Last updated on RxList: 9/4/2019
Gammagard Side Effects Center

Last reviewed on RxList 9/4/2019

Gammagard S/D Immune Globulin Intravenous (Human) is a sterilized solution made from human plasma used to treat primary immune deficiency, and to reduce the risk of infection in individuals with poorly functioning immune systems such as those with chronic lymphocytic leukemia (CLL). IGIV is also used to increase platelets (blood clotting cells) in people with idiopathic thrombocytopenic purpura (ITP) and to prevent aneurysm caused by a weakening of the main artery in the heart associated with Kawasaki syndrome. Gammagard is also used to treat chronic inflammatory demyelinating polyneuropathy (CIDP), a debilitating nerve disorder that causes muscle weakness and can affect daily activities. Gammagard is available in generic form. Common side effects of Gammagard include:

  • flushing (warmth, redness, or tingly feeling),
  • headache,
  • dizziness,
  • chills,
  • muscle cramps,
  • back or joint pain,
  • fever,
  • nausea,
  • vomiting,
  • injection site reactions (pain, redness, and swelling),
  • tired feeling, or
  • minor chest pain

Dose of Gammagard depends on the condition being treated and the patient's weight, among other factors. Gammagard may interact with lithium, methotrexate, pain or arthritis medicines, medicines used to treat ulcerative colitis, medicines used to prevent organ transplant rejection, IV antibiotics, antiviral medicines, or cancer medicines. Tell your doctor all medications you use. During pregnancy, Gammagard should be used only when prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Gammagard S/D Immune Globulin Intravenous (Human) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


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Gammagard Consumer Information

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 the injection. Tell your caregiver if you feel dizzy, nauseated, light-headed, sweaty, or have a headache, pounding in your neck or ears, fever, chills, chest tightness, or warmth or redness in your face.

Call your doctor at once if you have:

  • a blood cell disorder--pale or yellowed skin, dark colored urine, fever, confusion or weakness;
  • dehydration symptoms--feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin;
  • kidney problems--little or no urination, swelling, rapid weight gain, feeling short of breath;
  • lung problems--chest pain, trouble breathing, blue colored lips, fingers, or toes;
  • signs of a new infection--fever with a severe headache, neck stiffness, eye pain, and increased sensitivity to light; or
  • signs of a blood clot--shortness of breath, chest pain with deep breathing, rapid heart rate, numbness or weakness on one side of the body, swelling and warmth or discoloration in an arm or leg.

Common side effects may include:

  • headache, back pain, joint pain;
  • fever, chills, sweating, warmth or tingling;
  • stomach pain, nausea, diarrhea;
  • increased blood pressure, fast heartbeats;
  • dizziness, tiredness, lack of energy;
  • stuffy nose, sinus pain; or
  • pain, swelling, burning, or irritation around the IV needle.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Gammagard (Immune Globulin)


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Gammagard Professional Information


Increases in creatinine and blood urea nitrogen (BUN) have been observed as soon as one to two days following infusion. Progression to oliguria and anuria requiring dialysis has been observed, although some patients have improved spontaneously following cessation of treatment.35

Types of severe renal adverse reactions that have been seen following IGIV therapy include:

In general, reported adverse reactions to GAMMAGARD (immune globulin) , in patients with either congenital or acquired immunodeficiencies are similar in kind and frequency. Various minor reactions, such as mild to moderate hypotension, headache, fatigue, chills, backache, leg cramps, lightheadedness, fever, urticaria, flushing, slight elevation of blood pressure, nausea and vomiting may occasionally occur. Slowing or stopping the infusion usually allows the symptoms to disappear promptly.

Immediate anaphylactic and hypersensitivity reactions are a remote possibility. Epinephrine and antihistamines should be available for treatment of any acute anaphylactoid reaction (See WARNINGS).

Primary Immunodeficiency Diseases

Twenty-one adverse reactions occurred in 341 infusions (6%), when using GAMMAGARD (immune globulin) (5% solution), in a clinical trial of 17 patients with primary immunodeficiency.40 Of the 17 patients, 12 (71%) were adults, and 5 (29%) were children (16 years or younger).

In a cross-over study comparing GAMMAGARD and GAMMAGARD S/D (immune globulin) (5% solutions) conducted in a small number (n=10) of primary immunodeficient patients, no unusual or unexpected adverse reactions were observed in the GAMMAGARD S/D (immune globulin) group. The adverse reactions experienced in the GAMMAGARD S/D (immune globulin) group were similar in frequency and nature to those observed in the control group consisting of patients receiving GAMMAGARD (immune globulin) .

GAMMAGARD (immune globulin) , reconstituted to a concentration of 10%, was administered intravenously at rates varying from 2 to 11 mL/kg/Hr. Systemic reactions occurred in 23 (10.5%) of 219 infusions. This compares with an adverse reaction incidence of 6% (only systemic reactions reported) for primary immunodeficient patients previously treated with a 5% solution at infusion rates varying between 2 and 8 mL/kg/Hr, as described above (see reference 40). Local pain or irritation was experienced during 35 (16%) of 219 infusions. Application of a warm compress to the infusion site alleviated local symptoms. These local reactions tended to be associated with hand vein infusions and their incidence may be reduced by infusions via the antecubital vein.

B-cell Chronic Lymphocytic Leukemia (CLL)

In the study of patients with B-cell Chronic Lymphocytic Leukemia, the incidence of adverse reactions associated with GAMMAGARD (immune globulin) infusions was approximately 1.3% while that associated with placebo (normal saline) infusions was 0.6%.9

Idiopathic Thrombocytopenic Purpura (ITP)

During the clinical study of GAMMAGARD (immune globulin) for the treatment of Idiopathic Thrombocytopenic Purpura, the only adverse reaction reported was headache which occurred in 12 of 16 patients (75%). Of these 12 patients, 11 had chronic ITP (9 adults, 2 children), and one child had acute ITP. Oral antihistamines and analgesics alleviated the symptoms and were used as pretreatment for those patients requiring additional IGIV therapy. The remaining 4 patients did not report any side effects and did not require pretreatment.

Kawasaki Syndrome

In a study of patients (n=51) with Kawasaki syndrome, no hypersensitivity-type reactions (urticaria, bronchospasm or generalized anaphylaxis) were reported in patients receiving either a single 1g/kg dose of IGIV, GAMMAGARD (immune globulin) , or 400 mg/kg of IGIV, GAMMAGARD (immune globulin) , for four consecutive days.13 Mild adverse reactions, including chills, flushing, cramping, headache, hypotension, nausea, rash and wheezing, were reported with both dose regimens. These adverse reactions occurred in 7/51 (13.7%) patients and in association with 7/129 (5.4%) infusions. Of the 25 patients who received a single 1 g/kg dose, 4 patients experienced adverse reactions for an incidence of 16%. Of the 26 patients who received 400 mg/kg/day over 4 days, 3 experienced a single adverse reaction for an incidence of 11.5%.3


The following list of adverse reaction have been identified and reported during the post-approval use of IGIV products:

Respiratory: cyanosis, hypoxemia, pulmonary edema, dyspnea, bronchospasm

Cardiovascular: thromboembolism, hypotension

Neurological: seizures, tremor

Hematologic: hemolysis, positive direct antiglobulin (Coombs) test

General/Body as a Whole: pyrexia, rigors

Musculoskeletal: back pain

Gastrointestinal:hepatic dysfunction, abdominal pain

Rare and Uncommon Adverse Events:

Respiratory: apnea, Acute Respiratory Distress Syndrome (ARDS), Transfusion Associated Lung Injury (TRALI)

Integumentary: bullous dermatitis, epidermolysis, erythema multiforme, Stevens- Johnson syndrome

Cardiovascular: cardiac arrest, vascular collapse

Neurological: coma, loss of consciousness

Hematologic: pancytopenia, leukopenia

Because postmarketing reporting of these reactions is voluntary and the at-risk populations are of uncertain size, it is not always possible to reliably estimate the frequency of the reaction or establish a causal relationship to exposure to the product. Such is also the case with literature reports authored independently.41 (See PRECAUTIONS)

Read the entire FDA prescribing information for Gammagard (Immune Globulin)

© Gammagard Patient Information is supplied by Cerner Multum, Inc. and Gammagard Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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