Prescription medicine
Zanamivir Brand names: Relenza
Zanamivir (Relenza) is a prescription medicine with an FDA approval on record since 1999. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the zanamivir FDA label on DailyMed (effective October 24, 2023, GlaxoSmithKline LLC); the NDA 21036 record on Drugs@FDA; every zanamivir label on DailyMed.
Highlights of the record
FDA label of October 24, 2023; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageRELENZA, an influenza virus neuraminidase inhibitor (NAI), is indicated for: Treatment of acute, uncomplicated influenza type A and B infections in patients aged 7 years and older who have been symptomatic for no more than 2 days.
Forms and strengths
- 5 mg
Powder.
On the market
- Earliest approval on file
- July 26, 1999 Relenza, Glaxosmithkline; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 2 of which 0 under generic applications, 2 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
- 2,524 through July 30, 2026
What is zanamivir used for?
From the label: indications and usageRELENZA, an influenza virus neuraminidase inhibitor (NAI), is indicated for: Treatment of acute, uncomplicated influenza type A and B infections in patients aged 7 years and older who have been symptomatic for no more than 2 days. ( 1.1 ) Prophylaxis of influenza in patients aged 5 years and older. ( 1.2 ) Important Limitations of Use: Not recommended for treatment or prophylaxis of influenza in:
Individuals with underlying airways disease. ( 5.1 ) Not proven effective for:
Treatment in individuals with underlying airways disease. ( 1.3 )
Prophylaxis in nursing home residents. ( 1.3 ) Not a substitute for annual influenza vaccination. […]
Conditions named in the indications of zanamivir's FDA labels, with every medicine labeled for each:
From other zanamivir labelsInfluenza: Treatment of Influenza RELENZA (zanamivir) inhalation powder is indicated for treatment of uncomplicated acute illness due to influenza A and B virus in adults and pediatric patients aged 7 years and older who have been symptomatic for no …
FDA pharmacologic class: Neuraminidase Inhibitor.
Source: FDA drug label (RELENZA), GlaxoSmithKline LLC, effective October 24, 2023 (SPL set d7c3bcc3-0c0d-4068-fd80-88cf54a376ef), via openFDA; the full label on DailyMed
Is there a generic for zanamivir (Relenza)?
No generic zanamivir is approved (Drugs@FDA, October 8, 2026).
- 1999 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for zanamivir?
The FDA Adverse Event Reporting System holds 2,524 reports that list zanamivir among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 250 are coded as a death and 390 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?
- Other neuraminidase inhibitors
- the pharmacologic class, with prices and generics
- Zanamivir side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other