Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Levomefolate calcium
Drug ID BADD_D01277
Description Levomefolic acid (INN) is the metabolite of folic acid (Vitamin B9) and it is a predominant active form of folate found in foods and in the blood circulation, accounting for 98% of folates in human plasma [A19276]. It is transported across the membranes including the blood-brain barrier into various tissues where it plays an essential role in the DNA synthesis, cysteine cycle and regulation of homocysteine, where it methylates homocysteine and forms methionine and tetrahydrofolate (THF). Levomefolate is approved as a food additive and is designated a GRAS (generally regarded as safe) compound [L773]. It is available commercially as a crystalline form of the calcium salt (Metafolin(R)), which has the stability required for use as a supplement [A19276]. Supplementation of levomefolic acid is desired over folic acid due to reduced potential for masking vitamin B12 deficiency symptoms.
Indications and Usage For the treatment and prevention of folate deficiency and for use as an antidote against folic acid antagonists. Contained in oral contraceptives to reduce the risk of neural tube defects arising from folic acid deficiency for pregnant women who conceived during use or shortly after the discontinuation of the product. Being studied for use as a treatment for cardiovascular diseases [A19273] and adjunct therapy for patients undergoing antidepressant pharmacotherapy [A19271, A19272].
Marketing Status Prescription
ATC Code Not Available
DrugBank ID DB11256
KEGG ID D09354
MeSH ID C569381
PubChem ID 135564391
TTD Drug ID Not Available
NDC Product Code 58159-062; 69723-002; 43615-002; 80680-001; 54239-008
Synonyms levomefolate calcium | N-(4-(((2-amino-1,4,5,6,7,8-hexahydro-5-methyl-4-oxo-6-pteridinyl)methyl)amino)benzoyl)-L-glutamic acid calcium salt | safyral | metafolin
Chemical Information
Molecular Formula C20H23CaN7O6
CAS Registry Number 151533-22-1
SMILES CN1C(CNC2=C1C(=O)NC(=N2)N)CNC3=CC=C(C=C3)C(=O)NC(CCC(=O)[O-])C(=O)[O-].[Ca+2]
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal discomfort07.01.06.001--Not Available
Abdominal pain07.01.05.002--
Breast pain21.05.05.003--
Breast tenderness21.05.05.004--Not Available
Cardiovascular disorder24.03.02.009; 02.01.01.001--Not Available
Cerebrovascular accident17.08.01.007; 24.03.05.001--
Chloasma23.05.01.001; 18.08.02.002--Not Available
Depressed mood19.15.02.001--Not Available
Depression19.15.01.001--
Embolism arterial24.01.01.014--
Embolism venous24.01.01.003--Not Available
Gallbladder disorder09.03.02.001--Not Available
Headache17.14.01.001--
Hyperkalaemia14.05.03.001--
Hypersensitivity10.01.03.003--
Hypertension24.08.02.001--
Irritability19.04.02.013; 08.01.03.011--
Liver disorder09.01.08.001--Not Available
Migraine17.14.02.001; 24.03.05.003--Not Available
Mood altered19.04.02.007--Not Available
Myocardial infarction24.04.04.009; 02.02.02.007--
Nausea07.01.07.001--
Premenstrual syndrome21.01.01.007; 19.04.02.009--Not Available
Pulmonary embolism22.06.02.001; 24.01.06.001--Not Available
Retinal vein occlusion24.01.07.006; 06.10.01.010--Not Available
Superior sagittal sinus thrombosis24.01.04.004; 17.08.03.001--Not Available
Tenderness08.01.08.005--Not Available
Uterine haemorrhage24.07.03.004; 21.07.01.005--
Uterine leiomyoma21.07.02.004; 16.04.02.001--Not Available
Vomiting07.01.07.003--
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