.S. population, all clinically recognized pregnancies, regardless of drug exposure, have a background rate of 2% to 4% for major malformations, and 15% to 20% for pregnancy loss. In animal reproduction studies, oral administration of oxaprozin to pregnant rabbits at doses 0.1 times the maximum daily human dose (based on body surface area) resulted in evidence of teratogenicity; however, oral administration of oxaprozin to pregnant mice and rats during organogenesis at doses equivalent to the maximum recommended human dose revealed no evidence of teratogenicity or embryotoxicity. In rat reproduction studies in which oxaprozin was administered through late gestation failure to deliver and a reduction in live birth index was observed at doses equivalent to the maximum recommended human dose. Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization. In animal studies, administration of prostaglandin synthesis inhibitors such as oxaprozin, resulted in increased pre- and post-implantation loss. Clinical Considerations Labor or Delivery There are no studies on the effects of oxaprozin during labor or delivery. In animal studies, NSAIDS, including oxaprozin, inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth. Data Animal data Teratology studies with oxaprozin were performed in mice, rats,

Data sourced from U.S. FDA drug labeling via openFDA and the NIH National Library of Medicine. For informational purposes only. Always consult your pharmacist or physician.