Brilintaticagrelor
According to the FDA label: BRILINTA is a P2Y 12 platelet inhibitor indicated to reduce the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI. For at least the first 12 months following ACS, it is superior to clopidogrel. BRILINTA also reduces the risk of stent thrombosis in patients who have been stented for treatment of ACS.
31,315 adverse event reports submitted to the FDA (2008–2026)
Top Reported Adverse Events
The most frequently reported events in association with Brilinta in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Tap any term below for a plain-language definition.
Dyspnoea 3,977 reports
Shortness of breath or difficulty breathing. Also spelled dyspnea in American English.
Full definition in the glossary → See all drugs reporting this event →Myocardial Infarction 2,760 reports
The medical term for a heart attack.
Full definition in the glossary →Death 1,720 reports
A report that the person died. A death appearing in reports for a drug does not mean the drug caused it. Reports record that a death occurred while the medication was being used, which can happen for many unrelated reasons.
Full definition in the glossary →Fatigue 1,537 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Off Label Use 1,514 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Chest Pain 1,458 reports
Pain or discomfort in the chest. Chest pain has many causes, but it is always worth taking seriously and discussing with a doctor.
Full definition in the glossary → See all drugs reporting this event →Dizziness 1,238 reports
A feeling of being lightheaded, unsteady, or like the room is spinning.
Full definition in the glossary → See all drugs reporting this event →Contusion 1,085 reports
The medical term for a bruise.
Full definition in the glossary →Drug Interaction 947 reports
A report that two or more medications may have affected each other when taken together.
Full definition in the glossary →Asthenia 913 reports
Physical weakness or lack of strength.
Full definition in the glossary →Malaise 891 reports
A general feeling of being unwell or uncomfortable, without a specific symptom.
Full definition in the glossary →Haemorrhage 869 reports
Bleeding, particularly heavy or uncontrolled bleeding. Also spelled hemorrhage in American English.
Full definition in the glossary →Nausea 849 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Drug Ineffective 842 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Chest Discomfort 763 reports
A feeling of unease, tightness, or mild pain in the chest. Related to chest pain, and like chest pain it is worth discussing with a doctor.
Full definition in the glossary →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Male | 17,556 |
| Female | 10,994 |
| Unknown | 158 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 81 |
| 18-34 | 150 |
| 35-49 | 1,295 |
| 50-64 | 5,777 |
| 65-74 | 5,197 |
| 75+ | 3,716 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Brilinta. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Other Serious | 13,878 |
| Hospitalization | 11,944 |
| Non-Serious | 7,412 |
| Death | 3,412 |
| Life-Threatening | 2,253 |
| Disability | 658 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Brilinta. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2008 | 3 |
| 2009 | 8 |
| 2010 | 5 |
| 2011 | 52 |
| 2012 | 1,008 |
| 2013 | 1,229 |
| 2014 | 1,596 |
| 2015 | 2,107 |
| 2016 | 4,309 |
| 2017 | 3,151 |
| 2018 | 2,956 |
| 2019 | 2,251 |
| 2020 | 2,189 |
| 2021 | 2,195 |
| 2022 | 1,880 |
| 2023 | 2,106 |
| 2024 | 2,174 |
| 2025 | 1,696 |
| 2026 (partial) | 400 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Brilinta
In FDA adverse event reports that mention Brilinta, these medications appeared most often in the same report.
- Aspirin (9,578 reports)
- Rosuvastatin (3,019 reports)
- Metoprolol (3,005 reports)
- Bisoprolol (2,852 reports)
- Clopidogrel (2,148 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026