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)
Bone loss15.02.04.0200.000224%-
Cytopenia01.03.03.0120.006402%-
Pharyngeal disorder22.04.05.0070.000492%-
Oral disorder07.05.01.0050.002619%-
Vulvovaginal burning sensation21.08.02.0070.000112%-
Toxic neuropathy12.03.01.055; 17.09.03.0170.000112%-
Oropharyngeal blistering07.05.05.006; 22.12.03.0140.000437%-
Anal pruritus07.03.03.0020.000437%-
Tumour compression16.32.03.0210.000112%-
Oropharyngeal discomfort07.05.05.008; 22.12.03.0150.002183%-
Oropharyngeal pain07.05.05.004; 22.12.03.0160.021871%
Vulvovaginal pain21.08.02.0090.000571%
Upper-airway cough syndrome22.12.03.0360.001892%
Nail bed disorder23.02.05.0170.000302%-
Oesophageal irritation07.08.05.0040.000627%-
Skin sensitisation10.02.01.038; 23.03.03.0520.000437%-
Functional gastrointestinal disorder07.11.01.0160.000604%-
Faeces soft07.01.03.0080.004746%-
Noninfective gingivitis07.09.13.0160.001556%-
Peripheral venous disease24.04.02.0220.000112%-
Mouth swelling07.05.04.007; 10.01.05.020; 23.04.01.0200.001119%-
Respiratory symptom22.12.02.0130.000246%-
Excessive cerumen production04.01.01.0040.000381%-
Gingival discomfort07.09.13.0030.000571%-
Abdominal mass07.01.01.0030.000381%-
Blood blister12.01.06.013; 23.03.01.0280.000761%-
Bone cancer15.09.03.012; 16.29.02.0020.000660%-
Breast cancer recurrent16.10.01.009; 21.05.01.0170.000246%-
Breast haemorrhage21.05.05.014; 24.07.03.0210.000280%-
Chronic gastritis07.08.02.005; 10.04.04.011; 11.07.01.0160.000168%-
The 16th Page    First    Pre   16 17 18    Next   Last    Total 18 Pages