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).
Verify with FDA → · CMS NADAC pricing →
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.
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.
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.
This is a plain-language summary of prasugrel's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
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.
This is a plain-language summary of prasugrel's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
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.
This is a plain-language summary of prasugrel's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
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 2,254 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for prasugrel, by number of reports
- Heart attack
Heart attack
172 reports
- Shortness of breath
Shortness of breath
106 reports
- Sudden heart attack
Sudden heart attack
102 reports
- Chest pain
Chest pain
90 reports
- Feeling sick to your stomach
Feeling sick to your stomach
90 reports
- Interaction with another drug
Interaction with another drug
79 reports
- Feeling lightheaded
Feeling lightheaded
78 reports
- Tiredness
Tiredness
71 reports
- Blood clot in a stent 67
Blood clot in a stent
67 reports
- Loose stools 64
Loose stools
64 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.
Reports over time
Adverse-event reports filed for prasugrel each year to the FDA Adverse Event Reporting System (FAERS).
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.
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
Age Distribution
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
Reactions in Hospitalization Reports
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
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.
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.
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.
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.
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.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
Common Questions
What should I do if I experience unusual bleeding while taking prasugrel?
Can I take other medications with prasugrel?
How long will I need to take prasugrel?
What if I need to have surgery while taking prasugrel?
Can prasugrel cause allergic reactions?
Will prasugrel interact with my other medications?
What should I do if I experience side effects?
Is it safe to drink alcohol while taking prasugrel?
How often should I see my doctor while taking prasugrel?
Can I stop taking prasugrel on my own?
What are the common side effects of prasugrel?
Does prasugrel interact with other medications?
What drug class is prasugrel?
Is there a generic version of prasugrel?
Is prasugrel safe during pregnancy?
Has prasugrel been recalled?
Active Recalls
Failed Dissolution Specifications - low dissolution results
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clopidogrel
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dabigatran
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Medication Guides
Understanding Drug Interactions
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Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
Why some drugs demand precise dosing and monitoring
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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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 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
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages