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Prasugrel

Prasugrel is a blood-thinning antiplatelet medicine (a P2Y12 platelet inhibitor) used to lower the risk of heart attack-type clots and stent clots in people with acute coronary syndrome who are having a stent procedure (PCI).

Brand name Effient
Drug classes Decreased Platelet Aggregation
Rx Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 12 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 5, 2026 🚨Recall on record · 4
Prasugrel at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Prasugrel (Effient) is a strong antiplatelet medicine, taken with daily aspirin, that permanently stops platelets from clumping, lowering the risk of heart attacks and stent clots after a stent procedure (PCI) for a heart attack or unstable angina; more potent than clopidogrel, it has been on the market since about 2009 and is available generically. Most people feel little from it, but bruising and nosebleeds are common. Its boxed warning is serious, sometimes fatal, bleeding, so get emergency help for black stools, coughing up blood or bleeding that will not stop. Never stop it on your own, because stopping early raises the risk of a stent clot, heart attack and death.

Clinical pearls

  • Never take it after any stroke or mini-stroke (TIA), and at 75 or older it is generally avoided.
  • Tell every surgeon and dentist you take it, since it is stopped at least 7 days before surgery when possible.
  • For pain, ask about acetaminophen instead of regular ibuprofen or naproxen, which raise bleeding risk with prasugrel.
  • Feeling faint or dizzy soon after a heart procedure can mean hidden bleeding, so get help right away.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Prasugrel can cause serious, sometimes fatal, bleeding.

  • Do not use it if you have active bleeding or have ever had a stroke or mini-stroke (TIA).
  • People 75 or older generally should not take it, except in high-risk situations (diabetes or a prior heart attack) where a doctor may consider it.
  • It should not be started if you are likely to need urgent bypass surgery (CABG). When possible, it is stopped at least 7 days before any surgery.
  • Other bleeding risks include weighing under 60 kg, a tendency to bleed, and taking warfarin, heparin, clot-dissolving drugs, or regular NSAIDs.
  • Low blood pressure after a heart procedure or surgery may signal hidden bleeding.
  • If bleeding occurs, doctors try to manage it without stopping Prasugrel, since stopping early raises the risk of heart events.
Read the full warning on DailyMed →
How you get itPrescription only
Comes asTablet
Earliest FDA record2009
Companies listing it with the FDA11
FDA label last updatedJun 29, 2022
FDA’s strongest warning (boxed)Yes, read the warning

Patient information guide A plain-language walkthrough of Prasugrel, written from its FDA label.

What Prasugrel is used for

▾

Prasugrel is used to lower the risk of clot-related heart problems in people having a stent procedure after acute coronary syndrome.

  • Effient and Prasugrel tablets (oral) reduce thrombotic cardiovascular events, including stent thrombosis, in acute coronary syndrome managed with PCI.
  • This includes unstable angina or non-ST-elevation heart attack (NSTEMI).
  • It also includes ST-elevation heart attack (STEMI) managed with primary or delayed PCI.
  • Compared with clopidogrel, it reduced a combined measure of cardiovascular death, nonfatal heart attack, or nonfatal stroke. The difference was driven mostly by fewer heart attacks, with no difference in strokes and little difference in cardiovascular death.

How Prasugrel works

▾

Prasugrel is a prodrug, meaning your body converts it into its active form. That active form permanently binds to the P2Y12 receptor on platelets. This blocks platelets from activating and clumping together, which helps prevent clots in your arteries and stent.

Prasugrel dosage

▾

Prasugrel is taken by mouth as a tablet. Treatment starts with a one-time loading dose, then continues once daily.

  • You can take it with or without food.
  • You are expected to take daily aspirin with it.
  • A lower maintenance dose may be considered for people under 60 kg.
  • Avoid gaps in treatment. Ask your pharmacist or prescriber what to do if you miss a dose.

Follow your prescriber's directions and the label.

Dosing details from the FDA-approved label

From the Prasugrel prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Acute coronary syndrome (treatment initiation)
    • Initiate treatment as a single 60 mg oral loading dose and then continue at 10 mg orally once daily
    • Patients should also take aspirin (75 mg to 325 mg) daily
    • May be administered with or without food
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION Initiate prasugrel tablets treatment as a single 60 mg oral loading dose and then continue at 10 mg orally once daily. Patients taking prasugrel tablets should also take aspirin (75 mg to 325 mg) daily [see Drug Interactions ( 7.4 ) and Clinical Pharmacology ( 12.3 )]. Prasugrel tablets may be administered with or without food [see Clinical Pharmacology ( 12.3 ) and Clinical Studies ( 14 )]. Timing of Loading Dose In the clinical trial that established the efficacy and safety of prasugrel tablets, the loading dose of prasugrel tablets was not administered until coronary anatomy was established in UA/NSTEMI patients and in STEMI patients presenting more than 12 hours after symptom onset. In STEMI patients presenting within 12 hours of symptom onset, the loading dose of prasugrel tablets was administered at the time of diagnosis, although most received prasugrel tablets at the time of PCI [see Clinical Studies ( 14 )] . For the small fraction of patients that required urgent CABG after treatment with prasugrel tablets, the risk of significant bleeding was substantial. Although it is generally recommended that antiplatelet therapy be administered promptly in the management of ACS because many cardiovascular events occur within hours of initial presentation, in a trial of 4033 NSTEMI patients, no clear benefit was observed when prasugrel tablets loading dose was administered prior to diagnostic coronary angiography compared to at the time of PCI; however, risk of bleeding was increased with early administration in patients undergoing PCI or early CABG. Dosing in Low Weight Patients Compared to patients weighing ≥60 kg, patients weighing <60 kg have an increased exposure to the active metabolite of prasugrel and an increased risk of bleeding on a 10 mg once daily maintenance dose. Consider lowering the maintenance dose to 5 mg in patients <60 kg. The effectiveness and safety of the 5 mg dose have not been prospectively studied [see Warnings and Precautions ( 5.1 ), Adverse Reactions ( 6.1 ), and Clinical Pharmacology ( 12.3 )]. • Initiate treatment with a single 60 mg oral loading dose ( 2 ). • Continue at 10 mg once daily with or without food. Consider 5 mg once daily for patients <60 kg ( 2 ). • Patients should also take aspirin (75 mg to 325 mg) daily ( 2 ).

Read the full Dosage and Administration section on DailyMed →

Prasugrel side effects

▾

Bleeding is the most common side effect. Others are listed below.

Common side effects

  • Bleeding, including nosebleeds (the most common side effect)
  • Bruising or blood collecting under the skin
  • High blood pressure
  • High cholesterol
  • Headache
  • Back pain
  • Shortness of breath
  • Nausea and dizziness
  • Stomach or intestinal bleeding

When to get medical help

  • Call your doctor or get emergency help for bleeding that is heavy, won't stop, or is life-threatening, such as black or bloody stools or coughing up blood.
  • Get urgent help for signs of a stroke or mini-stroke (TIA), and tell your doctor right away.
  • Seek emergency care for severe allergic reactions, including swelling of the face, lips or throat (angioedema) or anaphylaxis.
  • Get urgent help for possible TTP, a rare and serious blood condition. Warning signs include low platelets, fever, nervous system symptoms, and kidney problems. It can happen within the first 2 weeks.
  • Feeling faint or having low blood pressure after a heart procedure or surgery can signal hidden bleeding. Get help right away.
  • Do not stop Prasugrel early without talking to your prescriber. Stopping early raises the risk of stent clots, heart attack and death.

Prasugrel warnings and precautions

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  • Serious or fatal bleeding is the biggest risk, and it is highest early in treatment.
  • Not for people with active bleeding or a history of stroke or TIA.
  • Generally not recommended at 75 or older, except in high-risk people with diabetes or a prior heart attack.
  • Higher risk if you weigh under 60 kg, bleed easily, or take other drugs that raise bleeding risk.
  • Do not start if you are likely to need urgent bypass surgery. Stop it at least 7 days before surgery when possible.
  • Stopping early raises the risk of stent clots, heart attack and death.
  • TTP and severe allergic reactions, including angioedema, have been reported.

Prasugrel interactions

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Several medicines can add to bleeding risk or change how Prasugrel is absorbed.

  • Warfarin: increases bleeding risk.
  • Regular NSAIDs: may increase bleeding risk.
  • Oral anticoagulants and clot-dissolving drugs: add to bleeding risk.
  • Opioids such as morphine: slow and reduce absorption of Prasugrel's active form.
  • Aspirin and heparin: used with Prasugrel but increase bleeding time.
  • Proton pump inhibitors, H2 blockers, statins and digoxin: can be taken with it.

Interactions listed in the FDA-approved label

From the Prasugrel prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Warfarin: Coadministration of prasugrel tablets and warfarin increases the risk of bleeding.
  • Nonsteroidal anti-inflammatory drugs (NSAIDs, used chronically): Coadministration may increase the risk of bleeding.
  • Opioids (including morphine): Coadministration of opioid agonists delays and reduces the absorption of prasugrel's active metabolite, presumably because of slowed gastric emptying. Consider the use of a parenteral anti-platelet agent in acute coronary syndrome patients requiring coadministration of morphine or other opioid agonists.
  • CYP3A inhibitors (verapamil, diltiazem, indinavir, ciprofloxacin, clarithromycin, grapefruit juice; ketoconazole studied): Not expected to have a significant effect on the pharmacokinetics of the active metabolite of prasugrel; ketoconazole decreased the Cmax by 34% to 46% but did not affect platelet aggregation inhibition, AUC or Tmax. Prasugrel tablets can be administered with inducers or inhibitors of cytochrome P450 enzymes.
  • CYP3A and other cytochrome P450 inducers (rifampicin, carbamazepine): Not expected to have a significant effect on the pharmacokinetics of the active metabolite of prasugrel or its inhibition of platelet aggregation. Prasugrel tablets can be administered with inducers or inhibitors of cytochrome P450 enzymes.
  • Drugs that elevate gastric pH (ranitidine, lansoprazole; proton pump inhibitors and H2 blockers): Decreased the Cmax of the prasugrel active metabolite by 14% and 29%, respectively, but did not change the AUC and Tmax. Can be administered with proton pump inhibitors and H2 blockers.
  • Statins (atorvastatin): Atorvastatin 80 mg daily did not alter the pharmacokinetics of prasugrel's active metabolite or its inhibition of platelet aggregation. Prasugrel tablets can be administered with statins.
  • Heparin: A single intravenous dose of unfractionated heparin (100 units/kg) did not significantly alter coagulation or prasugrel-mediated inhibition of platelet aggregation; bleeding time was increased compared with either drug alone. Prasugrel tablets can be administered with heparin.
  • Aspirin: Aspirin 150 mg daily did not alter prasugrel-mediated inhibition of platelet aggregation; bleeding time was increased compared with either drug alone. Prasugrel tablets can be administered with aspirin (75 mg to 325 mg per day).
  • Digoxin: Prasugrel is not an inhibitor of Pgp, as digoxin clearance was not affected by prasugrel coadministration. Prasugrel tablets can be administered with digoxin.
Read the label’s full interactions text

7 DRUG INTERACTIONS Opioids: Decreased exposure to prasugrel. Consider use of parenteral antiplatelet agent ( 7.3 ). 7.1 Warfarin Coadministration of prasugrel tablets and warfarin increases the risk of bleeding [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3) ] . 7.2 Nonsteroidal Anti-Inflammatory Drugs Coadministration of prasugrel tablets and NSAIDs (used chronically) may increase the risk of bleeding [see Warnings and Precautions (5.1) ] . 7.3 Opioids As with other oral P2Y 12 inhibitors, coadministration of opioid agonists delay and reduce the absorption of prasugrel’s active metabolite presumably because of slowed gastric emptying [see Clinical Pharmacology (12.3) ] . Consider the use of a parenteral anti-platelet agent in acute coronary syndrome patients requiring coadministration of morphine or other opioid agonists. 7.4 Other Concomitant Medications Prasugrel tablets can be administered with drugs that are inducers or inhibitors of cytochrome P450 enzymes [see Clinical Pharmacology (12.3) ] . 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) ] .

Drug Interaction Studies Potential for Other Drugs to Affect Prasugrel Inhibitors of CYP3A Ketoconazole (400 mg daily), a selective and potent inhibitor of CYP3A4 and CYP3A5, did not affect prasugrel-mediated inhibition of platelet aggregation or the active metabolite’s AUC and T max , but decreased the C max by 34% to 46%. Therefore, CYP3A inhibitors such as verapamil, diltiazem, indinavir, ciprofloxacin, clarithromycin, and grapefruit juice are not expected to have a significant effect on the pharmacokinetics of the active metabolite of prasugrel [see Drug Interactions (7.4) ] .

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Before taking Prasugrel

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  • Do not use with active bleeding, past stroke or TIA, or allergy to Prasugrel.
  • Be cautious if you are 75 or older or weigh under 60 kg.
  • Tell your doctor about recent surgery or trauma, past GI bleeding, ulcers, severe liver problems, or moderate to severe kidney problems.
  • Tell your doctor if bypass surgery may be needed.
  • Pregnancy: there are no human data, so benefits and risks should be weighed.
  • Breastfeeding: it is unknown whether it passes into human milk.
  • Children: safety and effectiveness have not been established.

Prasugrel overdose

▾

Prasugrel's platelet-blocking effect is rapid and lasts for the life of the platelet. It is unlikely to increase much with an overdose. A platelet transfusion may restore clotting ability, and dialysis is not likely to remove the active form. If you take too much, seek medical help right away.

What Prasugrel does in the body

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After a loading dose, about 90% of people had at least 50% platelet inhibition within 1 hour. Maximum inhibition was about 80%. With daily dosing, steady-state inhibition was about 70%. Platelet function returns to baseline over 5 to 9 days after stopping, as new platelets are made.

How your body processes Prasugrel

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At least 79% of a dose is absorbed. The active form peaks in about 30 minutes. Food does not change the total exposure but lowers the peak and delays it, so Prasugrel can be taken without regard to food. The active form has a half-life of about 7 hours and does not build up with daily dosing. Most of the dose leaves as inactive metabolites in urine (about 68%) and feces (about 27%).

How to store Prasugrel

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Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) .

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

295

Supplements & herbs that interact with Prasugrel

295 supplements and herbal products have documented interactions with Prasugrel in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 5
  • Moderate · 248
  • Minor · 42
Every supplement checked against Prasugrel — ranked by severity The full interaction hub: 5 major · 248 moderate · 42 minor · every one linked to its full report. Check Prasugrel against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

Prasugrel: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Prasugrel — the kind of thing our pharmacy team would talk through with you at the counter.

What is Prasugrel for?

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It helps prevent blood clots in your heart arteries and stent if you have had unstable angina or a heart attack and are having a stent procedure (PCI). It works by keeping your platelets from clumping together.

How do I take it?

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You take it by mouth, once a day after a starting loading dose, with or without food. You will also take aspirin daily. Try not to miss doses, and ask me or your prescriber if you do.

Can I stop it if I feel fine?

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Please don't stop it on your own. Stopping early, especially in the first few weeks, raises the risk of a stent clot, heart attack and death. If bleeding is a problem, call your doctor first.

What side effects should I expect?

▾
Bleeding is the most common one, such as nosebleeds and easy bruising. Headache, back pain, nausea and dizziness can also happen. Call your doctor for bleeding that is heavy or won't stop, black or bloody stools, or signs of a stroke.

Can I take ibuprofen or other pain relievers with it?

▾
Regular use of NSAIDs like ibuprofen or naproxen may raise your bleeding risk, so check with me before using them. Warfarin and other blood thinners also raise the risk. Opioids like morphine can slow how well Prasugrel is absorbed.

What should I tell my surgeon or dentist?

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Tell them you take Prasugrel before any procedure. When possible, it is stopped at least 7 days before surgery, but only your prescriber should decide that.

Is Prasugrel available over the counter?

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No. Prasugrel is a prescription medicine: every Prasugrel product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Prasugrel first available?

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The earliest FDA record we hold for Prasugrel is from 2009: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Prasugrel was first used.

Who makes Prasugrel?

▾
11 companies currently list Prasugrel products in the FDA's NDC Directory, including Apotex Corp., Accord Healthcare Inc., Amneal Pharmaceuticals LLC. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Prasugrel on HelloPharmacist

Detailed data & references for Prasugrel Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Prasugrel forms and strengths (how it comes)

Prasugrel is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Tablet

By mouth
Brands Effient
How this form is used
What it may be used for
  • Effient is used to reduce thrombotic cardiovascular events, including stent thrombosis, in people with acute coronary syndrome managed with PCI.
  • Prasugrel tablets are used for the same purpose in people with unstable angina, NSTEMI, or STEMI managed with PCI.
Important instructions
  • Effient is started with a single loading dose, then taken once daily by mouth.
  • Effient may be taken with or without food.
  • Effient is taken together with daily aspirin.
Available strengths 2 strengths
41 FDA-listed product records ⓘ

Prasugrel on the U.S. market: products, makers and brands

How Prasugrel appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

11 companies list 21 Prasugrel product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2009. Brand names on the directory include Effient; the rest are generics.

1
Dose forms ⓘ
11
Labelers (makers, repackagers, distributors)
2
Brand names
21
FDA-listed product records ⓘ
2009
Earliest FDA record ⓘ

Also listed with the FDA, not a patient dose form: Powder (10) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Apotex Corp.14%
Accord Healthcare Inc.10%
Amneal Pharmaceuticals LLC10%
Aurobindo Pharma Limited10%
Cosette Pharmaceuticals, Inc.10%
Golden State Medical Supply, Inc.10%
Other makers38%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Prasugrel is used (Medicaid data)

A general measure of how commonly Prasugrel is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Prasugrel is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

69,460
Medicaid prescriptions filled (Q1–Q4 2025)
$1.7M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Prasugrel prescribed? Of the 1,601 medications we measure, Prasugrel ranks #567 by Medicaid prescriptions — more than 65% of them.

Where Prasugrel ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Prasugrel product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 10 mg oral tablet is the most-dispensed Prasugrel product — about 98% of these Medicaid prescriptions.

prasugrel 10 MG Oral Tablet Most dispensed

68,082 Medicaid prescriptions (Q1–Q4 2025) 98% of Prasugrel prescriptions shown $1.7M gross reimbursement (before rebates) ≈ $25 per prescription (gross)

Summed across the 6 of 25 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 855812

prasugrel 5 MG Oral Tablet

1,378 Medicaid prescriptions (Q1–Q4 2025) 2% of Prasugrel prescriptions shown $38,310 gross reimbursement (before rebates) ≈ $28 per prescription (gross)

Summed across the 3 of 17 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 855818

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Prasugrel, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 9 of 42 listed Prasugrel NDCs with Medicaid activity.

Compare Prasugrel products

A representative set of FDA-listed product records for Prasugrel — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 21 of 21 products — FDA National Drug Code Directory. See every product, package size and price: browse all 21 Prasugrel NDCs →

Prasugrel side effects reported to the FDA (FAERS)

After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Prasugrel — a signal of what to watch for, not proof the drug caused it.

The effects most often named in FDA reports that mention Prasugrel are myocardial infarction, chest pain, dyspnoea; about 77% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.

12,432
Reports mentioning it
77%
Reported as serious
12
Distinct effects shown
Most reported effects
Myocardial Infarction
676
Chest Pain
550
Dyspnoea
546
Gastrointestinal Haemorrhage
534
Haemorrhage
510
Contusion
450
Fatigue
404
Nausea
404
Dizziness
381
Acute Myocardial Infarction
318
Age groups
Elderly · 814Adult · 648Child · 1Adolescent · 1

Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Prasugrel in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.

Prasugrel FDA approval history

How Prasugrel went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.

Prasugrel was first approved by the FDA in 2009 (Brand: EFFIENT · Cosette); the first generic version was approved in 2017. It remains available in U.S. pharmacies today.

2009
Brand approved
Brand: EFFIENT · Cosette
2017
First generic approved
Lower-cost ANDA competition begins
2026
Available today
Active in U.S. pharmacies

Source: Drugs@FDA.

Prasugrel recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list 4 Prasugrel recalls since July 2021. All of them are still ongoing or began in the last six months. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Ongoing Class II Aug 21, 2026 · Golden State Medical Supply Inc.
Failed Dissolution Specifications. Notification from the manufacturer that lot is being recalled due to failed dissolution
  • Prasugrel HCI, Tablets, USP, 10mg, 30-count bottle, Rx only, Marketed by: GSMS, Incorporated, Camarillo, CA 93012, USA, NDC: 51407-445-30. Lots: Lot # GS062298, Exp Date: 09/30/ 2026. FDA record D-0847-2026 →
Ongoing Class II Aug 17, 2026 · Mylan Pharmaceuticals Inc
Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria
  • Prasugrel Tablets, USP, 10mg, Rx only, 30 Tablets in each bottle, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 0378-5186-93. Lots: Lot #: 3225272, Exp. September 30, 2026 FDA record D-0839-2026 →
Ongoing Class II Mar 5, 2025 · Golden State Medical Supply Inc.
Failed Dissolution Specifications
  • PRASUGREL TABLETS, 5 mg, 30 tablet bottles, Rx only, packaged by GSMS, Incorporated, Camarillo, CA 93012 NDC 51407-444-30 Lots: Lot no's: GS059908, GS060228, GS060709, GS061233, GS061704, GS062158, GS062405, Exp.: 04/30/2026 FDA record D-0287-2025 →
Ongoing Class II Feb 25, 2025 · MYLAN PHARMACEUTICALS INC
Failed Dissolution Specifications - low dissolution results
  • Prasugrel Tablets, USP, 5 mg, 30-count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5185-93 Lots: Lot # 3211073, 3211074, 3211075, Exp 4/30/2026 FDA record D-0280-2025 →

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Prasugrel RxCUI 613391 1 dose form · 2 strengths
  1. Dose form (SCDF) Oral Tablet RxCUI 855811 In current FDA listings
    Clinical drug / strength (SCD) 5 MG RxCUI 855818 10 MG RxCUI 855812

Look up RxCUI 613391 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Prasugrel costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Tablet, Film Coated · Oral 10 mg $0.263 per tablet NDC details & price history
Tablet, Film Coated · Oral 5 mg $0.259 per tablet NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Prasugrel brand names

Prasugrel is sold under one brand name in the FDA directory — Effient. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Effient

Who makes Prasugrel: manufacturers and labelers

11 companies list Prasugrel products with the FDA. By number of product records, the largest are Apotex Corp., Accord Healthcare Inc., Amneal Pharmaceuticals LLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Apotex Corp. 3 Accord Healthcare Inc. 2 Amneal Pharmaceuticals LLC 2 Aurobindo Pharma Limited 2 Cosette Pharmaceuticals, Inc. 2 Golden State Medical Supply, Inc. 2 Mylan Pharmaceuticals Inc. 2 Panacea Biotec Limited 2 Unichem Pharmaceuticals (USA), Inc. 2 American Health Packaging 1 Bryant Ranch Prepack 1

Prasugrel drug class (RxNorm)

Prasugrel belongs to the P2Y12 Platelet Inhibitor class.

Pharmacologic class P2Y12 Platelet Inhibitor
Drug family (ATC) Platelet aggregation inhibitors excl. heparin
How it works P2Y12 Receptor Antagonists

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Prasugrel page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jun 29, 2022
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Prasugrel.
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Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
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Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Prasugrel after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
12
Finished products in the current FDA directory
21
Companies listing them (makers, repackagers, distributors)
11
FDA labeler codes behind them ⓘ
11
Linked representative label ⓘ
Mylan Pharmaceuticals Inc.
Linked label effective
Jun 29, 2022
Composite sections available
25
Linked SPL Set ID
41a4e332-6725-4cb7-940a-8291cf56cfe4
Linked SPL Document ID
9e234352-49b7-46e3-bc59-acf63e0a7a14
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Mylan Pharmaceuticals Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →