Adverse Drug Reaction Classification System

         

Pharmaceutical Information
Drug Name Erlotinib
Drug ID BADD_D00800
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 D07907
MeSH ID D000069347
PubChem ID 176870
TTD Drug ID D07POC
NDC Product Code 68554-0052; 59923-725; 63850-7566; 59651-530; 68382-914; 70771-1522; 59651-531; 59923-726; 63304-135; 0093-7663; 59651-532; 63304-095; 63304-096; 68382-915; 0093-7664; 59923-727; 70771-1521; 0093-7662; 68382-913; 70771-1523
UNII J4T82NDH7E
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 C22H23N3O4
CAS Registry Number 183321-74-6
SMILES COCCOC1=C(C=C2C(=C1)C(=NC=N2)NC3=CC=CC(=C3)C#C)OCCOC
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)
Head and neck cancer16.16.01.0030.000112%Not Available
Anal pruritus07.03.03.0020.000381%Not Available
Atrophic glossitis07.14.01.0040.000381%Not Available
Acute kidney injury20.01.03.016--
Alopecia scarring23.02.02.0090.000112%Not Available
Bronchial carcinoma22.08.01.015; 16.19.02.0040.000168%Not Available
Lung adenocarcinoma22.08.01.007; 16.19.01.0020.000280%Not Available
Lung carcinoma cell type unspecified recurrent22.08.01.018; 16.19.02.0050.000168%Not Available
Lung carcinoma cell type unspecified stage IV22.08.01.019; 16.19.02.0060.000504%Not Available
Malignant ascites16.32.03.013; 07.07.01.0040.000112%Not Available
Malignant pleural effusion16.32.03.014; 22.05.04.0010.000448%Not Available
Metastases to adrenals05.01.04.007; 16.22.02.0120.000112%Not Available
Metastases to bone16.22.02.005; 15.09.03.0060.001119%Not Available
Metastases to breast21.05.01.024; 16.22.02.0140.000112%Not Available
Metastases to kidney20.01.04.010; 16.22.02.0170.000112%Not Available
Metastases to lymph nodes01.09.01.015; 16.22.02.0060.000280%Not Available
Metastases to neck16.22.02.018; 15.09.03.0190.000392%Not Available
Metastases to pleura16.22.02.022; 22.05.04.0020.000168%Not Available
Metastases to skin23.07.04.026; 16.22.02.0230.000168%Not Available
Metastases to the mediastinum22.09.03.009; 16.22.02.0270.000112%Not Available
Non-small cell lung cancer stage IV16.19.01.010; 22.08.01.0220.000112%Not Available
Obstruction gastric07.13.04.0020.000168%
Pancreatic carcinoma metastatic16.13.10.003; 07.21.09.0060.000728%Not Available
Recurrent cancer16.16.01.0150.000302%Not Available
Neck mass15.03.02.0070.000112%Not Available
Metastases to stomach07.21.03.007; 16.22.02.0260.000168%Not Available
Anti-neutrophil cytoplasmic antibody positive vasculitis10.02.02.023; 24.12.04.0020.000112%Not Available
Metastases to chest wall15.09.03.018; 16.22.02.0150.000112%Not Available
Metastases to spleen16.22.02.025; 01.09.02.0100.000112%Not Available
Metastases to thorax22.08.03.001; 16.22.02.0280.000392%Not Available
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