Ticagrelor Side Effects

Some side effects of ticagrelor may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to ticagrelor: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking ticagrelor: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• feeling light-headed or short of breath, even with mild exertion or while lying down;

• nosebleed or other bleeding that will not stop;

• bloody or tarry stools, blood in your urine;

• coughing up blood or vomit that looks like coffee grounds;

• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

• sudden numbness or weakness, especially on one side of the body;

• sudden severe headache, confusion, problems with vision, speech, or balance;

• pale skin, weakness, fever, or jaundice (yellowing of the skin or eyes); or

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin.

Less serious side effects of ticagrelor may include:

• headache, mild dizziness;

• cough; or

• nausea, diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to ticagrelor: oral tablet

Hematologic

Hematologic side effects have included fatal/life-threatening bleeding such as intracranial; intrapericardial bleed with cardiac tamponade; hypovolemic shock or severe hypotension due to bleeding and requiring pressors or surgery; clinically overt or apparent bleeding associated with a decrease in hemoglobin (Hb) of more than 5 g/dL; transfusion of 4 or more units (whole blood or packed red blood cells (PRBCs)) for bleeding; major bleeding such as significantly disabling (e.g., intraocular with permanent vision loss); clinically overt or apparent bleeding associated with a decrease in Hb of 3 g/dL; transfusion of 2 to 3 units (whole blood or PRBCs) for bleeding; minor bleeding which requires medical intervention to stop or treat bleeding (e.g., epistaxis requiring visit to medical facility for packing); minimal bleeding such as bruising, bleeding gums, oozing from injection sites, not requiring intervention or treatment.

Cardiovascular

Cardiovascular side effects have included atrial fibrillation, hypertension, hypotension, chest pain, and bradycardia.

Musculoskeletal

Musculoskeletal side effects have included noncardiac chest pain and back pain.

Nervous system

Nervous system side effects have included headache and dizziness.

Respiratory

Respiratory side effects have included cough, dyspnea, exertional dyspnea, dyspnea at rest, nocturnal dyspnea, and paroxysmal nocturnal dyspnea.

Gastrointestinal

Gastrointestinal side effects have include nausea and diarrhea.

General

General side effects have included fatigue.

Endocrine

Endocrine side effects have included gynecomastia.

Hypersensitivity

Hypersensitivity side effects have included postmarketing reports of hypersensitivity reactions including angioedema.

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