HIGH-VOLUME · FEMALE-LED
denosumab Side Effects
denosumab (also sold as Prolia, Xgeva) is HIGH-VOLUME in this FAERS book #30 of 524 by FAERS report count. Signature opener: FEMALE-LED - 84% of sex-coded reports are female (146,088 F / 28,091 M).
Data updated 2026-05-15
- 196,342
- FAERS reports
FAERS voluntary reports, 2008 to 2025. High volume tracks exposure and reporting culture; see methodology for de-dup rules.
denosumab reporting skew - 84% of sex-coded reports are female (146,088 F / 28,091 M). Volume band HIGH-VOLUME #30 of 524 by FAERS report count; caseload MEGA-CASE.
High-report extract for denosumab (Prolia): 196,342 FAERS rows (2008-2025). Top named reactions: DEATH, ARTHRALGIA, OSTEONECROSIS OF JAW. Outcome stamps DEATH-HEAVY · HOSP-MID · FEMALE-LED. FAERS is voluntary signal detection, not incidence.
Counts from the openFDA FAERS extract (2008–2025). Stamps MEGA-CASE · DEATH-HEAVY · HOSP-MID · FEMALE-LED.
DEATH leads 19,930 of 196,342 reports
FEMALE-LED reporters · age peak 75+
Female-led reporters (84% of sex-coded rows)
Age peak 75+ (49,014 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (25,105 reports, 12.8%). Top co-reported reactions in that subset - voluntary, not causal.
| Reaction | Reports |
|---|---|
| DEATH | 19,825 |
| FATIGUE | 544 |
| PNEUMONIA | 541 |
| MALIGNANT NEOPLASM PROGRESSION | 520 |
| DISEASE PROGRESSION | 467 |
| NAUSEA | 444 |
| DIARRHOEA | 400 |
| ASTHENIA | 372 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 364 |
| DYSPNOEA | 355 |
| DECREASED APPETITE | 307 |
| ANAEMIA | 303 |
| VOMITING | 294 |
| HOSPITALISATION | 291 |
| FALL | 289 |
| HYPOCALCAEMIA | 284 |
| SEPSIS | 258 |
| RESPIRATORY FAILURE | 245 |
| OSTEONECROSIS OF JAW | 239 |
Reactions in Hospitalization Reports
Hospitalization mid-share (30,164, 15.4%). Co-reported reactions:
| Reaction | Reports |
|---|---|
| HOSPITALISATION | 2,427 |
| FALL | 2,023 |
| FATIGUE | 1,905 |
| DIARRHOEA | 1,878 |
| NAUSEA | 1,809 |
| HYPOCALCAEMIA | 1,806 |
| PNEUMONIA | 1,727 |
| DYSPNOEA | 1,531 |
| ASTHENIA | 1,396 |
| OSTEONECROSIS OF JAW | 1,392 |
| PAIN | 1,261 |
| PYREXIA | 1,211 |
| VOMITING | 1,210 |
| ARTHRALGIA | 1,118 |
| MALAISE | 1,116 |
| DEATH | 1,062 |
| BACK PAIN | 1,047 |
| PAIN IN EXTREMITY | 1,030 |
| ANAEMIA | 1,011 |
How to read denosumab FAERS figures (MEGA-CASE · DEATH-HEAVY · HOSP-MID)
FAERS holds 196,342 voluntary reports linked to denosumab (Prolia, Xgeva), 2008-2025. Death is listed on 25,105 (12.8%). Hospitalization appears on 30,164 (15.4%). Top co-reported indication: Product Used For Unknown Indication.
MEGA-CASE books overweight common drugs and loud reporting cultures; FEMALE-LED is the page opener, not a per-patient risk.
Read with denosumab
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 197,074 FAERS cases (Δ 732 heavier vs denosumab); DEATH-RARE · HOSP-LIGHT · FEMALE-LED vs this page's MEGA-CASE · DEATH-HEAVY · HOSP-MID · FEMALE-LED.
ABS(total_reports) peer at 197,405 FAERS cases (Δ 1,063 heavier vs denosumab); DEATH-HEAVY · HOSP-MID · SEX-BALANCED vs this page's MEGA-CASE · DEATH-HEAVY · HOSP-MID · FEMALE-LED.
ABS(total_reports) peer at 194,743 FAERS cases (Δ 1,599 lighter vs denosumab); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's MEGA-CASE · DEATH-HEAVY · HOSP-MID · FEMALE-LED.
ABS(total_reports) peer at 192,921 FAERS cases (Δ 3,421 lighter vs denosumab); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's MEGA-CASE · DEATH-HEAVY · HOSP-MID · FEMALE-LED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 49.3 pp vs denosumab's DEATH-HEAVY): CASELOAD · HOSP-MID.
denosumab stamps DEATH-HEAVY · HOSP-MID; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload MEGA-CASE and the label guide.