Brilinta: adverse event reports filed with FDA

17,760

reports as suspect product

0.1% of all reports · about 960 a year

210

reports, 12 months to June 2026

691 in the 12 months before

67.5%

marked serious by the reporter

88.3% across the class

12.4%

record death among outcomes, as reported

2,204 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Brilinta reports recording the termmedian drug in p2y12 platelet inhibitor

1. Dyspnoeashortness of breath16.8%2,980
2. Myocardial infarctionheart attack9.4%1,666
3. Deaththe patient died; cause not stated by this term7.4%1,312
4. Off label useused for a purpose or in a way not on the label6%1,064
5. Fatiguetiredness5.5%977
6. Contusiona bruise5.4%961
7. Chest painchest pain5.2%922
8. Dizzinesslight-headedness or unsteadiness4.1%735
9. Malaisegeneral feeling of being unwell3.7%651
10. Haemorrhagebleeding3.6%634
11. Astheniaweakness or lack of energy3%539
12. Epistaxisnosebleed2.9%510
13. Drug dose omissiona dose was missed2.8%498
14. Feeling abnormalfeeling odd or not right2.8%498
15. Product use issuea problem in how the product was used2.7%480
16. Intentional product misusedeliberate use not as intended2.6%468
17. Vascular stent thrombosis2.6%464
18. Headachehead pain2.4%435
19. Nauseafeeling sick2.4%430
20. Weight decreasedweight loss2.4%424
21. Coughcough2.3%417
22. Coronary artery occlusion2.3%416
23. Chest discomfortchest discomfort2.2%385
24. Gastrointestinal haemorrhagebleeding in the stomach or bowel2.1%366
25. Blood pressure increaseda raised blood pressure reading2%350
26. Cerebrovascular accidentstroke1.9%343
27. Painpain, site not specified1.9%338
28. Insomniadifficulty sleeping1.8%326
29. Thrombosis in devicea blood clot in the device1.7%295
30. Drug ineffectivethe medicine did not work as expected1.6%292

Top 30 of 1,213 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 8 drugs in the p2y12 platelet inhibitor class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 99,787 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 71.9% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 17,760 reports.

Drugs most often listed in the same reports

Other products listed in reports where Brilinta is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the p2y12 platelet inhibitor class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Brilinta as a suspect or interacting product; reports listing it only as a concomitant medication (4,304) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.