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oxaprozin Side Effects

Also known as: Daypro

Analysis of 2,050 adverse event reports submitted to the FDA from 2003 to 2025.

Total Reports

2,050

Death-Related

80

3.9% of reports

Hospitalizations

475

23.2% of reports

Top Indication

Product Used For Unknown Indication

Most Reported Adverse Reactions

DRUG HYPERSENSITIVITY
386
DRUG INEFFECTIVE
178
PAIN
151
NAUSEA
134
HEADACHE
104
ARTHRALGIA
103
CHRONIC KIDNEY DISEASE
103
FATIGUE
103
DYSPNOEA
91
DIZZINESS
88
DEPRESSION
85
PAIN IN EXTREMITY
82
RENAL FAILURE
80
RASH
76
HYPERTENSION
74
BACK PAIN
73
DIARRHOEA
73
FALL
72
ANXIETY
65
ACUTE KIDNEY INJURY
64

Who Reports Side Effects

Gender Distribution

Female 1,459 (75%)
Male 488 (25%)
Unknown 8

Age Distribution

0-17 7 (1%)
18-44 187 (15%)
45-64 669 (52%)
65-74 272 (21%)
75+ 150 (12%)

Reporting Trend by Year

2003 2025

Reactions in Death Reports

Top reactions reported in 80 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
DEATH 24
ACUTE KIDNEY INJURY 14
CHRONIC KIDNEY DISEASE 14
RENAL FAILURE 13
HYPERTENSION 11
ANXIETY 10
PAIN 10
FATIGUE 9
MYOCARDIAL INFARCTION 9
ASTHENIA 8
CARDIAC FAILURE CONGESTIVE 8
END STAGE RENAL DISEASE 8
OSTEOARTHRITIS 8
CARDIAC ARREST 7
CHEST PAIN 7
PNEUMONIA 7
ANAEMIA 6
BACK PAIN 6
DYSPNOEA 6
EMOTIONAL DISTRESS 6

Reactions in Hospitalization Reports

Top reactions in 475 reports where hospitalization was an outcome.

Reaction Reports
PAIN 58
DYSPNOEA 50
NAUSEA 47
CHEST PAIN 45
HYPERTENSION 45
FALL 44
ANXIETY 42
DEPRESSION 41
DIZZINESS 38
BACK PAIN 37
ASTHENIA 36
PAIN IN EXTREMITY 35
MYOCARDIAL INFARCTION 34
OSTEOARTHRITIS 34
FATIGUE 33
HEADACHE 33
ARTHRALGIA 31
DRUG INEFFECTIVE 31
PNEUMONIA 28
EMOTIONAL DISTRESS 27

Nearby — Related Medications

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What the FAERS Data Reveals About oxaprozin Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 2,050 voluntary reports linked to oxaprozin and its brand equivalents (Daypro), spanning 2003 through 2025. Of those, 80 (3.9%) listed death as an outcome and 475 (23.2%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.

Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 75% were female and 25% male; age distribution skews toward 45-64, with 669 reports in that bracket. The single most reported reaction is drug hypersensitivity with 386 submissions, followed by drug ineffective and pain.

FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.