HIGH-VOLUME · FEMALE-LED
hydroxychloroquine Side Effects
hydroxychloroquine (also sold as Plaquenil) is HIGH-VOLUME in this FAERS book #103 of 524 by FAERS report count. Signature opener: FEMALE-LED - 78% of sex-coded reports are female (48,695 F / 13,464 M).
Data updated 2026-05-15
- 71,900
- FAERS reports
FAERS voluntary reports, 2004 to 2025. High volume tracks exposure and reporting culture; see methodology for de-dup rules.
hydroxychloroquine reporting skew - 78% of sex-coded reports are female (48,695 F / 13,464 M). Volume band HIGH-VOLUME #103 of 524 by FAERS report count; caseload CASELOAD.
High-report extract for hydroxychloroquine (Plaquenil): 71,900 FAERS rows (2004-2025). Top named reactions: RHEUMATOID ARTHRITIS, PAIN, ARTHRALGIA. Outcome stamps DEATH-HEAVY · HOSP-MID · FEMALE-LED. FAERS is voluntary signal detection, not incidence.
Counts from the openFDA FAERS extract (2004–2025). Stamps CASELOAD · DEATH-HEAVY · HOSP-MID · FEMALE-LED.
RHEUMATOID ARTHRITIS leads 12,921 of 71,900 reports
FEMALE-LED reporters · age peak 45-64
Female-led reporters (78% of sex-coded rows)
Age peak 45-64 (19,883 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (7,814 reports, 10.9%). Top co-reported reactions in that subset - voluntary, not causal.
| Reaction | Reports |
|---|---|
| SYSTEMIC LUPUS ERYTHEMATOSUS | 1,618 |
| RHEUMATOID ARTHRITIS | 1,595 |
| GLOSSODYNIA | 1,577 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 1,575 |
| JOINT SWELLING | 1,571 |
| TYPE 2 DIABETES MELLITUS | 1,555 |
| HAND DEFORMITY | 1,537 |
| INFUSION RELATED REACTION | 1,535 |
| FATIGUE | 1,520 |
| FIBROMYALGIA | 1,518 |
| PAIN | 1,504 |
| HYPERTENSION | 1,500 |
| HEPATIC ENZYME INCREASED | 1,492 |
| PSORIATIC ARTHROPATHY | 1,492 |
| RASH | 1,492 |
| DUODENAL ULCER PERFORATION | 1,488 |
| SYNOVITIS | 1,478 |
| WOUND | 1,475 |
| HYPOAESTHESIA | 1,472 |
Reactions in Hospitalization Reports
Hospitalization mid-share (20,530, 28.6%). Co-reported reactions:
| Reaction | Reports |
|---|---|
| RHEUMATOID ARTHRITIS | 3,601 |
| PAIN | 3,570 |
| FATIGUE | 3,397 |
| ARTHRALGIA | 3,387 |
| CONDITION AGGRAVATED | 3,134 |
| RASH | 3,054 |
| JOINT SWELLING | 3,006 |
| SYNOVITIS | 3,005 |
| ARTHROPATHY | 2,919 |
| NAUSEA | 2,876 |
| SYSTEMIC LUPUS ERYTHEMATOSUS | 2,544 |
| DRUG HYPERSENSITIVITY | 2,534 |
| ABDOMINAL DISCOMFORT | 2,479 |
| INFUSION RELATED REACTION | 2,461 |
| HEADACHE | 2,458 |
| VOMITING | 2,422 |
| HYPERSENSITIVITY | 2,420 |
How to read hydroxychloroquine FAERS figures (CASELOAD · DEATH-HEAVY · HOSP-MID)
FAERS holds 71,900 voluntary reports linked to hydroxychloroquine (Plaquenil), 2004-2025. Death is listed on 7,814 (10.9%). Hospitalization appears on 20,530 (28.6%). Top co-reported indication: Rheumatoid Arthritis.
CASELOAD books overweight common drugs and loud reporting cultures; FEMALE-LED is the page opener, not a per-patient risk.
Read with hydroxychloroquine
Peers ranked by ABS(total_reports), then an ABS(death_share) pole; guide hop follows DEATH-HEAVY · HOSP-MID stamps.
ABS(total_reports) peer at 72,117 FAERS cases (Δ 217 heavier vs hydroxychloroquine); DEATH-MARKED · HOSP-MID · SEX-BALANCED vs this page's CASELOAD · DEATH-HEAVY · HOSP-MID · FEMALE-LED.
ABS(total_reports) peer at 72,146 FAERS cases (Δ 246 heavier vs hydroxychloroquine); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's CASELOAD · DEATH-HEAVY · HOSP-MID · FEMALE-LED.
ABS(total_reports) peer at 72,729 FAERS cases (Δ 829 heavier vs hydroxychloroquine); DEATH-HEAVY · HOSP-HEAVY · FEMALE-LED vs this page's CASELOAD · DEATH-HEAVY · HOSP-MID · FEMALE-LED.
ABS(total_reports) peer at 72,798 FAERS cases (Δ 898 heavier vs hydroxychloroquine); DEATH-MARKED · HOSP-MID · FEMALE-LED vs this page's CASELOAD · DEATH-HEAVY · HOSP-MID · FEMALE-LED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 51.2 pp vs hydroxychloroquine's DEATH-HEAVY): CASELOAD · HOSP-MID.
hydroxychloroquine stamps DEATH-HEAVY · HOSP-MID; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload CASELOAD and the label guide.