Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Irinotecan
Drug ID BADD_D01195
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 approved; investigational
ATC Code L01CE02
DrugBank ID DB00762
KEGG ID D08086
MeSH ID D000077146
PubChem ID 60838
TTD Drug ID D07HOB
NDC Product Code 68554-0054
UNII 7673326042
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 C33H38N4O6
CAS Registry Number 97682-44-5
SMILES CCC1=C2CN3C(=CC4=C(C3=O)COC(=O)C4(CC)O)C2=NC5=C1C=C(C=C5)OC(=O)N6CCC(CC6)N7CCCCC 7
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)
Abdominal distension07.01.04.001--
Abdominal pain07.01.05.0020.001578%
Abdominal pain lower07.01.05.0100.000112%Not Available
Abdominal tenderness07.01.05.0040.000112%Not Available
Alanine aminotransferase increased13.03.04.005--
Alopecia23.02.02.001--
Altered state of consciousness17.02.04.001; 19.07.01.0030.000112%Not Available
Amenorrhoea21.01.02.001; 05.05.01.0020.000112%
Amnesia19.20.01.001; 17.03.02.001--
Amylase increased13.05.01.009--
Anaemia01.03.02.0010.000694%
Anaphylactic shock24.06.02.004; 10.01.07.0020.000112%Not Available
Anaphylactoid reaction10.01.07.003; 24.06.03.0070.000224%Not Available
Aphasia19.21.01.001; 17.02.03.0010.000168%
Ascites09.01.05.003; 07.07.01.001; 02.05.04.0020.000448%
Aspartate aminotransferase increased13.03.04.011--
Asthenia08.01.01.001--Not Available
Back pain15.03.04.0050.000470%
Blepharospasm17.17.02.001; 06.05.01.0010.000302%Not Available
Blood bilirubin increased13.03.04.018--
Bradycardia02.03.02.002--Not Available
Burning sensation17.02.06.001; 08.01.09.0290.000112%Not Available
Cardiac arrest02.03.04.0010.000280%
Chest pain22.12.02.003; 08.01.08.002; 02.02.02.0110.000604%Not Available
Chills15.05.03.016; 08.01.09.0010.000448%
Cholangitis09.02.01.0020.000280%Not Available
Cholinergic syndrome17.05.01.0020.000224%Not Available
Circulatory collapse24.06.02.001--Not Available
Cold sweat23.02.03.002; 08.01.03.0240.000112%Not Available
Colitis07.08.01.001--
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ADReCS-Target
Drug Name ADR Term Target
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