Prescription medicine

Mepolizumab Brand names: Nucala

Mepolizumab (Nucala) is a prescription medicine with an FDA approval on record since 2015. No generic is listed in FDA's NDC Directory.

No generic listed

Check it at the source: the mepolizumab FDA label on DailyMed (effective August 6, 2025); the BLA 125526 record on Drugs@FDA; every mepolizumab label on DailyMed.

Highlights of the record

FDA label of August 6, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage
NUCALA is an interleukin-5 (IL-5) antagonist 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

40 mg/.4ml
100 mg/ml

Injection (solution); injection (powder) for solution.

On the market

Earliest approval on file: November 4, 2015 Nucala, Glaxosmithkline Llc; Drugs@FDA’s file, where older or withdrawn approvals can be missing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 2019 0 Class I among all firms' recalls; latest September 6, 2019
FAERS reports: 49,399 through July 30, 2026

What is mepolizumab used for?

From the label: indications and usage
NUCALA is an interleukin-5 (IL-5) antagonist 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 )
Add-on maintenance treatment of adult patients aged 18 years and older with chronic rhinosinusitis with nasal polyps (CRSwNP). ( 1.2 )
Add-on maintenance treatment of adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. ( 1.3 )
The treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA). […]

Conditions named in the indications of mepolizumab's FDA labels, with every medicine labeled for each:

FDA pharmacologic class: Interleukin-5 Antagonist.

Source: FDA drug label (Nucala), GlaxoSmithKline LLC, effective August 6, 2025 (SPL set fefb887c-e4ac-431e-8893-e9d1a5a63fea), via openFDA; the full label on DailyMed

Is there a generic for mepolizumab (Nucala)?

No generic mepolizumab is approved (Drugs@FDA, October 8, 2026).

2015 earliest approval on file
red ticks recalls

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

Has mepolizumab been recalled?

The FDA's Enforcement Report lists 1 recall naming mepolizumab since 2019: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.

Started	Class	Company	Reason
September 6, 2019	Class II	Cardinal Health dba Specialty Pharmaceutical Services	Temperature Abuse; Product stored and shipped outside of labeled storage requirements.

Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026

What do FAERS reports show for mepolizumab?

The FDA Adverse Event Reporting System holds 49,399 reports that list mepolizumab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 3,989 are coded as a death and 15,956 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

Asthma (a use or a product term, not a reaction)12,767
Dyspnoea (named in the label)10,576
Wheezing7,131
Product Dose Omission Issue (a use or a product term, not a reaction)6,636
Cough (named in the label)5,100
Therapeutic Product Effect Incomplete (a use or a product term, not a reaction)5,051
Pneumonia4,644
Drug Ineffective (a use or a product term, not a reaction)4,622

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What else is labeled for the same conditions as mepolizumab?

3 other medicines are given the same way (subcutaneous) and in the same FDA class as mepolizumab 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
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 mepolizumab

Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)

What next?

Alternatives to mepolizumab: 3 medicines for the same use
Other interleukin-5 antagonists: the pharmacologic class, with prices and generics
Mepolizumab side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other