FDA — authorised 30 April 1987
- Application: ANDA062654
- Marketing authorisation holder: HOFFMANN LA ROCHE
- Local brand name: ROCEPHIN
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 ceftrioxone in United States
FDA authorised ceftrioxone on 30 April 1987 · 10 US adverse-event reports
Marketing authorisations
FDA
- Status: approved
FDA
- Application: ANDA062510
- Marketing authorisation holder: ROCHE
- Local brand name: ROCEPHIN
- Indication: INJECTABLE — INJECTION
- Status: approved
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: 20 April 2025 – 20 April 2026
- Total reports: 10
Most-reported reactions
- Acute Kidney Injury — 1 report (10%)
- Chronic Kidney Disease — 1 report (10%)
- Death — 1 report (10%)
- Ear Infection — 1 report (10%)
- Endocarditis Bacterial — 1 report (10%)
- Gastritis — 1 report (10%)
- Gastrooesophageal Reflux Disease — 1 report (10%)
- Hepatic Function Abnormal — 1 report (10%)
- Hyperparathyroidism Secondary — 1 report (10%)
- Nephrogenic Anaemia — 1 report (10%)
ceftrioxone in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is ceftrioxone approved in United States?
Yes. FDA authorised it on 30 April 1987; FDA has authorised it; FDA has authorised it.
Who is the marketing authorisation holder for ceftrioxone in United States?
HOFFMANN LA ROCHE holds the US marketing authorisation.