Gammagard Side Effects

Generic name: immune globulin intravenous and subcutaneous

Note: This document contains side effect information about immune globulin intravenous and subcutaneous. Some of the dosage forms listed on this page may not apply to the brand name Gammagard.

Some side effects of Gammagard 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 immune globulin intravenous and subcutaneous: injectable solution

Get emergency medical help if you have any of these signs of an allergic reaction while taking immune globulin intravenous and subcutaneous (the active ingredient contained in Gammagard) hives; wheezing, difficulty breathing; dizziness, feeling like you might pass out; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• swelling, rapid weight gain, feeling short of breath, urinating less than usual or not at all;

• pain, swelling, redness, warmth, or a lump in your arms or legs;

• pale or yellowed skin, dark colored urine, fever, confusion or weakness;

• fever, chills, headache, neck stiffness, increased sensitivity to light, purple spots on the skin, and/or seizure (convulsions);

• chest pain or tightness, trouble breathing; or

• signs of new infection such as high fever, chills, body aches, flu symptoms, or sores in your mouth and throat.

Less serious side effects of immune globulin intravenous and subcutaneous may include:

• mild headache, blurred vision, tired feeling;

• low fever, sore throat, cough;

• redness, itching, and swelling of skin where the injection was given;

• nausea, vomiting;

• muscle spasm or weakness;

• back pain, joint pain, pain in your arms or legs; or

• mild skin rash.

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 immune globulin intravenous and subcutaneous: injectable solution

Dermatologic

Dermatologic side effects have included injection site reactions, rash, erythema, pain, swelling, ecchymosis, purpura, petechia, pruritus, urticaria, Stevens-Johnson syndrome, epidermolysis, erythema multiforme, bullous dermatitis, and hives.

Cardiovascular

Cardiovascular side effects have included hypertension, cardiac arrest, thromboembolism, vascular collapse, and hypotension.

Hypersensitivity

Hypersensitivity side effects have included anaphylaxis.

General

General side effects have included accidental injury, ear pain, and cough.

Immunologic

Immunologic side effects have included have included influenza, flu syndrome, and aseptic meningitis. All U.S. immune globulin products undergo viral inactivation and/or removal; however, no method has been totally effective in removing all risk and the potential exists for the presence of unknown infectious agents.

Hematologic

Hematologic side effects have included hemorrhage (all systems), epistaxis, thrombocytopenia, anemia, hemolytic anemia, pancytopenia, leucopenia, hemolysis, and positive direct antiglobulin (Coombs test).

Musculoskeletal

Musculoskeletal side effects have included arthralgia, back pain, neck pain, and rigors.

Nervous system

Nervous system side effects have included headache, dizziness, fatigue, coma, loss of consciousness, seizures, and tremor.

Metabolic

Metabolic side effects have included pyrexia, chills, and asthenia.

Gastrointestinal

Gastrointestinal side effects have included nausea, vomiting, abdominal pain, and dyspepsia.

Respiratory

Respiratory side effects have included rhinitis, pharyngitis, asthma, apnea, acute respiratory distress syndrome (ARDS), transfusion related acute lung injury (TRALI), cyanosis, hypoxemia, pulmonary edema, dyspnea, and bronchospasm.

Hepatic

Hepatic side effects have included hepatic dysfunction and transient elevations (less than 3 times the upper limit) of ALT and AST.

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