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Effient Side Effects

Generic Name: prasugrel

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.

For the Consumer

Applies to prasugrel: oral tablet

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:

More Common

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

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

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]

References

1. "Product Information. Effient (prasugrel)." Lilly, Eli and Company, Indianapolis, IN.

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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