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)
Chronic gastritis11.07.01.016; 10.04.04.011; 07.08.02.0050.000799%Not Available
Computerised tomogram abnormal13.18.03.0020.000533%Not Available
Full blood count abnormal13.01.07.0030.005062%Not Available
Full blood count decreased13.01.07.0040.077792%Not Available
Infected skin ulcer11.01.12.025; 23.07.03.0170.000533%Not Available
Jaw fracture15.08.02.006; 12.04.05.0010.000799%Not Available
Malignant pleural effusion16.32.03.014; 22.05.04.0010.000139%Not Available
Mean cell haemoglobin concentration increased13.01.05.0260.000533%Not Available
Mean cell volume decreased13.01.05.0270.000533%Not Available
Metastases to bone16.22.02.005; 15.09.03.0060.003463%Not Available
Overweight14.03.02.0210.000799%Not Available
Pelvic mass21.07.04.012; 07.11.01.028; 08.03.05.0090.000533%Not Available
Positron emission tomogram abnormal13.18.03.0040.000533%Not Available
Red blood cell count abnormal13.01.05.0280.001066%Not Available
X-ray abnormal13.18.03.0070.000533%Not Available
Bladder prolapse20.03.01.0130.000533%Not Available
Tumour marker increased13.22.01.0170.020514%Not Available
Lower extremity mass15.03.01.0150.000799%Not Available
Axillary mass15.03.02.0140.000533%Not Available
Lumbar vertebral fracture15.08.05.007; 12.04.04.0070.000533%Not Available
Carbohydrate antigen 15-3 increased13.22.01.0060.000799%Not Available
Carbohydrate antigen 27.29 increased13.22.01.0080.000799%Not Available
Full blood count increased13.01.07.0020.001066%Not Available
Clostridium difficile infection11.02.02.0090.003463%Not Available
Breast cancer metastatic21.05.01.016; 16.10.01.0080.005212%Not Available
Gastric infection11.01.07.008; 07.19.03.0030.001332%Not Available
Gastrointestinal oedema07.11.01.0120.000533%Not Available
Neutrophil count abnormal13.01.06.0180.001865%Not Available
Bone scan abnormal13.16.01.0060.000533%Not Available
Onychalgia23.02.05.0260.000799%Not Available
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