MID-VOLUME · SEX-BALANCED
lubiprostone Side Effects
lubiprostone (also sold as Amitiza) sits MID-VOLUME #330 of 524 by FAERS report count. Lead signal: SEX-BALANCED - 70% of sex-coded reports are female (5,912 F / 2,538 M). Demographics and serious-outcome tables follow.
Data updated 2026-05-15
- 9,102
- FAERS reports
FDA Adverse Event Reporting System extract for lubiprostone. Stamp set WATCHLIST · DEATH-HEAVY · HOSP-HEAVY. How figures are compiled.
lubiprostone reporting skew - 70% of sex-coded reports are female (5,912 F / 2,538 M). Volume band MID-VOLUME #330 of 524 by FAERS report count; caseload WATCHLIST.
Mid-book FAERS page for lubiprostone (Amitiza) (9,102 reports). Signature SEX-BALANCED. Dominant age band on file: 45-64. Educational reference only.
Counts from the openFDA FAERS extract (2006–2025). Stamps WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
NAUSEA leads 765 of 9,102 reports
Who reports · age peak 45-64 (SEX-BALANCED)
Sex coding · SEX-BALANCED
Age peak 45-64 (2,066 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (927 reports, 10.2%). Top co-reported reactions in that subset - voluntary, not causal.
| Reaction | Reports |
|---|---|
| DEATH | 237 |
| PNEUMONIA | 70 |
| SEPSIS | 55 |
| MALIGNANT NEOPLASM PROGRESSION | 54 |
| CONSTIPATION | 51 |
| PYREXIA | 49 |
| DECREASED APPETITE | 47 |
| DIARRHOEA | 46 |
| RENAL FAILURE | 45 |
| INTERSTITIAL LUNG DISEASE | 42 |
| CHRONIC KIDNEY DISEASE | 40 |
| NAUSEA | 36 |
| ANAEMIA | 35 |
| ACUTE KIDNEY INJURY | 34 |
| COMPLETED SUICIDE | 34 |
| RESPIRATORY FAILURE | 32 |
| VOMITING | 31 |
| PLATELET COUNT DECREASED | 30 |
| CARDIAC FAILURE | 29 |
Reactions in Hospitalization Reports
Hospitalization is HEAVY (3,000, 33.0% of the book). Top reactions in those rows:
| Reaction | Reports |
|---|---|
| NAUSEA | 246 |
| FALL | 221 |
| DIARRHOEA | 218 |
| CONSTIPATION | 217 |
| PNEUMONIA | 209 |
| PYREXIA | 182 |
| PAIN | 174 |
| VOMITING | 161 |
| DYSPNOEA | 159 |
| FATIGUE | 156 |
| DECREASED APPETITE | 142 |
| ASTHENIA | 134 |
| DEHYDRATION | 132 |
| DIZZINESS | 132 |
| HEADACHE | 128 |
| URINARY TRACT INFECTION | 128 |
| MALAISE | 126 |
| ANXIETY | 114 |
| WEIGHT DECREASED | 111 |
How to read lubiprostone FAERS figures (WATCHLIST · DEATH-HEAVY · HOSP-HEAVY)
FAERS holds 9,102 voluntary reports linked to lubiprostone (Amitiza), 2006-2025. Death is listed on 927 (10.2%). Hospitalization appears on 3,000 (33.0%). Top co-reported indication: Product Used For Unknown Indication.
Mid-volume extract - treat DEATH-HEAVY · HOSP-HEAVY as signal-detection rates next to 70% of sex-coded reports are female (5,912 F / 2,538 M).
Read with lubiprostone
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 9,140 FAERS cases (Δ 38 heavier vs lubiprostone); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 8,979 FAERS cases (Δ 123 lighter vs lubiprostone); DEATH-HEAVY · HOSP-MID · FEMALE-LED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 9,259 FAERS cases (Δ 157 heavier vs lubiprostone); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 9,400 FAERS cases (Δ 298 heavier vs lubiprostone); DEATH-RARE · HOSP-LIGHT · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 51.9 pp vs lubiprostone's DEATH-HEAVY): CASELOAD · HOSP-MID.
lubiprostone stamps DEATH-HEAVY · HOSP-HEAVY; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload WATCHLIST and the label guide.