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] as initial endocrine-based therapy for the treatment of human epidermal growth factor receptor type 2 (HER2)-negative and hormone receptor(HR)-positive tumors in adult patients with advanced/metastatic breast cancer. It is as well approved in combination with [fulvestrant] in patients with disease progression with prior endocrine therapy.[A176783] In the official labeling, the use of palbociclib should be accompanied with either an aromatase inhibition, no restricted to letrozole, as initial endocrine-based therapy in postmenopausal women or in man.[FDA label] The breast cancer starts as a group of cancer cells that grow into and destroy the nearby breast tissue. This growth can spread into other parts of the body which is called metastasis. According to the location of the cancer cells, it can be categorized in ductal carcinoma and lobular carcinoma. However, other types of breast cancer include inflammatory breast cancer, Paget disease of the breast, triple negative breast cancer non-Hodgkin lymphoma and soft tissue sarcoma.[L5870] In males, breast cancer is usually treated as the cases of postmenopausal women and almost all the cases are ductal carcinoma.[L5873]
Marketing Status approved; investigational
ATC Code L01EF01
DrugBank ID DB09073
KEGG ID D10372
MeSH ID C500026
PubChem ID 5330286
TTD Drug ID D00UZR
NDC Product Code 0069-0188; 54893-0076; 76055-0036; 82245-0111; 63539-688; 63539-187; 0069-0284; 49386-022; 65015-885; 68554-0112; 63539-284; 0069-0688; 52076-6263; 61662-0014; 71796-007; 63539-188; 63539-189; 63539-486; 0069-0187; 0069-0486; 65129-1394; 0069-0189; 83137-0003
UNII G9ZF61LE7G
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
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)
Thyroid mass05.02.01.0030.000683%-
Restless legs syndrome15.05.03.012; 17.02.07.0080.001724%-
Bicytopenia01.03.03.0100.000168%-
Early satiety07.01.06.027; 08.01.09.004; 14.03.01.0100.000112%-
Hot flush08.01.03.027; 21.02.02.001; 24.03.01.0050.062635%
Abdominal hernia07.16.06.0050.000437%-
Appetite disorder14.03.01.004; 19.09.01.0020.003358%-
Bladder disorder20.03.01.0020.001231%-
Breast disorder21.05.04.0040.000627%-
Eyelid disorder06.08.03.010; 23.03.03.0280.000381%-
Feeding disorder14.03.02.003; 19.09.01.0030.004052%-
Gastrointestinal motility disorder07.02.03.0010.000851%-
Haematotoxicity01.05.01.007; 12.03.01.0250.001735%-
Limb discomfort15.03.04.0140.004600%-
Jaw disorder15.02.04.0090.001063%-
Metastatic neoplasm16.16.01.0070.000929%-
Neoplasm progression16.16.02.0050.384989%-
Oesophageal disorder07.11.02.0010.000526%-
Peripheral embolism24.01.02.0050.000246%-
Vaginal disorder21.08.01.0050.000437%-
White blood cell disorder01.02.05.0020.005608%-
Decreased appetite08.01.09.028; 14.03.01.0050.111537%
Feeling of body temperature change08.01.09.0120.002642%-
Gastrointestinal ulcer07.04.04.0020.000246%-
Psychiatric symptom19.01.02.0010.001175%-
Polyp08.01.06.010; 16.02.02.0050.000414%-
Red blood cell abnormality01.07.02.0060.000112%-
Urinary tract obstruction20.08.01.0040.000168%
Ulcer haemorrhage08.03.06.003; 24.07.01.0400.000224%-
Vitamin B complex deficiency14.12.02.0030.000492%-
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