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)
Optic ischaemic neuropathy24.04.10.001; 17.04.05.006; 06.07.03.0010.000302%Not Available
Oral discomfort07.05.05.0010.003134%Not Available
Oral mucosal blistering07.05.05.0170.006682%Not Available
Oral mucosal discolouration07.05.05.0070.000302%Not Available
Oral mucosal eruption07.05.05.0180.000492%Not Available
Oral pain07.05.05.0340.033265%
Osteosclerosis15.02.04.0120.000112%Not Available
Ovarian cancer16.12.04.001; 21.11.01.0030.000414%Not Available
Ovarian disorder21.11.02.0040.000246%Not Available
Pain in extremity15.03.04.0100.046025%
Pain in jaw15.02.01.0030.003190%Not Available
Pain of skin23.03.03.0030.004119%
Painful respiration22.12.02.0110.000627%Not Available
Pancreatic disorder07.18.02.0010.000246%Not Available
Pancytopenia01.03.03.0030.009525%Not Available
Parosmia22.04.03.007; 17.04.04.0020.002261%Not Available
Pathological fracture16.32.03.007; 15.08.02.008; 12.04.02.0060.000336%Not Available
Peripheral coldness23.06.04.008; 24.04.03.006; 08.01.09.0100.001724%Not Available
Peripheral sensory neuropathy17.09.03.005--
Pharyngeal haemorrhage24.07.02.017; 22.04.05.0020.000112%
Pharyngeal ulceration22.04.05.0040.000246%Not Available
Pharyngitis07.05.07.004; 22.07.03.004; 11.01.13.003--
Plantar fasciitis15.03.03.0020.000358%Not Available
Platelet count decreased13.01.04.001--
Platelet disorder01.08.03.0010.001444%Not Available
Pleural disorder22.05.03.0020.000112%Not Available
Pleural effusion22.05.02.0020.010409%
Pleurisy22.05.01.0010.000414%Not Available
Pneumonitis22.01.01.0060.009469%
Poikilocytosis01.07.02.0090.000246%Not Available
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