Prasugrel Side Effects

Medically reviewed by Drugs.com. Last updated on Sep 21, 2023.

Applies to prasugrel: oral tablet.

Important warnings This medicine can cause some serious health issues

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]

Further information

Prasugrel side effects can vary depending on the individual. 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.

Medical Disclaimer