Synagis Side Effects

Generic Name: palivizumab

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

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

For the Consumer

Applies to palivizumab: intramuscular powder for solution, intramuscular solution

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

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

More common
  • Bluish color of the fingernails, lips, skin, palms, or nail beds
  • blurred vision
  • confusion
  • cough
  • difficulty with breathing
  • difficulty with swallowing
  • dizziness
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fast heartbeat
  • fever
  • hives or welts
  • irregular, fast or slow, or shallow breathing
  • itching
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • loss of strength or energy
  • muscle pain or weakness
  • redness of the skin
  • shortness of breath
  • skin rash
  • sweating
  • tightness in the chest
  • unresponsiveness
  • unusual tiredness or weakness
  • wheezing
Incidence not known
  • Black, tarry stools
  • bleeding gums
  • blood in the urine or stools
  • pinpoint red spots on the skin
  • unusual bleeding or bruising

Some palivizumab 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:

Incidence not known
  • Bleeding, blistering, burning, coldness, discoloration of the 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

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.[Ref]

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.[Ref]

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.[Ref]

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.

References

1. "Product Information. Synagis (palivizumab)." Ross Product Division Pharmaceuticals, Columbus, OH.

2. Boeckh M, Berrey MM, Bowden RA, Crawford SW, Balsley J, Corey L "Phase 1 evaluation of the respiratory syncytial virus-specific monoclonal antibody palivizumab in recipients of hematopoietic stem cell transplants." J Infect Dis 184 (2001): 350-4

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