FDA — authorised 28 January 2022
- Application: ANDA215822
- Marketing authorisation holder: VKT PHARMA
- Status: approved
🇺🇸 Famotidine 20 MG in United States
FDA authorised Famotidine 20 MG on 28 January 2022 · 110 US adverse-event reports
Marketing authorisations
FDA — authorised 8 March 2023
- Application: ANDA217543
- Marketing authorisation holder: MARKSANS PHARMA
- 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: 110
Most-reported reactions
- Infusion Related Reaction — 18 reports (16.36%)
- Alanine Aminotransferase Increased — 14 reports (12.73%)
- Dyspnoea — 14 reports (12.73%)
- Death — 11 reports (10%)
- Aspartate Aminotransferase Increased — 10 reports (9.09%)
- Blood Creatinine Increased — 10 reports (9.09%)
- Chest Pain — 9 reports (8.18%)
- Cardiac Arrest — 8 reports (7.27%)
- Drug Ineffective — 8 reports (7.27%)
- Hypotension — 8 reports (7.27%)
Famotidine 20 MG 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 Famotidine 20 MG approved in United States?
Yes. FDA authorised it on 28 January 2022; FDA authorised it on 8 March 2023.
Who is the marketing authorisation holder for Famotidine 20 MG in United States?
VKT PHARMA holds the US marketing authorisation.