openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings sections page 1 of 1 · 1 matching rows.
warnings
WARNINGS WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration. Patients with early Leber’s disease (hereditary optic nerve atrophy) who were treated with cyanocobalamin suffered severe and swift optic atrophy. Hypokalemia and sudden death may occur in severe megaloblastic anemia which is treated intensely. Anaphylactic shock and death have been reported after parenteral Vitamin B 12 administration. An intradermal test dose is recommended before cyanocobalamin injection is administered to patients suspected of being sensitive to this drug. This product contains benzyl alcohol. Benzyl alcohol has been reported to be associated with a fatal ‘‘Gasping Syndrome’’ in premature infants.
ADVERSE REACTIONS Generalized Anaphylactic shock and death have been reported with administration of parenteral Vitamin B 12 (see WARNINGS ). Cardiovascular Pulmonary edema and congestive heart failure early in treatment; peripheral vascular thrombosis. Hematological Polycythemia vera. Gastrointestinal Mild transient diarrhea. Dermatological Itching; transitory exanthema. Miscellaneous Feeling of swelling of entire body.
adverse reactions
Generalized Anaphylactic shock and death have been reported with administration of parenteral Vitamin B 12 (see WARNINGS ).
adverse reactions
Cardiovascular Pulmonary edema and congestive heart failure early in treatment; peripheral vascular thrombosis.