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Palbociclib Side Effects

The most commonly reported side effects of palbociclib include fatigue, white blood cell count decreased, and neoplasm progression, based on 93,722 FDA adverse event reports from 2006 to 2025.

Palbociclib side effects

Percentages show how often each reaction appears relative to total reports for palbociclib.

1
Fatigue16.6%15,593
2
White Blood Cell Count Decreased12.1%11,339
3
Neoplasm Progression11.3%10,630
4
Nausea9.0%8,475
5
Death8.2%7,660
6
Neutropenia7.1%6,628
7
Alopecia6.7%6,312
8
Diarrhoea6.3%5,877
9
Asthenia4.0%3,733
10
Off Label Use3.9%3,632
11
Decreased Appetite3.7%3,457
12
Pain3.7%3,447
13
Malaise3.6%3,329
14
Dyspnoea3.5%3,245
15
Vomiting3.3%3,121

These are voluntary reports and do not establish that palbociclib caused these reactions.

Report severity

52.5%Serious49,179 reports
15.0%Hospitalizations14,105 reports
11.0%Fatal10,306 reports

Seriousness is determined by the reporter, not by OpenClaim.

Palbociclib drug interactions

Other drugs that appear in adverse event reports alongside palbociclib. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Letrozole9.6%9,034
2
Fulvestrant7.0%6,548
3
Denosumab1.9%1,772
4
Anastrozole1.6%1,520
5
Exemestane1.2%1,102
6
Capecitabine1.2%1,085
7
Zoledronic-acid1.1%1,032
8
Tamoxifen-citrate1.0%978
9
Paclitaxel0.8%779
10
Everolimus0.8%768
11
Ribociclib0.7%697
12
Goserelin0.6%573
13
Trastuzumab0.5%423
14
Docetaxel0.4%390
15
Cyclophosphamide0.4%356

Taken alongside

1
Letrozole13.0%12,198
2
Fulvestrant7.8%7,315
3
Ergocalciferol5.2%4,862
4
Acetaminophen3.8%3,600
5
Denosumab3.6%3,414
6
Levothyroxine-sodium3.5%3,284
7
Calcium3.1%2,905
8
Anastrozole2.9%2,686
9
Aspirin2.6%2,461
10
Ondansetron2.6%2,421
11
Omeprazole2.3%2,168
12
Amlodipine2.3%2,138
13
Gabapentin2.2%2,095
14
Atorvastatin-calcium2.2%2,091
15
Oxycodone2.2%2,068

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports palbociclib side effects

92.4% of palbociclib adverse event reports involve female patients and 2.4% involve male patients. The largest age group is elderly at 56%. These figures reflect who reports side effects, not underlying risk.

Sex

Female92.4%
Male2.4%
Unknown5.2%

Age group

< 2<0.1%
2–11<0.1%
12–17<0.1%
18–6443.5%
65+56.4%

What is palbociclib used for

Conditions and purposes for which patients were taking palbociclib when the adverse event was reported.

Abdominal NeoplasmAbdominal PainAcinic Cell Carcinoma Of Salivary GlandAcute LeukaemiaAcute Lymphocytic LeukaemiaAcute Myeloid LeukaemiaAdenocarcinomaAdenocarcinoma GastricAdenocarcinoma Of ColonAdenocarcinoma PancreasAdrenal Gland CancerAdrenal Gland Cancer MetastaticAdrenal NeoplasmAdrenocortical CarcinomaAdverse Drug Reaction

Showing 15 of 968 indications

Palbociclib brand names and reporting trend

Palbociclib is sold under the brand name Palbociclib Capsules.

Brand names

Palbociclib Capsules16,122

Quarterly reports (20062025)

201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking palbociclib with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.