ENTECAVIR

N/A

Manufactured by E.R. Squibb & Sons, L.L.C.

15,216 FDA adverse event reports analyzed

Last updated: 2026-04-14

About ENTECAVIR

ENTECAVIR is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by E.R. Squibb & Sons, L.L.C.. The most commonly reported adverse reactions for ENTECAVIR include DEATH, OFF LABEL USE, DRUG INEFFECTIVE, DRUG RESISTANCE, DIARRHOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ENTECAVIR.

Top Adverse Reactions

DEATH539 reports
OFF LABEL USE501 reports
DRUG INEFFECTIVE432 reports
DRUG RESISTANCE401 reports
DIARRHOEA364 reports
FATIGUE353 reports
PYREXIA349 reports
HEPATITIS B327 reports
NAUSEA313 reports
PLATELET COUNT DECREASED289 reports
PNEUMONIA286 reports
ANAEMIA230 reports
RENAL IMPAIRMENT225 reports
WHITE BLOOD CELL COUNT DECREASED221 reports
HEPATIC FAILURE219 reports
NEUTROPENIA218 reports
ASTHENIA217 reports
HEPATOCELLULAR CARCINOMA211 reports
ALANINE AMINOTRANSFERASE INCREASED207 reports
DECREASED APPETITE204 reports
ACUTE KIDNEY INJURY195 reports
THROMBOCYTOPENIA195 reports
FEBRILE NEUTROPENIA191 reports
HEADACHE185 reports
DYSPNOEA183 reports
RASH181 reports
MALAISE177 reports
HEPATITIS B REACTIVATION165 reports
BLOOD CREATININE INCREASED160 reports
RENAL FAILURE160 reports
VOMITING159 reports
ASCITES157 reports
HEPATIC CIRRHOSIS155 reports
HEPATIC FUNCTION ABNORMAL155 reports
PAIN155 reports
SEPSIS152 reports
CONDITION AGGRAVATED150 reports
NEUTROPHIL COUNT DECREASED147 reports
DIZZINESS146 reports
HEPATITIS B DNA INCREASED142 reports
PATHOGEN RESISTANCE142 reports
ASPARTATE AMINOTRANSFERASE INCREASED138 reports
MATERNAL EXPOSURE DURING PREGNANCY136 reports
ARTHRALGIA132 reports
VIRAL MUTATION IDENTIFIED131 reports
HYPOPHOSPHATAEMIA129 reports
HYPOKALAEMIA127 reports
VIRAL LOAD INCREASED127 reports
WEIGHT DECREASED124 reports
ABDOMINAL PAIN UPPER120 reports
DRUG INTERACTION119 reports
ABDOMINAL PAIN117 reports
HOSPITALISATION117 reports
BACK PAIN115 reports
HYPERTENSION114 reports
BLOOD BILIRUBIN INCREASED112 reports
HEPATIC CANCER112 reports
PRURITUS108 reports
CONSTIPATION107 reports
HEPATIC NEOPLASM MALIGNANT107 reports
PRODUCT USE IN UNAPPROVED INDICATION106 reports
COVID 19105 reports
HEPATIC ENCEPHALOPATHY105 reports
LEUKOPENIA100 reports
DRUG DOSE OMISSION98 reports
LIVER DISORDER98 reports
MYALGIA98 reports
SEPTIC SHOCK98 reports
FALL97 reports
INSOMNIA96 reports
DISEASE PROGRESSION94 reports
INFECTION93 reports
COUGH89 reports
BLOOD CREATINE PHOSPHOKINASE INCREASED88 reports
HYPOTENSION88 reports
INTERSTITIAL LUNG DISEASE88 reports
PAIN IN EXTREMITY88 reports
LYMPHOCYTE COUNT DECREASED86 reports
CARDIAC FAILURE85 reports
JAUNDICE85 reports
HAEMOGLOBIN DECREASED83 reports
BLOOD ALKALINE PHOSPHATASE INCREASED81 reports
OSTEOPOROSIS81 reports
URINARY TRACT INFECTION81 reports
CHILLS78 reports
CHRONIC KIDNEY DISEASE77 reports
ABDOMINAL DISTENSION75 reports
MALIGNANT NEOPLASM PROGRESSION74 reports
GASTROINTESTINAL HAEMORRHAGE73 reports
PROTEINURIA73 reports
NEUROPATHY PERIPHERAL72 reports
VIRAL INFECTION72 reports
GAIT DISTURBANCE71 reports
GENERAL PHYSICAL HEALTH DETERIORATION71 reports
RESPIRATORY FAILURE71 reports
ALOPECIA70 reports
BONE PAIN70 reports
FANCONI SYNDROME ACQUIRED70 reports
BLOOD PRESSURE INCREASED69 reports
LACTIC ACIDOSIS69 reports

Report Outcomes

Out of 11,244 classified reports for ENTECAVIR:

Serious 87.1%Non-Serious 12.9%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Male6,383 (64.9%)
Female3,417 (34.7%)
Unknown36 (0.4%)

Reports by Age

Age 61251 reports
Age 68231 reports
Age 59228 reports
Age 55226 reports
Age 64225 reports
Age 63224 reports
Age 56211 reports
Age 72205 reports
Age 65203 reports
Age 71200 reports
Age 57199 reports
Age 60198 reports
Age 62198 reports
Age 66198 reports
Age 58196 reports
Age 70192 reports
Age 67191 reports
Age 50185 reports
Age 69173 reports
Age 52169 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with ENTECAVIR?

This profile reflects 15,216 FDA FAERS reports that mention ENTECAVIR. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ENTECAVIR?

Frequently reported terms in FAERS include DEATH, OFF LABEL USE, DRUG INEFFECTIVE, DRUG RESISTANCE, DIARRHOEA, FATIGUE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ENTECAVIR?

Labeling and FAERS entries often list E.R. Squibb & Sons, L.L.C. in connection with ENTECAVIR. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.