Octagam Side Effects

Generic name: immune globulin intravenous

Medically reviewed by Drugs.com. Last updated on Sep 7, 2024.

Note: This document provides detailed information about Octagam Side Effects associated with immune globulin intravenous. Some dosage forms listed on this page may not apply specifically to the brand name Octagam.

Applies to immune globulin intravenous: intravenous solution.

Important warnings This medicine can cause some serious health issues

Intravenous route (solution)

Warning: Thrombosis, Renal Dysfunction, and Acute Renal Failure. Thrombosis may occur with immune globulin intravenous (IGIV) products, including immune globulin-ifas.

Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors.Renal dysfunction, acute renal failure, osmotic nephropathy, and death may occur with the administration of IGIV products in predisposed patients.

Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose.

Immune globulin-ifas does not contain sucrose.For patients at risk of thrombosis, renal dysfunction, or renal failure, administer immune globulin-ifas at the minimum infusion rate practicable.

Ensure adequate hydration in patients before administration.

Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

Serious side effects of Octagam

Along with its needed effects, immune globulin intravenous (the active ingredient contained in Octagam) 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 side effects

• cough
• cough producing mucus
• difficulty breathing
• fever
• headache
• pain or tenderness around the eyes and cheekbones
• pale skin
• stuffy or runny nose
• tightness of the chest
• trouble breathing
• unusual bleeding or bruising
• unusual tiredness or weakness

Incidence not known

• agitation
• anxiety
• back pain
• black, tarry stools
• blistering, peeling, or loosening of the skin
• bloody or cloudy urine
• bloody, black, or tarry stools
• blue lips and fingernails
• bluish lips or skin
• blurred vision
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• change in color vision
• changes in skin color
• chest pain or discomfort
• chills
• confusion
• coughing that sometimes produces a pink frothy sputum
• dark urine
• decreased frequency or amount of urine
• decreased urination
• decreased urine output
• diarrhea
• difficult or painful urination
• difficult, fast, noisy breathing
• difficulty in speaking
• difficulty seeing at night
• difficulty swallowing
• dizziness or lightheadedness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• double vision
• drowsiness
• fainting
• fast or irregular heartbeat
• hallucinations
• high fever
• hives, itching, skin rash
• inability to move the arms, legs, or facial muscles
• inability to speak
• increased blood pressure
• increased sensitivity of the eyes to sunlight
• increased sweating
• increased thirst
• irritability
• joint or muscle pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• loss of appetite loss of consciousness
• lower back or side pain
• mood or mental changes
• muscle pain or cramps
• nausea
• nervousness
• noisy breathing
• noisy, rattling breathing
• pain, redness, or swelling in the arm or leg
• painful or difficult urination
• pounding in the ears
• puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
• red skin lesions, often with a purple center
• red, irritated eyes
• seizures
• slow heartbeat
• slow speech
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stiff neck or back
• stomach pain
• sudden decrease in the amount of urine
• swelling of the face, fingers, hands, feet, or lower legs
• swollen glands
• tenderness
• unusual bleeding or bruising
• unusual drowsiness, dullness, or feeling of sluggishness
• vomiting
• weight gain
• yellow eyes or skin

Other side effects of Octagam

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 side effects

• blistering, crusting, irritation, itching, or reddening of the skin
• cracked, dry, scaly skin
• swelling
• upper stomach pain

Incidence not known

• anxiety
• bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• bone pain
• difficulty in moving
• hair loss, thinning of hair
• joint swelling
• nervousness

For healthcare professionals

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

General adverse events

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]

Further information

Octagam side effects can vary depending on the individual. 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.

Medical Disclaimer