Drug Landscape ›
entecavir tablets ›
Regulatory · United States
Marketing authorisation
FDA
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
Window: 20 April 2025 – 20 April 2026
Total reports: 62
Most-reported reactions
White Blood Cell Count Decreased — 10 reports (16.13%) Neutrophil Count Decreased — 9 reports (14.52%) Anaemia — 8 reports (12.9%) Platelet Count Decreased — 7 reports (11.29%) Myelosuppression — 6 reports (9.68%) Death — 5 reports (8.06%) Hypokalaemia — 5 reports (8.06%) Alanine Aminotransferase Increased — 4 reports (6.45%) Hypoalbuminaemia — 4 reports (6.45%) Lymphocyte Count Decreased — 4 reports (6.45%)
Source database →
entecavir tablets in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is entecavir tablets approved in United States?
Yes. FDA has authorised it.
Who is the marketing authorisation holder for entecavir tablets in United States?
Sunshine Lake Pharma Co., Ltd. is the originator. The local marketing authorisation holder may differ — check the official source linked above.