Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Gefitinib
Drug ID BADD_D01008
Description Gefitinib (originally coded ZD1839) is a drug used in the treatment of certain types of cancer. Acting in a similar manner to erlotinib (marketed as Tarceva), gefitinib selectively targets the mutant proteins in malignant cells. It is marketed by AstraZeneca under the trade name Iressa.
Indications and Usage For the continued treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of either platinum-based or docetaxel chemotherapies.
Marketing Status approved; investigational
ATC Code L01EB01
DrugBank ID DB00317
KEGG ID D01977
MeSH ID D000077156
PubChem ID 123631
TTD Drug ID D09XZB
NDC Product Code 61200-002; 65344-0029; 54245-1359; 60505-4512; 69339-168; 50742-366; 67184-0531; 0310-0482; 53104-7700; 63850-8070; 0480-4053; 68554-0060; 73377-128; 54893-0036
UNII S65743JHBS
Synonyms Gefitinib | N-(3-Chloro-4-fluorophenyl)-7-methoxy-6-(3-(4-morpholinyl)propoxy)-4-quinazolinamide | Iressa | ZD1839 | ZD 1839
Chemical Information
Molecular Formula C22H24ClFN4O3
CAS Registry Number 184475-35-2
SMILES COC1=C(C=C2C(=C1)N=CN=C2NC3=CC(=C(C=C3)F)Cl)OCCCN4CCOCC4
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)
Hepatotoxicity09.01.07.009; 12.03.01.0080.000224%-
Hydrocephalus17.07.01.0010.000112%
Hypersensitivity10.01.03.003--
Hypokalaemia14.05.03.002--
Hypomagnesaemia14.04.02.001--
Hypoproteinaemia09.01.02.004; 14.10.01.003---
Hypotension24.06.03.002--
Hypoxia22.02.02.0030.000168%
Ileus07.13.01.0010.000168%
Impaired healing08.03.02.0010.000112%-
Infection11.01.08.002---
Inguinal hernia07.16.02.0010.000112%-
International normalised ratio increased13.01.02.008--
Interstitial lung disease10.02.01.033; 22.01.02.0030.001903%-
Intestinal ischaemia07.15.02.001; 24.04.08.0010.000112%-
Jaundice01.06.04.004; 09.01.01.004; 23.03.03.0300.000112%-
Keratitis06.04.02.002--
Large intestine perforation07.04.06.005; 12.02.03.0050.000112%
Lip swelling07.05.04.005; 10.01.05.005; 23.04.01.007---
Liver disorder09.01.08.0010.002709%-
Lung disorder22.02.07.0010.002071%-
Lymphadenopathy01.09.01.0020.000168%-
Malaise08.01.01.003--
Melaena07.12.02.004; 24.07.02.0130.000112%-
Metastases to liver09.04.02.004; 16.22.02.0010.000504%-
Metastases to lung16.22.02.002; 22.08.01.0050.001175%-
Metastases to spine15.09.03.007; 16.22.02.0070.000280%-
Micturition urgency20.02.02.0060.000112%
Mouth ulceration07.05.06.004---
Mucosal inflammation08.01.06.0020.000224%-
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ADReCS-Target
Drug Name ADR Term Target
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