What the label lists and what reports show
Ticagrelor side effects
Ticagrelor's FDA label: “Most common adverse reactions (>5%) are bleeding and dyspnea.” FAERS holds 31,712 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is dyspnoea (4,009 reports).
- Generic listed
- Boxed warning
Check it at the source: the ticagrelor FDA label on DailyMed (effective May 7, 2026, AstraZeneca Pharmaceuticals LP); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of BRILINTA?BRILINTA can cause serious side effects, including: • See “What is the most important information I should know about BRILINTA?” • Shortness of breath. Tell your healthcare provider if you have new, worsening or unexpected shortness of breath when you are at rest, at night, or when you are doing any activity. Slow or irregular heartbeat. • Irregular breathing. Tell your healthcare provider if you develop irregular breathing patterns when asleep or awake such as speeding up, slowing down or short pauses in breathing. Your healthcare provider will decide if you need further evaluation. These are not all of the possible side effects of BRILINTA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Source: FDA drug label, AstraZeneca Pharmaceuticals LP, effective May 7, 2026 (SPL set f7b3f443-e83d-4bf2-0e96-023448fed9a8), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (>5%) are bleeding and dyspnea.
Table 1 - Non-CABG related bleeds (PLATO)
| Reaction | BRILINTA 90 mg BID N=9235 n (%) patients with event | Clopidogrel N=9186 n (%) patients with event |
|---|---|---|
| PLATO Major + Minor | 713 (7.7) | 567 (6.2) |
| Major | 362 (3.9) | 306 (3.3) |
| Fatal/Life-threatening | 171 (1.9) | 151 (1.6) |
| Fatal | 15 (0.2) | 16 (0.2) |
| Intracranial hemorrhage (Fatal/Life-threatening) | 26 (0.3) | 15 (0.2) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe 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 AstraZeneca at 1-800-236-9933 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. BRILINTA has 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. …
Source: FDA drug label, AstraZeneca Pharmaceuticals LP, effective May 7, 2026 (SPL set f7b3f443-e83d-4bf2-0e96-023448fed9a8), via openFDA; the full label on DailyMed
What do FAERS reports show?
31,712 reports list ticagrelor among the medicines taken, each a report of something that happened, not proof the medicine caused it; 3,436 are coded as a death and 12,112 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 5 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Ticagrelor: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions