pharmacopeia
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/api/v1/drug/hydroxocobalamin

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Enzyme Interactions.

Contraindications

Sourced from openFDA
  • 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.contraindicated

Warnings & precautions

Sourced from openFDA

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.

Adverse reactions

Sourced from openFDA

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

Approval history

Sourced from openFDA
  • Aug 16, 1978ANDAANDA085998Actavis
  • Dec 15, 2006NDANDA022041Btg Intl

FDA shortages

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Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

  • Cyanokit, Injection, 5 g/250mL (NDC 50633-310-11)Active
    Sponsor: BTG International Inc. · Reason: Requirements related to complying with good manufacturing practices
    Updated
  • Hydroxocobalamin, Injection, 1000 MCG/ML, 30 ML Multi-Dose Vial (NDC 0591-2888-30)Active
    Sponsor: Teva Pharmaceuticals USA, Inc. · Reason: Other
    Updated

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
4,023 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Acute Kidney Injury2075.1%
  2. 2Diarrhoea1984.9%
  3. 3Nausea1944.8%
  4. 4Dyspnoea1884.7%
  5. 5Dizziness1734.3%
  6. 6Vomiting1664.1%
  7. 7Off Label Use1594.0%
  8. 8Malaise1503.7%
  9. 9Hyponatraemia1373.4%
  10. 10Fatigue1263.1%
  11. 11Confusional State1193.0%
  12. 12Rash1182.9%
  13. 13Somnolence1132.8%
  14. 14Drug Ineffective1042.6%
  15. 15Headache1012.5%

Literature

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Recent PubMed references pinned to Hydroxocobalamin as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 719 ClinicalTrials.gov registrations naming Hydroxocobalamin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Hydroxocobalamin work?
Mechanism-of-action class: Enzyme Interactions.
What class of drug is Hydroxocobalamin?
Hydroxocobalamin is classified as Antidotes, Vitamin B12 (cyanocobalamin and analogues), Antidote, Enzyme Interactions, Cellular Activity Alteration.
What are the brand names for Hydroxocobalamin?
Hydroxocobalamin is marketed under brand names including Cyanokit.
What are the contraindications for Hydroxocobalamin?
Hydroxocobalamin labeling lists contraindications including: 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.. Always consult the full prescribing information and a clinician.
Note. Data for hydroxocobalamin is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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