HIGH-VOLUME · FEMALE-LED
zoledronic acid Side Effects
zoledronic acid (also sold as Reclast, Zometa) is HIGH-VOLUME in this FAERS book #164 of 524 by FAERS report count. Signature opener: FEMALE-LED - 75% of sex-coded reports are female (26,319 F / 8,912 M).
Data updated 2026-05-15
- 38,197
- FAERS reports
FAERS voluntary reports, 2003 to 2025. High volume tracks exposure and reporting culture; see methodology for de-dup rules.
zoledronic acid reporting skew - 75% of sex-coded reports are female (26,319 F / 8,912 M). Volume band HIGH-VOLUME #164 of 524 by FAERS report count; caseload CASELOAD.
High-report extract for zoledronic acid (Reclast): 38,197 FAERS rows (2003-2025). Top named reactions: ARTHRALGIA, PAIN, PYREXIA. Outcome stamps DEATH-HEAVY · HOSP-MID · FEMALE-LED. FAERS is voluntary signal detection, not incidence.
Counts from the openFDA FAERS extract (2003–2025). Stamps CASELOAD · DEATH-HEAVY · HOSP-MID · FEMALE-LED.
ARTHRALGIA leads 3,083 of 38,197 reports
FEMALE-LED reporters · age peak 45-64
Female-led reporters (75% of sex-coded rows)
Age peak 45-64 (9,001 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (4,999 reports, 13.1%). Top co-reported reactions in that subset - voluntary, not causal.
| Reaction | Reports |
|---|---|
| DEATH | 2,434 |
| DYSPNOEA | 359 |
| ASTHENIA | 357 |
| PYREXIA | 334 |
| SEPSIS | 329 |
| DIARRHOEA | 326 |
| VOMITING | 322 |
| FATIGUE | 320 |
| DECREASED APPETITE | 307 |
| NAUSEA | 289 |
| MALAISE | 278 |
| FALL | 262 |
| MALIGNANT NEOPLASM PROGRESSION | 255 |
| ARTHRALGIA | 243 |
| HEADACHE | 243 |
| COUGH | 241 |
| PNEUMONIA | 235 |
| DIZZINESS | 230 |
| CARDIO-RESPIRATORY ARREST | 221 |
| TACHYCARDIA | 220 |
Reactions in Hospitalization Reports
Hospitalization mid-share (11,023, 28.9%). Co-reported reactions:
| Reaction | Reports |
|---|---|
| PYREXIA | 1,056 |
| NAUSEA | 887 |
| VOMITING | 878 |
| PAIN | 815 |
| DIARRHOEA | 755 |
| DYSPNOEA | 674 |
| PNEUMONIA | 657 |
| FATIGUE | 644 |
| ARTHRALGIA | 622 |
| ASTHENIA | 604 |
| FALL | 569 |
| ACUTE KIDNEY INJURY | 568 |
| OSTEONECROSIS OF JAW | 551 |
| ANAEMIA | 539 |
| HEADACHE | 522 |
| MALAISE | 503 |
| DECREASED APPETITE | 439 |
| BACK PAIN | 431 |
| MYALGIA | 390 |
How to read zoledronic acid FAERS figures (CASELOAD · DEATH-HEAVY · HOSP-MID)
FAERS holds 38,197 voluntary reports linked to zoledronic acid (Reclast, Zometa), 2003-2025. Death is listed on 4,999 (13.1%). Hospitalization appears on 11,023 (28.9%). Top co-reported indication: Product Used For Unknown Indication.
CASELOAD books overweight common drugs and loud reporting cultures; FEMALE-LED is the page opener, not a per-patient risk.
Read with zoledronic acid
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 37,936 FAERS cases (Δ 261 lighter vs zoledronic acid); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's CASELOAD · DEATH-HEAVY · HOSP-MID · FEMALE-LED.
ABS(total_reports) peer at 38,664 FAERS cases (Δ 467 heavier vs zoledronic acid); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's CASELOAD · DEATH-HEAVY · HOSP-MID · FEMALE-LED.
ABS(total_reports) peer at 37,361 FAERS cases (Δ 836 lighter vs zoledronic acid); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's CASELOAD · DEATH-HEAVY · HOSP-MID · FEMALE-LED.
ABS(total_reports) peer at 39,048 FAERS cases (Δ 851 heavier vs zoledronic acid); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's CASELOAD · DEATH-HEAVY · HOSP-MID · FEMALE-LED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 49.0 pp vs zoledronic acid's DEATH-HEAVY): CASELOAD · HOSP-MID.
zoledronic acid stamps DEATH-HEAVY · HOSP-MID; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload CASELOAD and the label guide.