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prasugrel

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Brand names: Effient

P2Y12 Inhibitor (Antiplatelet) Rx

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 →

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.

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.

How to Take It

You will usually take a 60 mg dose of prasugrel to start. After that, you will take 10 mg once a day. You can take prasugrel with or without food. You should also take aspirin (75 mg to 325 mg) every day while you are taking prasugrel.

Pregnancy & Breastfeeding

There is not enough information about the safety of prasugrel during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant. It is not known if prasugrel passes into breast milk, so talk to your doctor about the risks and benefits of breastfeeding while taking this medicine.

Missed Dose

If you miss a dose of prasugrel, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule.

Storage

Store prasugrel tablets at room temperature (68° to 77°F) in the original container, and do not break the tablets.

Side Effects (from patient reports)

Based on 987 FDA adverse event reports.

Heart attack
172
Drug not working
106
Shortness of breath
106
Sudden heart attack
102
Using the drug for a non-approved purpose
93
Chest pain
90
Feeling sick to your stomach
90
Interaction with another drug
79
Feeling lightheaded
78
Tiredness
71

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

Death-Related Reports

251

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
2 DRUG INEFFECTIVE 106
3 DYSPNOEA 106
4 ACUTE MYOCARDIAL INFARCTION 102
5 OFF LABEL USE 93
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

Reactions in Death Reports

DEATH 40
COMPLETED SUICIDE 24
CEREBRAL HAEMORRHAGE 22
SEPSIS 21
RENAL FAILURE 16
CARDIAC ARREST 15
OFF LABEL USE 14
ACUTE MYOCARDIAL INFARCTION 13
INTRAVENTRICULAR HAEMORRHAGE 12
RESPIRATORY FAILURE 12

Reactions in Hospitalization Reports

MYOCARDIAL INFARCTION 109
ACUTE MYOCARDIAL INFARCTION 80
DYSPNOEA 63
CHEST PAIN 61
GASTROINTESTINAL HAEMORRHAGE 56
NAUSEA 54
DRUG INEFFECTIVE 44
HYPERTENSION 44
OFF LABEL USE 43
DIZZINESS 38

Source: FDA FAERS (Adverse Event Reporting System) 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, venlafa...

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.

What to do: Your doctor should monitor you closely for any signs of bleeding. They may need to adjust your dose or check your blood more often.

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.

What to do: These medications are safe to take together as directed by your doctor, usually to help prevent heart-related issues.

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.

What to do: Your doctor may consider using an injectable blood thinner if you need morphine for heart-related pain.

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.

What to do: You can safely take these medications together as directed by your healthcare provider.

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.

What to do: No special changes are needed when taking these two medications together.

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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 most commonly reported side effects of prasugrel include Bleeding. Based on 987 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does prasugrel interact with other medications?
Yes, prasugrel has 6 known drug interactions. Notable interactions include warfarin, aspirin, morphine. Always inform your doctor about all medications you are taking.
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.
Is prasugrel safe during pregnancy?
There is not enough information about the safety of prasugrel during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.
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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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 987 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 further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.

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. Always consult a healthcare professional before making medication decisions.

Last updated: March 2, 2025

All federal data sources used on this page