HIGH-VOLUME · HOSP-HEAVY
diclofenac Side Effects
diclofenac (also sold as Voltaren, Cataflam) is HIGH-VOLUME in this FAERS book #93 of 524 by FAERS report count. Signature opener: HOSP-HEAVY - 36.6% mention hospitalization (30,047 reports).
Data updated 2026-05-15
- 82,165
- FAERS reports
FAERS voluntary reports, 2001 to 2025. High volume tracks exposure and reporting culture; see methodology for de-dup rules.
diclofenac: 36.6% mention hospitalization (30,047 reports). Death stamp DEATH-HEAVY; volume band HIGH-VOLUME #93 of 524 by FAERS report count.
High-report extract for diclofenac (Voltaren): 82,165 FAERS rows (2001-2025). Top named reactions: PAIN, FATIGUE, RHEUMATOID ARTHRITIS. Outcome stamps DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED. FAERS is voluntary signal detection, not incidence.
Counts from the openFDA FAERS extract (2001–2025). Stamps CASELOAD · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
PAIN leads 12,281 of 82,165 reports
Who reports · age peak 45-64 (SEX-BALANCED)
Sex coding · SEX-BALANCED
Age peak 45-64 (19,381 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (10,052 reports, 12.2%). Top co-reported reactions in that subset - voluntary, not causal.
| Reaction | Reports |
|---|---|
| GENERAL PHYSICAL HEALTH DETERIORATION | 2,274 |
| RHEUMATOID ARTHRITIS | 2,257 |
| SYSTEMIC LUPUS ERYTHEMATOSUS | 2,257 |
| FATIGUE | 2,248 |
| GLOSSODYNIA | 2,230 |
| RASH | 2,226 |
| HYPERTENSION | 2,224 |
| JOINT SWELLING | 2,208 |
| INFUSION RELATED REACTION | 2,194 |
| TYPE 2 DIABETES MELLITUS | 2,188 |
| HEPATIC ENZYME INCREASED | 2,186 |
| HAND DEFORMITY | 2,175 |
| HYPOAESTHESIA | 2,170 |
| PSORIATIC ARTHROPATHY | 2,128 |
| PAIN | 2,121 |
| WOUND | 2,104 |
| PEMPHIGUS | 2,100 |
| DUODENAL ULCER PERFORATION | 2,099 |
| FIBROMYALGIA | 2,098 |
Reactions in Hospitalization Reports
Hospitalization is HEAVY (30,047, 36.6% of the book). Top reactions in those rows:
| Reaction | Reports |
|---|---|
| FATIGUE | 4,087 |
| PAIN | 3,989 |
| VOMITING | 3,727 |
| ARTHRALGIA | 3,709 |
| NAUSEA | 3,349 |
| DYSPNOEA | 3,338 |
| ABDOMINAL DISCOMFORT | 3,311 |
| RASH | 3,263 |
| RHEUMATOID ARTHRITIS | 3,234 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 3,127 |
| JOINT SWELLING | 3,101 |
| DIARRHOEA | 3,080 |
| CONDITION AGGRAVATED | 3,073 |
| HEADACHE | 3,039 |
| PYREXIA | 3,039 |
| SWELLING | 3,037 |
| SYSTEMIC LUPUS ERYTHEMATOSUS | 3,026 |
| ARTHROPATHY | 2,950 |
How to read diclofenac FAERS figures (CASELOAD · DEATH-HEAVY · HOSP-HEAVY)
FAERS holds 82,165 voluntary reports linked to diclofenac (Voltaren, Cataflam), 2001-2025. Death is listed on 10,052 (12.2%). Hospitalization appears on 30,047 (36.6%). Top co-reported indication: Product Used For Unknown Indication.
CASELOAD books overweight common drugs and loud reporting cultures; HOSP-HEAVY is the page opener, not a per-patient risk.
Read with diclofenac
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 82,622 FAERS cases (Δ 457 heavier vs diclofenac); DEATH-HEAVY · HOSP-MID · FEMALE-LED vs this page's CASELOAD · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 83,476 FAERS cases (Δ 1,311 heavier vs diclofenac); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's CASELOAD · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 83,781 FAERS cases (Δ 1,616 heavier vs diclofenac); DEATH-MARKED · HOSP-MID · FEMALE-LED vs this page's CASELOAD · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 79,748 FAERS cases (Δ 2,417 lighter vs diclofenac); DEATH-MARKED · HOSP-MID · FEMALE-LED vs this page's CASELOAD · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 49.9 pp vs diclofenac's DEATH-HEAVY): CASELOAD · HOSP-MID.
diclofenac stamps DEATH-HEAVY · HOSP-HEAVY; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload CASELOAD and the label guide.