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 In the US, nintedanib is indicated for the treatment of idiopathic pulmonary fibrosis (IPF)[L8453] and to slow declining pulmonary function in patients with systemic sclerosis-associated interstitial lung disease.[L8462] In the EU, nintedanib is indicated in combination with docetaxel for the treatment of adult patients with metastatic, locally advanced, or locally recurrent non-small cell lung cancer of adenocarcinoma histology who have already tried first-line therapy.[L8459]
Marketing Status approved
ATC Code L01EX09
DrugBank ID DB09079
KEGG ID D10481
MeSH ID C530716
PubChem ID 135423438
TTD Drug ID D09HNV
NDC Product Code 55361-0020; 66499-0061; 0597-0143; 0597-0145; 51869-0040; 55361-0021
UNII G6HRD2P839
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
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice.
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Disease progression08.01.03.0380.002742%
Drug intolerance08.06.01.0130.004018%-
Non-small cell lung cancer16.19.01.001; 22.08.01.0020.000280%-
Food intolerance14.02.01.0050.000112%-
Retinal vascular thrombosis06.10.01.004; 24.01.07.0010.000112%-
Metastasis16.22.01.0010.000112%-
Renal impairment20.01.03.010---
Sinus disorder22.04.06.0020.000112%
Poor quality sleep17.15.04.002; 19.02.05.005---
Increased upper airway secretion22.12.03.007---
Bowel movement irregularity07.02.03.0030.000381%-
Hypophagia07.01.06.010; 14.03.01.006; 19.09.01.0040.001388%-
Osteonecrosis of jaw15.02.04.010; 24.04.05.0050.000448%
Pulmonary arterial hypertension22.06.01.002; 24.08.03.0030.000336%-
Liver injury09.01.07.022; 12.01.17.0120.001086%-
Regurgitation07.01.07.004---
Adverse reaction08.06.01.0180.000246%-
Gastrointestinal sounds abnormal07.01.01.002---
Head and neck cancer16.16.01.0030.000112%-
Hypertransaminasaemia09.01.02.0050.000112%-
Anorectal discomfort07.03.03.003---
Oropharyngeal discomfort07.05.05.008; 22.12.03.0150.000112%-
Oropharyngeal pain07.05.05.004; 22.12.03.016--
Acute kidney injury20.01.03.016--
Upper-airway cough syndrome22.12.03.036--
Gastrointestinal tract irritation07.08.03.0080.000381%-
Functional gastrointestinal disorder07.11.01.0160.000246%-
Drug-induced liver injury09.01.07.023; 12.03.01.044---
Peripheral artery thrombosis24.01.02.0100.000112%-
Hepatic cancer09.04.02.008; 16.07.02.004---
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