FDA — authorised 3 July 1968
- Application: ANDA060711
- Marketing authorisation holder: TEVA
- Local brand name: PENICILLIN-VK
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Penicillin VK in United States
FDA authorised Penicillin VK on 3 July 1968 · 975 US adverse-event reports
Marketing authorisations
FDA — authorised 31 July 1968
- Application: ANDA060456
- Marketing authorisation holder: TEVA
- Local brand name: PENICILLIN-VK
- Indication: FOR SOLUTION — ORAL
- Status: approved
FDA
- 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: 975
Most-reported reactions
- Pain — 146 reports (14.97%)
- Chronic Kidney Disease — 139 reports (14.26%)
- Anxiety — 113 reports (11.59%)
- Renal Failure — 101 reports (10.36%)
- Acute Kidney Injury — 92 reports (9.44%)
- Fatigue — 89 reports (9.13%)
- Injury — 77 reports (7.9%)
- Nausea — 77 reports (7.9%)
- Diarrhoea — 73 reports (7.49%)
- Dyspnoea — 68 reports (6.97%)
Penicillin VK 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 Penicillin VK approved in United States?
Yes. FDA authorised it on 3 July 1968; FDA authorised it on 31 July 1968; FDA has authorised it.
Who is the marketing authorisation holder for Penicillin VK in United States?
TEVA holds the US marketing authorisation.