Gammaked 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 Gammaked.
For the Consumer
Applies to immune globulin intravenous and subcutaneous: injection solution
What are some side effects that I need to call my doctor about right away?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
- Signs of high or low blood pressure like very bad headache or dizziness, passing out, change in eyesight.
- Fever or chills.
- Change in color of skin to a bluish color like on the lips, nail beds, fingers, or toes.
- Feeling very tired or weak.
- Feeling confused.
- A heartbeat that does not feel normal.
- Any unexplained bruising or bleeding.
- Mood changes.
- Muscle or joint pain.
- Change in speech.
- Change in eyesight.
- Blurred eyesight.
- Sweating a lot.
- Very bad belly pain.
- Dark urine or yellow skin or eyes.
- Very bad irritation where the shot was given.
- Lung problems have happened with this drug. Call your doctor right away if you have lung or breathing problems like trouble breathing, shortness of breath, or a cough that is new or worse.
- This drug may raise the chance of a very bad brain problem called aseptic meningitis. Call your doctor right away if you have a headache, fever, chills, very upset stomach or throwing up, stiff neck, rash, bright lights bother your eyes, feeling sleepy, or feeling confused.
What are some other side effects of this drug?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
- Irritation where this drug is given.
- Loose stools (diarrhea).
- Feeling tired or weak.
- Back pain.
- Sore throat.
- Runny nose.
- Stuffy nose.
- Upset stomach or throwing up.
- Belly pain.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
For Healthcare Professionals
Applies to immune globulin intravenous and subcutaneous: injectable solution
The most common adverse events were headache and injection/infusion site reactions.[Ref]
Very common (10% or more): Infusion site reaction (75%)
Common (1% to 10%): Injection site reaction
Frequency not reported: Hives/urticaria, itching
Very common (10% or more): Headache (58%)
Common (1% to 10%): Dizziness
Postmarketing reports: Aseptic meningitis, coma, loss of consciousness, seizures/convulsions, tremor[Ref]
Very common (10% or more): Ecchymosis/purpura (40%), petechiae (21%), rash (10%)
Common (1% to 10%): Pruritus, urticaria
Frequency not reported: Hives
Postmarketing reports: Stevens-Johnson syndrome, epidermolysis, erythema multiforme, bullous dermatitis[Ref]
Very common (10% or more): Hemorrhage (all systems) (29%), thrombocytopenia (15%)
Common (1% to 10%): Anemia
Uncommon (0.1% to 1%): Coombs negative hypochromic anemia, autoimmune pure red cell aplasia, exacerbation of autoimmune pure red cell aplasia
Postmarketing reports: Hemolytic anemia, pancytopenia, leukopenia, hemolysis, positive direct antiglobulin (Coombs test)[Ref]
Very common (10% or more): Diarrhea (28%), nausea (21%), vomiting (21%)
Common (1% to 10%): Abdominal pain, dyspepsia[Ref]
Very common (10% or more): Cough increased (54%), rhinitis (51%), pharyngitis (41%), asthma (29%), epistaxis (23%)
Common (1% to 10%): Influenza, flu syndrome, sinusitis
Postmarketing reports: Apnea, acute respiratory distress syndrome (ARDS), transfusion related acute lung injury (TRALI), cyanosis, hypoxemia, pulmonary edema, dyspnea, bronchospasm[Ref]
Common (1% to 10%): Hypertension
Frequency not reported: Myocarditis
Postmarketing reports: Cardiac arrest, thromboembolism, vascular collapse, hypotension[Ref]
Very common (10% or more): Elevated ALT (18%), alkaline phosphatase elevated (13%)
Common (1% to 10%): AST elevated, low alkaline phosphatase
Postmarketing reports: Hepatic dysfunction[Ref]
Very common (10% or more): Fever (28%), ear pain (18%), accidental injury (13%), asthenia (10%)
Common (1% to 10%): Fatigue
Postmarketing reports: Rigors
Common (1% to 10%): Arthralgia, back pain, neck pain
Uncommon (0.1% to 1%): Severe chills[Ref]
Frequency not reported: Anxiety
1. "Product Information. Gamunex-C (immune globulin intravenous and subcutaneous)." Talecris Biotherapeutics, Research Triangle Park, NC.
Some side effects of Gammaked may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
More about Gammaked (immune globulin intravenous and subcutaneous)
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