82/100 · Critical
Manufactured by AstraZeneca Pharmaceuticals LP
Ticagrelor Adverse Events: High Serious Event Rate and Hemorrhagic Concerns
52,671 FDA adverse event reports analyzed
Last updated: 2026-05-12
TICAGRELOR is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by AstraZeneca Pharmaceuticals LP. Based on analysis of 52,671 FDA adverse event reports, TICAGRELOR 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 TICAGRELOR include DYSPNOEA, MYOCARDIAL INFARCTION, DEATH, FATIGUE, OFF LABEL USE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for TICAGRELOR.
Ticagrelor 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 52,671 adverse event reports for this medication, which is primarily manufactured by Astrazeneca Pharmaceuticals Lp.
The most commonly reported adverse events include Dyspnoea, Myocardial Infarction, Death. Of classified reports, 76.2% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. High serious event rate, particularly for myocardial infarction and death.
Significant hemorrhagic events, including intracranial hemorrhage and gastrointestinal hemorrhage. Common gastrointestinal and cardiovascular symptoms reported.
Patients taking Ticagrelor should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Ticagrelor is associated with a risk of hemorrhagic events, including intracranial hemorrhage and gastrointestinal hemorrhage. Patients should be monitored for signs of bleeding and treated promptly if necessary. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Ticagrelor received a safety concern score of 82/100 (high concern). This is based on a 76.2% serious event ratio across 30,886 classified reports. The score accounts for 52,671 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: Male: 17,340, Female: 10,869, Unknown: 158. The most frequently reported age groups are age 70 (658 reports), age 72 (549 reports), age 62 (548 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 30,886 classified reports for TICAGRELOR:
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.
Ticagrelor is associated with a risk of hemorrhagic events, including intracranial hemorrhage and gastrointestinal hemorrhage. Patients should be monitored for signs of bleeding and treated promptly if necessary.
If you are taking Ticagrelor, here are important things to know. The most commonly reported side effects include dyspnoea, myocardial infarction, death, fatigue, off label use. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor for signs of bleeding, especially gastrointestinal and intracranial hemorrhage. Follow prescribed dosing instructions to minimize the risk of adverse events. 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.
Regulatory oversight includes monitoring for serious cardiovascular events and hemorrhagic complications. Ticagrelor is approved for use in patients with acute coronary syndrome or stable angina.
The FDA has received approximately 52,671 adverse event reports associated with Ticagrelor. 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 Ticagrelor include Dyspnoea, Myocardial Infarction, Death, Fatigue, Off Label Use. By volume, the top reported reactions are: Dyspnoea (3,952 reports), Myocardial Infarction (2,741 reports), Death (1,714 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Ticagrelor.
Out of 30,886 classified reports, 23,537 (76.2%) were classified as serious and 7,349 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 Ticagrelor break down by patient sex as follows: Male: 17,340, Female: 10,869, Unknown: 158. 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 Ticagrelor adverse events are: age 70: 658 reports, age 72: 549 reports, age 62: 548 reports, age 68: 539 reports, age 66: 538 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 Ticagrelor adverse event reports is Astrazeneca Pharmaceuticals Lp. 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 Ticagrelor include: Chest Pain, Dizziness, Contusion, Drug Interaction, Asthenia. 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 Ticagrelor 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.
Ticagrelor 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. High serious event rate, particularly for myocardial infarction and death.
Key safety signals identified in Ticagrelor's adverse event data include: High rate of serious events (76.2%). Multiple cardiovascular events including myocardial infarction and stroke. Significant hemorrhagic events, including intracranial and gastrointestinal hemorrhage. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Ticagrelor is associated with a risk of hemorrhagic events, including intracranial hemorrhage and gastrointestinal hemorrhage. Patients should be monitored for signs of bleeding and treated promptly if necessary. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Ticagrelor.
Monitor for signs of bleeding, especially gastrointestinal and intracranial hemorrhage. Follow prescribed dosing instructions to minimize the risk of adverse events.
Ticagrelor has 52,671 adverse event reports on file with the FDA. Significant hemorrhagic events, including intracranial hemorrhage and gastrointestinal hemorrhage. The volume of reports for Ticagrelor reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight includes monitoring for serious cardiovascular events and hemorrhagic complications. Ticagrelor is approved for use in patients with acute coronary syndrome or stable angina. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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