What the label lists and what reports show
Oxaprozin side effects
Oxaprozin's FDA label: “Most common adverse reactions (> 3%) are: constipation, diarrhea, dyspepsia, nausea, rash.” FAERS holds 883 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is chronic kidney disease (82 reports).
- Generic listed
- Boxed warning
Check it at the source: the oxaprozin FDA label on DailyMed (effective December 26, 2024, Amneal Pharmaceuticals NY LLC); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of NSAIDs?NSAIDs can cause serious side effects, including: See “What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?” new or worse high blood pressure heart failure stroke liver problems including liver failure kidney problems including kidney failure low red blood cells (anemia) life-threatening skin reactions life-threatening allergic reactions asthma attacks in people who have asthma bleeding and ulcers in the stomach and intestine Other side effects of NSAIDs include: stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, and dizziness. […]
Source: FDA drug label, Amneal Pharmaceuticals NY LLC, effective December 26, 2024 (SPL set d9b0ca6c-4c53-4f6e-918b-02a8c472a194), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (> 3%) are: constipation, diarrhea, dyspepsia, nausea, rash.
From the label: adverse reactions, continuedThe 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 (> 3%) are: constipation, diarrhea, dyspepsia, nausea, rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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. …
Source: FDA drug label, Amneal Pharmaceuticals NY LLC, effective December 26, 2024 (SPL set d9b0ca6c-4c53-4f6e-918b-02a8c472a194), via openFDA; the full label on DailyMed
What do FAERS reports show?
883 reports list oxaprozin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 31 are coded as a death and 226 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 23 reactions below, 12 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Oxaprozin: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions