Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Niraparib
Drug ID BADD_D02486
Description Niraparib is an orally active PARP inhibitor developed by Tesaro to treat ovarian cancer. FDA approval on March 2017.
Indications and Usage Niraparib is indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy
Marketing Status Not Available
ATC Code L01XK02
DrugBank ID DB11793
KEGG ID D10140
MeSH ID C545685
PubChem ID 24958200
TTD Drug ID D00BMF
NDC Product Code 71794-103; 69656-103; 61876-0723
Synonyms niraparib | 2-(4-(piperidin-3-yl)phenyl)-2H-indazole-7-carboxamide | niraparib hydrochloride | Zejula | MK 4827 | MK4827 | MK-4827
Chemical Information
Molecular Formula C19H20N4O
CAS Registry Number 1038915-60-4
SMILES C1CC(CNC1)C2=CC=C(C=C2)N3C=C4C=CC=C(C4=N3)C(=O)N
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)
Dyspnoea22.02.01.004; 02.01.03.0020.009324%
Dyspnoea exertional22.02.01.005; 02.01.03.0030.000533%Not Available
Ear pain04.03.01.0030.000533%
Emotional disorder19.04.02.0050.000533%Not Available
Epistaxis24.07.01.005; 22.04.03.0010.001598%
Erythema23.03.06.001--Not Available
Failure to thrive18.04.01.003; 19.07.05.001; 14.03.02.0080.000139%Not Available
Fatigue08.01.01.0020.032236%
Fear19.06.03.0010.001066%Not Available
Febrile neutropenia08.05.02.004; 01.02.03.0020.001332%
Feeling abnormal08.01.09.0140.006394%Not Available
Feeling jittery08.01.09.0160.000799%Not Available
Flatulence07.01.04.0020.001598%
Fluid retention20.01.02.003; 14.05.06.0020.001066%Not Available
Gait disturbance08.01.02.002; 17.02.05.016--
Gamma-glutamyltransferase increased13.03.01.0110.000533%
Gastrooesophageal reflux disease07.02.02.0030.002131%
Gastroenteritis viral11.05.04.005; 07.19.03.0050.000533%Not Available
Gastrointestinal disorder07.11.01.0010.001066%Not Available
Gingival bleeding24.07.02.010; 07.09.07.0010.001066%Not Available
Gingival swelling07.05.04.0030.000533%Not Available
Glomerular filtration rate decreased13.13.01.0090.000799%Not Available
Haematemesis24.07.02.011; 07.12.02.0020.000533%Not Available
Haematochezia07.12.02.003; 24.07.02.0120.000278%Not Available
Haematocrit decreased13.01.05.0010.004529%Not Available
Haematoma24.07.01.0010.000278%
Haematuria24.07.01.047; 20.02.01.0060.001066%
Blood urine present13.13.02.0020.000533%Not Available
Haemoglobin decreased13.01.05.0030.012255%Not Available
Haemoptysis24.07.01.006; 22.02.03.004; 02.01.02.0060.000533%Not Available
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