Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Talazoparib
Drug ID BADD_D02485
Description Talazoparib was approved by the FDA for use in germline BRCA mutated, HER2 negative, locally advanced or metastatic breast cancer on October 16, 2018 under the trade name Talzenna [L4661]. Talzenna was granted approval based on the results of the EMBRACA trial in which talazoparib resulted in a mean 8.6 months progression-free survival time versus physician's choice chemotherapy which resulted in 5.6 months progression-free survival.
Indications and Usage Talazoparib is indicated for the treatment of deleterious or suspected deleterious germline BRCA mutated, HER2 negative locally advanced or metastatic breast cancer in adults [FDA Label].
Marketing Status approved; investigational
ATC Code L01XK04
DrugBank ID DB11760
KEGG ID D10732
MeSH ID C586365
PubChem ID 135565082
TTD Drug ID D0GV8J
NDC Product Code 46014-0350; 0069-1195; 0069-1235; 0069-1031; 63539-051; 63539-295; 46014-3130; 0069-1751; 46014-1140; 46014-0370; 46014-0360; 46014-3120; 0069-1501; 0069-0296
UNII 9QHX048FRV
Synonyms talazoparib | Talzenna | BMN 673 | BMN-673 | BMN673
Chemical Information
Molecular Formula C19H14F2N6O
CAS Registry Number 1207456-01-6
SMILES CN1C(=NC=N1)C2C(NC3=CC(=CC4=C3C2=NNC4=O)F)C5=CC=C(C=C5)F
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 pain07.01.05.0020.000761%
Alopecia23.02.02.0010.000168%
Anaemia01.03.02.0010.003235%
Ascites09.01.05.003; 07.07.01.001; 02.05.04.0020.000112%
Asthenia08.01.01.0010.000336%Not Available
Back pain15.03.04.0050.000358%
Cardiac failure02.05.01.0010.000112%
Chest pain02.02.02.011; 22.12.02.003; 08.01.08.0020.000112%Not Available
Death08.04.01.0010.002127%
Diabetes mellitus14.06.01.001; 05.06.01.0010.000112%Not Available
Drug interaction08.06.03.0010.000437%Not Available
Dysphagia07.01.06.0030.000437%
Dyspnoea02.11.05.003; 22.02.01.0040.000582%
Dyspnoea exertional02.11.05.005; 22.02.01.0050.000112%Not Available
Fatigue08.01.01.0020.001399%
Febrile neutropenia08.05.02.004; 01.02.03.0020.000392%
Hepatocellular injury09.01.07.0080.000112%Not Available
Hypokalaemia14.05.03.0020.000112%
Hyponatraemia14.05.04.0020.000112%
Hypovolaemic shock24.06.02.0170.000112%Not Available
Leukopenia01.02.02.0010.000168%Not Available
Lymphadenopathy01.09.01.0020.000112%Not Available
Malaise08.01.01.0030.000627%
Migraine24.03.05.003; 17.14.02.0010.000246%Not Available
Muscular weakness17.05.03.005; 15.05.06.0010.000112%
Myelodysplastic syndrome16.01.04.001; 01.10.04.0010.000336%
Neutropenia01.02.03.0040.000839%Not Available
Pancytopenia01.03.03.0030.001119%Not Available
Pulmonary embolism24.01.06.001; 22.06.02.0010.000224%Not Available
Pyrexia08.05.02.0030.000392%
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