Prescription medicine
Nirsevimab Brand names: Beyfortus
Nirsevimab (Beyfortus) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the nirsevimab FDA label on DailyMed (effective July 13, 2026); every nirsevimab label on DailyMed.
Highlights of the record
FDA label of July 13, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageBEYFORTUS is indicated for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in: Neonates and infants born during or entering their first RSV season.
Forms and strengths
- 100 mg/ml
Injection.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,721 through July 30, 2026
What is nirsevimab used for?
From the label: indications and usageBEYFORTUS is indicated for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in: Neonates and infants born during or entering their first RSV season. Children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. BEYFORTUS is a respiratory syncytial virus (RSV) F protein-directed fusion inhibitor indicated for the prevention of RSV lower respiratory tract disease in: Neonates and infants born during or entering their first RSV season. ( 1 ) Children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
FDA pharmacologic class: Respiratory Syncytial Virus Anti-F Protein Monoclonal Antibody.
Source: FDA drug label (BEYFORTUS), Sanofi Vaccines US Inc., effective July 13, 2026 (SPL set 2f08fa60-f674-432d-801b-1f9514bd9b39), via openFDA; the full label on DailyMed
Is there a generic for nirsevimab (Beyfortus)?
No generic nirsevimab is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for nirsevimab?
The FDA Adverse Event Reporting System holds 1,721 reports that list nirsevimab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 41 are coded as a death and 726 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Nirsevimab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other