FDA
- Status: approved
🇺🇸 CARBENICILLIN DISODIUM in United States
10 US adverse-event reports
Marketing authorisations
FDA
- Application: NDA050298
- Marketing authorisation holder: GLAXOSMITHKLINE
- Local brand name: PYOPEN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: NDA050306
- Marketing authorisation holder: ROERIG
- Local brand name: GEOPEN
- 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
- Amputation — 1 report (10%)
- Bk Virus Infection — 1 report (10%)
- Chronic Allograft Nephropathy — 1 report (10%)
- Coagulation Time Prolonged — 1 report (10%)
- Cryptococcosis — 1 report (10%)
- Cytomegalovirus Infection — 1 report (10%)
- Diabetes Mellitus — 1 report (10%)
- Disease Recurrence — 1 report (10%)
- Embolism — 1 report (10%)
- Femoral Artery Occlusion — 1 report (10%)
CARBENICILLIN DISODIUM in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is CARBENICILLIN DISODIUM approved in United States?
Yes. FDA has authorised it; FDA has authorised it; FDA has authorised it.
Who is the marketing authorisation holder for CARBENICILLIN DISODIUM in United States?
Marketing authorisation holder not available in our data.