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 approved; investigational
ATC Code L01CE02
DrugBank ID DB00762
KEGG ID D01061
MeSH ID D000077146
PubChem ID 74990
TTD Drug ID D07HOB
NDC Product Code 57884-0009; 0143-9583; 0143-9702; 60505-6272; 67184-0513; 35369-0020; 67184-0014; 50742-402; 67184-0512; 61200-112; 15054-0043; 59923-715; 68083-382; 14778-1111; 25021-230; 0009-7529; 55150-354; 63323-193; 72485-213; 16714-027; 61703-349; 67184-0511; 72485-212; 12780-4860; 17337-0307; 16714-131; 59923-716; 65129-1025; 59923-714; 50742-401; 59923-702; 60505-6128; 72485-211; 0143-9701; 55150-352; 55150-355; 70700-170; 45963-614; 55150-353
UNII 042LAQ1IIS
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
*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)
Mucosal inflammation08.01.06.002---
Muscle contractions involuntary15.05.03.008; 17.05.03.001---
Muscle spasms15.05.03.004--
Myocardial infarction02.02.02.007; 24.04.04.009--
Myocardial ischaemia02.02.02.008; 24.04.04.010---
Nausea07.01.07.001--
Neoplasm16.16.02.001---
Neoplasm malignant16.16.01.001---
Nervous system disorder17.02.10.001---
Neutropenia01.02.03.004---
Oedema08.01.07.006; 14.05.06.010---
Orthostatic hypotension17.05.01.020; 24.06.03.004---
Osteoarthritis15.01.04.001---
Pain08.01.08.004--
Palmar-plantar erythrodysaesthesia syndrome17.02.07.009; 23.03.05.009--
Pancreatitis07.18.01.001--
Paraesthesia17.02.06.005; 23.03.03.094--
Peripheral vascular disorder24.03.01.003---
Piloerection23.02.06.005---
Pneumonia11.01.09.003; 22.07.01.003---
Pulmonary embolism22.06.02.001; 24.01.06.001---
Pyrexia08.05.02.003--
Rash23.03.13.001---
Renal failure20.01.03.005---
Respiratory disorder22.02.07.002---
Rhinitis11.01.13.004; 22.07.03.006--
Salivary hypersecretion07.06.01.009---
Sepsis11.01.11.003--
Shock24.06.02.002---
Skin reaction10.01.03.019; 23.03.03.013---
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