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)
Upper respiratory tract congestion22.12.03.0330.000739%Not Available
Nasal discomfort22.12.03.0120.002821%Not Available
Paranasal sinus discomfort22.12.03.0180.001366%Not Available
Large intestinal haemorrhage24.07.02.026; 07.12.03.0030.000112%
Cardiac flutter02.03.02.0120.000280%Not Available
Oral pruritus07.05.05.0020.000381%Not Available
Epigastric discomfort07.01.02.0040.000437%Not Available
Musculoskeletal discomfort15.03.04.0010.001175%Not Available
Febrile bone marrow aplasia08.05.02.005; 01.03.03.0070.000224%Not Available
Secretion discharge08.01.03.0190.001556%Not Available
Dental discomfort07.09.06.0020.000627%Not Available
Skin burning sensation17.02.06.009; 23.03.03.0210.002429%Not Available
Haemorrhoidal haemorrhage24.10.02.001; 07.15.03.0020.000548%
Throat lesion22.12.03.0300.000571%Not Available
Haemorrhage urinary tract24.07.01.007; 20.02.03.0050.000168%Not Available
Fluid intake reduced14.05.10.0010.000548%Not Available
Pulmonary mass22.02.07.0040.001097%Not Available
Food craving19.09.01.010; 14.03.01.0090.000437%Not Available
Cutaneous lupus erythematosus23.03.02.008; 15.06.02.007; 10.04.03.0070.000280%Not Available
Vulvovaginal pruritus23.03.12.009; 21.08.02.0040.001119%Not Available
Temperature intolerance08.01.09.0220.000985%Not Available
Urine odour abnormal20.02.01.0200.003268%Not Available
Hypoaesthesia oral17.02.06.021; 07.05.05.0030.002865%Not Available
Eyelid irritation23.03.04.023; 06.04.04.0070.000381%Not Available
Paranasal sinus hypersecretion22.04.06.0040.001019%Not Available
Breast cancer female21.05.01.011; 16.10.01.0040.002720%Not Available
Anxiety disorder19.06.01.0020.000168%Not Available
Cancer pain16.32.03.0040.002082%Not Available
Dysgraphia17.02.03.0060.000492%Not Available
Hand dermatitis23.03.04.0320.000381%Not Available
The 13th Page    First    Pre   13 14 15 16 17    Next   Last    Total 18 Pages