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)
Gastrointestinal disorder07.11.01.001--Not Available
Gastrointestinal haemorrhage24.07.02.009; 07.12.02.001--Not Available
Gastrointestinal infection11.01.07.012; 07.19.02.005--Not Available
Gastrointestinal pain07.01.05.0050.001066%
Genital rash23.03.13.016; 21.10.01.0090.000533%Not Available
Gingival bleeding24.07.02.010; 07.09.07.0010.003730%Not Available
Gingival discolouration07.09.11.0020.000533%Not Available
Gingival disorder07.09.03.0010.001066%Not Available
Gingival pain07.09.04.0010.005328%
Gingival swelling07.05.04.0030.001865%Not Available
Gingivitis11.01.04.013; 07.09.03.0030.002398%
Glaucoma06.03.01.002--
Glossitis07.14.01.0010.000533%Not Available
Glossodynia07.14.02.0010.009857%Not Available
Glycosylated haemoglobin increased13.02.02.005--Not Available
Gout15.01.06.001; 14.09.01.001--Not Available
Granulocyte count decreased13.01.06.0050.001066%Not Available
Granulocytopenia01.02.03.003--Not Available
Groin pain15.03.02.0040.002131%Not Available
Haematemesis24.07.02.011; 07.12.02.002--Not Available
Haematochezia07.12.02.003; 24.07.02.012--Not Available
Haematocrit decreased13.01.05.0010.003996%Not Available
Haematoma24.07.01.001--
Blood urine present13.13.02.002--Not Available
Haemoglobin abnormal13.01.05.0110.001332%Not Available
Haemoglobin decreased13.01.05.0030.044224%Not Available
Haemolysis01.06.04.002--
Haemolytic anaemia01.06.03.002--Not Available
Haemoptysis02.01.02.006; 24.07.01.006; 22.02.03.004--Not Available
Haemorrhage intracranial24.07.04.003; 17.08.01.008--
The 9th Page    First    Pre   9 10 11 12 13    Next   Last    Total 31 Pages