FDA — authorised 15 December 2023
- Application: NDA208653
- Marketing authorisation holder: ZEVRA THERAP
- Indication: Labeling
- Status: approved
🇺🇸 BENZHYDROCODONE in United States
FDA authorised BENZHYDROCODONE on 15 December 2023 · 34 US adverse-event reports
Marketing authorisation
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: 19 April 2025 – 19 April 2026
- Total reports: 34
Most-reported reactions
- Off Label Use — 5 reports (14.71%)
- Product Dose Omission Issue — 5 reports (14.71%)
- Urinary Tract Infection — 4 reports (11.76%)
- Fluid Retention — 3 reports (8.82%)
- Kidney Infection — 3 reports (8.82%)
- Localised Infection — 3 reports (8.82%)
- Peripheral Swelling — 3 reports (8.82%)
- Rash — 3 reports (8.82%)
- Skin Discomfort — 3 reports (8.82%)
- Condition Aggravated — 2 reports (5.88%)
BENZHYDROCODONE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is BENZHYDROCODONE approved in United States?
Yes. FDA authorised it on 15 December 2023.
Who is the marketing authorisation holder for BENZHYDROCODONE in United States?
ZEVRA THERAP holds the US marketing authorisation.