Prescription medicine
Benralizumab Brand names: Fasenra
Benralizumab (Fasenra) is a prescription medicine with an FDA approval on record since 2017. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the benralizumab FDA label on DailyMed (effective May 13, 2026, AstraZeneca Pharmaceuticals LP); the BLA 761070 record on Drugs@FDA; every benralizumab label on DailyMed.
Highlights of the record
FDA label of May 13, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageFASENRA is an interleukin-5 receptor alpha-directed cytolytic monoclonal antibody (IgG1, kappa) indicated for:
add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe asthma, and with an eosinophilic phenotype.
Forms and strengths
- 10 mg/.5ml
- 30 mg/ml
Injection (solution).
On the market
- Earliest approval on file
- November 14, 2017 Fasenra, Astrazeneca Ab; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- 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)
- 1 since 2025 0 Class I among all firms' recalls; latest October 8, 2025
- FAERS reports
- 19,893 through July 30, 2026
What is benralizumab used for?
From the label: indications and usageFASENRA is an interleukin-5 receptor alpha-directed cytolytic monoclonal antibody (IgG1, kappa) indicated for:
add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe asthma, and with an eosinophilic phenotype. ( 1.1 )
treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA). ( 1.2 )
treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) without an identifiable non-hematologic secondary cause. ( 1.3 ) Limitations of Use: Not for relief of acute bronchospasm or status asthmaticus. […]
Conditions named in the indications of benralizumab's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Interleukin-5 Receptor alpha-directed Cytolytic Antibody.
Source: FDA drug label (FASENRA), AstraZeneca Pharmaceuticals LP, effective May 13, 2026 (SPL set da6aca1a-19ed-44a4-abb7-696c7d58b784), via openFDA; the full label on DailyMed
Is there a generic for benralizumab (Fasenra)?
No generic benralizumab is approved (Drugs@FDA, October 8, 2026).
- 2017 earliest approval on file
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has benralizumab been recalled?
The FDA's Enforcement Report lists 1 recall naming benralizumab since 2025: 0 Class I (the most serious), 1 Class II, 0 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| October 8, 2025 | Class II | ASTRAZENECA PHARMACEUTICALS | Lack of Assurance of Sterility: |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for benralizumab?
The FDA Adverse Event Reporting System holds 19,893 reports that list benralizumab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2,002 are coded as a death and 4,792 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 else is labeled for the same conditions as benralizumab?
3 other medicines are given the same way (subcutaneous) and in the same FDA class as benralizumab 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 |
|---|---|---|---|---|
| Mepolizumab | Asthma | none listed | n/a | No current entry |
| Tezepelumab | 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 benralizumab
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to benralizumab
- 3 medicines for the same use
- Benralizumab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other