🇺🇸 Hepa-B in United States
10 US adverse-event reports
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: 22 April 2025 – 22 April 2026
- Total reports: 10
Most-reported reactions
- Abscess — 1 report (10%)
- Anaemia — 1 report (10%)
- Anal Atresia — 1 report (10%)
- Anal Fissure — 1 report (10%)
- Aphthous Ulcer — 1 report (10%)
- Apnoea — 1 report (10%)
- Arthralgia — 1 report (10%)
- Atrial Septal Defect — 1 report (10%)
- Brain Injury — 1 report (10%)
- Brain Malformation — 1 report (10%)
Other Immunology / Infectious Disease approved in United States
Frequently asked questions
Is Hepa-B approved in United States?
Hepa-B does not currently have US marketing authorisation in our dataset.
Who is the marketing authorisation holder for Hepa-B in United States?
International Centre for Diarrhoeal Disease Research, Bangladesh is the originator. The local marketing authorisation holder may differ — check the official source linked above.