Palivizumab Side Effects

Some side effects of palivizumab may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to palivizumab: intramuscular powder for injection, intramuscular solution

Get emergency medical help if your child has any of these signs of an allergic reaction: hives; difficult breathing; swelling of the face, lips, tongue, or throat.

Call your doctor at once if your child has a serious side effect such as:

• high fever, ear pain or drainage, tugging at the ear;

• warmth or swelling of the ear;

• crying or fussiness, especially while lying down;

• change in sleeping patterns;

• poor feeding or loss of appetite;

• easy bruising or bleeding; or

• trouble breathing.

Less serious side effects of palivizumab may include:

• low fever;

• cold symptoms such as stuffy nose, sneezing, cough;

• vomiting, diarrhea; or

• pain, redness, or swelling where the shot was given.

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

For Healthcare Professionals

Applies to palivizumab: intramuscular powder for injection, intramuscular solution

General

Most of the reported adverse reactions documented are derived from studies of the drug in the pediatric patient. These have included anaphylaxis, acute hypersensitivity reactions, upper respiratory infection, otitis media, fever, rhinitis, hernia, and SGOT elevation.

Cardiovascular

Cardiovascular side effects have included arrhythmia during studies of congenital heart disease patients.

Gastrointestinal

Gastrointestinal side effects have included mild nausea, moderate vomiting, and diarrhea.

Hematologic

Hematologic side effects have included mild eosinophilia and thrombocytopenia. Severe thrombocytopenia (platelet count less than 50,000/microliter) has been reported during postmarketing experience.

Hypersensitivity

Hypersensitivity side effects have included severe acute hypersensitivity reactions and anaphylaxis (including dyspnea, cyanosis, respiratory failure, urticaria, pruritus, angioedema, hypotonia, and unresponsiveness) during postmarketing experience.

Local

Local side effects have included injection site reactions during postmarketing experience.

Other

Other side effects have included cyanosis during studies of congenital heart disease patients.

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