FDA — authorised 27 September 2018
- Application: NDA211288
- Marketing authorisation holder: PFIZER
- Indication: Type 1 - New Molecular Entity
- Status: approved
🇺🇸 Vizimpro in United States
FDA authorised Vizimpro on 27 September 2018 · 241 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: 241
Most-reported reactions
- Death — 95 reports (39.42%)
- Diarrhoea — 37 reports (15.35%)
- Neoplasm Progression — 34 reports (14.11%)
- Rash — 26 reports (10.79%)
- Paronychia — 13 reports (5.39%)
- Decreased Appetite — 9 reports (3.73%)
- Pain — 8 reports (3.32%)
- Vomiting — 7 reports (2.9%)
- Dyspnoea — 6 reports (2.49%)
- Off Label Use — 6 reports (2.49%)
Pricing & reimbursement
- annual_list: USD 14400.00 per year
Vizimpro in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Vizimpro approved in United States?
Yes. FDA authorised it on 27 September 2018.
Who is the marketing authorisation holder for Vizimpro in United States?
PFIZER holds the US marketing authorisation.
What does Vizimpro cost in United States?
annual_list: USD 14400.00 per year. Final patient cost depends on reimbursement and any patient access scheme.