Prescription medicine
Tezepelumab Brand names: Tezspire
Tezepelumab (Tezspire) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the tezepelumab FDA label on DailyMed (effective October 17, 2025); every tezepelumab label on DailyMed.
Highlights of the record
FDA label of October 17, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageTEZSPIRE is a thymic stromal lymphopoietin (TSLP) blocker, human monoclonal antibody (IgG2λ), indicated:
for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.
Forms and strengths
- 210 mg/1.9ml
Injection (solution).
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
- 6,290 through July 30, 2026
What is tezepelumab used for?
From the label: indications and usageTEZSPIRE is a thymic stromal lymphopoietin (TSLP) blocker, human monoclonal antibody (IgG2λ), indicated:
for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma. ( 1.1 ) Limitations of Use: Not for relief of acute bronchospasm or status asthmaticus. ( 1.1 )
for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). ( 1.2 ) 1.1 Asthma TEZSPIRE is indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma. […]
Conditions named in the indications of tezepelumab's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Thymic Stromal Lymphopoietin Blocker.
Source: FDA drug label (TEZSPIRE), Amgen Inc, effective October 17, 2025 (SPL set 60f0aa03-ad25-4d48-80ce-7fcfa76f325f), via openFDA; the full label on DailyMed
Is there a generic for tezepelumab (Tezspire)?
No generic tezepelumab 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 tezepelumab?
The FDA Adverse Event Reporting System holds 6,290 reports that list tezepelumab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 236 are coded as a death and 1,161 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 rose sharply in 2025 (1,784, against a median of 7 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as tezepelumab?
3 other medicines are given the same way (subcutaneous) and in the same FDA class as tezepelumab or labeled mainly for the same use (asthma), the same class first. Asthma lists all 37 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (subcutaneous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Benralizumab | Asthma | none listed | n/a | No current entry |
| Mepolizumab | Asthma | none listed | n/a | No current entry |
| Depemokimab | Asthma | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as tezepelumab
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to tezepelumab
- 3 medicines for the same use
- Tezepelumab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other