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Botulism immune globulin Side Effects

For the Consumer

Applies to botulism immune globulin: parenteral powder for iv infusion

Side effects include:

Erythematous rash.

For Healthcare Professionals

Applies to botulism immune globulin: intravenous powder for injection

Cardiovascular

Very common (10% or more): Blood pressure increased (75%), pallor (28%), cardiac murmur (15%)

Common (1% to 10%): Tachycardia NOS, peripheral coldness

Postmarketing reports: Cardiac arrest, vascular collapse, hypotension, thromboembolism[Ref]

Respiratory

Very common (10% or more): Atelectasis (39%), rhonchi (34%), nasal congestion (18%), oxygen saturation decreased (17%), cough (13%), rales (13%), breath sounds decreased (10%)

Common (1% to 10%): Stridor, dyspnea NOS, tachypnea, respiratory arrest

Postmarketing reports: Apnea, acute respiratory distress syndrome, transfusion related acute lung injury, cyanosis, hypoxemia, pulmonary edema, bronchospasm[Ref]

Gastrointestinal

Very common (10% or more): Dysphagia (65%), loose stools (25%), vomiting (20%), abdominal distension (11%)

Postmarketing reports: Abdominal pain[Ref]

Dermatologic

Very common (10% or more): Dermatitis contact (24%), rash erythematous (22%)

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

Other

Very common (10% or more): Edema (18%), pyrexia (17%), body temperature decreased (16%)

Postmarketing reports: Rigors[Ref]

Metabolic

Very common (10% or more): Dehydration (10%)

Common (1% to 10%): Hyponatremia, metabolic acidosis[Ref]

Immunologic

Very common (10% or more): Otitis media (11%), pneumonia (11%)

Common (1% to 10%): Lower respiratory tract infection, oral candidiasis, urinary tract infection[Ref]

Local

Common (1% to 10%): Injection site reaction, injection site erythema[Ref]

Hematologic

Common (1% to 10%): Hemoglobin decreased, anemia

Postmarketing reports: Pancytopenia, leukopenia, hemolysis, positive direct antiglobulin (Coombs) test[Ref]

Nervous system

Postmarketing reports: Coma, loss of consciousness, seizures, tremor[Ref]

Hepatic

Postmarketing reports: Hepatic dysfunction[Ref]

Musculoskeletal

Postmarketing reports: Back pain[Ref]

Psychiatric

Very common (10% or more): Irritability (41%), agitation (10%)[Ref]

References

1. "Product Information. BabyBIG (botulism immune globulin)." FFF Enterprises, Temecula, CA.

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.

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