HIGH-VOLUME · FEMALE-LED
alendronate Side Effects
alendronate (also sold as Fosamax) is HIGH-VOLUME in this FAERS book #79 of 524 by FAERS report count. Signature opener: FEMALE-LED - 86% of sex-coded reports are female (76,873 F / 12,151 M).
Data updated 2026-05-15
- 98,033
- FAERS reports
FAERS voluntary reports, 2003 to 2025. High volume tracks exposure and reporting culture; see methodology for de-dup rules.
alendronate reporting skew - 86% of sex-coded reports are female (76,873 F / 12,151 M). Volume band HIGH-VOLUME #79 of 524 by FAERS report count; caseload CASELOAD.
High-report extract for alendronate (Fosamax): 98,033 FAERS rows (2003-2025). Top named reactions: PAIN, FATIGUE, FEMUR FRACTURE. Outcome stamps DEATH-HEAVY · HOSP-HEAVY · FEMALE-LED. FAERS is voluntary signal detection, not incidence.
Counts from the openFDA FAERS extract (2003–2025). Stamps CASELOAD · DEATH-HEAVY · HOSP-HEAVY · FEMALE-LED.
PAIN leads 13,527 of 98,033 reports
FEMALE-LED reporters · age peak 45-64
Female-led reporters (86% of sex-coded rows)
Age peak 45-64 (18,310 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (11,123 reports, 11.3%). Top co-reported reactions in that subset - voluntary, not causal.
| Reaction | Reports |
|---|---|
| DEATH | 2,940 |
| FATIGUE | 2,297 |
| HYPERTENSION | 2,233 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 2,175 |
| SYSTEMIC LUPUS ERYTHEMATOSUS | 2,129 |
| TYPE 2 DIABETES MELLITUS | 2,102 |
| GLOSSODYNIA | 2,095 |
| RHEUMATOID ARTHRITIS | 2,088 |
| ARTHRALGIA | 2,061 |
| HYPOAESTHESIA | 2,058 |
| INFUSION RELATED REACTION | 2,045 |
| HAND DEFORMITY | 2,040 |
| RASH | 2,028 |
| FIBROMYALGIA | 2,018 |
| PSORIATIC ARTHROPATHY | 2,017 |
| DUODENAL ULCER PERFORATION | 1,996 |
| WOUND | 1,994 |
| HELICOBACTER INFECTION | 1,989 |
| DIARRHOEA | 1,982 |
Reactions in Hospitalization Reports
Hospitalization is HEAVY (36,609, 37.3% of the book). Top reactions in those rows:
| Reaction | Reports |
|---|---|
| FEMUR FRACTURE | 6,662 |
| FALL | 6,341 |
| ARTHRALGIA | 5,721 |
| HYPERTENSION | 5,409 |
| FATIGUE | 5,117 |
| PAIN | 5,096 |
| OSTEOARTHRITIS | 4,674 |
| DYSPNOEA | 4,329 |
| RHEUMATOID ARTHRITIS | 4,199 |
| NAUSEA | 4,122 |
| ARTHROPATHY | 3,901 |
| DIARRHOEA | 3,890 |
| RASH | 3,877 |
| PAIN IN EXTREMITY | 3,777 |
| PNEUMONIA | 3,774 |
| HEADACHE | 3,746 |
| IMPAIRED HEALING | 3,584 |
| DEPRESSION | 3,553 |
How to read alendronate FAERS figures (CASELOAD · DEATH-HEAVY · HOSP-HEAVY)
FAERS holds 98,033 voluntary reports linked to alendronate (Fosamax), 2003-2025. Death is listed on 11,123 (11.3%). Hospitalization appears on 36,609 (37.3%). Top co-reported indication: Osteoporosis.
CASELOAD books overweight common drugs and loud reporting cultures; FEMALE-LED is the page opener, not a per-patient risk.
Read with alendronate
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 98,899 FAERS cases (Δ 866 heavier vs alendronate); DEATH-HEAVY · HOSP-MID · SEX-BALANCED vs this page's CASELOAD · DEATH-HEAVY · HOSP-HEAVY · FEMALE-LED.
ABS(total_reports) peer at 96,629 FAERS cases (Δ 1,404 lighter vs alendronate); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's CASELOAD · DEATH-HEAVY · HOSP-HEAVY · FEMALE-LED.
ABS(total_reports) peer at 95,293 FAERS cases (Δ 2,740 lighter vs alendronate); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's CASELOAD · DEATH-HEAVY · HOSP-HEAVY · FEMALE-LED.
ABS(total_reports) peer at 102,095 FAERS cases (Δ 4,062 heavier vs alendronate); DEATH-HEAVY · HOSP-MID · FEMALE-LED vs this page's CASELOAD · DEATH-HEAVY · HOSP-HEAVY · FEMALE-LED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 50.8 pp vs alendronate's DEATH-HEAVY): CASELOAD · HOSP-MID.
alendronate stamps DEATH-HEAVY · HOSP-HEAVY; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload CASELOAD and the label guide.