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)
Lung neoplasm malignant22.08.01.001; 16.19.02.0010.007331%Not Available
Eyelash thickening06.06.04.0050.000302%Not Available
Gastrointestinal toxicity12.03.01.019; 07.08.03.0060.000224%Not Available
Metastases to central nervous system17.02.10.013; 16.22.02.0040.001679%Not Available
Skin toxicity23.03.03.032; 12.03.01.0200.000772%Not Available
Brain neoplasm17.20.01.003; 16.30.01.0030.000224%Not Available
Connective tissue disorder10.04.04.026; 15.06.01.006--Not Available
Feeding disorder19.09.01.003; 14.03.02.0030.000817%Not Available
Infestation23.11.01.002; 11.09.01.001--Not Available
Inflammation10.02.01.089; 08.01.05.007--Not Available
Ischaemia24.04.02.004--Not Available
Malnutrition14.03.02.0040.000280%Not Available
Mediastinal disorder22.09.03.001--Not Available
Meningeal disorder17.02.10.0030.000168%Not Available
Mental disorder19.07.01.002--Not Available
Metastatic neoplasm16.16.01.0070.000974%Not Available
Pelvic neoplasm21.07.04.003; 16.16.02.0030.000112%Not Available
Decreased appetite14.03.01.005; 08.01.09.028--
Corneal disorder06.08.01.0040.000392%Not Available
Disease progression08.01.03.0380.030836%
Non-small cell lung cancer22.08.01.002; 16.19.01.0010.000918%Not Available
Pulmonary toxicity22.01.02.007; 12.03.01.013--Not Available
Hepatic lesion09.01.08.0050.000112%Not Available
Hepatobiliary disease09.01.08.003--Not Available
Large intestinal obstruction07.13.03.0030.000112%
Metastasis16.22.01.0010.001981%Not Available
Renal impairment20.01.03.010--Not Available
Hypophagia19.09.01.004; 14.03.01.006; 07.01.06.0100.000694%Not Available
Skin haemorrhage24.07.01.103; 23.06.07.0010.000246%Not Available
Ulcerative keratitis10.02.01.021; 06.04.02.0040.000358%
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