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)
Pulmonary embolism24.01.06.001; 22.06.02.0010.010656%Not Available
Pulmonary fibrosis22.01.02.0060.001181%
Pulmonary haemorrhage24.07.01.016; 22.02.04.0030.000533%
Pulmonary hypertension22.06.01.001; 24.08.03.0020.000903%
Pulmonary oedema22.01.03.003; 02.05.02.0030.001865%
Pulmonary thrombosis24.01.06.002; 22.06.02.0030.000533%Not Available
Pyrexia08.05.02.0030.009857%
Rales22.02.04.0040.000533%Not Available
Rash23.03.13.001--Not Available
Rash generalised23.03.13.002--Not Available
Rectal haemorrhage24.07.02.018; 07.12.03.0010.007193%
Renal disorder20.01.02.002--Not Available
Renal failure20.01.03.005--Not Available
Respiratory disorder22.02.07.0020.000486%Not Available
Respiratory distress22.02.01.0120.001066%Not Available
Respiratory failure22.02.06.002; 14.01.04.0030.003961%
Respiratory tract haemorrhage24.07.01.036; 22.02.07.0110.000139%Not Available
Retching07.01.07.0020.001066%Not Available
Retinal artery occlusion24.01.07.003; 06.10.01.0050.000208%Not Available
Retinal detachment12.01.04.004; 06.09.03.0030.000533%
Rheumatoid arthritis15.01.03.001; 10.04.06.0010.000799%Not Available
Rhinorrhoea22.02.05.0100.001066%
Right ventricular failure02.05.03.0020.000556%Not Available
Seizure17.12.03.001--
Sepsis11.01.11.0030.001181%
Septic shock24.06.02.011; 11.01.11.0040.000347%Not Available
Sinus congestion22.04.06.0010.000799%Not Available
Sinusitis22.07.03.007; 11.01.13.005--
Skin discolouration23.03.03.005--Not Available
Skin lesion23.03.03.0100.001598%Not Available
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