This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.
WARNING: BLEEDING RISK Ticagrelor tablets , like other antiplatelet agents, can cause significant, sometimes fatal bleeding (5.1, 6.1 ) . Do not use ticagrelor tablets in patients with active pathological bleeding or a history of intracranial hemorrhage ( 4.1, 4.2 ). Do not start ticagrelor tablets in patients undergoing urgent coronary artery bypass graft surgery (CABG) ( 5.1, 6.1). If possible, manage bleeding without discontinuing ticagrelor tablets. Stopping ticagrelor tablets increases the risk of subsequent cardiovascular events ( 5.2 ) . WARNING: BLEEDING RISK See full prescribing information for complete boxed warning. Ticagrelor tablets , like other antiplatelet agents, can cause significant, sometimes fatal bleeding. ( 5.1 , 6.1 ) Do not use ticagrelor tablets in patients with active pathological bleeding or a history of intracranial hemorrhage. ( 4.1 , 4.2 ) Do not start ticagrelor tablets in patients undergoing urgent coronary artery bypass graft surgery (CABG). ( 5.1, 6.1 ) If possible, manage bleeding without discontinuing ticagrelor tablets. Stopping ticagrelor tablets increases the risk of subsequent cardiovascular events. ( 5.2 )
Warnings the FDA chose to announce publicly after approval, as opposed to quiet label edits. Class-wide items name the drug's class, not this drug specifically.
Ticagrelor tablets are 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. Ticagrelor tablets also reduces the risk of stent thrombosis in patients who have been stented for treatment of ACS. (1.1) to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events. While use is not limited to this setting, the efficacy of ticagrelor tablets were established in a population with type 2 diabetes mellitus (T2DM). (1.2) to reduce the risk of stroke in patients with acute ischemic stroke (NIH Stroke Scale score ≤5) or high-risk transient ischemic attack (TIA). (1.3) 1.1 Acute Coronary Syndrome or a History of Myocardial Infarction Ticagrelor tablets are 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. Ticagrelor tablets also red...
History of intracranial hemorrhage. (4.1) Active pathological bleeding. (4.2) Hypersensitivity to ticagrelor or any component of the product. (4.3 ) 4.1 History of Intracranial Hemorrhage Ticagrelor tablets are contraindicated in patients with a history of intracranial hemorrhage (ICH) because of a high risk of recurrent ICH in this population [see Clinical Studies (14.1), (14.2) ]. 4.2 Active Bleeding Ticagrelor tablets are contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage [see Warnings and Precautions (5.1) and Adverse Reactions (6.1) ]. 4.3 Hypersensitivity Ticagrelor tablets are contraindicated in patients with hypersensitivity (e.g., angioedema) to ticagrelor or any component of the product.
Dyspnea was reported more frequently with ticagrelor tablets than with control agents in clinical trials. Dyspnea from ticagrelor tablets is self-limiting. (5.3 ) Severe Hepatic Impairment: Likely increase in exposure to ticagrelor. (5.5 ) Laboratory Test Interference: False negative platelet functional test results have been reported for Heparin Induced Thrombocytopenia (HIT). Ticagrelor tablets are not expected to impact PF4 antibody testing for HIT. (5.7 ) 5.1 Risk of Bleeding Drugs that inhibit platelet function including ticagrelor tablets increase the risk of bleeding [see Warnings and Precautions (5.2) and Adverse Reactions ( 6.1 )]. Patients treated for acute ischemic stroke or TIA Patients at NIHSS >5 and patients receiving thrombolysis were excluded from THALES and use of ticagrelor tablets in such patients is not recommended. 5.2 Discontinuation of Ticagrelor Tablets in Patients Treated for Coronary Artery Disease Discontinuation of ticagrelor tablets will increase the risk of myocardial infarction, stroke, and death in patients being treated for coronary artery disease. If ticagrelor tablets must be temporarily discontinued (e.g., to treat bleeding or for significant su...
The following adverse reactions are also discussed elsewhere in the labeling: Bleeding [see Warnings and Precautions (5.1) ] Dyspnea [see Warnings and Precautions (5.3) ] Most common adverse reactions (>5%) are bleeding and dyspnea. (5.1, 5.3, 6.1) To report SUSPECTED ADVERSE REACTIONS, contact Apotex Corp. at 1-800-706-5575 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Ticagrelor tablets have been evaluated for safety in more than 58,000 patients. Bleeding in PLATO (Reduction in risk of thrombotic events in ACS) Figure 1 is a plot of time to the first non-CABG major bleeding event. Figure 1 - Kaplan-Meier estimate of time to first non-CABG PLATO-defined major bleeding event (PLATO) Frequency of bleeding in PLATO is summarized in Tables 1 and 2. About half of the non-CABG major bleeding events were in the first 30 days. Table 1 – Non-CABG related bleeds (PLATO) Ticagrelor * N=9,235 Clopido...
RECENT MAJOR CHANGES SECTION Dosage and Administration ( 2.2 , 2.4 ) 03/2024
Source: FDA SPL label for Ticagrelor (Aphena Pharma Solutions - Tennessee, LLC), effective 20251124. Full label on DailyMed.
These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.
| 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | 2026 |
|---|---|---|---|---|---|---|---|
| 3,014 | 2,780 | 2,395 | 1,876 | 2,099 | 2,173 | 1,700 | 792 |
4,387 reports blaming this drug for every million Medicare prescriptions filled, which is 1.6× the typical drug on this site. (4,514 reports in 2024–2026, against 1,029,007 Medicare fills in one year. This is the one number here that accounts for how many people take the drug.)
Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.
| Date | Class | Firm | Reason |
|---|---|---|---|
| 03/2021 | Class II | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
| 05/2017 | Class I | AstraZeneca Pharmaceuticals, LP | Presence of Foriegn Tablets/Capsules: customer complaint that an 8-count professional sample bottle labeled as BRILINTA 90 mg tablets contained 5 ZURAMPIC 200 mg tablets, in addition to the expected 8 BRILINTA tablets. |
Class I = reasonable probability of serious harm. Class II = temporary or reversible harm. Class III = unlikely to harm. Most generic recalls are manufacturing or labeling defects for one lot, not a verdict on the molecule.
Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.
In 2024, drug companies reported $84,321 in payments to US physicians and hospitals tied to this drug across 2,495 transactions (Brilinta $84,321).
No pending federal MDL names this drug or its brands.
Not named in any federal pharmaceutical settlement of $100M or more on record.
Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.
3 drugs in the same class grade a letter or more higher than ticagrelor on this site. Worth asking whether one of them would do the same job for you.
Same ATC pharmacological class, graded ones first, best grade at the top. Being in the same class does not make them interchangeable for your condition; it makes them worth asking about.