Prescription medication · P2Y12 Inhibitor (Antiplatelet)

prasugrel

Also sold as Effient. Prasugrel helps prevent dangerous blood clots if you have acute coronary syndrome.

Data updated 2026-05-15

2,254
FDA reportsRarely reported
6
InteractionsFew interactions
99% less
Generic vs brandHuge savings
1
Recall record

What the data shows

prasugrel (Effient) is a prescription P2Y12 Inhibitor (Antiplatelet), among the least-reported drugs the FDA tracks (2,254 FDA reports), whose generic costs a fraction of the brand (about 99% less).

Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.

prasugrel (Effient) is a prescription P2Y12 Inhibitor (Antiplatelet). Prasugrel helps prevent dangerous blood clots if you have acute coronary syndrome.

Prasugrel is a drug that helps prevent blood clots. It is used to lower the risk of heart attack, stroke, and blood clots in people with acute coronary syndrome who are undergoing a procedure called percutaneous coronary intervention (PCI).

Drug Pricing (NADAC)

Brand Price

$19.45/unit

Generic Price

$0.27/unit

Generic Savings

99%

Generic Available

Yes (6 manufacturers)

Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →

View Alternatives → Compare with Another Drug → Full Side Effects Report →

What it does

Prasugrel helps prevent dangerous blood clots if you have acute coronary syndrome.

Common side effects

Bleeding

Key warnings

Prasugrel can cause serious bleeding, which can sometimes be fatal.

The sections below are summarized in plain English from prasugrel's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.

How It Works

Prasugrel belongs to a class of drugs called P2Y12 inhibitors. It works by blocking a substance in your blood called ADP. By blocking ADP, prasugrel helps prevent platelets (blood cells that cause clotting) from sticking together and forming unwanted blood clots.

Side Effects (from patient reports)

Based on 2,254 FDA adverse event reports.

Most-reported reactions

Adverse reactions in FAERS for prasugrel, by number of reports

reports

What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.

Source FDA Adverse Event Reporting System (FAERS) As of 2025

Reports over time

Adverse-event reports filed for prasugrel each year to the FDA Adverse Event Reporting System (FAERS).

050100150200250 2009201220152018202120242025 221

Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.

Where prasugrel sits

prasugrel has more FDA adverse-event reports than 14% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.

fewest reports most reports

Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is prasugrel; the line is the median (50th percentile).

FDA Adverse Event Report Analysis

Detailed analysis of 2,254 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2009–2025.

Total Reports

2,254

Reports Mentioning Death

251

11.1% of reports — not proof of cause

Hospitalization Reports

1,074

Top Indication

Product Used For Unknown Indication

Gender Distribution

Female 649 (33%)
Male 1,318 (66%)

Age Distribution

0–17 14
18–44 103
45–64 712
65–74 635
75+ 263

Most Reported Adverse Reactions (FAERS)

# Reaction Reports
1 MYOCARDIAL INFARCTION 172
3 DYSPNOEA 106
4 ACUTE MYOCARDIAL INFARCTION 102
6 CHEST PAIN 90
7 NAUSEA 90
8 DRUG INTERACTION 79
9 DIZZINESS 78
10 FATIGUE 71
11 VASCULAR STENT THROMBOSIS 67
12 DIARRHOEA 64
13 GASTROINTESTINAL HAEMORRHAGE 64
14 MYALGIA 63
15 HEADACHE 60
16 EPISTAXIS 59
17 HYPERTENSION 59

Reactions in Death Reports

DEATH 40
COMPLETED SUICIDE 24
CEREBRAL HAEMORRHAGE 22
SEPSIS 21
RENAL FAILURE 16
CARDIAC ARREST 15
ACUTE MYOCARDIAL INFARCTION 13
INTRAVENTRICULAR HAEMORRHAGE 12
RESPIRATORY FAILURE 12
DYSPNOEA 11

Reactions in Hospitalization Reports

MYOCARDIAL INFARCTION 109
ACUTE MYOCARDIAL INFARCTION 80
DYSPNOEA 63
CHEST PAIN 61
GASTROINTESTINAL HAEMORRHAGE 56
NAUSEA 54
HYPERTENSION 44
DIZZINESS 38
VOMITING 36
CORONARY ARTERY DISEASE 34

Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation

Serious Warnings

Prasugrel can cause serious bleeding, which can sometimes be fatal. You should not take this medicine if you have active bleeding or have had a stroke or transient ischemic attack (TIA). If you are 75 or older, prasugrel is generally not recommended due to the increased risk of bleeding, unless you have diabetes or have had a prior heart attack. Do not start prasugrel if you are likely to need urgent heart bypass surgery (CABG). If possible, stop taking prasugrel at least 7 days before any surgery. Other things that raise your bleeding risk are: body weight under 60 kg, a tendency to bleed easily, and taking other medicines that increase bleeding risk. If you have low blood pressure and recently had a heart procedure or surgery, suspect bleeding. If possible, manage bleeding without stopping prasugrel, because stopping it can raise your risk of heart problems.

Known Drug Interactions

moderate warfarin

Table 3: Drugs that Can Increase the Risk of Bleeding Drug Class Specific Drugs Anticoagulants argatroban, dabigatran, bivalirudin, desirudin, heparin, lepirudin Antiplatelet Agents aspirin, cilostazol, clopidogrel, dipyridamole, prasugrel, ticlopidine Non-steroidal Anti-Inflammatory Agents celecoxib, diclofenac, diflunisal, fenoprofen, ibuprofen, indomethacin, ketoprofen, ketorolac, mefenamic acid, naproxen, oxaprozin, piroxicam, sulindac Serotonin Reuptake Inhibitors citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, fluvoxamine, milnacipran, paroxetine, sertraline,...

Mechanism: Both drugs work to prevent blood clots, so taking them together makes it much harder for your blood to clot. This increases your risk of serious bleeding.

minor aspirin

Prasugrel can be administered with aspirin (75 mg to 325 mg per day), heparin, GPIIb/IIIa inhibitors, statins, digoxin, and drugs that elevate gastric pH, including proton pump inhibitors and H 2 blockers [see Clinical Pharmacology (12.3) ] .

Mechanism: These two drugs are often used together to help prevent blood clots by stopping platelets from sticking together in different ways.

Consider the use of a parenteral anti-platelet agent in acute coronary syndrome patients requiring coadministration of morphine or other opioid agonists.

Mechanism: Morphine can slow down how fast the body absorbs prasugrel, which may delay its effect on blood clotting.

minor digoxin

Prasugrel can be administered with aspirin (75 mg to 325 mg per day), heparin, GPIIb/IIIa inhibitors, statins, digoxin, and drugs that elevate gastric pH, including proton pump inhibitors and H 2 blockers [see Clinical Pharmacology (12.3) ] .

Mechanism: These two drugs do not have a known harmful interaction when used at the same time.

minor heparin

Prasugrel can be administered with aspirin (75 mg to 325 mg per day), heparin, GPIIb/IIIa inhibitors, statins, digoxin, and drugs that elevate gastric pH, including proton pump inhibitors and H 2 blockers [see Clinical Pharmacology (12.3) ] .

Mechanism: These drugs are safe to use together and do not cause a negative reaction in the body.

Check all your medications →

This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.

Common Questions

What should I do if I experience unusual bleeding while taking prasugrel?
Report any unusual or prolonged bleeding to your doctor immediately.
Can I take other medications with prasugrel?
Talk to your doctor or pharmacist before taking any new medications, including over-the-counter drugs, with prasugrel.
How long will I need to take prasugrel?
Your doctor will determine how long you need to take prasugrel.
What if I need to have surgery while taking prasugrel?
Tell your doctor and surgeon that you are taking prasugrel. You may need to stop taking it at least 7 days before surgery.
Can prasugrel cause allergic reactions?
Yes, some people may experience allergic reactions to prasugrel. Seek immediate medical attention if you develop symptoms such as hives, swelling, or difficulty breathing.
Will prasugrel interact with my other medications?
Yes, prasugrel can interact with certain medications, such as warfarin and NSAIDs, increasing the risk of bleeding. Review all medications with your doctor.
What should I do if I experience side effects?
Contact your doctor if you experience any concerning side effects while taking prasugrel.
Is it safe to drink alcohol while taking prasugrel?
Talk to your doctor about alcohol consumption while taking prasugrel, as it may increase the risk of bleeding.
How often should I see my doctor while taking prasugrel?
Follow your doctor's recommendations for regular check-ups and blood tests while taking prasugrel.
Can I stop taking prasugrel on my own?
Do not stop taking prasugrel without talking to your doctor first, as stopping it prematurely can increase your risk of heart problems.
What are the common side effects of prasugrel?
The registry lists Bleeding among the most-reported FAERS reaction terms for prasugrel. The compiled record contains 2,254 FDA adverse-event reports. These counts are not an individual symptom assessment.
Does prasugrel interact with other medications?
The registry has 6 documented interaction rows for prasugrel. Notable source-record pairings include warfarin, aspirin, morphine. These rows are not a complete medication review.
What drug class is prasugrel?
prasugrel belongs to the P2Y12 Inhibitor (Antiplatelet) drug class. It requires a prescription (Rx). Prasugrel helps prevent dangerous blood clots if you have acute coronary syndrome.
Is there a generic version of prasugrel?
Yes, generic prasugrel is available from 6 manufacturers. The generic costs $0.27 per unit compared to $19.45 for the brand version, saving approximately 99%. Pricing is based on NADAC (National Average Drug Acquisition Cost) data from CMS.
What pregnancy or breastfeeding source fields are listed for prasugrel?
The FDA label for prasugrel contains product-specific pregnancy or breastfeeding language. PlainMeds does not apply that source text to an individual.
Has prasugrel been recalled?
There is 1 recall associated with prasugrel products. Failed Dissolution Specifications - low dissolution results. Check the recalls section below for full details and affected products.

Active Recalls

Class II February 25, 2025

Failed Dissolution Specifications - low dissolution results

MYLAN PHARMACEUTICALS INC

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Compare beyond drug class

Nationwide peers by FAERS volume & death-report share

Two PlainMeds-derived comparison paths for prasugrel: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.

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What the FDA Data Shows for prasugrel

The FDA label for prasugrel (sold under brand names such as Effient) classifies it as a prescription-only medication in the P2Y12 Inhibitor (Antiplatelet) class. Prasugrel helps prevent dangerous blood clots if you have acute coronary syndrome. Official labeling lists 1 commonly reported side effect, including Bleeding.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 2,254 voluntary reports. The database also lists 6 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS shows a generic unit cost of $0.27 versus $19.45 for the brand - a 99% generic savings.

Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 1 recall record on file), and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.

Data Sources

Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).

FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.

Last updated: March 2, 2025

PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.

Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.

All federal data sources used on this page