Prasugrel

Name: Prasugrel

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

Effient Interactions

You should always tell your doctor about any prescription, non-prescription, illegal, and recreational drugs; herbal remedies; and nutritional and dietary supplements you're taking.

You should also tell your doctor if you're taking any medications that may cause bleeding, including:

  • Blood thinners such as Coumadin (warfarin)
  • Heparin
  • Non-steroidal anti-inflammatory medications (NSAIDs), such as Advil or Motrin (ibuprofen) and Aleve (naproxen)
  • Other medications to treat or prevent blood clots

Effient and Alcohol

Daily use of alcohol while taking Effient may increase your risk for stomach bleeding. Limit your alcohol consumption while taking this medication.

Effient and Other Interactions

You should try to avoid participating in activities that may increase your risk of bleeding or injury. Also, use extra care to prevent bleeding while brushing your teeth or shaving.

Prasugrel Brand Names

Prasugrel may be found in some form under the following brand names:

  • Effient

Side Effects of Prasugrel

Prasugrel can cause serious side effects, including:

  • See "Drug Precautions".
  • A blood clotting problem called Thrombotic Thrombocytopenic Purpura (TTP). TTP can happen with prasugrel, sometimes after a short time (less than 2 weeks). TTP is a blood clotting problem where blood clots form in blood vessels and can happen all over the body. TTP needs to be treated in a hospital right away, because you may die. Get medical help right away if you have any of these symptoms and they cannot be explained by another medical condition:
    • purplish spots called purpura on the skin or mucous membranes (such as on the mouth) due to bleeding under the skin
    • paleness or jaundice (a yellowish color of the skin or eyes)
    • feeling tired or weak
    • fever
    • fast heart rate or feeling short of breath
    • headache, speech changes, confusion, coma, stroke, or seizure
    • low amount of urine or urine that is pink-tinged or has blood in it
    • stomach area (abdominal) pain, nausea, vomiting, or diarrhea
    • visual changes
  • Serious allergic reactions. Serious allergic reactions can happen with prasugrel, or if you have had a serious allergic reaction to the medicine clopidogrel (Plavix) or ticlopidine (Ticlid). Get medical help right away if you get any of these symptoms of a severe allergic reaction while taking prasugrel.
    • swelling or hives of your face, lips, in or around your mouth, or throat
    • trouble breathing or swallowing
    • chest pain or pressure
    • dizziness or fainting

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of prasugrel. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088.

Prasugrel Dosage

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

Prasugrel treatment is typically initiated with a single 60 mg oral loading dose.

The recommended dose of prasugrel is 10 mg once daily.

For patients <60 kg the dose may be reduced to 5 mg once daily.

Other Requirements

  • Keep prasugrel at room temperature between 59°F to 86°F (15°C to 30°C).
  • Keep prasugrel in the container it comes in.
  • Keep the container closed tightly with the gray cylinder inside.
  • Protect prasugrel from moisture.

Keep prasugrel and all medicines out of the reach of children.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking prasugrel?

Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.

Ask your doctor before taking a nonsteroidal anti-inflammatory drug (NSAID) for pain, arthritis, fever, or swelling. This includes aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), and others. Using an NSAID with prasugrel may cause you to bruise or bleed easily.

Prasugrel dosing information

Usual Adult Dose for Acute Coronary Syndrome:

Initial dose: 60 mg orally once
Maintenance dose: 10 mg orally once a day

Comments:
-No clear benefit was observed when the loading dose of this drug was administered prior to diagnostic coronary angiography compared to at the time of percutaneous coronary intervention (PCI); however, risk of bleeding was increased with early administration in patients undergoing PCI or early coronary artery bypass graft surgery (CABG).
-Aspirin 75 to 325 mg daily should be taken with this drug.

Use: To reduce the rate of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndrome (ACS) who are to be managed with PCI for unstable angina (UA), non-ST segment elevation myocardial infarction (NSTEMI), or ST segment elevation myocardial infarction (STEMI).

Usual Geriatric Dose for Acute Coronary Syndrome:

65 to less than 75 years:
-Initial dose: 60 mg orally once
-Maintenance dose: 10 mg orally once a day

75 years or older: Use is generally not recommended in such patients, except in high-risk situations (e.g., diabetes or prior myocardial infarction) when benefit outweighs risk.

Comments:
-No clear benefit was observed when the loading dose of this drug was administered prior to diagnostic coronary angiography compared to at the time of percutaneous coronary intervention (PCI); however, risk of bleeding was increased with early administration in patients undergoing PCI or early coronary artery bypass graft surgery (CABG).
-Aspirin 75 to 325 mg daily should be taken with this drug.

Use: To reduce the rate of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndrome (ACS) who are to be managed with PCI for unstable angina (UA), non-ST segment elevation myocardial infarction (NSTEMI), or ST segment elevation myocardial infarction (STEMI).

Prasugrel Pharmacokinetics

Absorption

Bioavailability

Rapidly and completely absorbed following oral administration.1 13 27 28

Onset

Peak plasma concentrations of active metabolite attained approximately 30 minutes following oral administration; no evidence of accumulation with repeated administration.1 13 25 28

Following a 60-mg loading dose, approximately 90% of patients achieve at least 50% inhibition of platelet aggregation by 1 hour; maximum platelet inhibition was approximately 80%.1 Steady-state platelet inhibition (70%) occurs within 3–5 days following maintenance therapy with repeated dosages of 10 mg daily.1

Duration

Following discontinuance, platelet aggregation gradually returns to baseline values in about 5–9 days.1

Food

In healthy individuals, food (high-fat or high-caloric meal) decreased peak plasma concentrations by 49% but did not alter exposure to active metabolite.1

Special Populations

In patients with end-stage renal impairment, exposure to active metabolite was decreased to approximately half that in healthy individuals and those with moderate renal impairment.1

In low-weight individuals (weight <60 kg), increased exposure to active metabolite observed.1 Clearance of active metabolite appears to increase exponentially with increasing body weight.30

In patients ≥75 years of age, mean exposure to active metabolite increased by 19% compared with younger patients.1

Distribution

Plasma Protein Binding

Approximately 98% for active metabolite.1

Elimination

Metabolism

Rapidly hydrolyzed by esterases to an inactive thiolactone; subsequently metabolized to active metabolite by CYP isoenzymes (primarily by 3A4 and 2B6, and to a lesser extent by 2C9 and 2C19).1 13 14 22 23 28 30 Requires a single step for metabolic activation compared with clopidogrel, which undergoes a 2-step oxidative process.13 14 22 29 30 31

Elimination Route

Excreted in urine (68%) and feces (27%) as inactive metabolites.1 14 28 Active metabolite not expected to be removed by dialysis.1

Half-life

Manufacturer reports half-life of active metabolite about 7 hours (range 2–15 hours);1 half-life of about 3.7 hours also reported.13 14

Before Using prasugrel

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For prasugrel, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to prasugrel or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of prasugrel in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of prasugrel in the elderly. Because of prasugrel's toxicity, use in elderly patients 75 years of age and older is not recommended.

Pregnancy

Pregnancy Category Explanation
All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking prasugrel, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using prasugrel with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Defibrotide

Using prasugrel with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Aceclofenac
  • Acemetacin
  • Alipogene Tiparvovec
  • Alteplase, Recombinant
  • Amtolmetin Guacil
  • Anagrelide
  • Apixaban
  • Ardeparin
  • Argatroban
  • Aspirin
  • Bemiparin
  • Betrixaban
  • Bivalirudin
  • Bromfenac
  • Bufexamac
  • Bupropion
  • Celecoxib
  • Certoparin
  • Choline Salicylate
  • Cilostazol
  • Citalopram
  • Clonixin
  • Dabigatran Etexilate
  • Dalteparin
  • Danaparoid
  • Desirudin
  • Dexibuprofen
  • Dexketoprofen
  • Diclofenac
  • Diflunisal
  • Dipyridamole
  • Dipyrone
  • Droxicam
  • Edoxaban
  • Enoxaparin
  • Eptifibatide
  • Escitalopram
  • Etodolac
  • Etofenamate
  • Etoricoxib
  • Felbinac
  • Fenoprofen
  • Fepradinol
  • Feprazone
  • Floctafenine
  • Flufenamic Acid
  • Fluoxetine
  • Flurbiprofen
  • Fluvoxamine
  • Fondaparinux
  • Heparin
  • Ibuprofen
  • Indomethacin
  • Ketoprofen
  • Ketorolac
  • Lepirudin
  • Levomilnacipran
  • Lornoxicam
  • Loxoprofen
  • Lumiracoxib
  • Meclofenamate
  • Mefenamic Acid
  • Meloxicam
  • Morniflumate
  • Nabumetone
  • Nadroparin
  • Naproxen
  • Nefazodone
  • Nepafenac
  • Niflumic Acid
  • Nimesulide
  • Nimesulide Beta Cyclodextrin
  • Oxaprozin
  • Oxyphenbutazone
  • Parecoxib
  • Parnaparin
  • Paroxetine
  • Phenindione
  • Phenprocoumon
  • Phenylbutazone
  • Piketoprofen
  • Piracetam
  • Piroxicam
  • Proglumetacin
  • Propyphenazone
  • Proquazone
  • Protein C
  • Reviparin
  • Rivaroxaban
  • Rofecoxib
  • Salicylic Acid
  • Salsalate
  • Sertraline
  • Sodium Salicylate
  • Sulindac
  • Tenoxicam
  • Tiaprofenic Acid
  • Tinzaparin
  • Tolfenamic Acid
  • Tolmetin
  • Valdecoxib
  • Vilazodone
  • Vortioxetine
  • Warfarin

Using prasugrel with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Ritonavir

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of prasugrel. Make sure you tell your doctor if you have any other medical problems, especially:

  • Bleeding (e.g., head, stomach, or bowel bleeding), active or
  • Stroke, history of or
  • Transient ischemic attack (TIA) or "mini-stroke", history of—Should not be used in patients with these conditions.
  • Hypersensitivity reaction to clopidogrel (Plavix®) or ticlopidine (Ticlid®), history of or
  • Kidney disease, moderate to severe or
  • Liver disease, severe or
  • Low body weight (less than 60 kilograms or 132 pounds) or
  • Stomach or bowel bleeding, recurrent or
  • Stomach ulcer or
  • Surgery or other procedures (e.g., heart bypass surgery, coronary angiography, PCI), recent or
  • Trauma, recent—Use with caution. May increase risks for more serious side effects.

prasugrel Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
  • Blurred vision
  • dizziness
  • headache
  • nervousness
  • pounding in the ears
  • slow or fast heartbeat
Less common
  • Black, tarry stools
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • chest pain or discomfort
  • chills
  • cough
  • difficult or labored breathing
  • fainting
  • fever
  • irregular heartbeat
  • lightheadedness, dizziness, or fainting
  • painful or difficult urination
  • rapid weight gain
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • swollen glands
  • tightness in the chest
  • tingling of the hands or feet
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • unusual weight gain or loss
Incidence not known
  • Change in mental status
  • dark or bloody urine
  • difficulty with speaking
  • fever
  • pale color of the skin
  • pinpoint red spots on the skin
  • seizures
  • weakness
  • yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common
  • Back pain
  • diarrhea
  • nausea
  • pain in the arms or legs
  • rash

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Pharmacologic Category

  • Antiplatelet Agent
  • Antiplatelet Agent, Thienopyridine

Onset of Action

Inhibition of platelet aggregation (IPA): Dose dependent: 60 mg loading dose: <30 minutes; median time to reach ≥20% IPA: 30 minutes (Brandt, 2007)

Peak effect: Time to maximal IPA: Dose-dependent: Note: Degree of IPA based on adenosine diphosphate (ADP) concentration used during light aggregometry: 60 mg loading dose: Occurs ~4 hours post administration; Mean IPA (ADP 5 micromol/L): ~84.1%; Mean IPA (ADP 20 micromole/L): ~78.8% (Brandt, 2007)

Time to Peak

Active metabolite: ~30 minutes; With high-fat/high-calorie meal: 1.5 hours

Use Labeled Indications

Acute coronary syndrome to be managed with percutaneous coronary intervention (PCI): To reduce the rate of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndrome (ACS) who are to be managed with PCI for unstable angina (UA), non-ST-segment elevation MI (NSTEMI), or ST-elevation MI (STEMI).

Contraindications

Hypersensitivity (eg, anaphylaxis) to prasugrel or any component of the formulation; active pathological bleeding (eg, peptic ulcer, intracranial hemorrhage); prior TIA or stroke.

Dosing Geriatric

Refer to adult dosing. Patients ≥75 years: Use not recommended; may be considered in high-risk situations (eg, patients with diabetes or history of MI).

Drug Interactions

Agents with Antiplatelet Properties (e.g., P2Y12 inhibitors, NSAIDs, SSRIs, etc.): May enhance the antiplatelet effect of other Agents with Antiplatelet Properties. Monitor therapy

Anticoagulants: Agents with Antiplatelet Properties may enhance the anticoagulant effect of Anticoagulants. Monitor therapy

Apixaban: Antiplatelet Agents (P2Y12 Inhibitors) may enhance the adverse/toxic effect of Apixaban. Specifically, the risk for bleeding may be increased. Management: Carefully consider risks and benefits of this combination and monitor closely; Canadian labeling recommends avoiding prasugrel or ticagrelor. Consider therapy modification

Cangrelor: May diminish the antiplatelet effect of Prasugrel. More specifically, while the use of Cangrelor is expected to increase total platelet inhibition in patients who have previously received Prasugrel, Cangrelor is expected to decrease binding of Prasugrel metabolites to P2Y12 receptors and thus reduce the extent of irreversible platelet inhibition. Management: Avoid administration of prasugrel until cangrelor is discontinued. Consider therapy modification

Cephalothin: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Cephalothin. Specifically, the risk for bleeding may be increased. Monitor therapy

Collagenase (Systemic): Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Collagenase (Systemic). Specifically, the risk of injection site bruising and/or bleeding may be increased. Monitor therapy

CYP3A4 Inhibitors (Strong): May decrease serum concentrations of the active metabolite(s) of Prasugrel. Monitor therapy

Dabigatran Etexilate: Antiplatelet Agents (P2Y12 Inhibitors) may enhance the adverse/toxic effect of Dabigatran Etexilate. Specifically, the risk of bleeding may be increased. Antiplatelet Agents (P2Y12 Inhibitors) may increase the serum concentration of Dabigatran Etexilate. Specifically, clopidogrel may increase dabigatran serum concentrations. Management: Carefully consider risks and benefits of this combination and monitor closely; Canadian labeling recommends avoiding prasugrel or ticagrelor. Consider therapy modification

Dasatinib: May enhance the anticoagulant effect of Agents with Antiplatelet Properties. Monitor therapy

Deoxycholic Acid: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Deoxycholic Acid. Specifically, the risk for bleeding or bruising in the treatment area may be increased. Monitor therapy

Edoxaban: Antiplatelet Agents (P2Y12 Inhibitors) may enhance the adverse/toxic effect of Edoxaban. Specifically, the risk of bleeding may be increased. Management: Carefully consider the anticipated risks and benefits of this combination. If combined, increased monitoring for bleeding is recommended. Consider therapy modification

Glucosamine: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Monitor therapy

Herbs (Anticoagulant/Antiplatelet Properties) (eg, Alfalfa, Anise, Bilberry): May enhance the adverse/toxic effect of Agents with Antiplatelet Properties. Bleeding may occur. Consider therapy modification

Ibritumomab: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Ibritumomab. Both agents may contribute to impaired platelet function and an increased risk of bleeding. Monitor therapy

Ibrutinib: May enhance the adverse/toxic effect of Agents with Antiplatelet Properties. Monitor therapy

Limaprost: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Monitor therapy

Morphine (Liposomal): May diminish the antiplatelet effect of Antiplatelet Agents (P2Y12 Inhibitors). Morphine (Liposomal) may decrease the serum concentration of Antiplatelet Agents (P2Y12 Inhibitors). Management: Consider alternative anti-ischemic/analgesic therapies (eg, beta-blockers, nitroglycerin) in patients with acute coronary syndromes treated with a P2Y12 inhibitor when possible. The risks associated with other opioids are unknown. Consider therapy modification

Morphine (Systemic): May diminish the antiplatelet effect of Antiplatelet Agents (P2Y12 Inhibitors). Morphine (Systemic) may decrease the serum concentration of Antiplatelet Agents (P2Y12 Inhibitors). Management: Consider alternative anti-ischemic/analgesic therapies (eg, beta-blockers, nitroglycerin) in patients with acute coronary syndromes treated with a P2Y12 inhibitor when possible. The risks associated with other opioids are unknown. Consider therapy modification

Multivitamins/Fluoride (with ADE): May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Monitor therapy

Multivitamins/Minerals (with ADEK, Folate, Iron): May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Monitor therapy

Multivitamins/Minerals (with AE, No Iron): May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Monitor therapy

Obinutuzumab: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Obinutuzumab. Specifically, the risk of serious bleeding-related events may be increased. Monitor therapy

Omega-3 Fatty Acids: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Monitor therapy

Pentosan Polysulfate Sodium: May enhance the adverse/toxic effect of Agents with Antiplatelet Properties. Specifically, the risk of bleeding may be increased by concurrent use of these agents. Monitor therapy

Pentoxifylline: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Monitor therapy

Prostacyclin Analogues: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Monitor therapy

RaNITIdine: May decrease serum concentrations of the active metabolite(s) of Prasugrel. Monitor therapy

RifAMPin: May diminish the antiplatelet effect of Prasugrel. Monitor therapy

Rivaroxaban: Antiplatelet Agents (P2Y12 Inhibitors) may enhance the adverse/toxic effect of Rivaroxaban. Specifically, the risk of bleeding may be increased. Management: Carefully consider risks and benefits of this combination and monitor closely; Canadian labeling recommends avoiding prasugrel or ticagrelor. Consider therapy modification

Salicylates: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Salicylates. Increased risk of bleeding may result. Monitor therapy

Thrombolytic Agents: Agents with Antiplatelet Properties may enhance the anticoagulant effect of Thrombolytic Agents. Monitor therapy

Tipranavir: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Monitor therapy

Tositumomab and Iodine I 131 Tositumomab: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Tositumomab and Iodine I 131 Tositumomab. Specifically, the risk of bleeding-related adverse events may be increased. Monitor therapy

Urokinase: Agents with Antiplatelet Properties may enhance the anticoagulant effect of Urokinase. Avoid combination

Vitamin E (Systemic): May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Monitor therapy

For Healthcare Professionals

Applies to prasugrel: oral tablet

General

The most common adverse reaction leading to drug discontinuation was bleeding.[Ref]

Hematologic

Very common (10% or more): CABG (coronary artery bypass graft surgery)-related TIMI (Thrombolysis in Myocardial Infarction) Major (clinically overt bleeding associated with hemoglobin decreased by 5 g/dL or more, or intracranial hemorrhage) or Minor (overt bleeding associated with hemoglobin decreased by 3 to less than 5 g/dL) bleeding (14.1%), non-CABG-related TIMI Major or Minor bleeding in patients less than 60 kg (10.1%)
Common (1% to 10%): Non-CABG-related TIMI Major bleeding, non-CABG-related TIMI Minor bleeding, non-CABG-related life-threatening TIMI Major bleeding, non-CABG-related TIMI fatal bleeding in patients 75 years or older, CABG-related reoperation TIMI Major bleeding, CABG-related TIMI Major bleeding requiring transfusion of 5 units or more, anemia, leukopenia (less than 4 x 10(9) WBC/L)
Uncommon (0.1% to 1%): Non-CABG-related fatal TIMI Major bleeding, non-CABG-related symptomatic intracranial hemorrhage (ICH), non-CABG-related TIMI Major bleeding requiring inotropes, non-CABG-related TIMI Major bleeding requiring surgical intervention, non-CABG-related TIMI Major bleeding requiring transfusion of 4 units or more, CABG-related fatal TIMI Major bleeding, post-procedural hemorrhage
Rare (less than 0.1%): Severe thrombocytopenia
Postmarketing reports: Thrombocytopenia[Ref]

Cardiovascular

Common (1% to 10%): Hypertension, hypotension, atrial fibrillation, bradycardia, hematoma
Uncommon (0.1% to 1%): Retroperitoneal hemorrhage, pericardial effusion/hemorrhage/tamponade
Very rare (less than 0.01%): Thrombotic thrombocytopenic purpura[Ref]

Gastrointestinal

Common (1% to 10%): Gastrointestinal hemorrhage, nausea, diarrhea
Uncommon (0.1% to 1%): Rectal hemorrhage, gingival bleeding, hematochezia[Ref]

Dermatologic

Common (1% to 10%): Rash, contusion, ecchymosis
Uncommon (0.1% to 1%): Subcutaneous hematoma
Rare (less than 0.1%): Angioedema[Ref]

Respiratory

Common (1% to 10%): Dyspnea, cough, epistaxis
Uncommon (0.1% to 1%): Hemoptysis[Ref]

Musculoskeletal

Common (1% to 10%): Back pain, non-cardiac chest pain, pain in extremity[Ref]

Local

Common (1% to 10%): Vessel puncture site hematoma, puncture site hemorrhage[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness[Ref]

Metabolic

Common (1% to 10%): Hypercholesterolemia/hyperlipidemia, peripheral edema[Ref]

Other

Common (1% to 10%): Fatigue, pyrexia[Ref]

Genitourinary

Common (1% to 10%): Hematuria[Ref]

Oncologic

Common (1% to 10%): Newly-diagnosed malignancies[Ref]

Immunologic

Uncommon (0.1% to 1%): Allergic reactions
Rare (less than 0.1%): Hypersensitivity, anaphylaxis[Ref]

Hepatic

Uncommon (0.1% to 1%): Abnormal hepatic function[Ref]

Ocular

Uncommon (0.1% to 1%): Eye hemorrhage[Ref]

Some side effects of prasugrel may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Liver Dose Adjustments

Mild to moderate liver dysfunction (Child-Pugh A and B): No adjustment recommended
Severe liver dysfunction (Child-Pugh C): Not recommended

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