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Octagam Side Effects

Generic Name: immune globulin intravenous

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

For the Consumer

Applies to immune globulin intravenous: powder for solution, solution

As well as its needed effects, immune globulin intravenous (the active ingredient contained in Octagam) may cause unwanted side effects that require medical attention.

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

More common
  • Chills
  • cough
  • fast, pounding, or irregular heartbeat or pulse
  • fever
  • noisy breathing
  • tightness in the chest
  • troubled breathing
  • unusual tiredness or weakness
Less common
  • Bluish coloring of the lips or nail beds
  • burning sensation in the head
  • faintness or lightheadedness
Rare
  • Difficulty with swallowing
  • hives or welts
  • itching, especially of the feet or hands
  • reddening of the skin, especially around the ears
  • swelling of the eyes, face, or inside of the nose
Incidence not known
  • Back, leg, or stomach pains
  • blistering, peeling, or loosening of the skin
  • change in vision
  • changes in urination
  • chest pain or discomfort
  • cold, clammy, or pale skin
  • confusion
  • convulsions
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fever
  • headache that is severe and occurs suddenly
  • light-colored stools
  • loss of consciousness
  • low blood pressure or pulse
  • muscle spasm or jerking of all extremities
  • nausea or vomiting
  • pains in the chest, groin, or legs, especially calves of the legs
  • shakiness in the legs, arms, hands, or feet
  • skin blisters
  • slow breathing
  • slurred speech that occurs suddenly
  • sores, ulcers, or white spots in the mouth or on the lips
  • sudden, severe weakness or numbness in the arm or leg
  • sweating
  • swelling in the legs and ankles
  • tightness in the chest
  • unusual bleeding or bruising
  • yellow eyes or skin

Severity: Minor

Some immune globulin intravenous 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:

More common
  • Diarrhea
  • dizziness
  • headache
  • joint pain
  • muscle pain
  • redness, swelling, itching, or pain at the injection site
  • skin rash
Less common
  • Hip pain
  • leg cramps
Incidence not known
  • Feeling of warmth
  • redness of the face, neck, arms, and occasionally, upper chest
  • stomach pain
  • swollen glands
  • tiredness
  • weakness

For Healthcare Professionals

Applies to immune globulin intravenous: intravenous powder for injection, intravenous solution

General

The most common adverse events were headache, cough, fatigue, infusion site reaction, nausea, urticaria, sinusitis, blood pressure increased, diarrhea, dizziness, and lethargy.[Ref]

Cardiovascular

Very common (10% or more): Hypotension (25%), tachycardia (25%), diastolic hypertension (21%)
Common (1% to 10%): Blood pressure increased, blood pressure diastolic decreased, palpitations
Uncommon (0.1% to 1%): Tachycardia, hypertension, blood pressure systolic decreased, blood pressure systolic increased, blood pressure fluctuation
Frequency not reported: Myocardial infarction
Postmarketing reports: Cardiac arrest, thromboembolism, vascular collapse, changes in blood pressure, flushing, cyanosis, bradycardia, thrombophlebitis, pallor vena cava thrombosis, arterial thrombosis, deep vein thrombosis[Ref]

Nervous system

Very common (10% or more): Headache (64.9%)
Common (1% to 10%): Dizziness, lethargy, migraine, vertigo, sensory disturbance
Uncommon (0.1% to 1%): Tinnitus, tremor, dysgeusia
Frequency not reported: Aseptic meningitis, death from cerebrovascular hemorrhage, sleepiness
Postmarketing reports: Coma, loss of consciousness, seizures, photophobia, cerebrovascular accident, transient ischemic attack, convulsion, paresthesia, syncope, dysesthesia[Ref]

Hematologic

Very common (10% or more): Anemia (10.5%)
Common (1% to 10%): Hematocrit decreased, positive direct antiglobulin (Coombs/DAT) test
Uncommon (0.1% to 1%): Hemoglobin decreased, white blood cell count increased, anisocytosis
Frequency not reported: Autoimmune pure red cell aplasia, Coombs negative hypochromic anemia, hemolysis, decrease in hemoglobin level, active bleeding, anemia, thrombocytopenia, hemolytic anemia
Postmarketing reports: Pancytopenia, leukopenia, hemoglobinuria/hematuria/chromaturia, lymphadenopathy[Ref]

Local

Very common (10% or more): Local pain and/or irritation (15.2%), injection site reaction (13%)
Common (1% to 10%): Infusion site pain
Uncommon (0.1% to 1%): Infusion site inflammation, injection site edema, injection site pruritus, injection site swelling, migration of implant[Ref]

Hypersensitivity

Common (1% to 10%): Hypersensitivity
Postmarketing reports: Anaphylactic shock, anaphylactic/anaphylactoid reaction[Ref]

Metabolic

Common (1% to 10%): Fluid retention, dehydration
Uncommon (0.1% to 1%): Loss of appetite
Postmarketing reports: Fluid overload[Ref]

Renal

Uncommon (0.1% to 1%): Urinary hemosiderin positive, proteinuria
Frequency not reported: Increase in serum creatinine
Postmarketing reports: Renal failure[Ref]

Immunologic

Frequency not reported: Infection[Ref]

References

1. "Product Information. Flebogamma (immune globulin intravenous)." Grifols USA LLC, Los Angeles, CA.

2. "Product Information. Gammagard S/D (immune globulin intravenous)." Baxter Healthcare Corporation, Deerfield, IL.

3. "Product Information. Privigen (immune globulin intravenous)." CSL Behring Canada Inc, Ottawa, IA.

4. Cerner Multum, Inc. "Australian Product Information." O 0

5. "Product Information. Bivigam (immune globulin intravenous)." Biotest Pharmaceuticals Corporation, Boca Raton, FL.

6. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

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

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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