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)
Thyroid cancer05.02.05.001; 16.24.03.001---
Haematological malignancy01.13.01.003; 16.21.01.002---
Treatment failure08.06.01.0170.100291%-
Liver injury09.01.07.022; 12.01.17.0120.003286%-
Regurgitation07.01.07.0040.000114%-
Cytotoxic oedema17.07.02.0060.000114%-
Pharyngeal disorder22.04.05.007---
Herpes simplex hepatitis09.01.09.002; 11.05.02.006---
Organising pneumonia22.01.02.008---
Adverse reaction08.06.01.018---
Type 2 diabetes mellitus05.06.01.003; 14.06.01.003---
Oral disorder07.05.01.0050.001842%-
Upper airway obstruction22.12.03.032---
Head and neck cancer16.16.01.003---
Skin mass23.07.04.0140.001444%-
Renal cell carcinoma16.08.02.002; 20.01.04.003---
Brain injury17.11.01.003; 19.07.03.007---
Cholestatic liver injury09.01.07.0160.000114%-
Intellectual disability17.03.07.001; 19.21.06.001---
Anal pruritus07.03.03.002---
Hypertransaminasaemia09.01.02.0050.001672%-
Anorectal discomfort07.03.03.003---
Oropharyngeal discomfort07.05.05.008; 22.12.03.015---
Oropharyngeal pain07.05.05.004; 22.12.03.016--
X-linked lymphoproliferative syndrome01.13.02.003; 03.17.01.002; 10.03.01.003; 11.05.10.005; 16.21.02.003---
Epstein-Barr virus associated lymphoproliferative disorder01.13.02.002; 11.05.10.001; 16.21.02.0020.001194%-
Vulvovaginal pain21.08.02.0090.000500%
Acute kidney injury20.01.03.016--
Upper-airway cough syndrome22.12.03.036--
Gastrointestinal tract irritation07.08.03.0080.000580%-
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ADReCS-Target
Drug Name ADR Term Target
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