Drug Reference

Hydroxocobalamin

Vitamin B12 (cyanocobalamin and analogues)

← All medicines · Vitamin B12 (cyanocobalamin and analogues)

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Fact box

Therapeutic class
Vitamin B12 (cyanocobalamin and analogues)
Action class
Antidote
Habit forming
No
Availability
Prescription (Rx)

Brand names

Cyanokit

Available as

1 MG/ML · Injectable Solution5000 MG · Injection

FDA label sections are from openFDA and may not reflect the most recent labeling — confirm against the current DailyMed label.

Side effects
Adverse Reactions The following adverse reactions have been reported with hydroxocobalamin injection and other parenteral vitamin B12 products: Hypersensitivity reactions including anaphylactic shock, urticaria, rash, pruritus, flushing, and edema Injection site pain, erythema, and injection site reactions Headache and dizziness Nausea and diarrhea Fever and chills Rare cases of hypokalemia during intensive treatment of severe megaloblastic anemia Serious hypersensitivity reactions, including anaphylaxis, may occur in sensitive patients. To report suspected adverse reactions, contact Xseer Pharmaceuticals at (888) 658-8005 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Safety advice

Conservative summary derived from FDA labeling — defaults to “consult your doctor” unless the label is explicit. Not a substitute for your clinician’s advice.

PregnancyNo information
No specific information in the FDA label.
BreastfeedingNo information
No specific information in the FDA label. Check LactMed →
AlcoholCaution
…Patients with known sensitivity to hydroxocobalamin, cobalt, benzyl alcohol, or any component of the formulation may be at increased risk for serious allergic reactions.…
DrivingNo information
No specific information in the FDA label.
KidneyNo information
No specific information in the FDA label.
LiverNo information
No specific information in the FDA label.
Warnings & precautions
Warnings and Precautions Hypersensitivity reactions, including anaphylactic shock, rash, pruritus, urticaria, and edema, have been reported following parenteral administration of vitamin B12 products, including hydroxocobalamin. Patients with known sensitivity to hydroxocobalamin, cobalt, benzyl alcohol, or any component of the formulation may be at increased risk for serious allergic reactions. This product contains benzyl alcohol as a preservative. Benzyl alcohol has been associated with serious and fatal adverse reactions, including “gasping syndrome,” in premature infants and neonates. Administer under appropriate medical supervision. Monitor patients for signs and symptoms of hypersensitivity during administration. Do not use if the solution is cloudy, discolored, or contains particulate matter. Use aseptic technique during handling and administration. Protect from light. Not for intravenous administration.
Contraindications
Contraindications Hydroxocobalamin Injection is contraindicated in patients with known hypersensitivity to hydroxocobalamin, vitamin B12 preparations, cobalt, benzyl alcohol, or any component of the formulation. Hypersensitivity reactions, including anaphylactic shock and serious allergic reactions, have been reported following parenteral administration of hydroxocobalamin and other vitamin B12 products. Administration to patients with hereditary optic nerve atrophy (Leber’s disease) may result in severe and rapid optic nerve atrophy.
Current FDA labels (DailyMed)

3 marketed products on record (RxNorm)

Authoritative sources

Reference only — not clinical advice. Verify against current FDA labeling and consult a licensed provider. About half of pediatric drug use is off-label and is not reflected in FDA labels; absence of pediatric information does not mean a medicine is unused or unsafe in children.