LOW-VOLUME · HOSP-HEAVY
entacapone Side Effects
entacapone (also sold as Comtan) is a LOW-VOLUME FAERS extract #408 of 524 by FAERS report count. Still opens on HOSP-HEAVY: 33.9% mention hospitalization (1,340 reports).
Data updated 2026-05-15
- 3,955
- FAERS reports
Thinner FAERS book - still a temporal association ledger, not proof of cause. Methodology.
entacapone: 33.9% mention hospitalization (1,340 reports). Death stamp DEATH-HEAVY; volume band LOW-VOLUME #408 of 524 by FAERS report count.
Thinner FAERS extract for entacapone (Comtan) (3,955 reports #408 of 524 by FAERS report count). 33.9% mention hospitalization (1,340 reports). Sparse books still carry named reaction rows when present; not medical advice.
Counts from the openFDA FAERS extract (2003–2025). Stamps SIGNAL · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
DYSKINESIA leads 461 of 3,955 reports
Who reports · age peak 65-74 (SEX-BALANCED)
Sex coding · SEX-BALANCED
Age peak 65-74 (1,011 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (603 reports, 15.2%). Top co-reported reactions in that subset - voluntary, not causal.
| Reaction | Reports |
|---|---|
| DEATH | 318 |
| PARKINSON^S DISEASE | 88 |
| HALLUCINATION | 74 |
| FALL | 71 |
| PNEUMONIA | 45 |
| DYSKINESIA | 44 |
| CONFUSIONAL STATE | 42 |
| AGITATION | 35 |
| DEMENTIA | 25 |
| HYPONATRAEMIA | 25 |
| CARDIAC ARREST | 24 |
| ASTHENIA | 23 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 23 |
| ORTHOSTATIC HYPOTENSION | 22 |
| URINARY RETENTION | 21 |
| DYSPHAGIA | 20 |
| MYOCARDIAL INFARCTION | 20 |
| CONSTIPATION | 19 |
Reactions in Hospitalization Reports
Hospitalization is HEAVY (1,340, 33.9% of the book). Top reactions in those rows:
| Reaction | Reports |
|---|---|
| FALL | 238 |
| DYSKINESIA | 195 |
| HALLUCINATION | 159 |
| CONFUSIONAL STATE | 120 |
| ON AND OFF PHENOMENON | 105 |
| PARKINSON^S DISEASE | 102 |
| GAIT DISTURBANCE | 97 |
| URINARY TRACT INFECTION | 88 |
| MUSCLE RIGIDITY | 87 |
| TREMOR | 84 |
| ASTHENIA | 83 |
| PSYCHOTIC DISORDER | 74 |
| PNEUMONIA | 73 |
| AGITATION | 68 |
| HALLUCINATION, VISUAL | 67 |
| FATIGUE | 65 |
| THERAPEUTIC PRODUCT EFFECT INCOMPLETE | 64 |
| DYSTONIA | 63 |
| MOBILITY DECREASED | 63 |
How to read entacapone FAERS figures (SIGNAL · DEATH-HEAVY · HOSP-HEAVY)
FAERS holds 3,955 voluntary reports linked to entacapone (Comtan), 2003-2025. Death is listed on 603 (15.2%). Hospitalization appears on 1,340 (33.9%). Top co-reported indication: Parkinson^S Disease.
Sparse extract - named reactions and SEX-BALANCED skew still differ by drug; not a complete safety profile.
Read with entacapone
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 3,948 FAERS cases (Δ 7 lighter vs entacapone); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's SIGNAL · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 3,944 FAERS cases (Δ 11 lighter vs entacapone); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's SIGNAL · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 3,848 FAERS cases (Δ 107 lighter vs entacapone); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's SIGNAL · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 4,079 FAERS cases (Δ 124 heavier vs entacapone); DEATH-HEAVY · HOSP-MID · SEX-BALANCED vs this page's SIGNAL · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 46.9 pp vs entacapone's DEATH-HEAVY): CASELOAD · HOSP-MID.
entacapone stamps DEATH-HEAVY · HOSP-HEAVY; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload SIGNAL and the label guide.