ENTECAVIR ANHYDROUS

N/A

Manufactured by Amneal Pharmaceuticals LLC

10,248 FDA adverse event reports analyzed

Last updated: 2026-04-15

About ENTECAVIR ANHYDROUS

ENTECAVIR ANHYDROUS is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Amneal Pharmaceuticals LLC. The most commonly reported adverse reactions for ENTECAVIR ANHYDROUS include OFF LABEL USE, DRUG RESISTANCE, DRUG INEFFECTIVE, DEATH, HEPATITIS B. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ENTECAVIR ANHYDROUS.

Top Adverse Reactions

OFF LABEL USE384 reports
DRUG RESISTANCE351 reports
DRUG INEFFECTIVE344 reports
DEATH282 reports
HEPATITIS B250 reports
PYREXIA238 reports
DIARRHOEA234 reports
FATIGUE213 reports
PLATELET COUNT DECREASED208 reports
PNEUMONIA197 reports
NAUSEA180 reports
ASTHENIA157 reports
FEBRILE NEUTROPENIA153 reports
NEUTROPENIA153 reports
WHITE BLOOD CELL COUNT DECREASED153 reports
ANAEMIA150 reports
HEPATITIS B REACTIVATION147 reports
ACUTE KIDNEY INJURY145 reports
THROMBOCYTOPENIA140 reports
PATHOGEN RESISTANCE138 reports
HEPATIC FAILURE134 reports
RENAL IMPAIRMENT129 reports
VIRAL MUTATION IDENTIFIED129 reports
DECREASED APPETITE126 reports
HEPATOCELLULAR CARCINOMA125 reports
ALANINE AMINOTRANSFERASE INCREASED123 reports
DYSPNOEA121 reports
CONDITION AGGRAVATED113 reports
PAIN113 reports
BLOOD CREATININE INCREASED112 reports
NEUTROPHIL COUNT DECREASED104 reports
HEADACHE102 reports
VOMITING99 reports
HYPOPHOSPHATAEMIA95 reports
ASCITES94 reports
DRUG INTERACTION94 reports
COVID 1993 reports
HYPOKALAEMIA92 reports
RENAL FAILURE92 reports
ARTHRALGIA90 reports
HEPATIC CIRRHOSIS90 reports
SEPSIS90 reports
VIRAL LOAD INCREASED89 reports
HEPATIC FUNCTION ABNORMAL88 reports
HEPATITIS B DNA INCREASED86 reports
RASH86 reports
ASPARTATE AMINOTRANSFERASE INCREASED84 reports
MALAISE80 reports
WEIGHT DECREASED80 reports
DIZZINESS79 reports
LYMPHOCYTE COUNT DECREASED77 reports
PRODUCT USE IN UNAPPROVED INDICATION77 reports
BLOOD BILIRUBIN INCREASED76 reports
HYPERTENSION75 reports
BACK PAIN74 reports
CONSTIPATION74 reports
DISEASE PROGRESSION73 reports
LEUKOPENIA73 reports
ABDOMINAL PAIN72 reports
HOSPITALISATION72 reports
INFECTION72 reports
CHRONIC KIDNEY DISEASE71 reports
HYPOTENSION68 reports
SEPTIC SHOCK68 reports
OSTEOPOROSIS67 reports
VIRAL INFECTION67 reports
FALL65 reports
HAEMOGLOBIN DECREASED62 reports
MATERNAL EXPOSURE DURING PREGNANCY62 reports
ABDOMINAL PAIN UPPER61 reports
PAIN IN EXTREMITY61 reports
BONE PAIN60 reports
COUGH60 reports
HEPATIC ENCEPHALOPATHY60 reports
PRURITUS59 reports
RESPIRATORY FAILURE59 reports
OSTEOMALACIA58 reports
JAUNDICE57 reports
DRUG INDUCED LIVER INJURY55 reports
TREATMENT FAILURE55 reports
GAIT DISTURBANCE54 reports
HEPATIC ENZYME INCREASED54 reports
MULTIPLE DRUG RESISTANCE54 reports
NEUROPATHY PERIPHERAL54 reports
URINARY TRACT INFECTION53 reports
CHILLS52 reports
CYTOKINE RELEASE SYNDROME51 reports
BLOOD PRESSURE INCREASED50 reports
CARDIAC FAILURE50 reports
GASTROINTESTINAL HAEMORRHAGE50 reports
MYALGIA50 reports
PLEURAL EFFUSION50 reports
RHABDOMYOLYSIS50 reports
FANCONI SYNDROME ACQUIRED49 reports
MYELOSUPPRESSION49 reports
ABDOMINAL DISTENSION48 reports
GENERAL PHYSICAL HEALTH DETERIORATION48 reports
INTENTIONAL PRODUCT USE ISSUE48 reports
PROTEINURIA48 reports
HYPOCALCAEMIA47 reports

Report Outcomes

Out of 6,594 classified reports for ENTECAVIR ANHYDROUS:

Serious 90.9%Non-Serious 9.1%

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 Age

Age 61170 reports
Age 68161 reports
Age 55159 reports
Age 72153 reports
Age 56139 reports
Age 58136 reports
Age 59136 reports
Age 63136 reports
Age 64134 reports
Age 65133 reports
Age 70133 reports
Age 71132 reports
Age 66127 reports
Age 62126 reports
Age 57124 reports
Age 52121 reports
Age 60121 reports
Age 67115 reports
Age 69115 reports
Age 50113 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 ANHYDROUS?

This profile reflects 10,248 FDA FAERS reports that mention ENTECAVIR ANHYDROUS. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ENTECAVIR ANHYDROUS?

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

Who manufactures ENTECAVIR ANHYDROUS?

Labeling and FAERS entries often list Amneal Pharmaceuticals LLC in connection with ENTECAVIR ANHYDROUS. 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.