MID-VOLUME · HOSP-HEAVY
ketoprofen Side Effects
ketoprofen (also sold as Orudis) sits MID-VOLUME #296 of 524 by FAERS report count. Lead signal: HOSP-HEAVY - 50.2% mention hospitalization (6,176 reports). Demographics and serious-outcome tables follow.
Data updated 2026-05-15
- 12,302
- FAERS reports
FDA Adverse Event Reporting System extract for ketoprofen. Stamp set WATCHLIST · DEATH-HEAVY · HOSP-HEAVY. How figures are compiled.
ketoprofen: 50.2% mention hospitalization (6,176 reports). Death stamp DEATH-HEAVY; volume band MID-VOLUME #296 of 524 by FAERS report count.
Mid-book FAERS page for ketoprofen (Orudis) (12,302 reports). Signature HOSP-HEAVY. Dominant age band on file: 45-64. Educational reference only.
Counts from the openFDA FAERS extract (2003–2025). Stamps WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
HEADACHE leads 1,152 of 12,302 reports
Who reports · age peak 45-64 (SEX-BALANCED)
Sex coding · SEX-BALANCED
Age peak 45-64 (3,316 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (1,136 reports, 9.2%). Top co-reported reactions in that subset - voluntary, not causal.
| Reaction | Reports |
|---|---|
| PYREXIA | 174 |
| OVERDOSE | 165 |
| CONSTIPATION | 148 |
| PAIN | 147 |
| RASH | 143 |
| FATIGUE | 135 |
| DEATH | 134 |
| HYPERHIDROSIS | 130 |
| HYPERTENSION | 130 |
| HEADACHE | 129 |
| FOETAL DEATH | 124 |
| THROMBOCYTOPENIA | 124 |
| FLUID RETENTION | 123 |
| INTENTIONAL PRODUCT MISUSE | 123 |
| BACK PAIN | 122 |
| IMMUNODEFICIENCY | 120 |
| PSORIASIS | 118 |
Reactions in Hospitalization Reports
Hospitalization is HEAVY (6,176, 50.2% of the book). Top reactions in those rows:
| Reaction | Reports |
|---|---|
| ACUTE KIDNEY INJURY | 407 |
| VOMITING | 392 |
| NAUSEA | 333 |
| DIARRHOEA | 316 |
| DRUG INTERACTION | 309 |
| PYREXIA | 308 |
| DYSPNOEA | 274 |
| PAIN | 270 |
| HEADACHE | 264 |
| ASTHENIA | 251 |
| FATIGUE | 229 |
| PNEUMONIA | 209 |
| ANAEMIA | 208 |
| ABDOMINAL PAIN | 207 |
| CONDITION AGGRAVATED | 207 |
| HYPOTENSION | 188 |
| ARTHRALGIA | 183 |
| MALAISE | 175 |
| RASH | 175 |
How to read ketoprofen FAERS figures (WATCHLIST · DEATH-HEAVY · HOSP-HEAVY)
FAERS holds 12,302 voluntary reports linked to ketoprofen (Orudis), 2003-2025. Death is listed on 1,136 (9.2%). Hospitalization appears on 6,176 (50.2%). Top co-reported indication: Product Used For Unknown Indication.
Mid-volume extract - treat DEATH-HEAVY · HOSP-HEAVY as signal-detection rates next to 50.2% mention hospitalization (6,176 reports).
Read with ketoprofen
Peers ranked by ABS(total_reports), then an ABS(death_share) pole; guide hop follows DEATH-HEAVY · HOSP-HEAVY stamps.
ABS(total_reports) peer at 12,113 FAERS cases (Δ 189 lighter vs ketoprofen); DEATH-HEAVY · HOSP-HEAVY · MALE-LED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 12,687 FAERS cases (Δ 385 heavier vs ketoprofen); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 12,687 FAERS cases (Δ 385 heavier vs ketoprofen); DEATH-HEAVY · HOSP-MID · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 12,726 FAERS cases (Δ 424 heavier vs ketoprofen); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 52.9 pp vs ketoprofen's DEATH-HEAVY): CASELOAD · HOSP-MID.
ketoprofen stamps DEATH-HEAVY · HOSP-HEAVY; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload WATCHLIST and the label guide.