🇺🇸 hydrocodone/APAP in United States

1,294 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: 1,294

Most-reported reactions

1. Drug Ineffective — 201 reports (15.53%)
2. Nausea — 171 reports (13.21%)
3. Chronic Kidney Disease — 164 reports (12.67%)
4. Fatigue — 126 reports (9.74%)
5. Renal Failure — 116 reports (8.96%)
6. Diarrhoea — 111 reports (8.58%)
7. Acute Kidney Injury — 108 reports (8.35%)
8. Headache — 105 reports (8.11%)
9. Pain — 98 reports (7.57%)
10. Dyspnoea — 94 reports (7.26%)

Source database →

Frequently asked questions

Is hydrocodone/APAP approved in United States?

hydrocodone/APAP does not currently have US marketing authorisation in our dataset.

Who is the marketing authorisation holder for hydrocodone/APAP in United States?

VA Office of Research and Development is the originator. The local marketing authorisation holder may differ — check the official source linked above.