entecavir Side Effects
Also known as: Baraclude
Analysis of 11,247 adverse event reports submitted to the FDA from 2004 to 2025.
Total Reports
11,247
Death-Related
1,842
16.4% of reports
Hospitalizations
4,285
38.1% of reports
Top Indication
Hepatitis B
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 1,842 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 530 |
| HEPATIC FAILURE | 173 |
| HEPATITIS B | 99 |
| SEPSIS | 94 |
| PNEUMONIA | 81 |
| HEPATOCELLULAR CARCINOMA | 78 |
| PYREXIA | 75 |
| OFF LABEL USE | 65 |
| 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
Top reactions in 4,285 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| PYREXIA | 237 |
| DIARRHOEA | 206 |
| PNEUMONIA | 205 |
| OFF LABEL USE | 178 |
| 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 |
Nearby — Related Medications
What the FAERS Data Reveals About entecavir Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 11,247 voluntary reports linked to entecavir and its brand equivalents (Baraclude), spanning 2004 through 2025. Of those, 1,842 (16.4%) listed death as an outcome and 4,285 (38.1%) involved hospitalization. The most common indication reported alongside adverse events was Hepatitis B.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 35% were female and 65% male; age distribution skews toward 45-64, with 3,582 reports in that bracket. The single most reported reaction is death with 539 submissions, followed by off label use and drug ineffective.
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.
Read our methodology — how this data is sourced, computed, and verified.