Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Mitomycin
Drug ID BADD_D01478
Description Mitomycin is an antineoplastic antibiotic first isolated by Japanese microbiologists in the 1950s from cultures of _Streptomyces caespitosus_.[L12867,A193419] It is an alkylating agent that inhibits DNA synthesis (and, at higher concentrations, RNA and protein synthesis) by cross-linking the complementary strands of the DNA double helix.[A193419] Few other antibiotics have been discovered that work via this alkylating mechanism, making mitomycin relatively unique in the space of microbiota-derived therapies.[A193419] Mitomycin's cross-linking activity has resulted in its approval for the treatment of a variety of cancers - the most recent of which is an April 2020 approval for its use in low-grade Upper Tract Urothelial Cancer (LG-UTUC)[L12867] - as well as adjunctly to _ab externo_ glaucoma surgeries.
Indications and Usage For treatment of malignant neoplasm of lip, oral cavity, pharynx, digestive organs, peritoneum, female breast, and urinary bladder. Also used as an adjunct to ab externo glaucoma surgery. Mitomycin is also indicated as a pyelocalyceal solution for the treatment of adults with low-grade upper tract urothelial cancer (LG-UTUC).[L12867]
Marketing Status approved
ATC Code L01DC03
DrugBank ID DB00305
KEGG ID D00208
MeSH ID D016685
PubChem ID 5746
TTD Drug ID D0Y0GH
NDC Product Code 72819-154; 65050-0058; 0143-9135; 68001-390; 68083-483; 69448-003; 68254-0016; 25021-252; 69448-001; 25021-250; 25021-251; 65219-564; 68083-502; 71288-138; 72493-103; 71288-137; 73212-036; 0143-9136; 0143-9279; 69448-002; 72819-153; 58623-0045; 62158-0005; 68083-484; 72819-152; 0143-9280; 49771-002; 65219-568; 68001-389; 38779-0553; 51927-0286; 71052-644; 71288-139; 53183-7010; 16729-115; 16729-116; 68001-391; 51552-1509; 65219-566; 16729-108
UNII 50SG953SK6
Synonyms Mitomycin | Mitomycin C | Mitomycin-C | Mitocin-C | Mitocin C | MitocinC | NSC-26980 | NSC 26980 | NSC26980 | Ametycine | Mutamycin
Chemical Information
Molecular Formula C15H18N4O5
CAS Registry Number 50-07-7
SMILES CC1=C(C(=O)C2=C(C1=O)N3CC4C(C3(C2COC(=O)N)OC)N4)N
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)
Scleritis10.02.01.025; 06.04.07.0020.000280%Not Available
Scrotal ulcer21.12.02.007; 23.07.03.0070.000224%Not Available
Shock24.06.02.002--Not Available
Skin discolouration23.03.03.0050.000112%Not Available
Skin disorder23.03.03.007--Not Available
Skin exfoliation23.03.07.003--Not Available
Somnolence19.02.05.003; 17.02.04.006--
Stomatitis07.05.06.005--
Swelling08.01.03.0150.000112%Not Available
Syncope02.11.04.015; 24.06.02.012; 17.02.04.0080.000112%
Thrombocytopenia01.08.01.0020.000448%Not Available
Thrombophlebitis24.01.02.001--Not Available
Thrombotic microangiopathy01.01.02.006; 24.01.01.013; 20.01.07.0040.000112%Not Available
Ulcer08.03.06.0010.000112%Not Available
Ureteric obstruction20.06.01.0050.000168%Not Available
Uveitis10.02.01.023; 06.04.03.0030.000280%
Vision blurred17.17.01.010; 06.02.06.007--
Visual acuity reduced06.02.10.012; 17.17.01.0110.001007%
Visual field defect17.17.01.001; 06.02.07.0030.000112%Not Available
Vitreous haemorrhage24.07.05.005; 06.10.03.0010.000112%
Vomiting07.01.07.0030.000694%
Cardiotoxicity02.11.01.009; 12.03.01.007--Not Available
Injection site cellulitis23.11.02.012; 12.07.03.037; 11.02.01.012; 08.02.03.037--Not Available
Bladder necrosis24.04.09.006; 20.03.01.0170.000168%Not Available
Conjunctival bleb06.06.02.0030.000224%Not Available
Dystrophic calcification08.03.04.0090.000112%Not Available
Scleral thinning06.09.06.0040.001007%Not Available
Neurological examination abnormal13.15.01.009--Not Available
Toxic skin eruption12.03.01.073; 23.03.05.003; 10.01.01.0080.000168%Not Available
Cystoid macular oedema12.02.02.005; 06.04.06.0100.000112%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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