Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Methotrexate
Drug ID BADD_D01418
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 L01BA01; L04AX03
DrugBank ID DB00563
KEGG ID D00142
MeSH ID D008727
PubChem ID 126941
TTD Drug ID D0SV8E
NDC Product Code 49452-4601; 51927-1565; 0143-9516; 51285-369; 59137-510; 61703-408; 66220-807; 66220-822; 69238-1423; 12780-0491; 46014-1023; 51407-121; 54436-025; 61703-350; 66220-810; 71335-1772; 46014-1005; 16729-277; 0143-9518; 0143-9519; 50268-527; 51079-670; 70771-1058; 70518-1398; 0555-0572; 0143-9367; 66220-815; 70518-3263; 0703-3675; 58623-0040; 0143-9517; 0143-9830; 54436-020; 59137-505; 59137-535; 59137-540; 0378-0014; 66220-825; 42291-505; 47781-482; 52652-2001; 54436-012; 54436-015; 54436-022; 59137-515; 59137-550; 66220-812; 66220-820; 71335-1118; 50090-5457; 51285-368; 54436-010; 59137-520; 59651-182; 68382-775; 0703-3671; 16729-486; 51285-366; 51285-367; 59137-525; 59137-530; 61703-124; 46014-1133; 63660-0006; 66220-817; 70518-3672; 0703-3678; 0904-7141; 54436-017
UNII YL5FZ2Y5U1
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 C20H22N8O5
CAS Registry Number 59-05-2
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
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)
Stomatitis07.05.06.0050.036808%
Stress19.06.02.004--Not Available
Stress fracture15.08.02.002; 12.04.02.003--Not Available
Stupor19.02.05.004; 17.02.04.007--Not Available
Sudden death08.04.01.003; 02.03.04.013--
Sunburn23.03.09.007; 12.05.02.001--Not Available
Superior sagittal sinus thrombosis24.01.04.004; 17.08.03.001--Not Available
Supraventricular tachycardia02.03.03.012--
Swelling08.01.03.0150.016511%Not Available
Synovial cyst16.18.01.004; 15.04.02.0020.000307%Not Available
Synovitis15.04.02.0010.014100%Not Available
Systemic lupus erythematosus23.03.02.006; 15.06.02.003; 10.04.03.0040.001228%Not Available
T-cell lymphoma01.11.02.001; 16.17.02.001; 11.05.17.0060.000171%Not Available
Tachyphylaxis08.06.01.028; 10.02.01.050--Not Available
Tearfulness19.15.02.005--Not Available
Telangiectasia24.03.03.003; 23.06.03.001--
Tenderness08.01.08.0050.003650%Not Available
Tendon disorder15.07.01.002; 12.01.07.019--Not Available
Tendonitis15.07.01.003; 12.01.07.007--Not Available
Tenosynovitis15.07.01.0040.000557%Not Available
Thrombocytopenia01.08.01.002--Not Available
Thrombocytosis01.08.02.0010.000364%Not Available
Thrombophlebitis24.01.02.001--Not Available
Thrombotic stroke24.01.04.006; 17.08.01.021--Not Available
Thyroid disorder05.02.01.002--Not Available
Tinnitus17.04.07.004; 04.04.01.002--
Tongue blistering07.14.02.0140.000250%Not Available
Tongue ulceration07.14.01.0030.000671%Not Available
Tooth disorder07.09.05.001--Not Available
Tooth loss12.01.17.026; 07.09.09.001--Not Available
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ADReCS-Target
Drug Name ADR Term Target
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