Adverse Drug Reaction Classification System

         

Pharmaceutical Information
Drug Name Niraparib
Drug ID BADD_D02629
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 approved; investigational
ATC Code L01XK02
DrugBank ID DB11793
KEGG ID D10140
MeSH ID C545685
PubChem ID 24958200
TTD Drug ID D00BMF
NDC Product Code 71794-103; 0173-0912; 0173-0915; 11014-0565; 11014-0572; 61876-0723; 0173-0909; 69656-103; 11014-0573; 11014-0571
UNII HMC2H89N35
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
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)
Abdominal distension07.01.04.001--
Amnesia17.03.02.001; 19.20.01.001--
Anaemia01.03.02.001--
Arthritis15.01.01.001--
Back pain15.03.04.005--
Breast mass21.05.04.002---
Chills08.01.09.001; 15.05.03.016--
Constipation07.02.02.001--
Death08.04.01.001--
Dizziness02.11.04.006; 17.02.05.003; 24.06.02.007--
Dyspepsia07.01.02.001--
Dyspnoea02.11.05.003; 22.02.01.004--
Epistaxis22.04.03.001; 24.07.01.005--
Fatigue08.01.01.002--
Flatulence07.01.04.002--
Hypertension24.08.02.001--
Insomnia17.15.03.002; 19.02.01.002--
Intestinal obstruction07.13.01.002---
Intracranial pressure increased17.07.02.002---
Loss of consciousness17.02.04.004---
Lymphadenopathy01.09.01.002---
Middle insomnia17.15.03.003; 19.02.01.003---
Nausea07.01.07.001--
Neoplasm16.16.02.001---
Nephrolithiasis20.04.01.002--
Neuropathy peripheral17.09.03.003---
Neutropenia01.02.03.004---
Palpitations02.11.04.012--
Pancytopenia01.03.03.003---
Paraesthesia17.02.06.005; 23.03.03.094--
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