🇺🇸 Varilrix in United States

116 US adverse-event reports

Marketing authorisation

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: 27 March 2025 – 27 March 2026
• Total reports: 116

Most-reported reactions

1. Drug Ineffective — 17 reports (14.66%)
2. Drug Intolerance — 14 reports (12.07%)
3. Pyrexia — 14 reports (12.07%)
4. Pneumonia — 11 reports (9.48%)
5. Alopecia — 10 reports (8.62%)
6. Contraindicated Product Administered — 10 reports (8.62%)
7. Hepatocellular Injury — 10 reports (8.62%)
8. Hyperthermia — 10 reports (8.62%)
9. Lymphoma — 10 reports (8.62%)
10. Neoplasm Malignant — 10 reports (8.62%)

Source database →

Frequently asked questions

Is Varilrix approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Varilrix in United States?

GlaxoSmithKline is the originator. The local marketing authorisation holder may differ — check the official source linked above.