Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Erlotinib hydrochloride
Drug ID BADD_D00801
Description Erlotinib is an inhibitor of the epidermal growth factor receptor (EGFR) tyrosine kinase that is used in the treatment of non-small cell lung cancer, pancreatic cancer and several other types of cancer. It is typically marketed under the trade name Tarceva. Erlotinib binds to the epidermal growth factor receptor (EGFR) tyrosine kinase in a reversible fashion at the adenosine triphosphate (ATP) binding site of the receptor. Recent studies demonstrate that erlotinib is also a potent inhibitor of JAK2V617F, which is a mutant form of tyrosine kinase JAK2 found in most patients with polycythemia vera (PV) and a substantial proportion of patients with idiopathic myelofibrosis or essential thrombocythemia. This finding introduces the potential use of erlotinib in the treatment of JAK2V617F-positive PV and other myeloproliferative disorders.
Indications and Usage Erlotinib is indicated for: - The treatment of metastatic non-small cell lung cancer (NSCLC) with tumors showing epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations [FDA label]. - In combination with first-line treatment for patients diagnosed with locally advanced, unresectable or metastatic pancreatic cancer [FDA label]. The safety and efficacy of erlotinib have not been established for patients with NSCLC whose tumors show other EGFR mutations. Additionally it is not recommended for use in combination with platinum-based chemotherapy. [FDA label]
Marketing Status approved; investigational
ATC Code L01EB02
DrugBank ID DB00530
KEGG ID D04023
MeSH ID D000069347
PubChem ID 176871
TTD Drug ID D07POC
NDC Product Code 46708-566; 50242-062; 69539-092; 81955-0010; 46708-565; 62332-566; 69539-091; 72485-218; 62332-567; 72205-080; 61200-013; 51991-892; 62332-565; 63592-3400; 51991-891; 50242-064; 72485-217; 72485-219; 53104-7716; 72205-081; 72205-082; 48087-0133; 59997-0003; 63592-3407; 73309-141; 50242-063; 82920-021; 69539-090; 54893-0012; 82891-001; 46708-567; 51991-890
UNII DA87705X9K
Synonyms Erlotinib Hydrochloride | Hydrochloride, Erlotinib | Erlotinib HCl | HCl, Erlotinib | OSI-774 | OSI 774 | OSI774 | CP 358774 | 358774, CP | CP 358,774 | 358,774, CP | CP-358,774 | CP358,774 | CP-358774 | CP358774 | 11C-erlotinib | 11C erlotinib | Erlotinib | N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)quinazolin-4-amine | Tarceva
Chemical Information
Molecular Formula C22H24ClN3O4
CAS Registry Number 183319-69-9
SMILES COCCOC1=C(C=C2C(=C1)C(=NC=N2)NC3=CC=CC(=C3)C#C)OCCOC.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)
Abdominal pain07.01.05.002--
Alanine aminotransferase increased13.03.04.005--
Alopecia23.02.02.001--
Anxiety19.06.02.002--
Aspartate aminotransferase increased13.03.04.011--
Blood bilirubin increased13.03.04.018--
Bone pain15.02.01.001--
Chills15.05.03.016; 08.01.09.001--
Conjunctivitis11.01.06.012; 06.04.01.002--
Constipation07.02.02.001--
Cough22.02.03.001--
Depression19.15.01.001--
Diarrhoea07.02.01.001--
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.003--
Dry eye06.08.02.001--
Dry skin23.03.03.001--
Dyspepsia07.01.02.001--
Dyspnoea02.11.05.003; 22.02.01.004--
Fatigue08.01.01.002--
Flatulence07.01.04.002--
Gastrointestinal perforation07.04.04.001--Not Available
Hair colour changes23.02.06.001--
Headache17.14.01.001--
Hepatic failure09.01.03.002--
Infection11.01.08.002--Not Available
Insomnia19.02.01.002; 17.15.03.002--
Myalgia15.05.02.001--
Nail disorder23.02.05.002--
Nausea07.01.07.001--
Neuropathy peripheral17.09.03.003--Not Available
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