72/100 · Elevated
Manufactured by Pfizer Laboratories Div Pfizer Inc
Moderate Safety Concerns with Palbociclib: Focus on Hematological and Gastrointestinal Reactions
205,909 FDA adverse event reports analyzed
Last updated: 2026-05-12
PALBOCICLIB is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Pfizer Laboratories Div Pfizer Inc. Based on analysis of 205,909 FDA adverse event reports, PALBOCICLIB has a safety score of 72 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for PALBOCICLIB include FATIGUE, WHITE BLOOD CELL COUNT DECREASED, NEOPLASM PROGRESSION, NAUSEA, DEATH. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for PALBOCICLIB.
Palbociclib has a safety concern score of 72 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 205,909 adverse event reports for this medication, which is primarily manufactured by Pfizer Laboratories Div Pfizer Inc.
The most commonly reported adverse events include Fatigue, White Blood Cell Count Decreased, Neoplasm Progression. Of classified reports, 52.4% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Palbociclib reports show a high incidence of hematological adverse events such as neutropenia and anemia.
Gastrointestinal symptoms like nausea and diarrhea are also frequently reported. Serious adverse events, particularly related to disease progression and death, are concerning.
Patients taking Palbociclib should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Palbociclib can cause significant hematological side effects, including neutropenia and anemia, and patients should be monitored closely. Drug interactions are not specifically warned against, but caution is advised due to its impact on blood cell co This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Palbociclib received a safety concern score of 72/100 (elevated concern). This is based on a 52.4% serious event ratio across 93,575 classified reports. The score accounts for 205,909 total adverse event reports and 100 distinct reaction types. This elevated score indicates a notable proportion of serious adverse events and warrants careful monitoring.
Adverse event reports by sex: Female: 86,509, Male: 2,243, Unknown: 50. The most frequently reported age groups are age 65 (2,532 reports), age 70 (2,473 reports), age 69 (2,405 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 93,575 classified reports for PALBOCICLIB:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Palbociclib can cause significant hematological side effects, including neutropenia and anemia, and patients should be monitored closely. Drug interactions are not specifically warned against, but caution is advised due to its impact on blood cell co
If you are taking Palbociclib, here are important things to know. The most commonly reported side effects include fatigue, white blood cell count decreased, neoplasm progression, nausea, death. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should report any signs of infection, such as fever or chills, to their healthcare provider immediately. Regular blood tests are recommended to monitor for hematological side effects. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA continues to monitor Palbociclib for safety, and updates will be provided as necessary. Healthcare providers should report any adverse events to the FDA's MedWatch program.
The FDA has received approximately 205,909 adverse event reports associated with Palbociclib. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Palbociclib include Fatigue, White Blood Cell Count Decreased, Neoplasm Progression, Nausea, Death. By volume, the top reported reactions are: Fatigue (15,580 reports), White Blood Cell Count Decreased (11,337 reports), Neoplasm Progression (10,628 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Palbociclib.
Out of 93,575 classified reports, 49,052 (52.4%) were classified as serious and 44,523 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Palbociclib break down by patient sex as follows: Female: 86,509, Male: 2,243, Unknown: 50. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Palbociclib adverse events are: age 65: 2,532 reports, age 70: 2,473 reports, age 69: 2,405 reports, age 66: 2,401 reports, age 73: 2,397 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Palbociclib adverse event reports is Pfizer Laboratories Div Pfizer Inc. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Palbociclib include: Neutropenia, Alopecia, Diarrhoea, Asthenia, Off Label Use. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Palbociclib to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Palbociclib has a safety concern score of 72 out of 100 (elevated concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. Palbociclib reports show a high incidence of hematological adverse events such as neutropenia and anemia.
Key safety signals identified in Palbociclib's adverse event data include: Neutropenia and anemia are the most common hematological reactions.. Nausea and diarrhea are the most frequent gastrointestinal reactions.. Disease progression and death are reported as serious adverse events.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Palbociclib can cause significant hematological side effects, including neutropenia and anemia, and patients should be monitored closely. Drug interactions are not specifically warned against, but caution is advised due to its impact on blood cell co Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Palbociclib.
Patients should report any signs of infection, such as fever or chills, to their healthcare provider immediately. Regular blood tests are recommended to monitor for hematological side effects.
Palbociclib has 205,909 adverse event reports on file with the FDA. Gastrointestinal symptoms like nausea and diarrhea are also frequently reported. The volume of reports for Palbociclib reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor Palbociclib for safety, and updates will be provided as necessary. Healthcare providers should report any adverse events to the FDA's MedWatch program. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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