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 is indicated in the treatment of gestational choriocarcinoma, chorioadenoma destruens and hydatidiform mole. In acute lymphocytic leukemia, methotrexate is indicated in the prophylaxis of meningeal leukemia and is used in maintenance therapy in combination with other chemotherapeutic agents. Methotrexate is also indicated in the treatment of meningeal leukemia. Methotrexate is used alone or in combination with other anticancer agents in the treatment of breast cancer, epidermoid cancers of the head and neck, advanced mycosis fungoides (cutaneous T cell lymphoma), and lung cancer, particularly squamous cell and small cell types. Methotrexate is also used in combination with other chemotherapeutic agents in the treatment of advanced stage non-Hodgkin’s lymphomas. Methotrexate is indicated in the symptomatic control of severe, recalcitrant, disabling psoriasis. Methotrexate is indicated in the management of selected adults with severe, active rheumatoid arthritis (ACR criteria), or children with active polyarticular-course juvenile rheumatoid arthritis.
Marketing Status Prescription; Discontinued
ATC Code L01BA01; L04AX03
DrugBank ID DB00563
KEGG ID D02115
MeSH ID D008727
PubChem ID 11329481
TTD Drug ID D0D3DU
NDC Product Code 12780-6690; 63323-123; 50090-3418; 70518-2711; 63629-1472; 63323-122; 47335-235; 0054-8550; 0054-4550
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
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
ApoptosisCellular tumor antigen p53P04637T15739Not Available
ApoptosisThymidine kinase, cytosolicP04183T30081Not Available
Chromosomal abnormalities and abnormal gene carriersUracil-DNA glycosylaseP13051Not AvailableNot Available
DeathAlanine aminotransferase 2Q28DB5Not AvailableNot Available
DeathAspartate aminotransferase, cytoplasmicP17174T33367Not Available
EnterocolitisGlutathione peroxidase 3P23764Not AvailableNot Available
HepatotoxicityCatalaseP04762Not AvailableNot Available
HepatotoxicityTumor necrosis factorP16599Not AvailableNot Available
HepatotoxicityNitric oxide synthase, inducibleQ06518Not AvailableNot Available
HepatotoxicityGlutathione peroxidase 1P04041Not AvailableNot Available
HepatotoxicitySuperoxide dismutase [Cu-Zn]P07632Not AvailableNot Available
HepatotoxicityDiazepam-binding inhibitor-like 5P56702Not AvailableNot Available
Intestinal angioedemaGlutathione peroxidase 3P23764Not AvailableNot Available
Liver injuryLysosome-associated membrane glycoprotein 1P11279T31145Not Available
Nephropathy toxicGlutathione peroxidase 1P04041Not AvailableNot Available
Nephropathy toxicSuperoxide dismutase [Cu-Zn]P07632Not AvailableNot Available
Nephropathy toxicDiazepam-binding inhibitor-like 5P56702Not AvailableNot Available
Nephropathy toxicCatalaseP04762Not AvailableNot Available
Nephropathy toxicTumor necrosis factorP16599Not AvailableNot Available
Nephropathy toxicNitric oxide synthase, inducibleQ06518Not AvailableNot Available
Traumatic lung injuryPulmonary surfactant-associated protein DP35247T35862Not Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Pruritus23.03.12.001--
Pulmonary embolism22.06.02.001; 24.01.06.001--Not Available
Pulmonary fibrosis22.01.02.006--
Pyrexia08.05.02.003--
Rash23.03.13.001--Not Available
Rash erythematous23.03.06.003--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 disorder22.02.05.034; 19.19.02.002; 17.02.08.003--Not Available
Spermatogenesis abnormal21.03.03.002--Not Available
Stevens-Johnson syndrome23.03.01.007; 12.03.01.014; 11.07.01.005; 10.01.03.020--
Stomatitis07.05.06.005--
Stress fracture15.08.02.002; 12.04.02.003--Not Available
Sudden death08.04.01.003; 02.03.04.013--
Telangiectasia24.03.03.003; 23.06.03.001--
Thrombocytopenia01.08.01.002--Not Available
Thrombophlebitis24.01.02.001--Not Available
Tinnitus17.04.07.004; 04.04.01.002--
Toxic epidermal necrolysis23.03.01.008; 12.03.01.015; 11.07.01.006; 10.01.01.006--
Tumour lysis syndrome14.05.01.004; 16.32.03.002--
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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