Adverse Drug Reaction Classification System

         

Pharmaceutical Information
Drug Name Nintedanib
Drug ID BADD_D02470
Description Nintedanib is a small molecule kinase inhibitor used in the treatment of pulmonary fibrosis, systemic sclerosis-associated interstitial lung disease, and non-small cell lung cancer (NSCLC).[L8453,L8459] It was first approved for use in the United States in 2014.[L8453] Within the spectrum of idiopathic pulmonary fibrosis treatment options, nintedanib is currently one of only two disease-modifying therapies available and indicated for the condition (the other being [Pirfenidone]) and as such is used as a first-line treatment following diagnosis to slow down the progressive loss of lung function.[A185237] As a chemotherapeutic agent for NSCLC, nintedanib, in combination with [Docetaxel], is reserved for patients who have tried and failed first-line chemotherapeutic options.[L8459]
Indications and Usage In the US, nintedanib is indicated for the treatment of idiopathic pulmonary fibrosis (IPF)[L8453] and to slow declining pulmonary function in patients with systemic sclerosis-associated interstitial lung disease.[L8462] In the EU, nintedanib is indicated in combination with docetaxel for the treatment of adult patients with metastatic, locally advanced, or locally recurrent non-small cell lung cancer of adenocarcinoma histology who have already tried first-line therapy.[L8459]
Marketing Status approved
ATC Code L01EX09
DrugBank ID DB09079
KEGG ID D10481
MeSH ID C530716
PubChem ID 135423438
TTD Drug ID D09HNV
NDC Product Code 55361-0020; 66499-0061; 0597-0143; 0597-0145; 51869-0040; 55361-0021
UNII G6HRD2P839
Synonyms nintedanib | Nintedanib esylate | Ofev | Vargatef | BIBF 1120 | BIBF1120 | BIBF-1120
Chemical Information
Molecular Formula C31H33N5O4
CAS Registry Number 656247-17-5
SMILES CN1CCN(CC1)CC(=O)N(C)C2=CC=C(C=C2)N=C(C3=CC=CC=C3)C4=C(NC5=C4C=CC(=C5)C(=O)OC)O
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)
Vision blurred17.17.01.010; 06.02.06.007--
Vomiting07.01.07.0030.013028%
Wheezing22.03.01.0090.000448%
Yellow skin23.03.03.042; 09.01.01.009; 08.01.03.0460.000112%Not Available
Intracardiac thrombus02.11.01.017; 24.01.05.0030.000112%Not Available
Deafness unilateral04.02.01.0110.000112%Not Available
Underweight14.03.02.0170.000112%Not Available
Seasonal allergy22.04.04.008; 10.01.04.001; 06.04.01.0130.000112%Not Available
Performance status decreased08.01.03.0420.000112%Not Available
Peripheral swelling08.01.03.053; 02.05.04.015--Not Available
Localised oedema14.05.06.009; 08.01.07.011; 02.05.04.0060.000112%
Weight fluctuation14.03.02.0020.000112%Not Available
Food aversion19.09.03.002; 14.03.02.0290.000224%Not Available
General physical health deterioration08.01.03.0180.003358%Not Available
Balance disorder08.01.03.081; 17.02.02.007--Not Available
Lung cancer metastatic16.19.02.003; 22.08.01.0040.000168%Not Available
Pneumomediastinum22.09.03.0040.000638%Not Available
Dysstasia15.03.05.011; 08.01.03.089; 17.02.02.012--Not Available
Subileus07.13.01.0040.000112%Not Available
Musculoskeletal chest pain22.09.01.001; 15.03.04.0120.000112%
Lower gastrointestinal haemorrhage07.12.03.011; 24.07.02.0300.000224%
Dyschezia07.02.03.0050.000168%Not Available
Exercise tolerance decreased08.01.03.0360.000224%Not Available
Large intestine polyp16.05.02.006; 07.20.01.0100.000168%Not Available
Acute coronary syndrome24.04.04.011; 02.02.02.0150.000839%Not Available
Respiratory tract congestion22.02.07.0030.000224%Not Available
Large intestinal haemorrhage24.07.02.026; 07.12.03.0030.000112%
Musculoskeletal stiffness15.03.05.027--Not Available
Musculoskeletal discomfort15.03.04.001--Not Available
Secretion discharge08.01.03.0190.000638%Not Available
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