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)
Sinus disorder22.04.06.0020.000533%
Respiratory tract infection22.07.07.001; 11.01.08.0170.001332%Not Available
Unevaluable event08.01.03.0510.002931%Not Available
Hypophagia19.09.01.004; 14.03.01.006; 07.01.06.010--Not Available
Osteonecrosis of jaw24.04.05.005; 15.02.04.010--
Pulmonary arterial hypertension24.08.03.003; 22.06.01.0020.000278%Not Available
Liver injury12.01.02.003; 09.01.07.0220.002131%Not Available
Oropharyngeal pain22.02.05.022; 07.05.05.004--
Acute kidney injury20.01.03.016--
Traumatic lung injury22.01.02.013; 12.01.03.0030.000533%Not Available
Drug-induced liver injury09.01.07.023; 12.03.01.0440.001332%Not Available
Peripheral artery thrombosis24.01.02.0100.000139%Not Available
Hepatic cancer09.04.02.008; 16.07.02.0040.000799%Not Available
Pneumocystis jirovecii pneumonia22.07.08.009; 11.03.07.0050.000208%Not Available
Faeces soft07.01.03.0080.001332%Not Available
Myocardial necrosis marker increased13.04.01.0130.000533%Not Available
Multiple organ dysfunction syndrome08.01.03.057--
Anal incontinence07.01.06.029; 17.05.01.0210.000533%
Liver function test increased13.03.01.0440.002931%Not Available
Abnormal loss of weight14.03.02.0190.004529%Not Available
Biopsy lung13.19.03.0040.000533%Not Available
Catheterisation cardiac13.14.07.0030.000799%Not Available
Chronic respiratory failure14.01.04.005; 22.02.06.0050.000208%Not Available
Diverticulum intestinal haemorrhagic24.07.02.043; 07.10.01.0030.000533%Not Available
Full blood count decreased13.01.07.004--Not Available
Oxygen saturation abnormal13.02.01.0280.000533%Not Available
Pneumonia pseudomonal22.07.06.014; 11.02.12.0040.000533%Not Available
Pneumothorax spontaneous22.05.02.0070.000208%Not Available
Respiratory rate increased13.15.01.0040.000533%Not Available
Total lung capacity decreased13.19.01.0130.001332%Not Available
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