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Nucala Side Effects

Generic Name: mepolizumab

Note: This page contains side effects data for the generic drug mepolizumab. It is possible that some of the dosage forms included below may not apply to the brand name Nucala.

In Summary

More frequent side effects include: injection site reaction. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to mepolizumab: subcutaneous powder for solution

As well as its needed effects, mepolizumab (the active ingredient contained in Nucala) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking mepolizumab, check with your doctor or nurse immediately:

Incidence not known:
  • Blurred vision
  • confusion
  • cough
  • difficulty with breathing
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • hives or welts, itching, or skin rash
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • noisy breathing
  • painful blisters on the trunk of the body
  • redness of the skin
  • sweating
  • tightness in the chest
  • unusual tiredness or weakness

Minor Side Effects

Some mepolizumab side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common:
  • Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
  • headache
Less common:
  • Back pain
  • bladder pain
  • bloody or cloudy urine
  • chills
  • cough
  • diarrhea
  • difficult, burning, or painful urination
  • fever
  • frequent urge to urinate
  • general feeling of discomfort or illness
  • joint pain
  • loss of appetite
  • lower back or side pain
  • muscle aches and pains
  • muscle spasms
  • nausea
  • runny nose
  • shivering
  • skin rash, encrusted, scaly, and oozing
  • sore throat
  • sweating
  • trouble sleeping
  • upper abdominal or stomach pain
  • vomiting

For Healthcare Professionals

Applies to mepolizumab: subcutaneous powder for injection

General

The more commonly reported side effects were headache, injection site reactions, and back pain.[Ref]

Nervous system

Dizziness occurred in at least 3% of patients treated with this drug in a controlled, long-term clinical study.[Ref]

Very common (10% or more): Headache (up to 19%)
Frequency not reported: Dizziness[Ref]

Hypersensitivity

Common (1% to 10%): Systemic non-allergic/administration-related reactions (including rash, flushing, myalgia), systemic/hypersensitivity reactions (including rash, pruritus, headache, myalgia)
Frequency not reported: Allergic rhinitis, angioedema, urticaria[Ref]

Many systemic reactions occurred on the day of dosing. Systemic reactions occurred in 10% of patients treated with this drug compared to 7% of placebo-treated patients. Non-allergic reactions occurred in 2% of patients given this drug versus 3% of patients with placebo; allergic systemic reactions occurred in 1% and 2% of patients given this drug or placebo, respectively.

Allergic rhinitis occurred in at least 3% of patients treated with this drug in a controlled, long-term clinical study.[Ref]

Local

Common (1% to 10%): Injection site reactions (e.g., pain, swelling, erythema, itching, burning)[Ref]

Injection site reactions occurred in 8% and 3% of patients given this drug or placebo, respectively. The reactions more commonly occurred within the first 3 injections, with a decrease in frequency on subsequent injections.[Ref]

Immunologic

In a clinical trial, 6% of patients developed anti-mepolizumab (the active ingredient contained in Nucala) antibodies; these antibodies were shown to slightly increase drug clearance, but the clinical relevance is unknown.

Viral infection occurred in at least 3% of patients treated with this drug in a controlled, long-term clinical study.[Ref]

Common (1% to 10%): Influenza, anti-mepolizumab antibody formation
Frequency not reported: Viral infection[Ref]

Dermatologic

Common (1% to 10%): Pruritus, eczema
Frequency not reported: Rash, flushing, herpes zoster reaction[Ref]

Rash and herpes zoster occurred in at least 3% of patients treated with this drug in a controlled, long-term clinical study.[Ref]

Musculoskeletal

Common (1% to 10%): Back pain, muscle spasms
Frequency not reported: Musculoskeletal pain, myalgia[Ref]

Musculoskeletal pain occurred in at least 3% of patients treated with this drug in a controlled, long-term clinical study.[Ref]

Gastrointestinal

Gastroenteritis, abdominal pain, nausea, toothache, and vomiting occurred in at least 3% of patients treated with this drug in a controlled, long-term clinical study.[Ref]

Common (1% to 10%): Upper abdominal pain
Frequency not reported: Gastroenteritis, abdominal pain, nausea, toothache, vomiting[Ref]

Other

Common (1% to 10%): Fatigue, pyrexia
Frequency not reported: Asthenia, ear infection[Ref]

Asthenia, ear infection, and pyrexia occurred in at least 3% of patients treated with this drug in a controlled, long-term clinical study.[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection[Ref]

Respiratory

Bronchitis, dyspnea, lower respiratory tract infection, nasal congestion, nasopharyngitis, pharyngitis, and viral respiratory tract infection occurred in at least 3% of patients treated with this drug in a controlled, long-term clinical study.[Ref]

Common (1% to 10%): Lower respiratory tract infection, pharyngitis, nasal congestion
Frequency not reported: Bronchitis, dyspnea, nasopharyngitis, viral respiratory tract infection, bronchospasm[Ref]

Cardiovascular

Frequency not reported: Hypotension[Ref]

Renal

Frequency not reported: Cystitis[Ref]

Cystitis occurred in at least 3% of patients treated with this drug in a controlled, long-term clinical study.[Ref]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. "Product Information. Nucala (mepolizumab)." GlaxoSmithKline, Research Triangle Park, NC.

3. Cerner Multum, Inc. "Australian Product Information." O 0

It is possible that some side effects of Nucala may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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