72/100 · Elevated
Manufactured by Pfizer Laboratories Div Pfizer Inc
Oxaprozin Adverse Events: High Incidence of Drug Hypersensitivity and Renal Issues
4,788 FDA adverse event reports analyzed
Last updated: 2026-05-12
OXAPROZIN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Pfizer Laboratories Div Pfizer Inc. Based on analysis of 4,788 FDA adverse event reports, OXAPROZIN has a safety score of 72 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for OXAPROZIN include DRUG HYPERSENSITIVITY, DRUG INEFFECTIVE, PAIN, NAUSEA, HEADACHE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for OXAPROZIN.
Oxaprozin has a safety concern score of 72 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 4,788 adverse event reports for this medication, which is primarily manufactured by Pfizer Laboratories Div Pfizer Inc.
The most commonly reported adverse events include Drug Hypersensitivity, Drug Ineffective, Pain. Of classified reports, 49.1% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Oxaprozin has a high incidence of drug hypersensitivity reactions, affecting nearly 8% of users.
Renal issues, including chronic kidney disease and renal failure, are significant safety concerns. Pain and gastrointestinal issues are also common, with reports of abdominal pain, nausea, and diarrhea. Serious adverse events, such as chronic kidney disease and renal failure, account for nearly half of non-serious reports.
Patients taking Oxaprozin should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Oxaprozin can cause drug hypersensitivity and renal issues, which may require monitoring and dose adjustments, especially in patients with pre-existing renal conditions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Oxaprozin received a safety concern score of 72/100 (elevated concern). This is based on a 49.1% serious event ratio across 2,050 classified reports. The score accounts for 4,788 total adverse event reports and 100 distinct reaction types. This elevated score indicates a notable proportion of serious adverse events and warrants careful monitoring.
Adverse event reports by sex: Female: 1,458, Male: 489, Unknown: 8. The most frequently reported age groups are age 61 (52 reports), age 59 (49 reports), age 62 (45 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 2,050 classified reports for OXAPROZIN:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Oxaprozin can cause drug hypersensitivity and renal issues, which may require monitoring and dose adjustments, especially in patients with pre-existing renal conditions.
If you are taking Oxaprozin, here are important things to know. The most commonly reported side effects include drug hypersensitivity, drug ineffective, pain, nausea, headache. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor for signs of drug hypersensitivity, such as rash or fever, and seek medical attention if they occur. Regularly check kidney function, especially if you have pre-existing renal conditions. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA continues to monitor oxaprozin safety, and updates will be provided based on ongoing reviews. Patients should report any adverse events to the FDA's MedWatch program.
The FDA has received approximately 4,788 adverse event reports associated with Oxaprozin. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Oxaprozin include Drug Hypersensitivity, Drug Ineffective, Pain, Nausea, Headache. By volume, the top reported reactions are: Drug Hypersensitivity (386 reports), Drug Ineffective (178 reports), Pain (152 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Oxaprozin.
Out of 2,050 classified reports, 1,006 (49.1%) were classified as serious and 1,044 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Oxaprozin break down by patient sex as follows: Female: 1,458, Male: 489, Unknown: 8. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Oxaprozin adverse events are: age 61: 52 reports, age 59: 49 reports, age 62: 45 reports, age 60: 44 reports, age 63: 44 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Oxaprozin adverse event reports is Pfizer Laboratories Div Pfizer Inc. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Oxaprozin include: Arthralgia, Chronic Kidney Disease, Fatigue, Dyspnoea, Dizziness. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Oxaprozin to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Oxaprozin has a safety concern score of 72 out of 100 (elevated concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. Oxaprozin has a high incidence of drug hypersensitivity reactions, affecting nearly 8% of users.
Key safety signals identified in Oxaprozin's adverse event data include: Drug hypersensitivity reactions are frequent, with 8% of reports.. Renal issues, including chronic kidney disease and renal failure, are common and serious.. Pain and gastrointestinal symptoms are prevalent, affecting a significant portion of users.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Oxaprozin can cause drug hypersensitivity and renal issues, which may require monitoring and dose adjustments, especially in patients with pre-existing renal conditions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Oxaprozin.
Monitor for signs of drug hypersensitivity, such as rash or fever, and seek medical attention if they occur. Regularly check kidney function, especially if you have pre-existing renal conditions.
Oxaprozin has 4,788 adverse event reports on file with the FDA. Renal issues, including chronic kidney disease and renal failure, are significant safety concerns. The volume of reports for Oxaprozin reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor oxaprozin safety, and updates will be provided based on ongoing reviews. Patients should report any adverse events to the FDA's MedWatch program. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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