Oxaprozin side effects: what 883 FDA adverse event reports show
Drug class
Nonsteroidal Anti-inflammatory Drug
Who reports
883 reports · 55% serious · 31 with death outcome · 70% female
Used for
OXAPROZIN is 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 OXAPROZIN CAPSULES is a non-steroidal anti.
What it is
OXAPROZIN CAPSULES (oxaprozin) is a nonsteroidal anti-inflammatory drug, available as capsules of 300 mg for oral administration.
Boxed warning
RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS . WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS See full prescribing information for complete boxed warning. Nonsteroidal anti-inflamma.
Causality screen of the 19 strongest signals
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 6 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Chronic kidney disease | 82 | 25.4 20.7–31.3ROR 27.9 · χ² 1,905 / p <1e-300 | 25.3 EB05 21.0 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 26.9 | no trial data cached |
| End stage renal disease | 18 | 23.2 14.7–36.7ROR 23.7 · χ² 361 / p 9e-81 | 22.7 EB05 15.1 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 24.1 | no trial data cached |
| Increased tendency to bruise | 8 | 20.6 10.3–41.1ROR 20.8 · χ² 130 / p 2e-30 | 18.8 EB05 8.8 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=7 | no trial data cached |
| Renal injury | 20 | 15.8 10.3–24.4ROR 16.2 · χ² 263 / p 2e-59 | 15.3 EB05 10.1 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 16.5 | no trial data cached |
| Intervertebral disc degeneration | 6 | 15.3 6.9–34.0ROR 15.4 · χ² 67 / p 2e-16 | 11.8 EB05 4.5 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 18.3 | no trial data cached |
| Joint range of motion decreased | 7 | 12.4 5.9–26.0ROR 12.5 · χ² 63 / p 1e-15 | 9.4 EB05 4.1 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 | no trial data cached |
| Wrist fracture | 6 | 11.9 5.4–26.4ROR 12.0 · χ² 49 / p 1e-12 | 8.4 EB05 3.5 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 14.5 | no trial data cached |
| Drug-induced liver injury | 15 | 11.6 7.0–19.1ROR 11.7 · χ² 134 / p 2e-31 | 10.2 EB05 6.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 12.1 | no trial data cached |
| Tubulointerstitial nephritis | 9 | 11.4 6.0–21.9ROR 11.5 · χ² 75 / p 2e-18 | 9.1 EB05 4.5 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 11.9 | no trial data cached |
| Injection site irritation | 6 | 11.3 5.1–25.0ROR 11.3 · χ² 46 / p 5e-12 | 7.8 EB05 3.4 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious n=2 | no trial data cached |
| Back injury | 5 | 11.0 4.6–26.3ROR 11.0 · χ² 36 / p 1e-9 | 7.0 EB05 2.9 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 15.1 | no trial data cached |
| Economic problem | 7 | 10.8 5.2–22.6ROR 10.9 · χ² 53 / p 2e-13 | 7.8 EB05 3.6 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 12.3 | no trial data cached |
| Drug dispensing error | 7 | 10.7 5.1–22.4ROR 10.8 · χ² 52 / p 2e-13 | 7.8 EB05 3.6 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious n=2 | no trial data cached |
| Carpal tunnel syndrome | 6 | 10.2 4.6–22.5ROR 10.2 · χ² 41 / p 9e-11 | 6.9 EB05 3.1 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.7 | no trial data cached |
| Activities of daily living impaired | 7 | 8.3 4.0–17.3ROR 8.3 · χ² 38 / p 4e-10 | 5.9 EB05 3.0 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 11.6 | no trial data cached |
| Multiple fractures | 5 | 7.2 3.0–17.2ROR 7.2 · χ² 21 / p 3e-6 | 4.7 EB05 2.2 · IC025 +0.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 | no trial data cached |
| Rheumatoid arthritis | 25 | 5.3 3.6–7.7ROR 5.4 · χ² 82 / p 6e-20 | 4.8 EB05 3.4 · IC025 +1.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 5.4 | no trial data cached |
| Tardive dyskinesia (persistent involuntary movements) | 6 | 5.0 2.3–11.1ROR 5.0 · χ² 15 / p 4e-5 | 3.8 EB05 1.9 · IC025 +0.5 | Not in label — unassessed | serious PRR 6.2 | no trial data cached |
| Injection site pruritus | 10 | 3.6 1.9–6.6ROR 3.6 · χ² 16 / p 3e-5 | 3.2 EB05 1.9 · IC025 +0.6 | Labeled (related wording) related wording | serious PRR 2.6 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Chronic kidney disease | 82 | 25.4 20.7–31.3ROR 27.9 · χ² 1,905 / p <1e-300 | 25.3 EB05 21.0 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 26.9 | no trial data cached |
| Rheumatoid arthritis | 25 | 5.3 3.6–7.7ROR 5.4 · χ² 82 / p 6e-20 | 4.8 EB05 3.4 · IC025 +1.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 5.4 | no trial data cached |
| Renal injury | 20 | 15.8 10.3–24.4ROR 16.2 · χ² 263 / p 2e-59 | 15.3 EB05 10.1 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 16.5 | no trial data cached |
| End stage renal disease | 18 | 23.2 14.7–36.7ROR 23.7 · χ² 361 / p 9e-81 | 22.7 EB05 15.1 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 24.1 | no trial data cached |
| Drug-induced liver injury | 15 | 11.6 7.0–19.1ROR 11.7 · χ² 134 / p 2e-31 | 10.2 EB05 6.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 12.1 | no trial data cached |
| Injection site pruritus | 10 | 3.6 1.9–6.6ROR 3.6 · χ² 16 / p 3e-5 | 3.2 EB05 1.9 · IC025 +0.6 | Labeled (related wording) related wording | serious PRR 2.6 | no trial data cached |
| Tubulointerstitial nephritis | 9 | 11.4 6.0–21.9ROR 11.5 · χ² 75 / p 2e-18 | 9.1 EB05 4.5 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 11.9 | no trial data cached |
| Increased tendency to bruise | 8 | 20.6 10.3–41.1ROR 20.8 · χ² 130 / p 2e-30 | 18.8 EB05 8.8 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=7 | no trial data cached |
| Activities of daily living impaired | 7 | 8.3 4.0–17.3ROR 8.3 · χ² 38 / p 4e-10 | 5.9 EB05 3.0 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 11.6 | no trial data cached |
| Drug dispensing error | 7 | 10.7 5.1–22.4ROR 10.8 · χ² 52 / p 2e-13 | 7.8 EB05 3.6 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious n=2 | no trial data cached |
| Economic problem | 7 | 10.8 5.2–22.6ROR 10.9 · χ² 53 / p 2e-13 | 7.8 EB05 3.6 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 12.3 | no trial data cached |
| Joint range of motion decreased | 7 | 12.4 5.9–26.0ROR 12.5 · χ² 63 / p 1e-15 | 9.4 EB05 4.1 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 | no trial data cached |
| Tardive dyskinesia (persistent involuntary movements) | 6 | 5.0 2.3–11.1ROR 5.0 · χ² 15 / p 4e-5 | 3.8 EB05 1.9 · IC025 +0.5 | Not in label — unassessed | serious PRR 6.2 | no trial data cached |
| Carpal tunnel syndrome | 6 | 10.2 4.6–22.5ROR 10.2 · χ² 41 / p 9e-11 | 6.9 EB05 3.1 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.7 | no trial data cached |
| Injection site irritation | 6 | 11.3 5.1–25.0ROR 11.3 · χ² 46 / p 5e-12 | 7.8 EB05 3.4 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious n=2 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Chronic kidney disease — n=82, PRR 25.4
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Oxaprozin?
In FDA FAERS, the most frequently co-reported reaction terms for Oxaprozin are chronic kidney disease, rheumatoid arthritis, renal injury, end stage renal disease, drug-induced liver injury, injection site pruritus. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Oxaprozin have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS . WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS See full prescribing information for complete boxed warning. Nonsteroidal anti-inflamma.
Do FAERS signals prove that Oxaprozin causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 450f5941-7f10-42fe-e063-6394a90a4803, effective 20251203; matched on
openfda.generic_name.exact:"OXAPROZIN") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 25 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.