Prescription medicine
Prasugrel Brand names: Effient
Prasugrel (Effient) is a prescription medicine with an FDA approval on record since 2009. FDA's NDC Directory lists it from 10 generic labelers, and pharmacies paid $0.263 per prasugrel 10 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the prasugrel FDA label on DailyMed (effective February 11, 2025, Panacea Biotec Limited); the NDA 22307 record on Drugs@FDA; every prasugrel label on DailyMed.
Highlights of the record
FDA label of February 11, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
BLEEDING RISK.
Prasugrel tablets can cause significant, sometimes fatal, bleeding [see Warnings and Precautions ( 5.1 , 5.2 ) and Adverse Reactions ( 6.1 )]. Do not use prasugrel tablets in patients with active pathological bleeding or a history of transient ischemic attack or stroke [see Contraindications ( 4.1 , 4.2 )]. In patients ≥ 75 years of age, prasugrel tablets is generally not recommended, because of the increased risk of fatal and intracranial bleeding and uncertain benefit, except in high-risk situations (patients with diabetes or a history of prior myocardial infarction [MI]) where its effect appears to be greater and its use may be considered [see Use in Specific Populations ( 8.5 )]. Do not start prasugrel tablets in patients likely to undergo urgent coronary artery bypass graft surgery (CABG). When possible, discontinue prasugrel tablets at least 7 days prior to any surgery. [see Warnings and Precautions ( 5.2 )]. Additional risk factors for bleeding include: body weight <60 kg; propensity to bleed; concomitant use of medications that increase the risk of bleeding (e.g., warfarin, heparin, fibrinolytic therapy, chronic use of non-steroidal anti-inflammatory drugs [NSAIDs]) [see Warnings and Precautions ( 5.1 )]. […]
Used for
From the label: indications and usagePrasugrel tablets is a P2Y 12 platelet inhibitor indicated for the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndrome who are to be managed with percutaneous coronary intervention (PCI) as follows: Patients with unstable angina or non-ST-elevation myocardial infarction (NSTEMI) ( 1.1 ).
Forms and strengths
- 5 mg
- 10 mg
Film-coated tablet; coated tablet.
On the market
- Earliest approval on file
- July 10, 2009 Effient, Cosette; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 10 first July 12, 2017; 6 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 11 of which 10 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.263 per tablet Prasugrel 10 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 5 since 2019 0 Class I among all firms' recalls; latest August 21, 2026
- FAERS reports
- 12,433 through July 30, 2026
What is prasugrel used for?
From the label: indications and usagePrasugrel tablets is a P2Y 12 platelet inhibitor indicated for the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndrome who are to be managed with percutaneous coronary intervention (PCI) as follows: Patients with unstable angina or non-ST-elevation myocardial infarction (NSTEMI) ( 1.1 ). […]
Conditions named in the indications of prasugrel's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: P2Y12 Platelet Inhibitor.
Source: FDA drug label (PRASUGREL), Panacea Biotec Limited, effective February 11, 2025 (SPL set 944c195a-de24-a44c-8baa-84b624b5ddcb), via openFDA; the full label on DailyMed
What does the patient leaflet for prasugrel say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about prasugrel tablets?Prasugrel tablet is used to lower your chance of having a heart attack or other serious problems with your heart or blood vessels. But, prasugrel tablets can cause bleeding, which can be serious, and sometimes lead to death. You should not start to take prasugrel tablets if it is likely that you will have heart bypass surgery (coronary artery bypass graft surgery or CABG) right away. You have a higher risk of bleeding if you take prasugrel tablets and then have heart bypass surgery.
From the patient leaflet: How should I store prasugrel tablets?Keep prasugrel tablets at room temperature between 59°F to 86°F (15°C to 30°C). Keep and dispense only in original container. Keep the container closed tightly with the gray cylinder inside. Protect prasugrel tablets from moisture. Keep prasugrel tablets and all medicines out of the reach of children. General Information about safe and effective use of prasugrel tablets Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use prasugrel tablets for a condition for which it was not prescribed. Do not give your prasugrel tablets to other people, even if they have the same symptoms you have. It may harm them. This Medication Guide summarizes the most important information about prasugrel tablets. If you would like more information about prasugrel tablets, talk with your doctor or pharmacist. […]
Source: FDA drug label (PRASUGREL), Panacea Biotec Limited, effective February 11, 2025 (SPL set 944c195a-de24-a44c-8baa-84b624b5ddcb), via openFDA; the full label on DailyMed
Is there a generic for prasugrel (Effient)?
The FDA approved the first generic prasugrel on July 12, 2017. 10 generic applications are approved; 6 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists prasugrel from 10 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2009 earliest approval on file
- 2017 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for prasugrel (Effient)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.263 per Prasugrel 10 mg tablet, down 7% from $0.283 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Prasugrel 10 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Prasugrel 10 mg tablet | Generic | $0.263 per tablet | $7.89 | -7% |
| Prasugrel 5 mg tablet | Generic | $0.259 per tablet | $7.78 | -26% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has prasugrel been recalled?
The FDA's Enforcement Report lists 5 recalls naming prasugrel since 2019: 0 Class I (the most serious), 5 Class II, 0 Class III; 4 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| August 21, 2026 | Class II | Golden State Medical Supply Inc. | Failed Dissolution Specifications. Notification from the manufacturer that lot is being recalled due to failed dissolution |
| August 17, 2026 | Class II | Mylan Pharmaceuticals Inc | Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria |
| March 5, 2025 | Class II | Golden State Medical Supply Inc. | Failed Dissolution Specifications |
| February 25, 2025 | Class II | MYLAN PHARMACEUTICALS INC | Failed Dissolution Specifications - low dissolution results |
| October 18, 2019 | Class II | Mylan Pharmaceuticals Inc. | Failed Dissolution Specification: Low out of specification dissolution results. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the prasugrel label say about other medicines?
The prasugrel label names 6 other medicines in its interaction, contraindication or warning sections. The labels of 11 other medicines name prasugrel. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Aspirin | drug interactions | Prasugrel tablets 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 )]. |
| Clopidogrel | contraindications | … 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). |
| Digoxin | drug interactions | Prasugrel tablets 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 )]. |
| Heparin | boxed warning | Additional risk factors for bleeding include: body weight <60 kg; propensity to bleed; concomitant use of medications that increase the risk of bleeding (e.g., warfarin, heparin, fibrinolytic therapy, chronic use of non-steroidal anti-inflammatory drugs [NSAIDs]) [see Warnings and Precautions ( 5.1 )]. |
| Morphine | drug interactions | Consider the use of a parenteral anti-platelet agent in acute coronary syndrome patients requiring co-administration of morphine or other opioid agonists |
| Warfarin | boxed warning | Additional risk factors for bleeding include: body weight <60 kg; propensity to bleed; concomitant use of medications that increase the risk of bleeding (e.g., warfarin, heparin, fibrinolytic therapy, chronic use of non-steroidal anti-inflammatory drugs [NSAIDs]) [see Warnings and Precautions ( 5.1 )]. |
Source: FDA drug label (PRASUGREL), Panacea Biotec Limited, effective February 11, 2025 (SPL set 944c195a-de24-a44c-8baa-84b624b5ddcb), via openFDA; the full label on DailyMed
What do FAERS reports show for prasugrel?
The FDA Adverse Event Reporting System holds 12,433 reports that list prasugrel among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,110 are coded as a death and 5,102 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as prasugrel?
2 other medicines are given the same way (oral) and in the same FDA class as prasugrel or labeled mainly for the same use (heart attack and coronary artery disease), the same class first. Heart attack and coronary artery disease lists all 38 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Clopidogrel | Angina, Heart attack and coronary artery disease | 35 labelers | $0.0472 per tablet 75 mg tablet | No current entry |
| Ticagrelor | Heart attack and coronary artery disease | 28 labelers | $0.253 per tablet 90 mg tablet | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does prasugrel compare with medicines for the same use?
2 side-by-side pages set prasugrel beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to prasugrel
- 2 medicines for the same use
- Other p2y12 inhibitors
- the pharmacologic class, with prices and generics
- Prasugrel side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other