82/100 · Critical
Manufactured by E.R. Squibb & Sons, L.L.C.
High Incidence of Serious Adverse Events with DASATINIB
55,495 FDA adverse event reports analyzed
Last updated: 2026-05-12
DASATINIB is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by E.R. Squibb & Sons, L.L.C.. Based on analysis of 55,495 FDA adverse event reports, DASATINIB has a safety score of 82 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 DASATINIB include PLEURAL EFFUSION, FATIGUE, DIARRHOEA, NAUSEA, DEATH. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DASATINIB.
Dasatinib has a safety concern score of 82 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 55,495 adverse event reports for this medication, which is primarily manufactured by E.R. Squibb & Sons, L.L.C..
The most commonly reported adverse events include Pleural Effusion, Fatigue, Diarrhoea. Of classified reports, 59.9% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. DASATINIB reports a high percentage of serious adverse events, particularly pleural effusion and death.
Fatigue, diarrhea, and nausea are common non-serious adverse events. The drug is associated with a range of serious reactions including pulmonary edema, pneumonia, and sepsis.
Patients taking Dasatinib should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. DASATINIB can cause severe hematological and respiratory adverse events, and patients should be monitored closely for these conditions. Drug interactions, particularly with other hematological agents, should be avoided. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Dasatinib received a safety concern score of 82/100 (high concern). This is based on a 59.9% serious event ratio across 36,259 classified reports. The score accounts for 55,495 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Female: 16,891, Male: 16,320, Unknown: 152. The most frequently reported age groups are age 62 (619 reports), age 63 (580 reports), age 65 (579 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 36,259 classified reports for DASATINIB:
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.
DASATINIB can cause severe hematological and respiratory adverse events, and patients should be monitored closely for these conditions. Drug interactions, particularly with other hematological agents, should be avoided.
If you are taking Dasatinib, here are important things to know. The most commonly reported side effects include pleural effusion, fatigue, diarrhoea, 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 severe respiratory or hematological issues to their healthcare provider immediately. Avoid concurrent use of DASATINIB with other hematological agents to prevent drug interactions. 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 DASATINIB for safety, and healthcare providers should report any adverse events to the FDA's MedWatch program.
The FDA has received approximately 55,495 adverse event reports associated with Dasatinib. 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 Dasatinib include Pleural Effusion, Fatigue, Diarrhoea, Nausea, Death. By volume, the top reported reactions are: Pleural Effusion (3,168 reports), Fatigue (2,515 reports), Diarrhoea (2,155 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Dasatinib.
Out of 36,259 classified reports, 21,720 (59.9%) were classified as serious and 14,539 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 Dasatinib break down by patient sex as follows: Female: 16,891, Male: 16,320, Unknown: 152. 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 Dasatinib adverse events are: age 62: 619 reports, age 63: 580 reports, age 65: 579 reports, age 58: 569 reports, age 61: 565 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 Dasatinib adverse event reports is E.R. Squibb & Sons, L.L.C.. 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 Dasatinib include: Headache, Rash, Drug Ineffective, Dyspnoea, Adverse Event. 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 Dasatinib 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.
Dasatinib has a safety concern score of 82 out of 100 (high 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. DASATINIB reports a high percentage of serious adverse events, particularly pleural effusion and death.
Key safety signals identified in Dasatinib's adverse event data include: Pleural effusion and death are the most frequent serious adverse events.. Pulmonary edema and pneumonia are significant respiratory issues.. Neutropenia and thrombocytopenia are common hematological adverse events.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
DASATINIB can cause severe hematological and respiratory adverse events, and patients should be monitored closely for these conditions. Drug interactions, particularly with other hematological agents, should be avoided. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Dasatinib.
Patients should report any signs of severe respiratory or hematological issues to their healthcare provider immediately. Avoid concurrent use of DASATINIB with other hematological agents to prevent drug interactions.
Dasatinib has 55,495 adverse event reports on file with the FDA. Fatigue, diarrhea, and nausea are common non-serious adverse events. The volume of reports for Dasatinib reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor DASATINIB for safety, and 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.
Explore other medications manufactured by E.R. Squibb & Sons, L.L.C. and compare their safety profiles:
The following drugs share commonly reported adverse reactions with DASATINIB:
Drugs related to DASATINIB based on therapeutic use, drug class, or shared indications: