Skip to Content

Flebogamma Side Effects

Generic Name: immune globulin intravenous

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

For the Consumer

Applies to immune globulin intravenous: powder for solution, solution

Along with its needed effects, immune globulin intravenous (the active ingredient contained in Flebogamma) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking immune globulin intravenous:

More Common

  • Back pain
  • black, tarry stools
  • blurred vision
  • chest pain
  • chills
  • cough
  • dark urine
  • decreased urination
  • diarrhea
  • dizziness
  • fast, pounding, or irregular heartbeat or pulse
  • fever
  • general feeling of discomfort or illness
  • headache
  • joint pain
  • loss of appetite
  • muscle aches and pains
  • nausea
  • nervousness
  • noisy breathing
  • pain in the arms or legs
  • painful or difficult urination
  • pounding in the ears
  • rash
  • runny nose
  • shivering
  • slow or fast heartbeat
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • stomach pain
  • sweating
  • swollen glands
  • tightness in the chest
  • trouble sleeping
  • troubled breathing
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vomiting
  • yellow eyes or skin

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
  • blood in the urine
  • change in vision
  • changes in blood pressure
  • changes in urination
  • chest pain or discomfort
  • cold, clammy, or pale skin
  • confusion
  • decreased frequency or amount of urine
  • difficult or labored breathing
  • difficulty seeing at night
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • feeling of warmth
  • headache that is severe and occurs suddenly
  • increased sensitivity of the eyes to sunlight
  • increased thirst
  • light-colored stools
  • loss of appetite
  • loss of consciousness
  • low blood pressure or pulse
  • lower back or side pain
  • muscle spasm or jerking of all extremities
  • pains in the chest, groin, or legs, especially calves of the legs
  • redness of the face, neck, arms and occasionally, upper chest
  • seizures
  • shakiness in the legs, arms, hands, or feet
  • skin blisters
  • slow breathing
  • slurred speech that occurs suddenly
  • sudden, severe weakness or numbness in the arm or leg
  • sweating
  • swelling in the legs and ankles
  • swelling of the face, fingers, or lower legs
  • weight gain

Some side effects of immune globulin intravenous may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common

  • Lack or loss of strength
  • redness, swelling, itching, or pain at the injection site

Less Common

Incidence Not Known

  • Feeling of warmth
  • redness of the face, neck, arms, and occasionally, upper chest
  • swollen glands

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]

Respiratory

Very common (10% or more): Cough increased (54%), rhinitis (51%), pharyngitis (41%), asthma (29%), upper respiratory tract infection (25%), cough (22%), bronchitis (19%), epistaxis (10.5%)

Common (1% to 10%): Sinusitis, pharyngolaryngeal pain, pharyngitis, nasal congestion

Uncommon (0.1% to 1%): Bronchospasm

Frequency not reported: Dyspnea, wheezing

Postmarketing reports: Apnea, acute respiratory distress syndrome (ARDS), transfusion associated lung injury (TRALI), cyanosis, hypoxemia, pulmonary edema, bronchospasm, pulmonary embolism, hyperventilation, hypoxia, throat tightness, respiratory failure[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]

Gastrointestinal

Very common (10% or more): Diarrhea (28%), nausea (22.2%)

Common (1% to 10%): Vomiting, upper abdominal pain, stomach discomfort

Uncommon (0.1% to 1%): Abdominal distension, flatulence

Frequency not reported: Gingival bleeding

Postmarketing reports: Abdominal pain, dyspepsia[Ref]

Other

Very common (10% or more): Fatigue (38%), fever/pyrexia (38.6%), pain (25.5%), ear pain (18%), chills (19.4%), asthenia (10%)

Common (1% to 10%): Influenza-like illness, blood lactate dehydrogenase increased

Uncommon (0.1% to 1%): Hot flush, feeling jittery

Frequency not reported: Increased body temperature

Postmarketing reports: Rigors, chest pain/discomfort[Ref]

Hepatic

Very common (10% or more): Transient borderline elevation in liver enzyme (13%), blood unconjugated bilirubin increased (10.5%)

Common (1% to 10%): Blood conjugated bilirubin increased, blood total bilirubin increased, hyperbilirubinemia, alanine aminotransferase increased, aspartate aminotransferase increased, hepatic enzymes increased

Postmarketing reports: Hepatic dysfunction, jaundice, non-infectious hepatitis[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]

Dermatologic

Common (1% to 10%): Hyperhidrosis, flushing, urticaria, pruritus, dermatitis exfoliative NOS, rash macular, eczema

Uncommon (0.1% to 1%): Exanthema, erythema multiforme, acne

Frequency not reported: Mild to moderate hives, itching, recurrence of chronic cellulitis

Postmarketing reports: Stevens-Johnson syndrome, epidermolysis, bullous dermatitis, rash, angioedema, dermatitis, erythema[Ref]

Hypersensitivity

Common (1% to 10%): Hypersensitivity

Postmarketing reports: Anaphylactic shock, anaphylactic/anaphylactoid reaction[Ref]

Musculoskeletal

Very common (10% or more): Backache (11.8%)

Common (1% to 10%): Joint pain/effusion, back pain, fibromyalgia, myalgia, arthralgia, muscle spasms, neck pain

Uncommon (0.1% to 1%): Leg cramps, musculoskeletal stiffness, pain in extremity[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]

Psychiatric

Uncommon (0.1% to 1%): Anxiety, agitation, insomnia

Postmarketing reports: Restlessness[Ref]

Ocular

Uncommon (0.1% to 1%): Vision blurred, conjunctivitis, maculopathy

Postmarketing reports: Photophobia, retinal vein thrombosis, eye pain, visual disturbance[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. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

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

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

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

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Hide