MID-VOLUME · HOSP-HEAVY
entecavir Side Effects
entecavir (also sold as Baraclude) sits MID-VOLUME #306 of 524 by FAERS report count. Lead signal: HOSP-HEAVY - 38.1% mention hospitalization (4,285 reports). Demographics and serious-outcome tables follow.
Data updated 2026-05-15
- 11,247
- FAERS reports
FDA Adverse Event Reporting System extract for entecavir. Stamp set WATCHLIST · DEATH-HEAVY · HOSP-HEAVY. How figures are compiled.
entecavir: 38.1% mention hospitalization (4,285 reports). Death stamp DEATH-HEAVY; volume band MID-VOLUME #306 of 524 by FAERS report count.
Mid-book FAERS page for entecavir (Baraclude) (11,247 reports). Signature HOSP-HEAVY. Dominant age band on file: 45-64. Educational reference only.
Counts from the openFDA FAERS extract (2004–2025). Stamps WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
DEATH leads 539 of 11,247 reports
Who reports · age peak 45-64 (SEX-BALANCED)
Sex coding · SEX-BALANCED
Age peak 45-64 (3,582 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (1,842 reports, 16.4%). Top co-reported reactions in that subset - voluntary, not causal.
| Reaction | Reports |
|---|---|
| DEATH | 530 |
| HEPATIC FAILURE | 173 |
| HEPATITIS B | 99 |
| SEPSIS | 94 |
| PNEUMONIA | 81 |
| HEPATOCELLULAR CARCINOMA | 78 |
| PYREXIA | 75 |
| SEPTIC SHOCK | 64 |
| DIARRHOEA | 51 |
| RENAL FAILURE | 50 |
| HEPATIC ENCEPHALOPATHY | 49 |
| DISEASE PROGRESSION | 48 |
| RESPIRATORY FAILURE | 48 |
| MULTIPLE ORGAN DYSFUNCTION SYNDROME | 47 |
| ANAEMIA | 45 |
| HEPATIC FUNCTION ABNORMAL | 44 |
| HEPATIC CIRRHOSIS | 43 |
| MALIGNANT NEOPLASM PROGRESSION | 43 |
| PLATELET COUNT DECREASED | 43 |
Reactions in Hospitalization Reports
Hospitalization is HEAVY (4,285, 38.1% of the book). Top reactions in those rows:
| Reaction | Reports |
|---|---|
| PYREXIA | 237 |
| DIARRHOEA | 206 |
| PNEUMONIA | 205 |
| PLATELET COUNT DECREASED | 157 |
| NAUSEA | 148 |
| FEBRILE NEUTROPENIA | 133 |
| ANAEMIA | 126 |
| ACUTE KIDNEY INJURY | 122 |
| DECREASED APPETITE | 116 |
| FATIGUE | 112 |
| HOSPITALISATION | 105 |
| ASCITES | 101 |
| ASTHENIA | 101 |
| THROMBOCYTOPENIA | 99 |
| DYSPNOEA | 98 |
| SEPSIS | 98 |
| VOMITING | 98 |
| WHITE BLOOD CELL COUNT DECREASED | 96 |
| ALANINE AMINOTRANSFERASE INCREASED | 94 |
How to read entecavir FAERS figures (WATCHLIST · DEATH-HEAVY · HOSP-HEAVY)
FAERS holds 11,247 voluntary reports linked to entecavir (Baraclude), 2004-2025. Death is listed on 1,842 (16.4%). Hospitalization appears on 4,285 (38.1%). Top co-reported indication: Hepatitis B.
Mid-volume extract - treat DEATH-HEAVY · HOSP-HEAVY as signal-detection rates next to 38.1% mention hospitalization (4,285 reports).
Read with entecavir
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 11,257 FAERS cases (Δ 10 heavier vs entecavir); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 11,311 FAERS cases (Δ 64 heavier vs entecavir); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 11,380 FAERS cases (Δ 133 heavier vs entecavir); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 11,382 FAERS cases (Δ 135 heavier vs entecavir); DEATH-HEAVY · HOSP-MID · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 45.7 pp vs entecavir's DEATH-HEAVY): CASELOAD · HOSP-MID.
entecavir stamps DEATH-HEAVY · HOSP-HEAVY; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload WATCHLIST and the label guide.