What are the most common side effects of PRASUGREL?

Reported side effects vary by individual. The side-effects section on this page lists the events most frequently reported to FDA FAERS for PRASUGREL. FAERS is voluntary reporting, so it reflects what was reported, not absolute incidence.

Is PRASUGREL the same as Prasugrel?

Prasugrel is a brand name for PRASUGREL. They share the same active ingredient and FDA-approved indications. Biosimilars and authorised generics may differ in inactive ingredients such as buffers or preservatives.

PRASUGREL

Q: What is PRASUGREL used for?

PRASUGREL (brand name Prasugrel) is a Antiplatelet indicated for nonfatal myocardial infarction (MI), or nonfatal stroke compared to clopidogrel. The difference between treatments was driven predominantly by MI, with no difference on strokes and little difference on CV death [see Clinical Studies (14) ] ..

Q: How does PRASUGREL work?

PRASUGREL works through the following mechanism: 12.1 Mechanism of Action Prasugrel is an inhibitor of platelet activation and aggregation through the irreversible binding of its active metabolite to the P2Y 12 class of ADP receptors on platelets..

Antiplatelet

Brand names: Prasugrel, Effient

Oral

Mechanism of Action

12.1 Mechanism of Action Prasugrel is an inhibitor of platelet activation and aggregation through the irreversible binding of its active metabolite to the P2Y 12 class of ADP receptors on platelets.

Indications

nonfatal myocardial infarction (MI)

or nonfatal stroke compared to clopidogrel. The difference between treatments was driven predominantly by MI

with no difference on strokes and little difference on CV death [see Clinical Studies (14) ] .

Contraindications

• patients with a history of TIA or ischemic stroke (>3 months prior to enrollment) had a higher rate of stroke on prasugrel tablets (6.5%
• of which 4.2% were thrombotic stroke and 2.3% were intracranial hemorrhage [ICH]) than on clopidogrel (1.2%
• all thrombotic). In patients without such a history
• the incidence of stroke was 0.9% (0.2% ICH) and 1.0% (0.3% ICH) with prasugrel tablets and clopidogrel
• anaphylaxis) to prasugrel or any component of the product [see Adverse Reactions (6.2) ] .

FDA Warnings

5 WARNINGS AND PRECAUTIONS CABG-related bleeding: Risk increases in patients receiving prasugrel who undergo CABG (5
Discontinuation of Prasugrel: Premature discontinuation increases risk of stent thrombosis, MI, and death (5
1 General Risk of Bleeding Thienopyridines, including prasugrel, increase the risk of bleeding
The bleeding risk is highest initially, as shown in Figure 1 (events through 450 days; inset shows events through 7 days)

Known Side Effects

7 documented side effects by frequency

Chest Pain

1-10%

Shortness of Breath

1-10%

Fatigue

1-10%

Nausea

1-10%

Dizziness

1-10%

Drug Not Working

1-10%

Headache

0.1-1%

Community Discussions

No community discussions found for PRASUGREL yet.

Primary sources

Every figure on this page links back to its primary source. See data sources for full provenance.

DailyMed FDA label search → PRASUGREL openFDA label JSON → PRASUGREL FAERS adverse-event reports → PRASUGREL ClinicalTrials.gov → completed Phase 2+ trials of PRASUGREL

Compare With

8 available comparisons

Formulations

Dosage Forms

Tablet

Route

Oral