Nipocalimab Side Effects

Applies to nipocalimab: intravenous solution.

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Some side effects may occur during or after the injection. Tell your medical caregiver if you feel dizzy, nauseated, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.

You may get infections more easily. Call your doctor right away if you have signs of infection such as:

• fever, chills, sore throat;

• mouth sores, red or swollen gums;

• pale skin, easy bruising, unusual bleeding; or

• chest discomfort, wheezing, dry cough or hack, rapid weight loss.

Your treatment may be delayed if you have certain side effects.

Common side effects may include:

• cold symptoms such as stuffy nose, sneezing, sore throat;

• swelling in your hands, ankles, or feet; or

• muscle spasms.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

See also:

For healthcare professionals

Applies to nipocalimab: intravenous solution.

General adverse events

The most common adverse reactions reported in at least 10% of patients were muscle spasms, peripheral edema, and respiratory tract infection.^[Ref]

Hematologic

• Common (1% to 10%): Anemia

Hypersensitivity

• Very common (10% or more): Hypersensitivity reaction (16%)
• Frequency not reported: Urticaria

Hypersensitivity reactions included angioedema, atopic dermatitis, eczema, gingival swelling, rash (and other related terms), and urticaria.

Musculoskeletal

• Very common (10% or more): Muscle spasm (12%)
• Common (1% to 10%): Back pain

Psychiatric

• Common (1% to 10%): Insomnia

Genitourinary

• Very common (10% or more): Urinary tract infection (15%)

Respiratory

• Very common (10% or more): Respiratory tract infection (28%), upper respiratory tract infection (46%)
• Common (1% to 10%): Cough, influenza

Respiratory tract infection included bronchitis, bacterial pneumonia, COVID-19 (and other related terms), and pneumonia.

Other

• Very common (10% or more): Elevated fasting total cholesterol (24%), elevated low density lipoprotein cholesterol (11%), infusion-related reactions (11%), peripheral edema (12%)
• Common (1% to 10%): Decreased high-density lipoprotein cholesterol, herpes, pyrexia

Herpes included herpes simplex, herpes zoster, and herpes zoster oticus.

Nervous system

• Common (1% to 10%): Dizziness

Cardiovascular

• Common (1% to 10%): Hypertension

Dermatologic

• Common (1% to 10%): Skin infection

Skin infection included cellulitis.

Gastrointestinal

• Common (1% to 10%): Abdominal pain, diarrhea, nausea, oral infection

Oral infection included dental pulpitis, glossitis, oral candidiasis, pericoronitis, tooth abscess, and tooth infection.

Further information

Nipocalimab side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer