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)
Fracture15.08.02.001; 12.04.02.001--
Frequent bowel movements07.02.04.0020.000533%Not Available
Gait disturbance17.02.05.016; 08.01.02.002--
Gallbladder disorder09.03.02.0010.000799%Not Available
Gamma-glutamyltransferase abnormal13.03.01.0280.000533%Not Available
Gamma-glutamyltransferase increased13.03.01.0110.001598%
Gastric cancer16.13.03.001; 07.21.02.0010.000208%Not Available
Gastrooesophageal reflux disease07.02.02.0030.002664%
Gastroenteritis11.01.07.004; 07.19.03.0010.000799%Not Available
Gastroenteritis viral11.05.04.005; 07.19.03.0050.000799%Not Available
Gastrointestinal disorder07.11.01.0010.006660%Not Available
Gastrointestinal haemorrhage24.07.02.009; 07.12.02.0010.006927%Not Available
Gastrointestinal perforation07.04.04.0010.000417%Not Available
Generalised oedema08.01.07.004; 14.05.06.0070.000533%
Glaucoma06.03.01.0020.001332%
Glomerulonephritis20.05.01.001; 10.02.01.0060.000799%Not Available
Gout15.01.06.001; 14.09.01.0010.001066%Not Available
Haematemesis24.07.02.011; 07.12.02.0020.001598%Not Available
Haematochezia24.07.02.012; 07.12.02.0030.004529%Not Available
Haematoma24.07.01.001--
Haematuria24.07.01.047; 20.02.01.006--
Blood urine present13.13.02.0020.001332%Not Available
Haemoglobin decreased13.01.05.003--Not Available
Haemolytic anaemia01.06.03.0020.000533%Not Available
Haemoptysis02.01.02.006; 24.07.01.006; 22.02.03.0040.002664%Not Available
Haemorrhage intracranial17.08.01.008; 24.07.04.003--
Haemorrhagic stroke24.07.04.014; 17.08.01.0110.000533%Not Available
Haemorrhoids24.10.02.002; 07.15.03.0010.001332%
Hallucination19.10.02.002--
Headache17.14.01.001--
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