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 0597-0145; 0597-0143
Brand Vargatef [Boehringer-Ingelheim]
Synonym 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)
Abdominal discomfort07.01.06.001--Not Available
Abdominal distension07.01.04.001--
Abdominal pain07.01.05.002--
Abdominal pain lower07.01.05.010--Not Available
Abdominal pain upper07.01.05.003--
Acute myocardial infarction24.04.04.001; 02.02.02.001--Not Available
Acute respiratory distress syndrome22.01.03.001--
Acute respiratory failure22.02.06.001; 14.01.04.004--Not Available
Adenocarcinoma16.16.01.004--Not Available
Ageusia17.02.07.001; 07.14.03.003--Not Available
Alanine aminotransferase abnormal13.03.01.001--Not Available
Alanine aminotransferase increased13.03.01.003--
Alopecia23.02.02.001--
Amnesia17.03.02.001; 19.20.01.001--
Anaemia01.03.02.001--
Angina pectoris24.04.04.002; 02.02.02.002--
Angina unstable24.04.04.004; 02.02.02.004--Not Available
Anosmia22.04.03.006; 17.04.04.001--
Anxiety19.06.02.002--
Aortic aneurysm24.02.03.001--Not Available
Aortic dissection24.02.03.002--Not Available
Aphasia19.21.01.001; 17.02.03.001--
Appendicitis11.01.07.001; 07.19.01.001--
Arthralgia15.01.02.001--
Arthritis15.01.01.001--
Ascites09.01.05.003; 07.07.01.001; 02.05.04.002--
Aspartate aminotransferase abnormal13.03.01.004--Not Available
Aspartate aminotransferase increased13.03.01.006--
Asthenia08.01.01.001--Not Available
Atrial fibrillation02.03.03.002--
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