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)
Dyspnoea22.02.01.004; 02.01.03.002--
Dyspnoea at rest22.02.01.025; 02.01.03.0070.000533%Not Available
Dyspnoea exertional02.01.03.003; 22.02.01.0050.007992%Not Available
Dysuria20.02.02.0020.007193%
Ear disorder04.03.01.0010.001598%Not Available
Ear haemorrhage24.07.01.004; 04.03.01.0020.000533%Not Available
Ear infection11.01.05.001; 04.03.01.0060.002398%Not Available
Ear pain04.03.01.0030.003197%
Eating disorder19.09.01.008; 14.03.01.0080.006927%Not Available
Eczema23.03.04.006--
Electrocardiogram QT prolonged13.14.05.004--
Electrolyte imbalance14.05.01.0020.001865%Not Available
Embolism venous24.01.01.003--Not Available
Emotional disorder19.04.02.0050.003996%Not Available
Emphysema22.01.02.0020.000278%Not Available
Endocarditis11.01.16.001; 02.09.01.001--
Enteritis07.08.03.002--
Epistaxis24.07.01.005; 22.04.03.0010.057012%
Eructation07.01.02.0030.002664%
Erythema23.03.06.001--Not Available
Eye discharge06.04.05.0010.001332%Not Available
Eye disorder06.08.03.0010.003463%Not Available
Eye haemorrhage24.07.05.002; 06.07.02.0010.001865%Not Available
Eye infection11.01.06.001; 06.04.05.0070.001865%
Eye irritation06.04.05.003--Not Available
Eye pain06.08.03.002--
Eye swelling06.08.03.003--Not Available
Eyelid oedema23.04.01.003; 10.01.05.001; 06.04.04.004--Not Available
Facial bones fracture15.08.04.001; 12.04.05.0020.000533%Not Available
Facial pain08.01.08.0120.000799%
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