PlainMeds provides educational information only. This is not medical advice. Always consult your doctor or pharmacist.

mepolizumab

Verify with FDA → · CMS NADAC pricing →

Brand names: Nucala

Anti-IL-5 Monoclonal Antibody Rx

Nucala is a medicine that can help control certain types of asthma and other conditions. It works by blocking a protein in your body that causes inflammation.

What it does

Nucala is used as an add-on treatment for severe asthma in adults and kids 6 years and older when their asthma is not well controlled and they have high levels of eosinophils (a type of white blood cell).

Common side effects

Headache, Injection site reaction (pain, redness, swelling), Back pain

Key warnings

Nucala can cause serious allergic reactions, including anaphylaxis.

How It Works

Nucala is a monoclonal antibody that targets interleukin-5 (IL-5). IL-5 is a protein that helps eosinophils grow and survive. By blocking IL-5, Nucala lowers the number of eosinophils in your blood and lungs, which can reduce inflammation and improve your symptoms.

How to Take It

Nucala is given as a shot under the skin (subcutaneous injection) every 4 weeks. The dose depends on your condition and age. For asthma, adults and kids 12+ get 100 mg, and kids 6-11 get 40 mg. For EGPA and HES, the dose is 300 mg, given as three separate 100 mg injections.

Pregnancy & Breastfeeding

It is not known if Nucala will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant. It is also not known if Nucala passes into breast milk, so talk to your doctor about breastfeeding while taking Nucala.

Missed Dose

If you miss a dose of Nucala, call your doctor right away to reschedule your injection. Do not double your next dose.

Storage

Store Nucala in the refrigerator, protected from light, and do not freeze.

Side Effects (from patient reports)

Based on 61,585 FDA adverse event reports.

Asthma
12,416
Shortness of breath
10,201
Wheezing
6,904
Missed dose
6,194
Cough
4,939
Treatment not fully effective
4,917
Pneumonia
4,419
Drug not working
4,405
Difficulty with daily activities
4,148
Sleep problems due to a medical condition
3,042

FDA Adverse Event Report Analysis

Detailed analysis of 47,215 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2008–2025.

Total Reports

47,215

Death-Related Reports

3,552

Hospitalization Reports

15,164

Top Indication

Product Used For Unknown Indication

Gender Distribution

Female 23,211 (68%)
Male 11,025 (32%)

Age Distribution

0–17 371
18–44 3,725
45–64 7,567
65–74 4,720
75+ 2,849

Most Reported Adverse Reactions (FAERS)

# Reaction Reports
1 ASTHMA 12,416
2 DYSPNOEA 10,201
3 WHEEZING 6,904
4 PRODUCT DOSE OMISSION ISSUE 6,194
5 COUGH 4,939
6 THERAPEUTIC PRODUCT EFFECT INCOMPLETE 4,917
7 PNEUMONIA 4,419
8 DRUG INEFFECTIVE 4,405
9 LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES 4,148
10 SLEEP DISORDER DUE TO A GENERAL MEDICAL CONDITION 3,042
11 OFF LABEL USE 2,930
12 FATIGUE 2,918
13 MALAISE 2,633
14 CONDITION AGGRAVATED 2,605
15 HEADACHE 2,524

Reactions in Death Reports

DEATH 1,677
OFF LABEL USE 889
PAIN 719
CONFUSIONAL STATE 685
MATERNAL EXPOSURE DURING PREGNANCY 685
PEMPHIGUS 680
GENERAL PHYSICAL HEALTH DETERIORATION 677
INFUSION RELATED REACTION 670
CONDITION AGGRAVATED 666
SYNOVITIS 664

Reactions in Hospitalization Reports

ASTHMA 6,643
DYSPNOEA 5,330
WHEEZING 3,748
PNEUMONIA 2,743
THERAPEUTIC PRODUCT EFFECT INCOMPLETE 2,457
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES 2,287
COUGH 2,205
DRUG INEFFECTIVE 2,048
HOSPITALISATION 1,977
SLEEP DISORDER DUE TO A GENERAL MEDICAL CONDITION 1,633

Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation

Serious Warnings

Nucala can cause serious allergic reactions, including anaphylaxis. Get medical help right away if you have signs of an allergic reaction like hives, swelling, or trouble breathing. You may get herpes zoster (shingles) while taking Nucala, so consider getting vaccinated. Do not stop taking steroid medicines suddenly when you start Nucala. Talk to your doctor about slowly reducing your steroid dose.

Common Questions

What if I have a parasitic infection?
Tell your doctor if you have a parasitic infection before starting Nucala. Your doctor will treat the infection before you start Nucala.
Can Nucala be used for sudden asthma attacks?
No, Nucala is not for treating sudden asthma symptoms or flare-ups. Use your rescue inhaler for those situations.
How will I know if Nucala is working?
You may notice fewer asthma symptoms, fewer flare-ups, or be able to lower your steroid dose. Your doctor will monitor your condition.
Can I stop taking my other asthma medicines?
Do not stop taking your other asthma medicines unless your doctor tells you to.
Where on my body can I get the injection?
Nucala is injected under the skin of your upper arm, thigh, or abdomen.
Will I administer the injection myself?
Nucala for injection should be prepared and given by a healthcare provider. Nucala injection may be self-administered if your doctor decides it is appropriate.
What should I do if I think I'm having an allergic reaction to Nucala?
Get medical help right away if you have signs of an allergic reaction, such as hives, swelling, or trouble breathing.
Can Nucala cure my asthma?
Nucala does not cure asthma, but it can help control your symptoms.
How long will I need to take Nucala?
You will likely need to take Nucala long-term to manage your condition. Talk to your doctor about how long you should continue treatment.
What ingredients are in Nucala?
Mepolizumab is the active ingredient. Other ingredients vary depending on the formulation, and include polysorbate 80, sodium phosphate dibasic heptahydrate, and sucrose.
What are the common side effects of mepolizumab?
The most commonly reported side effects of mepolizumab include Headache, Injection site reaction (pain, redness, swelling), Back pain, Fatigue, Oropharyngeal pain (pain in the mouth and throat). Based on 61,585 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
What drug class is mepolizumab?
mepolizumab belongs to the Anti-IL-5 Monoclonal Antibody drug class. It requires a prescription (Rx). Nucala is used as an add-on treatment for severe asthma in adults and kids 6 years and older when their asthma is not well controlled and they have high levels of eosinophils (a type of white blood cell).
Is mepolizumab safe during pregnancy?
It is not known if Nucala will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.

Related Medications in Anti-IL-5 Monoclonal Antibody

Other drugs grouped near mepolizumab — same-class peers and common alternatives.

Compare mepolizumab vs aclidinium side-by-side →

Medication Guides

Related Health & Safety Data

Save on mepolizumab

Compare prices and find discounts at pharmacies near you. Free coupons can save up to 80% on prescriptions.

Disclosure: This link may earn us a commission at no extra cost to you. See our terms.

What the FDA Data Shows for mepolizumab

The FDA label for mepolizumab (sold under brand names such as Nucala) classifies it as a prescription-only medication in the Anti-IL-5 Monoclonal Antibody class. Nucala is used as an add-on treatment for severe asthma in adults and kids 6 years and older when their asthma is not well controlled and they have high levels of eosinophils (a type of white blood cell). Official labeling lists 8 commonly reported side effects, including Headache, Injection site reaction (pain, redness, swelling), Back pain.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 61,585 voluntary reports. Interaction data is drawn directly from FDA-approved prescribing information. Acquisition-cost data is surveyed weekly by CMS and updated as manufacturers report changes.

Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.

Data Sources

Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS).

FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.

Last updated: August 6, 2025

All federal data sources used on this page