Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Irinotecan hydrochloride
Drug ID BADD_D01196
Description Irinotecan is an antineoplastic enzyme inhibitor primarily used in the treatment of colorectal cancer. It is a derivative of camptothecin that inhibits the action of topoisomerase I. Irinotecan prevents religation of the DNA strand by binding to topoisomerase I-DNA complex, and causes double-strand DNA breakage and cell death. It is a derivative of camptothecin. Irinotecan was approved for the treatment of advanced pancreatic cancer in October, 2015 (irinotecan liposome injection, trade name Onivyde).
Indications and Usage For the treatment of metastatic colorectal cancer (first-line therapy when administered with 5-fluorouracil and leucovorin). Also used in combination with cisplatin for the treatment of extensive small cell lung cancer. Irinotecan is currently under investigation for the treatment of metastatic or recurrent cervical cancer. Also used in combination with fluorouracil and leucovorin for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy.
Marketing Status Prescription; Discontinued
ATC Code L01CE02
DrugBank ID DB00762
KEGG ID D01061
MeSH ID D000077146
PubChem ID 74990
TTD Drug ID D07HOB
NDC Product Code 0143-9583; 72485-211; 67184-0511; 45963-614; 67184-0513; 55150-352; 0009-7529; 17337-0307; 65129-1025; 16714-027; 68083-382; 25021-230; 59923-714; 63323-193; 16714-131; 59923-702; 70700-170; 57884-0009; 72485-213; 61703-349; 59923-715; 59923-716; 55150-354; 50742-401; 72485-212; 50742-402; 61200-112; 0143-9701; 15054-0043; 14778-1111; 55150-353; 12780-4860; 60505-6128; 67184-0014; 0143-9702; 67184-0512
Synonyms Irinotecan | Irrinotecan | Camptothecin-11 | Camptothecin 11 | SN 38 11 | SN-38-11 | SN3811 | SN 38 | SN-38 | NK012 Compound | CPT-11 | CPT11 | CPT 11 | Camptosar | 7-Ethyl-10-hydroxycamptothecin | 7 Ethyl 10 hydroxycamptothecin | Irinotecan Hydrochloride
Chemical Information
Molecular Formula C33H39ClN4O6
CAS Registry Number 100286-90-6
SMILES CCC1=C2CN3C(=CC4=C(C3=O)COC(=O)C4(CC)O)C2=NC5=C1C=C(C=C5)OC(=O)N6CCC(CC6)N7CCCCC 7.Cl
Chemical Structure
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal distension07.01.04.001--
Abdominal pain07.01.05.002--
Acute leukaemia01.10.02.001; 16.01.02.001--Not Available
Akathisia17.01.02.002; 19.06.02.006--
Alopecia23.02.02.001--
Amylase increased13.05.01.009--
Anaemia01.03.02.001--
Anaphylactic reaction10.01.07.001; 24.06.03.006--
Anaphylactic shock10.01.07.002; 24.06.02.004--Not Available
Anaphylactoid reaction10.01.07.003; 24.06.03.007--Not Available
Angina pectoris02.02.02.002; 24.04.04.002--
Anorectal disorder07.03.01.001--Not Available
Arrhythmia02.03.02.001--Not Available
Arterial thrombosis24.01.01.002--Not Available
Aspartate aminotransferase increased13.03.01.006--
Asthenia08.01.01.001--Not Available
Back pain15.03.04.005--
Blood bilirubin increased13.03.01.008--
Blood creatinine increased13.13.01.004--
Body temperature increased13.15.01.001--Not Available
Bradycardia02.03.02.002--Not Available
Cardiac arrest02.03.04.001--
Cardiovascular disorder02.01.01.001; 24.03.02.009--Not Available
Cerebral infarction17.08.01.004; 24.04.06.002--Not Available
Cerebrovascular accident17.08.01.007; 24.03.05.001--
Chills08.01.09.001; 15.05.03.016--
Cholinergic syndrome17.05.01.002--Not Available
Circulatory collapse24.06.02.001--Not Available
Colitis07.08.01.001--
Colitis ischaemic07.08.01.004; 24.04.08.012--Not Available
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