Skip to Content

Prasugrel Side Effects

For the Consumer

Applies to prasugrel: oral tablet

As well as its needed effects, prasugrel may cause unwanted side effects that require medical attention.

Major Side Effects

If any of the following side effects occur while taking prasugrel, check with your doctor immediately:

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

Minor Side Effects

Some prasugrel side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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]

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

It is possible that some side effects of prasugrel may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

Hide