MID-VOLUME · FEMALE-LED
linaclotide Side Effects
linaclotide (also sold as Linzess) sits MID-VOLUME #209 of 524 by FAERS report count. Lead signal: FEMALE-LED - 73% of sex-coded reports are female (16,594 F / 6,185 M). Demographics and serious-outcome tables follow.
Data updated 2026-05-15
- 24,979
- FAERS reports
FDA Adverse Event Reporting System extract for linaclotide. Stamp set WATCHLIST · DEATH-MARKED · HOSP-MID. How figures are compiled.
linaclotide reporting skew - 73% of sex-coded reports are female (16,594 F / 6,185 M). Volume band MID-VOLUME #209 of 524 by FAERS report count; caseload WATCHLIST.
Mid-book FAERS page for linaclotide (Linzess) (24,979 reports). Signature FEMALE-LED. Dominant age band on file: 45-64. Educational reference only.
Counts from the openFDA FAERS extract (2012–2025). Stamps WATCHLIST · DEATH-MARKED · HOSP-MID · FEMALE-LED.
DIARRHOEA leads 4,502 of 24,979 reports
FEMALE-LED reporters · age peak 45-64
Female-led reporters (73% of sex-coded rows)
Age peak 45-64 (4,111 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death appears on 988 reports (4.0% - MARKED). Reactions below co-occur in those rows only.
| Reaction | Reports |
|---|---|
| DEATH | 479 |
| COMPLETED SUICIDE | 93 |
| CARDIAC ARREST | 71 |
| FALL | 39 |
| TOXICITY TO VARIOUS AGENTS | 35 |
| CHRONIC KIDNEY DISEASE | 33 |
| PNEUMONIA | 32 |
| ACUTE KIDNEY INJURY | 31 |
| CONSTIPATION | 31 |
| CARDIO-RESPIRATORY ARREST | 30 |
| DYSPNOEA | 29 |
| DECREASED APPETITE | 28 |
| NAUSEA | 28 |
| PARKINSON^S DISEASE | 28 |
| RENAL FAILURE | 25 |
| SEPSIS | 25 |
| FATIGUE | 24 |
| MALAISE | 24 |
| DIARRHOEA | 23 |
| ASTHENIA | 22 |
Reactions in Hospitalization Reports
Hospitalization mid-share (3,610, 14.5%). Co-reported reactions:
| Reaction | Reports |
|---|---|
| FALL | 335 |
| CONSTIPATION | 330 |
| NAUSEA | 319 |
| DIARRHOEA | 310 |
| PNEUMONIA | 249 |
| FATIGUE | 233 |
| DYSPNOEA | 231 |
| PAIN | 229 |
| VOMITING | 209 |
| HEADACHE | 191 |
| ASTHENIA | 189 |
| URINARY TRACT INFECTION | 182 |
| DEHYDRATION | 173 |
| DIZZINESS | 172 |
| ABDOMINAL PAIN | 165 |
| HOSPITALISATION | 162 |
| MALAISE | 154 |
| DECREASED APPETITE | 135 |
How to read linaclotide FAERS figures (WATCHLIST · DEATH-MARKED · HOSP-MID)
FAERS holds 24,979 voluntary reports linked to linaclotide (Linzess), 2012-2025. Death is listed on 988 (4.0%). Hospitalization appears on 3,610 (14.5%). Top co-reported indication: Product Used For Unknown Indication.
Mid-volume extract - treat DEATH-MARKED · HOSP-MID as signal-detection rates next to 73% of sex-coded reports are female (16,594 F / 6,185 M).
Read with linaclotide
Peers ranked by ABS(total_reports), then an ABS(death_share) pole; guide hop follows DEATH-MARKED · HOSP-MID stamps.
ABS(total_reports) peer at 25,027 FAERS cases (Δ 48 heavier vs linaclotide); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-MARKED · HOSP-MID · FEMALE-LED.
ABS(total_reports) peer at 24,883 FAERS cases (Δ 96 lighter vs linaclotide); DEATH-HEAVY · HOSP-MID · SEX-BALANCED vs this page's WATCHLIST · DEATH-MARKED · HOSP-MID · FEMALE-LED.
ABS(total_reports) peer at 25,229 FAERS cases (Δ 250 heavier vs linaclotide); DEATH-HEAVY · HOSP-MID · SEX-BALANCED vs this page's WATCHLIST · DEATH-MARKED · HOSP-MID · FEMALE-LED.
ABS(total_reports) peer at 24,667 FAERS cases (Δ 312 lighter vs linaclotide); DEATH-MARKED · HOSP-LIGHT · FEMALE-LED vs this page's WATCHLIST · DEATH-MARKED · HOSP-MID · FEMALE-LED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 58.2 pp vs linaclotide's DEATH-MARKED): CASELOAD · HOSP-MID.
linaclotide stamps WATCHLIST · FEMALE-LED; class peers and methodology beat restating the same FAERS caveats on every effects URL.