🇺🇸 Duphalac in United States

1,398 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: 28 March 2025 – 28 March 2026
• Total reports: 1,398

Most-reported reactions

1. Drug Interaction — 168 reports (12.02%)
2. Confusional State — 152 reports (10.87%)
3. Pyrexia — 147 reports (10.52%)
4. Hyponatraemia — 138 reports (9.87%)
5. Diarrhoea — 136 reports (9.73%)
6. Acute Kidney Injury — 135 reports (9.66%)
7. Thrombocytopenia — 135 reports (9.66%)
8. Anaemia — 132 reports (9.44%)
9. Asthenia — 128 reports (9.16%)
10. Vomiting — 127 reports (9.08%)

Source database →

Frequently asked questions

Is Duphalac approved in United States?

Duphalac does not currently have US marketing authorisation in our dataset.

Who is the marketing authorisation holder for Duphalac in United States?

National Taiwan University Hospital is the originator. The local marketing authorisation holder may differ — check the official source linked above.