HIGH-VOLUME · HOSP-HEAVY
docusate Side Effects
docusate (also sold as Colace) is HIGH-VOLUME in this FAERS book #129 of 524 by FAERS report count. Signature opener: HOSP-HEAVY - 43.8% mention hospitalization (24,530 reports).
Data updated 2026-05-15
- 55,963
- FAERS reports
FAERS voluntary reports, 1998 to 2025. High volume tracks exposure and reporting culture; see methodology for de-dup rules.
docusate: 43.8% mention hospitalization (24,530 reports). Death stamp DEATH-HEAVY; volume band HIGH-VOLUME #129 of 524 by FAERS report count.
High-report extract for docusate (Colace): 55,963 FAERS rows (1998-2025). Top named reactions: FATIGUE, NAUSEA, DYSPNOEA. Outcome stamps DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED. FAERS is voluntary signal detection, not incidence.
Counts from the openFDA FAERS extract (1998–2025). Stamps CASELOAD · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
FATIGUE leads 4,644 of 55,963 reports
Who reports · age peak 45-64 (SEX-BALANCED)
Sex coding · SEX-BALANCED
Age peak 45-64 (12,723 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (7,296 reports, 13.0%). Top co-reported reactions in that subset - voluntary, not causal.
| Reaction | Reports |
|---|---|
| DEATH | 3,046 |
| PNEUMONIA | 646 |
| DYSPNOEA | 581 |
| NAUSEA | 529 |
| FATIGUE | 476 |
| VOMITING | 458 |
| ASTHENIA | 453 |
| SEPSIS | 451 |
| ANAEMIA | 416 |
| RESPIRATORY FAILURE | 384 |
| RENAL FAILURE | 377 |
| CONSTIPATION | 376 |
| FALL | 356 |
| HYPOTENSION | 347 |
| ACUTE KIDNEY INJURY | 324 |
| DIARRHOEA | 320 |
| ABDOMINAL PAIN | 319 |
| PAIN | 307 |
| DISEASE PROGRESSION | 298 |
Reactions in Hospitalization Reports
Hospitalization is HEAVY (24,530, 43.8% of the book). Top reactions in those rows:
| Reaction | Reports |
|---|---|
| DYSPNOEA | 2,176 |
| NAUSEA | 2,168 |
| PNEUMONIA | 2,166 |
| FATIGUE | 1,852 |
| VOMITING | 1,830 |
| FALL | 1,786 |
| ASTHENIA | 1,646 |
| PAIN | 1,587 |
| DIARRHOEA | 1,553 |
| CONSTIPATION | 1,428 |
| PYREXIA | 1,378 |
| URINARY TRACT INFECTION | 1,278 |
| ANAEMIA | 1,208 |
| ABDOMINAL PAIN | 1,163 |
| DEHYDRATION | 1,095 |
| HYPOTENSION | 1,093 |
| DIZZINESS | 1,023 |
| HEADACHE | 983 |
| BACK PAIN | 940 |
| CHEST PAIN | 931 |
How to read docusate FAERS figures (CASELOAD · DEATH-HEAVY · HOSP-HEAVY)
FAERS holds 55,963 voluntary reports linked to docusate (Colace), 1998-2025. Death is listed on 7,296 (13.0%). Hospitalization appears on 24,530 (43.8%). 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 docusate
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 55,835 FAERS cases (Δ 128 lighter vs docusate); DEATH-HEAVY · HOSP-MID · FEMALE-LED vs this page's CASELOAD · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 55,714 FAERS cases (Δ 249 lighter vs docusate); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's CASELOAD · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 55,549 FAERS cases (Δ 414 lighter vs docusate); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's CASELOAD · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 55,389 FAERS cases (Δ 574 lighter vs docusate); 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 49.1 pp vs docusate's DEATH-HEAVY): CASELOAD · HOSP-MID.
docusate stamps DEATH-HEAVY · HOSP-HEAVY; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload CASELOAD and the label guide.