Note: This document contains side effect information about prasugrel. Some of the dosage forms listed on this page may not apply to the brand name Effient.
Applies to prasugrel: oral tablet
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.
Along with its needed effects, prasugrel (the active ingredient contained in Effient) 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:
Incidence not known
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:
Applies to prasugrel: oral tablet
The most common adverse reaction leading to drug discontinuation was bleeding.
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
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
Common (1% to 10%): Gastrointestinal hemorrhage, nausea, diarrhea
Uncommon (0.1% to 1%): Rectal hemorrhage, gingival bleeding, hematochezia
Common (1% to 10%): Rash, contusion, ecchymosis
Uncommon (0.1% to 1%): Subcutaneous hematoma
Rare (less than 0.1%): Angioedema
Common (1% to 10%): Dyspnea, cough, epistaxis
Uncommon (0.1% to 1%): Hemoptysis
Common (1% to 10%): Back pain, non-cardiac chest pain, pain in extremity
Common (1% to 10%): Vessel puncture site hematoma, puncture site hemorrhage
Common (1% to 10%): Headache, dizziness
Common (1% to 10%): Hypercholesterolemia/hyperlipidemia, peripheral edema
Common (1% to 10%): Fatigue, pyrexia
Common (1% to 10%): Hematuria
Common (1% to 10%): Newly-diagnosed malignancies
Uncommon (0.1% to 1%): Allergic reactions
Rare (less than 0.1%): Hypersensitivity, anaphylaxis
Uncommon (0.1% to 1%): Abnormal hepatic function
Uncommon (0.1% to 1%): Eye hemorrhage
Medically reviewed by BestRx Medical Team Last updated on 1/1/2020.
Source: Drugs.com Effient