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)
Skin reaction23.03.03.013; 10.01.03.0190.000799%Not Available
Sleep disorder19.02.04.001--Not Available
Small cell lung cancer22.08.01.013; 16.19.08.0030.000347%Not Available
Somnolence19.02.05.003; 17.02.04.006--
Speech disorder22.02.05.034; 19.19.02.002; 17.02.08.003--Not Available
Sputum discoloured22.02.03.0100.000533%Not Available
Squamous cell carcinoma of lung22.08.01.014; 16.19.01.0060.000533%Not Available
Stomatitis07.05.06.005--
Subcutaneous emphysema23.07.04.006; 12.02.06.0020.000533%
Subdural haematoma17.08.05.002; 12.01.10.003; 24.07.04.005--Not Available
Sudden death02.03.04.013; 08.04.01.0030.000278%
Suicidal ideation19.12.01.003--
Supraventricular tachycardia02.03.03.0120.000799%
Swelling08.01.03.015--Not Available
Syncope17.02.04.008; 02.01.02.008; 24.06.02.012--
Tachycardia02.03.02.007--Not Available
Thrombocytopenia01.08.01.002--Not Available
Thrombosis24.01.01.006--Not Available
Tinnitus17.04.07.004; 04.04.01.002--
Transient ischaemic attack24.04.06.005; 17.08.04.0010.004795%
Tremor17.01.06.002--
Tuberculosis11.04.01.0060.000347%Not Available
Upper respiratory tract infection22.07.03.011; 11.01.13.009--
Urinary tract infection20.08.02.001; 11.01.14.004--
Urticaria10.01.06.001; 23.04.02.001--
Vaginal haemorrhage21.08.01.001; 24.07.03.005--
Vasculitis24.05.02.001; 10.02.02.0060.000208%
Vision blurred17.17.01.010; 06.02.06.007--
Visual impairment06.02.06.008--Not Available
Vomiting07.01.07.0030.024510%
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