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BabyBIG Side Effects

Generic name: botulism immune globulin

Medically reviewed by Last updated on Aug 22, 2023.

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

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.


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]


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]


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

Postmarketing reports: Abdominal pain[Ref]


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

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


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

Postmarketing reports: Rigors[Ref]


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

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


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

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


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


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]


Postmarketing reports: Hepatic dysfunction[Ref]


Postmarketing reports: Back pain[Ref]


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


1. (2008) "Product Information. BabyBIG (botulism immune globulin)." FFF Enterprises

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.