Note: This document contains side effect information about ticagrelor. Some dosage forms listed on this page may not apply to the brand name Brilinta.

Summary

Common side effects of Brilinta include: dyspnea. Continue reading for a comprehensive list of adverse effects.

Applies to ticagrelor: oral tablet.

Serious side effects of Brilinta

Along with its needed effects, ticagrelor (the active ingredient contained in Brilinta) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking ticagrelor:

More common

• Back pain
• bleeding gums
• blurred vision
• chest pain, tightness, or discomfort
• confusion
• cough
• coughing up blood
• difficult or trouble breathing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fast, slow, or irregular heartbeat
• headache
• increased menstrual flow or vaginal bleeding
• lightheadedness, dizziness, or fainting
• loss of consciousness
• nausea or vomiting
• nervousness
• nosebleeds
• paralysis
• pounding in the ears
• prolonged bleeding from cuts
• red or black, tarry stools
• red or dark brown urine
• sweating
• unusual bleeding or bruising
• unusual tiredness or weakness

Rare

• Change in mental status
• difficulty in speaking
• fever
• pale skin
• pinpoint red spots on the skin
• seizures
• yellow eyes or skin

Incidence not known

• Difficulty with swallowing
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• rash

Other side effects of Brilinta

Some side effects of ticagrelor may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Diarrhea

For Healthcare Professionals

Applies to ticagrelor: oral tablet.

General

The most commonly reported side effects were bleeding and dyspnea.^[Ref]

Hematologic

Very common (10% or more): Bleeding (12%)

Postmarketing reports: Thrombotic thrombocytopenic purpura^[Ref]

In the PLATO study (PLATelet Inhibition and Patient Outcomes, n= 18,624), 9235 patients were treated with ticagrelor 90 mg orally twice a day. Patients were evaluated for non-CABG related major or minor bleeds compared to clopidogrel (n=9186). A minor bleed required medical intervention to stop or treat bleeding, whereas a major bleed included any of the following: fatal, intracranial, intrapericardial with cardiac tamponade, hypovolemic shock or severe hypotension requiring intervention, significantly disabling (e.g., intraocular with permanent vision loss), a decrease in hemoglobin of at least 3 g/dL (or a fall in hematocrit of at least 9%), or a transfusion of 2 or more units. A major bleed that was fatal/life-threatening was any of the events described as a major bleed plus a decrease in hemoglobin of more than 5 g/dL, a fall in hematocrit of at least 15%, or a transfusion of 4 or more units. A fatal bleed was a bleeding event that directly led to death within 7 days. For ticagrelor, the incidence of major and minor bleeds was 7.7% (clopidogrel 6.2%). These findings are broken down as followed: Major bleed (3.9%) major bleed fatal/life threatening (1.9%), fatal (0.2%), and intracranial hemorrhage fatal/life threatening (0.3%). Approximately half of the non-CABG major bleeding events occurred in the first 30 days.

In the PLATO study, when antiplatelet therapy was stopped 5 days prior to CABG, major bleeding occurred in 75% and 79% of patients receiving ticagrelor or clopidogrel, respectively.^[Ref]

Respiratory

During the PLATO study, (PLATelet Inhibition and Patient Outcomes, n= 18,624), dyspnea was reported in 13.8% of ticagrelor-treated patients, it was usually mild to moderate in intensity and often resolved during continued treatment, however, drug discontinuation was required in 0.9% of patients. In the PEGASUS study (n=21,162), 4.3% of patients taking ticagrelor (the active ingredient contained in Brilinta) 60 mg orally twice a day discontinued treatment due to dyspnea compared to 0.7% receiving aspirin alone. In a substudy of PLATO, 199 subjects underwent pulmonary function testing irrespective of whether they reported dyspnea. There was no indication of an adverse effect on pulmonary function assessed after one month or after at least 6 months of chronic treatment. During the THEMIS study (n=19,220), dyspnea was reported in 21% of ticagrelor-treated patients which led to drug discontinuation in 6.9% of patients.^[Ref]

Very common (10% or more): Dyspnea (up to 21%)

Common (1% to 10%): Epistaxis, cough

Uncommon (0.1% to 1%): Hemoptysis

Postmarketing reports: Central sleep apnea, Cheyne-Stokes respiration^[Ref]

Cardiovascular

In a Holter substudy of approximately 3000 patients from the PLATelet Inhibition and Patient Outcomes study, (PLATO, n= 18,624), more patients had ventricular pauses 3 seconds or longer with ticagrelor (the active ingredient contained in Brilinta) (6%) than with clopidogrel (3.5%) in the acute phase and 2.2% and 1.6% respectively after 1 month. Patients that were at an increased risk for bradycardic events were excluded from these studies. Patients with congestive heart failure (CHF) who were taking ticagrelor experienced ventricular pauses at a higher rate (9.2%) than those without CHF (5.4).^[Ref]

Common (1% to 10%): Ventricular pauses, cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, bradycardia, cardiac failure, atrial fibrillation, peripheral edema, hypertension, hypotension, syncope, pre-syncope

Uncommon (0.1% to 1%): Non-cardiac chest pain

Postmarketing reports: Atrioventricular block^[Ref]

Renal

Common (1% to 10%): Serum creatinine elevations^[Ref]

During the PLATO study, (PLATelet Inhibition and Patient Outcomes, n= 18,624), serum creatinine levels increased by more than 50% in 7.4% of patients receiving ticagrelor 90 mg orally. Levels did not continue to increase with ongoing treatment and often decreased with continued therapy. Reversibility occurred upon discontinuation even in those patients with the greatest increase in levels during treatment. Treatment groups did not differ for renal related serious adverse events (e.g. acute renal failure, chronic renal failure, toxic nephropathy, or oliguria).^[Ref]

Musculoskeletal

Common (1% to 10%): Back pain

Rare (0.01% to 0.1%): Hemarthrosis^[Ref]

Hypersensitivity

Postmarketing reports: Hypersensitivity reactions including angioedema^[Ref]

Nervous system

Common (1% to 10%): Dizziness, loss of consciousness

Uncommon (0.1% to 1%): Intracranial hemorrhage, paresthesia, headache^[Ref]

Gastrointestinal

Common (1% to 10%): Abdominal pain, dyspepsia, gastrointestinal hemorrhage, nausea, diarrhea, constipation, vomiting

Uncommon (0.1% to 1%): Retroperitoneal hemorrhage, gastritis, hematemesis, gastrointestinal ulcer hemorrhage, hemorrhoidal hemorrhage, oral hemorrhage^[Ref]

Metabolic

Uncommon (0.1% to 1%): Gout

Rare (0.01% to 0.1%): Hyperuricemia^[Ref]

In the PLATelet Inhibition and Patient Outcomes Study (PLATO, n= 18,624) the serum uric acid levels of patients taking ticagrelor 90 mg orally twice a day increased approximately 0.6 mg/dL from baseline. The difference disappeared within 30 days of stopping treatment. Gout occurred in 0.6% of patients.^[Ref]

Genitourinary

Common (1% to 10%): Urinary tract bleeding

Uncommon (0.1% to 1%): Vaginal bleeding^[Ref]

Dermatologic

Common (1% to 10%): Rash, pruritus, subcutaneous or dermal bleeding, bruising^[Ref]

Ocular

Uncommon (0.1% to 1%): Eye hemorrhage^[Ref]

Other

Common (1% to 10%): Vertigo, post procedural hemorrhage, fatigue, pyrexia

Uncommon (0.1% to 1%): Ear hemorrhage, wound hemorrhage, traumatic hemorrhage^[Ref]

Psychiatric

Rare (0.01% to 0.1%): Confusion^[Ref]