Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Palbociclib
Drug ID BADD_D01654
Description Palbociclib is a piperazine pyridopyrimidine[A176792] that acts in the cell cycle machinery. It is a second generation cyclin-dependent kinase inhibitor[A176798] selected from a group of pyridopyrimidine compounds due to its favorable physical and pharmaceutical properties.[A176810] Palbociclib was developed by Pfizer Inc after the discovery that identified the cyclin-dependent kinases as key regulators of cell growth.[L5867] It was originally FDA approved on March 2015 for the treatment of HR-positive, HER2-negative advanced or metastatic breast cancer and its indications were updated in April 2019 to include male patients based on findings from postmarketing reports and electronic health records demonstrating safety and clinical efficacy.[L4894]
Indications and Usage Palbociclib is indicated in combination with letrozole for the treatment of postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer as initial endocrine-based therapy for their metastatic disease. This indication is approved under accelerated approval based on progression-free survival (PFS). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Marketing Status Prescription
ATC Code L01EF01
DrugBank ID DB09073
KEGG ID D10372
MeSH ID C500026
PubChem ID 5330286
TTD Drug ID D00UZR
NDC Product Code 63539-189; 46708-910; 65129-1394; 52076-6263; 68554-0112; 61662-0014; 0069-0189; 76055-0036; 0069-0688; 63539-188; 63539-187; 0069-0284; 63539-688; 54893-0076; 0069-0486; 49386-022; 82245-0111; 63539-284; 76302-006; 0069-0188; 63539-486; 65015-885; 0069-0187; 71796-007
Synonyms palbociclib | 6-acetyl-8-cyclopentyl-5-methyl-2-(5-piperazin-1-ylpyridin-2-ylamino)-8H-pyrido(2,3-d)pyrimidin-7-one | Ibrance | PD 0332991 | PD0332991 | PD-0332991
Chemical Information
Molecular Formula C24H29N7O2
CAS Registry Number 571190-30-2
SMILES CC1=C(C(=O)N(C2=NC(=NC=C12)NC3=NC=C(C=C3)N4CCNCC4)C5CCCC5)C(=O)C
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)
Burning sensation17.02.06.001; 08.01.09.0290.011722%Not Available
C-reactive protein increased13.09.01.007--Not Available
Cachexia16.32.03.011; 14.03.02.001; 08.01.01.009--Not Available
Cardiac arrest02.03.04.001--
Cardiac failure02.05.01.001--
Cardiac failure acute02.05.01.005--Not Available
Cardiac failure congestive02.05.01.002--Not Available
Cardiac murmur13.14.01.001--Not Available
Cardio-respiratory arrest02.03.04.002; 22.02.06.007--Not Available
Cardiomegaly02.04.02.001--Not Available
Cardiomyopathy02.04.01.001--Not Available
Cardiovascular disorder24.03.02.009; 02.01.01.001--Not Available
Carpal tunnel syndrome17.09.02.0010.001865%Not Available
Cataract06.06.01.0010.006394%
Cellulitis23.09.01.001; 11.02.01.0010.007726%Not Available
Cerebral haemorrhage24.07.04.001; 17.08.01.003--Not Available
Cerebral infarction24.04.06.002; 17.08.01.004--Not Available
Cerebrovascular accident24.03.05.001; 17.08.01.007--
Cerebrovascular disorder24.03.05.002; 17.08.02.002--Not Available
Cheilitis23.03.03.025; 07.05.01.0010.002131%
Chest discomfort08.01.08.019; 02.02.02.009; 22.02.08.001--Not Available
Chest pain22.02.08.003; 08.01.08.002; 02.02.02.011--Not Available
Chills15.05.03.016; 08.01.09.0010.022911%
Choking22.02.05.001--Not Available
Cholecystitis09.03.01.001--
Cholelithiasis09.03.01.002--Not Available
Chromaturia20.02.01.002--
Chronic obstructive pulmonary disease22.03.01.007--Not Available
Clavicle fracture15.08.03.010; 12.04.01.0100.000799%Not Available
Coagulopathy01.01.02.001--Not Available
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