🇺🇸 Ambroxol Hydrochloride in United States

2,391 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: 2,391

Most-reported reactions

1. Pyrexia — 327 reports (13.68%)
2. Pneumonia — 326 reports (13.63%)
3. Dyspnoea — 324 reports (13.55%)
4. Off Label Use — 273 reports (11.42%)
5. Cough — 226 reports (9.45%)
6. Anaemia — 201 reports (8.41%)
7. Constipation — 198 reports (8.28%)
8. Nasopharyngitis — 176 reports (7.36%)
9. Nausea — 173 reports (7.24%)
10. Malaise — 167 reports (6.98%)

Source database →

Frequently asked questions

Is Ambroxol Hydrochloride approved in United States?

Ambroxol Hydrochloride does not currently have US marketing authorisation in our dataset.

Who is the marketing authorisation holder for Ambroxol Hydrochloride in United States?

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