LOW-VOLUME · FEMALE-LED
alosetron Side Effects
alosetron (also sold as Lotronex) is a LOW-VOLUME FAERS extract #521 of 524 by FAERS report count. Still opens on FEMALE-LED: 83% of sex-coded reports are female (59 F / 12 M).
Data updated 2026-05-15
- 73
- FAERS reports
Thinner FAERS book - still a temporal association ledger, not proof of cause. Methodology.
alosetron reporting skew - 83% of sex-coded reports are female (59 F / 12 M). Volume band LOW-VOLUME #521 of 524 by FAERS report count; caseload TRACE-CASE.
Thinner FAERS extract for alosetron (Lotronex) (73 reports #521 of 524 by FAERS report count). 83% of sex-coded reports are female (59 F / 12 M). Sparse books still carry named reaction rows when present; not medical advice.
Counts from the openFDA FAERS extract (2004–2025). Stamps TRACE-CASE · DEATH-HEAVY · HOSP-MID · FEMALE-LED.
DIARRHOEA leads 10 of 73 reports
FEMALE-LED reporters · age peak 45-64
Female-led reporters (83% of sex-coded rows)
Age peak 45-64 (19 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (8 reports, 11.0%). Top co-reported reactions in that subset - voluntary, not causal.
| Reaction | Reports |
|---|---|
| DEATH | 6 |
| AMYOTROPHIC LATERAL SCLEROSIS | 1 |
| CARDIAC FAILURE CONGESTIVE | 1 |
| CLOSTRIDIUM DIFFICILE COLITIS | 1 |
| FEELING JITTERY | 1 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 1 |
| INTENTIONAL DRUG MISUSE | 1 |
| OVERDOSE | 1 |
| PARKINSON^S DISEASE | 1 |
| PLASMA CELL MYELOMA | 1 |
| WEIGHT DECREASED | 1 |
Reactions in Hospitalization Reports
Hospitalization mid-share (18, 24.7%). Co-reported reactions:
| Reaction | Reports |
|---|---|
| DIARRHOEA | 6 |
| FAECALOMA | 3 |
| INFECTION | 3 |
| ABDOMINAL PAIN | 2 |
| ANXIETY | 2 |
| CONDITION AGGRAVATED | 2 |
| HIP ARTHROPLASTY | 2 |
| KNEE ARTHROPLASTY | 2 |
| LARGE INTESTINAL OBSTRUCTION | 2 |
| LUNG NEOPLASM MALIGNANT | 2 |
| MUSCLE SPASMS | 2 |
| PNEUMONIA | 2 |
| POST PROCEDURAL COMPLICATION | 2 |
| VARICOSE VEIN | 2 |
| WEIGHT DECREASED | 2 |
| ABDOMINAL DISTENSION | 1 |
| ANAL INCONTINENCE | 1 |
| APPENDICECTOMY | 1 |
| APPETITE DISORDER | 1 |
How to read alosetron FAERS figures (TRACE-CASE · DEATH-HEAVY · HOSP-MID)
FAERS holds 73 voluntary reports linked to alosetron (Lotronex), 2004-2025. Death is listed on 8 (11.0%). Hospitalization appears on 18 (24.7%). Top co-reported indication: Product Used For Unknown Indication.
Sparse extract - named reactions and FEMALE-LED skew still differ by drug; not a complete safety profile.
Read with alosetron
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 67 FAERS cases (Δ 6 lighter vs alosetron); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's TRACE-CASE · DEATH-HEAVY · HOSP-MID · FEMALE-LED.
ABS(total_reports) peer at 81 FAERS cases (Δ 8 heavier vs alosetron); DEATH-HEAVY · HOSP-HEAVY · FEMALE-LED vs this page's TRACE-CASE · DEATH-HEAVY · HOSP-MID · FEMALE-LED.
ABS(total_reports) peer at 51 FAERS cases (Δ 22 lighter vs alosetron); DEATH-HEAVY · HOSP-HEAVY · SEX-THIN vs this page's TRACE-CASE · DEATH-HEAVY · HOSP-MID · FEMALE-LED.
ABS(total_reports) peer at 96 FAERS cases (Δ 23 heavier vs alosetron); DEATH-RARE · HOSP-MID · SEX-BALANCED vs this page's TRACE-CASE · DEATH-HEAVY · HOSP-MID · FEMALE-LED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 51.1 pp vs alosetron's DEATH-HEAVY): CASELOAD · HOSP-MID.
alosetron stamps DEATH-HEAVY · HOSP-MID; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload TRACE-CASE and the label guide.