Mepolizumab: uses, dosing, side effects & brands
Mepolizumab is an interleukin-5 antagonist sold in the U.S. under one brand, for asthma. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Interleukin-5 Antagonist
- Treats (across its forms)
- Asthma
- Available as
- Injectable · Solution
- Sold as
- Nucala
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
How mepolizumab is dosed
From the FDA label for Nucala (application BLA125526). Other mepolizumab products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Severe asthma in patients aged 12 years and older: 100 mg administered subcutaneously once every 4 weeks. ( 2.1 ) • Severe asthma in patients aged 6 to 11 years: 40 mg administered subcutaneously once every 4 weeks. ( 2.1 ) • CRSwNP: 100 mg administered subcutaneously once every 4 weeks. ( 2.1 ) • COPD: 100 mg administered subcutaneously once every 4 weeks. ( 2.1 ) • EGPA: 300 mg administered subcutaneously once every 4 weeks. ( 2.1 ) • HES: 300 mg administered subcutaneously once every 4 weeks. ( 2.1 ) 2.1 Recommended Dosage NUCALA is for subcutaneous use only, and should be injected into the upper arm, thigh, or abdomen [see Dosage and Administration ( 2.2 , 2.3 )]. Table 1. Recommended Dosage of NUCALA a 300 mg dose is administered as 3 separate 100 mg dose injections administered at least 5 cm (approximately 2 inches) apart. Indication Adults Pediatric Patients Severe asthma 100 mg every 4 weeks • 12 to 17 years of age: 100 mg every 4 weeks • 6 to 11 years of age: 40 mg every 4 weeks Chronic rhinosinusitis with nasal polyps 100 mg every 4 weeks Not applicable Chronic obstructive pulmonary disease 100 mg every 4 weeks Not applicable Eosinophilic granulomatosis with polyangiitis 300 mg a every 4 weeks Not applicable Hypereosinophilic syndrome 300 mg a every 4 weeks 12 to 17 years of age: 300 mg a every 4 weeks 2.2 Preparation and Administration of NUCALA for Injection Vial…
Mepolizumab side effects
The following adverse reactions are described in greater detail in other sections: • Hypersensitivity reactions [see Warnings and Precautions ( 5.1 )] • Opportunistic infections: herpes zoster [see Warnings and Precautions ( 5.3 )] Most common adverse reactions (incidence ≥5%): • Asthma: Headache, injection site reaction, back pain, and fatigue. ( 6.1 ) • CRSwNP: Oropharyngeal pain and arthralgia. ( 6.1 ) • COPD: Back pain, diarrhea, and cough. ( 6.1 ) • EGPA and HES: Most common adverse reactions are similar to asthma. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions in Adult and Adolescent Patients Aged 12 Years and Older with Severe Asthma A total of 1,327 patients with severe asthma were evaluated in 3 randomized, placebo-controlled, multicenter trials of 24 to 52 weeks’ duration (Severe Asthma Trials DREAM, MENSA, and SIRIUS). Of these, 1,192 had a history of 2 or more exacerbations in the year prior to enrollment despite regular use of high-dose ICS plus additional…
Who shouldn’t take mepolizumab
NUCALA is contraindicated in patients with a history of hypersensitivity to mepolizumab or excipients in the formulation [see Warnings and Precautions ( 5.1 ), Description ( 11 )] . History of hypersensitivity to mepolizumab or excipients in the formulation. ( 4 )
Mepolizumab drug interactions
Formal drug interaction trials have not been performed with NUCALA.
Every mepolizumab product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Nucala.
Mepolizumab and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for mepolizumab: levels in milk, effects in breastfed infants, and the drugs it would consider insteadNo information is available on the clinical use of mepolizumab during breastfeeding. Because mepolizumab is a large protein molecule with a molecular weight of 149,000 Da, the amount in milk is likely to be very low. It is also likely to be partially destroyed in the infant's gastrointestinal tract and absorption by the infant is probably minimal. A task force respiratory experts from Europe, Australia and New Zealand found that mepolizumab is possibly acceptable during breastfeeding and an international consensus panel concluded that if the patient is in agreement, and the risks and benefits have been discussed, asthma biologics can be initiated or continued while breastfeeding. Waiting for at least 2 weeks postpartum to resume therapy may minimize transfer to the infant.
National Institute of Child Health and Human Development, record revised October 15, 2024. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about mepolizumab
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 16,643 reports naming mepolizumab, and the FDA flagged 97% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- asthma5,756 reports
- dyspnoea4,550 reports
- pneumonia2,903 reports
- wheezing2,759 reports
- cough2,450 reports
- loss of personal independence in daily activities1,769 reports
- therapeutic product effect incomplete1,655 reports
- malaise1,255 reports
Read these as a signal, not a rate. A report does not mean mepolizumab caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label.
Source: openFDA drug/event (FAERS), retrieved September 25, 2026.
Related calculators
Frequently asked questions
What is mepolizumab?
Nucala (Mepolizumab) is an interleukin-5 antagonist used to treat Asthma.
What kind of drug is mepolizumab?
The FDA classifies mepolizumab as an interleukin-5 antagonist. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take mepolizumab with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run mepolizumab against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does mepolizumab come in?
Across the brands we track, mepolizumab is currently marketed as injectable and solution, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic mepolizumab?
We do not currently list a generic-labelled mepolizumab product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Mepolizumab: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/mepolizumab
- MLA
- “Mepolizumab: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/mepolizumab.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for mepolizumab on DailyMed (NIH) ↗.