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 Prescription; Discontinued
ATC Code L01CE02
DrugBank ID DB00762
KEGG ID D08086
MeSH ID D000077146
PubChem ID 60838
TTD Drug ID D07HOB
NDC Product Code 68554-0054
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
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Adverse drug reactionCocaine esteraseO00748Not Available11716702; 10213229; 10728672
ApoptosisDNA topoisomerase 1P11387T098261997159; 1649059; 1333822; 1540962; 1596908; 1330289; 8382551; 2168279; 2168281; 1319346; 11062742; 1374671; 1646393; 7882360; 1322239; 7688316; 1659821; 8383887; 8144400; 1698546
ApoptosisDNA topoisomerase 1P11387T098261374671; 1333943; 1333822; 1279323; 1338332; 1649059; 1997159; 1596908; 8383887; 8601414; 7596166; 8227159; 7641180; 10536167; 8319228; 14504478; 1319346; 1540962; 2168279; 7508535
Bone marrow failureThiopurine S-methyltransferaseP51580Not Available15228171; 9893619; 12525681
Cytogenetic investigationsDNA topoisomerase 1P11387T098261374671; 1333943; 1333822; 1279323; 1338332; 1649059; 1997159; 1596908; 8383887; 8601414; 7596166; 8227159; 7641180; 10536167; 8319228; 14504478; 1319346; 1540962; 2168279; 7508535
Cytogenetic investigationsDNA topoisomerase 1P11387T098261997159; 1649059; 1333822; 1540962; 1596908; 1330289; 8382551; 2168279; 2168281; 1319346; 11062742; 1374671; 1646393; 7882360; 1322239; 7688316; 1659821; 8383887; 8144400; 1698546
DiarrhoeaThiopurine S-methyltransferaseP51580Not Available15228171; 9893619; 12525681
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 pain07.01.05.0020.003463%
Abdominal pain lower07.01.05.0100.000533%Not Available
Abdominal pain upper07.01.05.003--
Abdominal tenderness07.01.05.0040.000533%Not Available
Acute prerenal failure24.06.02.003; 20.01.03.0010.000533%Not Available
Alanine aminotransferase increased13.03.01.003--
Alopecia23.02.02.001--
Amenorrhoea21.01.02.001; 05.05.01.0020.000533%
Amylase increased13.05.01.009--
Anaemia01.03.02.001--
Anaphylactoid reaction24.06.03.007; 10.01.07.0030.001066%Not Available
Aphasia19.21.01.001; 17.02.03.0010.000799%
Ascites02.05.04.002; 09.01.05.003; 07.07.01.0010.000799%
Aspartate aminotransferase increased13.03.01.0060.000533%
Asthenia08.01.01.001--Not Available
Back pain15.03.04.0050.001332%
Blepharospasm17.17.02.001; 06.05.01.0010.000799%Not Available
Blood bilirubin increased13.03.01.008--
Blood magnesium decreased13.11.01.0080.000533%Not Available
Blood potassium decreased13.11.01.0100.000533%Not Available
Blood pressure increased13.14.03.0050.002398%Not Available
Bradycardia02.03.02.0020.000533%Not Available
Cardiac arrest02.03.04.0010.000208%
Cerebrovascular accident24.03.05.001; 17.08.01.007--
Chest discomfort22.02.08.001; 08.01.08.019; 02.02.02.0090.000533%Not Available
Chest pain08.01.08.002; 02.02.02.011; 22.02.08.0030.001332%Not Available
Chills08.01.09.001; 15.05.03.0160.001066%
Cholangitis09.02.01.0020.000533%Not Available
Cholinergic syndrome17.05.01.0020.000799%Not Available
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