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 Nintedanib is indicated for the treatment of idiopathic pulmonary fibrosis (IPF).
Marketing Status Not Available
ATC Code L01EX09
DrugBank ID DB09079
KEGG ID D10481
MeSH ID C530716
PubChem ID 135423438
TTD Drug ID D09HNV
NDC Product Code 55361-0021; 0597-0145; 66499-0061; 55361-0020; 0597-0143
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
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Weight decreased13.15.01.0050.030637%
Weight increased13.15.01.006--
Wheezing22.03.01.0090.001332%
White blood cell count abnormal13.01.06.0280.000533%Not Available
White blood cell count decreased13.01.06.012--
White blood cell count increased13.01.06.013--Not Available
Peripheral swelling02.05.04.015; 08.01.03.053--Not Available
Lung cancer metastatic22.08.01.004; 16.19.02.0030.000139%Not Available
Pneumomediastinum22.09.03.0040.001332%Not Available
Subileus07.13.01.0040.000139%Not Available
Ejection fraction decreased13.14.02.0030.001066%
Contusion23.03.11.002; 15.03.01.008; 12.01.06.001; 24.07.06.001--
Lower gastrointestinal haemorrhage24.07.02.030; 07.12.02.0070.001332%
Deep vein thrombosis24.01.02.003--Not Available
Post procedural haemorrhage24.07.01.014; 12.02.05.0040.001332%
Exercise tolerance decreased08.01.03.0360.000533%Not Available
Malignant neoplasm progression16.16.01.005--Not Available
Large intestine polyp16.05.02.006; 07.20.01.0100.000799%Not Available
Acute coronary syndrome24.04.04.011; 02.02.02.0150.002398%Not Available
Respiratory tract congestion22.02.07.0030.001332%Not Available
Pruritus generalised23.03.12.003--Not Available
Secretion discharge08.01.03.0190.000556%Not Available
Transaminases increased13.03.01.0150.003996%Not Available
Haemorrhage24.07.01.002--Not Available
Pulmonary mass22.02.07.0040.000799%Not Available
Congestive cardiomyopathy02.04.01.0030.001066%Not Available
Gastric disorder07.11.01.0030.001865%Not Available
Colitis microscopic07.08.01.0110.000533%Not Available
Urine odour abnormal20.02.01.0200.000533%Not Available
Cognitive disorder19.21.02.001; 17.03.03.003--
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