Applies to prasugrel: oral tablet.
Warning
Oral route (Tablet)
Prasugrel can cause significant and sometimes fatal bleeding. Do not use prasugrel in patients with active pathological bleeding or a history of transient ischemic attack or stroke. Risk factors for bleeding include body weight of less than 60 kg, propensity to bleed, and concomitant use of medications that increase the risk of bleeding (eg, warfarin, heparin, fibrinolytics, chronic use of NSAIDs). Prasugrel is not recommended in patients 75 years of age or older, except for high-risk situations (diabetes, history of prior myocardial infarction). Do not start prasugrel in patients likely to undergo urgent CABG, and discontinue at least 7 days prior to any surgery. If possible, manage bleeding without discontinuing prasugrel, as discontinuation in the first few weeks after acute coronary syndrome may increase risk for subsequent cardiovascular events.
Serious side effects of Prasugrel
Along with its needed effects, prasugrel 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 prasugrel:
More common
- Blurred vision
- dizziness
- headache
- nervousness
- pounding in the ears
- slow or fast heartbeat
Less common
- Black, tarry stools
- bloating or swelling of the face, arms, hands, lower legs, or feet
- chest pain or discomfort
- chills
- cough
- difficult or labored breathing
- fainting
- fever
- irregular heartbeat
- lightheadedness, dizziness, or fainting
- painful or difficult urination
- rapid weight gain
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- swollen glands
- tightness in the chest
- tingling of the hands or feet
- unusual bleeding or bruising
- unusual tiredness or weakness
- unusual weight gain or loss
Incidence not known
- Change in mental status
- dark or bloody urine
- difficulty with speaking
- fever
- pale color of the skin
- pinpoint red spots on the skin
- seizures
- weakness
- yellow eyes or skin
Other side effects of Prasugrel
Some side effects of prasugrel 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
- Back pain
- diarrhea
- nausea
- pain in the arms or legs
- rash
For Healthcare Professionals
Applies to prasugrel: oral tablet.
General
The most common adverse reaction leading to drug discontinuation was bleeding.[Ref]
Hematologic
Very common (10% or more): CABG (coronary artery bypass graft surgery)-related TIMI (Thrombolysis in Myocardial Infarction) Major (clinically overt bleeding associated with hemoglobin decreased by 5 g/dL or more, or intracranial hemorrhage) or Minor (overt bleeding associated with hemoglobin decreased by 3 to less than 5 g/dL) bleeding (14.1%), non-CABG-related TIMI Major or Minor bleeding in patients less than 60 kg (10.1%)
Common (1% to 10%): Non-CABG-related TIMI Major bleeding, non-CABG-related TIMI Minor bleeding, non-CABG-related life-threatening TIMI Major bleeding, non-CABG-related TIMI fatal bleeding in patients 75 years or older, CABG-related reoperation TIMI Major bleeding, CABG-related TIMI Major bleeding requiring transfusion of 5 units or more, anemia, leukopenia (less than 4 x 10(9) WBC/L)
Uncommon (0.1% to 1%): Non-CABG-related fatal TIMI Major bleeding, non-CABG-related symptomatic intracranial hemorrhage (ICH), non-CABG-related TIMI Major bleeding requiring inotropes, non-CABG-related TIMI Major bleeding requiring surgical intervention, non-CABG-related TIMI Major bleeding requiring transfusion of 4 units or more, CABG-related fatal TIMI Major bleeding, post-procedural hemorrhage
Rare (less than 0.1%): Severe thrombocytopenia
Postmarketing reports: Thrombocytopenia[Ref]
Cardiovascular
Common (1% to 10%): Hypertension, hypotension, atrial fibrillation, bradycardia, hematoma
Uncommon (0.1% to 1%): Retroperitoneal hemorrhage, pericardial effusion/hemorrhage/tamponade
Very rare (less than 0.01%): Thrombotic thrombocytopenic purpura[Ref]
Gastrointestinal
Common (1% to 10%): Gastrointestinal hemorrhage, nausea, diarrhea
Uncommon (0.1% to 1%): Rectal hemorrhage, gingival bleeding, hematochezia[Ref]
Dermatologic
Common (1% to 10%): Rash, contusion, ecchymosis
Uncommon (0.1% to 1%): Subcutaneous hematoma
Rare (less than 0.1%): Angioedema[Ref]
Respiratory
Common (1% to 10%): Dyspnea, cough, epistaxis
Uncommon (0.1% to 1%): Hemoptysis[Ref]
Musculoskeletal
Common (1% to 10%): Back pain, non-cardiac chest pain, pain in extremity[Ref]
Local
Common (1% to 10%): Vessel puncture site hematoma, puncture site hemorrhage[Ref]
Nervous system
Common (1% to 10%): Headache, dizziness[Ref]
Metabolic
Common (1% to 10%): Hypercholesterolemia/hyperlipidemia, peripheral edema[Ref]
Other
Common (1% to 10%): Fatigue, pyrexia[Ref]
Genitourinary
Common (1% to 10%): Hematuria[Ref]
Oncologic
Common (1% to 10%): Newly-diagnosed malignancies[Ref]
Immunologic
Uncommon (0.1% to 1%): Allergic reactions
Rare (less than 0.1%): Hypersensitivity, anaphylaxis[Ref]
Hepatic
Uncommon (0.1% to 1%): Abnormal hepatic function[Ref]
Ocular
Uncommon (0.1% to 1%): Eye hemorrhage[Ref]
