Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Cyanocobalamin
Drug ID BADD_D00542
Description Cyanocobalamin (commonly known as Vitamin B12) is a highly complex, essential vitamin, owing its name to the fact that it contains the mineral, cobalt. This vitamin is produced naturally by bacteria [A175276], and is necessary for DNA synthesis and cellular energy production. Vitamin B12 has many forms, including the cyano-, methyl-, deoxyadenosyl- and hydroxy-cobalamin forms. The _cyano_ form, is the most widely used form in supplements and prescription drugs [A175255], [FDA label]. Several pharmaceutical forms of cyanocobalamin have been developed, including the tablet, injection, and nasal spray forms [FDA label], [L5542], [L5545]. This drug was initially approved by the FDA in 1942 [FDA label].
Indications and Usage **Nasal spray** The cyanocobalamin nasal spray is indicated for the maintenance of vitamin B12 concentrations after normalization with intramuscular vitamin B12 therapy in patients with deficiency of this vitamin who have no nervous system involvement [FDA label]. Note: CaloMist [FDA label], the nasal spray form, has not been evaluated for the treatment of newly diagnosed vitamin B12 deficiency. **Injection forms (subcutaneous, intramuscular)** These forms are indicated for vitamin B12 deficiencies due to various causes, with or without neurologic manifestations [F3736]. Vitamin B12 deficiency is frequently caused by malabsorption, which is often associated with the following conditions [L5545]: Addisonian (pernicious) anemia Gastrointestinal pathology, dysfunction, or surgery, including gluten enteropathy or sprue, small bowel bacterial overgrowth, total or partial gastrectomy Fish tapeworm infestation Malignancy of the pancreas or bowel Folic acid deficiency **Oral forms** Vitamin B12 supplements are widely available and indicated in patients who require supplementation for various reasons. Dose requirements for vitamin B12 which are higher than normal (caused by pregnancy, thyrotoxicosis, hemolytic anemia, hemorrhage, malignancy, hepatic and renal disease) can usually be achieved with oral supplementation [L5545]. Oral products of vitamin B12 are not recommended in patients with malabsorption, as these forms are primarily absorbed in the gastrointestinal tract [F3739].
Marketing Status approved; nutraceutical
ATC Code B03BA01
DrugBank ID DB00115
KEGG ID D00166; D03615; D03616; D03617
MeSH ID D014805
PubChem ID 5311498
TTD Drug ID D0FR6I
NDC Product Code 51662-1440; 0517-0032; 70069-172; 76420-075; 43225-1001; 49452-2401; 50396-7800; 51552-1045; 51662-1394; 63323-044; 0143-9620; 69680-112; 70771-1688; 70710-1664; 76420-111; 0143-9621; 0517-0031; 0517-0130; 70512-840; 71288-303; 16729-533; 70710-1665; 70771-1690; 16714-302; 0143-9619; 50090-6229; 70529-290; 16714-609; 49884-270; 68083-449; 69680-121; 70710-1663; 40074-0013; 82298-201; 16714-165; 25021-502; 0404-9840; 68083-561; 68083-562; 69680-113; 70069-171; 70529-293; 63238-3700; 52584-399; 68001-542; 70069-005; 70771-1689; 51927-1662; 55150-364
UNII P6YC3EG204
Synonyms Vitamin B 12 | B 12, Vitamin | Vitamin B12 | B12, Vitamin | Cyanocobalamin | Cobalamins | Cobalamin | Eritron
Chemical Information
Molecular Formula C63H88CoN14O14P
CAS Registry Number 68-19-9
SMILES CC1=CC2=C(C=C1C)N(C=N2)C3C(C(C(O3)CO)OP(=O)([O-])OC(C)CNC(=O)CCC4(C(C5C6(C(C(C(= C(C7=NC(=CC8=NC(=C(C4=N5)C)C(C8(C)C)CCC(=O)N)C(C7(C)CC(=O)N)CCC(=O)N)C)[N-]6)CCC (=O)N)(C)CC(=O)N)C)CC(=O)N)C)O.[C-]#N.[Co+3]
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice.
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Flushing08.01.03.025; 23.06.05.003; 24.03.01.0020.000127%
Gait disturbance08.01.02.002; 15.03.05.013; 17.02.05.016--
Glossitis07.14.01.001---
Headache17.14.01.0010.000127%
Hypersensitivity10.01.03.0030.000330%
Hypoaesthesia17.02.06.023; 23.03.03.0810.000330%-
Hypokalaemia14.05.03.0020.000085%
Hyponatraemia14.05.04.0020.000169%
Hypoxia22.02.02.0030.000085%
Infection11.01.08.002---
Injection site rash08.02.03.032; 12.07.03.032; 23.03.13.0100.000186%-
Insomnia17.15.03.002; 19.02.01.0020.000085%
Lethargy08.01.01.008; 17.02.04.003; 19.04.04.0040.000169%
Malaise08.01.01.0030.000127%
Mitral valve incompetence02.07.01.0020.000085%-
Myalgia15.05.02.0010.000085%
Myoclonus17.02.05.0080.000127%-
Nausea07.01.07.0010.000313%
Nervousness19.06.02.003---
Pain08.01.08.004--
Pallor08.01.03.032; 23.03.03.031; 24.03.04.0010.000186%-
Paraesthesia17.02.06.005; 23.03.03.0940.000228%
Peripheral vascular disorder24.03.01.003---
Polycythaemia vera01.13.03.002; 16.21.03.003---
Protrusion tongue07.14.02.002; 17.02.05.0370.000085%-
Pruritus23.03.12.0010.000228%
Pulmonary oedema02.05.02.003; 22.01.03.003--
Pyrexia08.05.02.0030.000186%
Rash23.03.13.0010.000618%-
Rhinitis11.01.13.004; 22.07.03.006--
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ADReCS-Target
Drug Name ADR Term Target
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