HIGH-VOLUME · HOSP-HEAVY
lactulose Side Effects
lactulose (also sold as Enulose, Kristalose) is HIGH-VOLUME in this FAERS book #167 of 524 by FAERS report count. Signature opener: HOSP-HEAVY - 55.0% mention hospitalization (20,384 reports).
Data updated 2026-05-15
- 37,033
- FAERS reports
FAERS voluntary reports, 1997 to 2025. High volume tracks exposure and reporting culture; see methodology for de-dup rules.
lactulose: 55.0% mention hospitalization (20,384 reports). Death stamp DEATH-HEAVY; volume band HIGH-VOLUME #167 of 524 by FAERS report count.
High-report extract for lactulose (Enulose): 37,033 FAERS rows (1997-2025). Top named reactions: NAUSEA, CONSTIPATION, FALL. Outcome stamps DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED. FAERS is voluntary signal detection, not incidence.
Counts from the openFDA FAERS extract (1997–2025). Stamps CASELOAD · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
NAUSEA leads 2,524 of 37,033 reports
Who reports · age peak 45-64 (SEX-BALANCED)
Sex coding · SEX-BALANCED
Age peak 45-64 (9,655 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (6,511 reports, 17.6%). Top co-reported reactions in that subset - voluntary, not causal.
| Reaction | Reports |
|---|---|
| DEATH | 1,932 |
| PNEUMONIA | 487 |
| SEPSIS | 377 |
| DYSPNOEA | 362 |
| NAUSEA | 342 |
| ASTHENIA | 312 |
| VOMITING | 298 |
| HEPATIC FAILURE | 291 |
| CONSTIPATION | 284 |
| DIARRHOEA | 269 |
| RENAL FAILURE | 269 |
| RESPIRATORY FAILURE | 252 |
| CARDIAC ARREST | 249 |
| ABDOMINAL PAIN | 237 |
| DISEASE PROGRESSION | 236 |
| HYPOTENSION | 234 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 230 |
| HEPATIC ENCEPHALOPATHY | 224 |
| ACUTE KIDNEY INJURY | 223 |
Reactions in Hospitalization Reports
Hospitalization is HEAVY (20,384, 55.0% of the book). Top reactions in those rows:
| Reaction | Reports |
|---|---|
| FALL | 1,819 |
| CONSTIPATION | 1,698 |
| NAUSEA | 1,505 |
| PNEUMONIA | 1,422 |
| VOMITING | 1,368 |
| HYPOTENSION | 1,319 |
| DYSPNOEA | 1,288 |
| PAIN | 1,150 |
| DIARRHOEA | 1,050 |
| CONFUSIONAL STATE | 1,044 |
| PYREXIA | 1,031 |
| FATIGUE | 991 |
| ANAEMIA | 890 |
| ABDOMINAL PAIN | 886 |
| ASTHENIA | 851 |
| BALANCE DISORDER | 823 |
| ACUTE KIDNEY INJURY | 798 |
| URINARY TRACT INFECTION | 767 |
| ORTHOSTATIC HYPOTENSION | 746 |
How to read lactulose FAERS figures (CASELOAD · DEATH-HEAVY · HOSP-HEAVY)
FAERS holds 37,033 voluntary reports linked to lactulose (Enulose, Kristalose), 1997-2025. Death is listed on 6,511 (17.6%). Hospitalization appears on 20,384 (55.0%). Top co-reported indication: Product Used For Unknown Indication.
CASELOAD books overweight common drugs and loud reporting cultures; HOSP-HEAVY is the page opener, not a per-patient risk.
Read with lactulose
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 36,931 FAERS cases (Δ 102 lighter vs lactulose); DEATH-HEAVY · HOSP-MID · SEX-BALANCED vs this page's CASELOAD · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 36,917 FAERS cases (Δ 116 lighter vs lactulose); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's CASELOAD · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 36,885 FAERS cases (Δ 148 lighter vs lactulose); DEATH-MARKED · HOSP-MID · FEMALE-LED vs this page's CASELOAD · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 37,361 FAERS cases (Δ 328 heavier vs lactulose); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's CASELOAD · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 44.5 pp vs lactulose's DEATH-HEAVY): CASELOAD · HOSP-MID.
lactulose stamps DEATH-HEAVY · HOSP-HEAVY; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload CASELOAD and the label guide.