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)
Hepatic pain09.01.05.0050.001421%
Hepatic steatosis14.08.04.005; 09.01.07.003--Not Available
Hepatotoxicity12.03.01.008; 09.01.07.0090.002059%Not Available
Hernia08.01.04.0010.001321%Not Available
Hiccups07.01.06.009; 22.12.01.0010.001310%
Hunger14.03.02.012; 08.01.09.0030.001175%Not Available
Hydronephrosis20.01.05.0010.000448%Not Available
Hyperaesthesia23.03.03.080; 17.02.06.0040.003056%Not Available
Hyperchlorhydria07.11.03.0010.001063%Not Available
Hyperphagia19.09.01.005; 14.03.01.007; 07.01.06.0180.000246%Not Available
Hypersomnia19.02.05.001; 17.15.01.0010.004567%
Hypertonic bladder20.03.03.003; 17.10.01.0030.000381%Not Available
Hypoaesthesia23.03.03.081; 17.02.06.0230.032694%Not Available
Hypogeusia07.14.03.002; 17.02.07.0040.000929%Not Available
Immune system disorder10.02.01.0010.007846%Not Available
Impaired gastric emptying07.02.02.0040.000358%
Impaired healing08.03.02.0010.006391%Not Available
Incontinence20.02.02.004; 17.05.01.006; 07.01.06.0110.001231%Not Available
Increased appetite14.03.01.003; 08.01.09.0270.003201%Not Available
Increased tendency to bruise24.07.06.012; 23.06.01.009; 01.01.03.0050.002865%Not Available
Infection11.01.08.002--Not Available
Infection susceptibility increased11.01.08.004; 10.02.01.046--Not Available
Influenza22.07.02.001; 11.05.03.001--Not Available
Influenza like illness08.01.03.0100.005731%
Ingrowing nail23.02.05.0110.000246%Not Available
Initial insomnia19.02.01.005; 17.15.03.0050.001041%Not Available
Insomnia19.02.01.002; 17.15.03.0020.038302%
Intracranial aneurysm24.02.04.001; 17.08.06.0010.000224%Not Available
Iron deficiency anaemia14.13.02.001; 01.03.01.0020.000716%Not Available
Joint stiffness15.01.02.0030.005104%Not Available
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