HIGH-VOLUME · FEMALE-LED
letrozole Side Effects
letrozole (also sold as Femara) is HIGH-VOLUME in this FAERS book #123 of 524 by FAERS report count. Signature opener: FEMALE-LED - 98% of sex-coded reports are female (54,311 F / 837 M).
Data updated 2026-05-15
- 59,013
- FAERS reports
FAERS voluntary reports, 2004 to 2025. High volume tracks exposure and reporting culture; see methodology for de-dup rules.
letrozole reporting skew - 98% of sex-coded reports are female (54,311 F / 837 M). Volume band HIGH-VOLUME #123 of 524 by FAERS report count; caseload CASELOAD.
High-report extract for letrozole (Femara): 59,013 FAERS rows (2004-2025). Top named reactions: FATIGUE, NAUSEA, NEUTROPENIA. 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.
FATIGUE leads 7,159 of 59,013 reports
FEMALE-LED reporters · age peak 45-64
Female-led reporters (98% of sex-coded rows)
Age peak 45-64 (17,286 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (5,837 reports, 9.9%). Top co-reported reactions in that subset - voluntary, not causal.
| Reaction | Reports |
|---|---|
| DEATH | 2,577 |
| MALIGNANT NEOPLASM PROGRESSION | 699 |
| DYSPNOEA | 632 |
| FATIGUE | 629 |
| NAUSEA | 586 |
| ASTHENIA | 520 |
| VOMITING | 510 |
| DIARRHOEA | 498 |
| DECREASED APPETITE | 442 |
| NEOPLASM PROGRESSION | 423 |
| BREAST CANCER METASTATIC | 379 |
| ASCITES | 373 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 368 |
| MALAISE | 363 |
| SEPSIS | 362 |
| FALL | 355 |
| PYREXIA | 348 |
| COUGH | 340 |
| ARTHRALGIA | 330 |
| ABDOMINAL PAIN | 328 |
Reactions in Hospitalization Reports
Hospitalization mid-share (15,111, 25.6%). Co-reported reactions:
| Reaction | Reports |
|---|---|
| NAUSEA | 1,637 |
| FATIGUE | 1,521 |
| DIARRHOEA | 1,339 |
| DYSPNOEA | 1,290 |
| VOMITING | 1,193 |
| ASTHENIA | 962 |
| PYREXIA | 937 |
| ANAEMIA | 935 |
| PNEUMONIA | 891 |
| DECREASED APPETITE | 816 |
| PAIN | 815 |
| NEUTROPENIA | 781 |
| MALAISE | 756 |
| MALIGNANT NEOPLASM PROGRESSION | 747 |
| ARTHRALGIA | 731 |
| WHITE BLOOD CELL COUNT DECREASED | 723 |
| FALL | 682 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 648 |
| URINARY TRACT INFECTION | 638 |
| COUGH | 627 |
How to read letrozole FAERS figures (CASELOAD · DEATH-HEAVY · HOSP-MID)
FAERS holds 59,013 voluntary reports linked to letrozole (Femara), 2004-2025. Death is listed on 5,837 (9.9%). Hospitalization appears on 15,111 (25.6%). Top co-reported indication: Breast Cancer.
CASELOAD books overweight common drugs and loud reporting cultures; FEMALE-LED is the page opener, not a per-patient risk.
Read with letrozole
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 58,495 FAERS cases (Δ 518 lighter vs letrozole); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's CASELOAD · DEATH-HEAVY · HOSP-MID · FEMALE-LED.
ABS(total_reports) peer at 59,560 FAERS cases (Δ 547 heavier vs letrozole); DEATH-HEAVY · HOSP-MID · SEX-BALANCED vs this page's CASELOAD · DEATH-HEAVY · HOSP-MID · FEMALE-LED.
ABS(total_reports) peer at 58,038 FAERS cases (Δ 975 lighter vs letrozole); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's CASELOAD · DEATH-HEAVY · HOSP-MID · FEMALE-LED.
ABS(total_reports) peer at 57,675 FAERS cases (Δ 1,338 lighter vs letrozole); 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 52.2 pp vs letrozole's DEATH-HEAVY): CASELOAD · HOSP-MID.
letrozole stamps DEATH-HEAVY · HOSP-MID; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload CASELOAD and the label guide.