Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Methotrexate sodium
Drug ID BADD_D01419
Description Methotrexate is a folate derivative that inhibits several enzymes responsible for nucleotide synthesis.[A180322] This inhibition leads to suppression of inflammation as well as prevention of cell division.[A180322] Because of these effects, methotrexate is often used to treat inflammation caused by arthritis or to control cell division in neoplastic diseases such as breast cancer and non-Hodgkin's lymphoma.[A180322,L7144,L7147,L7150,L7180] Due to the toxic effects of methotrexate, it is indicated for treatment of some forms of arthritis and severe psoriasis only if first line treatment has failed or patients are intolerant of those treatments.[L7180] Methotrexate was granted FDA approval on 7 December 1953.[L7198]
Indications and Usage Methotrexate oral solution is indicated for pediatric acute lymphoblastic leukemia and pediatric polyarticular juvenile idiopathic arthritis.[L7144] Methotrexate injections for subcutaneous use are indicated for severe active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and severe, recalcitrant, disabling psoriasis.[L7147,L7150,L10457] Other formulations are indicated to treat gestational choriocarcinoma, chorioadenoma destruens, hydatiform mole, breast cancer, epidermoid cancer of the head and neck, advanced mycosis fungoides, lung cancer, and advanced non-Hodgkin's lymphoma.[L7180] It is also used in the maintenance of acute lymphocytic leukemia.[L7180] Methotrexate is also given before treatment with leucovorin to prolong relapse-free survival following surgical removal of a tumour in non-metastatic osteosarcoma.[L7180]
Marketing Status approved
ATC Code L04AX03; L01BA01
DrugBank ID DB00563
KEGG ID D02115
MeSH ID D008727
PubChem ID 11329481
TTD Drug ID D0D3DU
NDC Product Code 0054-8550; 12780-6690; 70518-2711; 0054-4550; 50090-3418; 47335-235; 63323-122; 63323-123
UNII 3IG1E710ZN
Synonyms Methotrexate | Amethopterin | Methotrexate, (D)-Isomer | Methotrexate, (DL)-Isomer | Mexate | Methotrexate Sodium | Sodium, Methotrexate | Methotrexate, Sodium Salt | Methotrexate, Disodium Salt | Methotrexate Hydrate | Hydrate, Methotrexate | Methotrexate, Dicesium Salt | Dicesium Salt Methotrexate
Chemical Information
Molecular Formula C20H20N8Na2O5
CAS Registry Number 7413-34-5
SMILES CN(CC1=CN=C2C(=N1)C(=NC(=N2)N)N)C3=CC=C(C=C3)C(=O)NC(CCC(=O)[O-])C(=O)[O-].[Na+] .[Na+]
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)
Pruritus23.03.12.001--
Pulmonary embolism24.01.06.001; 22.06.02.001--Not Available
Pulmonary fibrosis22.01.02.006--
Pyrexia08.05.02.003--
Rash23.03.13.001--Not Available
Rash erythematous23.03.13.029--Not Available
Renal failure20.01.03.005--Not Available
Respiratory failure22.02.06.002; 14.01.04.003--
Retinal vein thrombosis24.01.07.002; 06.10.01.003--Not Available
Seizure17.12.03.001--
Sepsis11.01.11.003--
Skin erosion23.07.03.002--Not Available
Skin necrosis23.03.03.011--Not Available
Skin ulcer24.04.03.007; 23.07.03.003--
Somnolence19.02.05.003; 17.02.04.006--
Speech disorder19.19.02.002; 22.12.03.027; 17.02.08.003--Not Available
Spermatogenesis abnormal21.03.03.002--Not Available
Stevens-Johnson syndrome12.03.01.014; 11.07.01.005; 10.01.01.045; 23.03.01.007--
Stomatitis07.05.06.005--
Stress fracture15.08.02.002; 12.04.02.003--Not Available
Sudden death08.04.01.003; 02.03.04.013--
Telangiectasia23.06.03.001; 24.03.03.003--
Thrombocytopenia01.08.01.002--Not Available
Thrombophlebitis24.01.02.001--Not Available
Tinnitus17.04.07.004; 04.04.01.002--
Toxic epidermal necrolysis12.03.01.015; 11.07.01.006; 10.01.01.006; 23.03.01.008--
Tumour lysis syndrome16.32.03.002; 14.05.01.004--
Upper respiratory tract infection22.07.03.011; 11.01.13.009--
Urticaria23.04.02.001; 10.01.06.001--
Vaginal discharge21.08.02.002--
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