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)
Scleromalacia06.09.06.0050.000560%Not Available
Fraction of inspired oxygen25.13.01.002--Not Available
Haematotoxicity12.03.01.025; 01.05.01.0070.000112%Not Available
Inflammation10.02.01.089; 08.01.05.0070.000112%Not Available
Metastatic neoplasm16.16.01.007--Not Available
Decreased appetite14.03.01.005; 08.01.09.0280.000224%
Ill-defined disorder08.01.03.049--Not Available
Neoplasm recurrence16.16.02.0040.000112%Not Available
Pulmonary toxicity22.01.02.007; 12.03.01.013--Not Available
Renal impairment20.01.03.0100.000168%Not Available
Cystitis noninfective20.03.02.0010.000224%
Bladder perforation20.03.01.005; 12.02.10.0010.000951%
Choroidal effusion06.09.01.0080.000112%Not Available
Chronic kidney disease20.01.03.017--
Ulcerative keratitis10.02.01.021; 06.04.02.0040.000112%
Bone marrow failure01.03.03.0050.000168%
Acute kidney injury20.01.03.0160.000168%
Anal incontinence17.05.01.021; 07.01.06.0290.000168%
Choroidal haemorrhage24.07.05.011; 06.10.03.0020.000336%Not Available
Conjunctival erosion06.06.02.0080.000504%Not Available
Ureteric stenosis20.06.01.0100.000112%Not Available
Necrotising scleritis06.04.07.0040.000392%Not Available
Necrotising retinitis24.04.10.006; 06.04.06.0120.000112%Not Available
Hypotony maculopathy12.02.02.013; 06.09.03.0320.000112%Not Available
Limbal stem cell deficiency06.06.03.0230.000224%Not Available
Mucosal disorder08.01.06.029--Not Available
Myelosuppression01.03.03.015--Not Available
Urethral fistula20.07.03.0060.000112%Not Available
Vesical fistula20.03.01.0270.000112%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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