Safety and Side Effects

The most common side effect of Effient^® (prasugrel) is bleeding. In some cases, bleeding can be serious, and sometimes lead to death. In this section, you will learn about:

• The most important information about Effient
• Risk factors for bleeding when taking Effient
• Signs and symptoms of bleeding
• What you should tell your doctor before taking Effient
• Possible side effects other than bleeding
• Drugs that may be taken with Effient

• Effient is used to lower your chance of having a heart attack or other serious problems with your heart or blood vessels. But, Effient can cause bleeding, which can be serious, and sometimes lead to death. You should not start to take Effient 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 Effient and then have heart bypass surgery.
• Do not take Effient if you:
  • Currently have abnormal bleeding, such as stomach or intestinal bleeding, or bleeding in your head
  • Have a history of stroke, or “mini-stroke” (transient ischemic attack or TIA)
• You should stop taking Effient if you have a stroke.
• Whenever possible, you should stop taking Effient at least 7 days before any surgery, as instructed by the doctor who prescribed Effient for you.

Please review the Effient Medication Guide to learn more about the safety profile of Effient.

You may also have a higher risk of bleeding if you take Effient and:

• Have had trauma, such as an accident or surgery
• Have stomach or intestine bleeding that is recent or keeps coming back, or you have a stomach ulcer
• Have severe liver problems
• Weigh less than 132 pounds
• Take other medicines that increase your risk of bleeding, including:
  • Warfarin sodium (Coumadin, Jantoven)
  • A medicine that contains heparin
  • Other medicines to prevent or treat blood clots
  • Nonsteroidal anti-inflammatory drugs (NSAIDs) for a long time

Please review the Effient Medication Guide to learn more about the safety profile of Effient.

Tell your doctor if you take any of these medicines. Ask your doctor if you are not sure if your medicine is one listed above.

• Effient increases your risk of bleeding because it lessens the ability of your blood to clot. While you take Effient:
  • You will bruise and bleed more easily
  • You are more likely to have nose bleeds
  • It will take longer for any bleeding to stop
• Call your doctor right away if you have any of these signs or symptoms of bleeding:
  • Unexpected bleeding or bleeding that lasts a long time
  • Bleeding that is severe or you can not control
  • Pink or brown urine
  • Red or black stools (looks like tar)
  • Bruises that happen without a known cause or get larger
  • Cough up blood or blood clots
  • Vomit blood or your vomit looks like “coffee grounds”
• Do not stop taking Effient without talking to the doctor who prescribes it for you. People who are treated with angioplasty and have a stent, and stop taking Effient too soon, have a higher risk of a blood clot in the stent, having a heart attack, or dying. If you must stop Effient because of bleeding, your risk of a heart attack may be higher.

Please review the Effient Medication Guide to learn more about the safety profile of Effient.

Effient may not be right for you. Tell your doctor about all of your medical conditions, including if you:

• Have any bleeding problems
• Have a history of stomach ulcers, colon polyps, diverticulosis
• Have liver problems
• Have had any recent severe injury or surgery
• Plan to have surgery or a dental procedure. See "What is the most important information I should know about Effient?"
• Pregnant, or are planning to get pregnant. It is not known if Effient will harm your baby.
• If you are breast-feeding. It is not known if Effient passes into your breast-milk. You and your doctor should decide if you will take Effient or breast-feed. You should not do both without talking with your doctor.

Tell all of your doctors and dentists that you are taking Effient. They should talk to the doctor who prescribed Effient for you, before you have any surgery or invasive procedure.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Certain medicines may increase your risk of bleeding. See “What is the most important information I should know about Effient?”

Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine.

Please review the Effient Medication Guide to learn more about the safety profile of Effient.

Effient can cause serious side effects, including:

• See “What is the most important information I should know about Effient?”
• A blood clotting problem called Thrombotic Thrombocytopenic Purpura (TTP). TTP can happen with other medicines that are like Effient, 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 can not 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

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 Effient. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects.

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

Please review the Effient Medication Guide to learn more about the safety profile of Effient.

Effient can be administered with these commonly prescribed medications:

• Statins
• ACE inhibitors
• ARBs
• Calcium channel blockers
• Beta blockers
• Proton pump inhibitors
• Antidiabetic agents (including insulin)
• Intermittent NSAIDs

Please read the Safety Information and Boxed Warning and Medication Guide.