Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Effient (Prasugrel). If you are concerned about side effects, discuss the risks and benefits of Effient (Prasugrel) with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• bleeding gums
• bleeding or bruising from a needle puncture
• bruising (that develops without a known cause and grows in size)
• nose bleeds
• skin rash

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• dizziness
• lightheadedness
• signs of Anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
• signs of  liver problems (e.g., nausea, vomiting, Diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• blood in the urine
• signs of bleeding in the stomach (e.g., bloody, black, or tarry stools, spitting up of blood, vomiting blood or material that looks like coffee grounds)
• bleeding from stomach, intestine, or rectum (black, tarry stools or fresh blood in the stool, spitting up of blood, vomiting blood or material that looks like coffee grounds)
• bleeding in the eye
• coughing up blood
• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
• symptoms of thrombotic thrombocytopenic purpura (purplish spots on the skin or mucous membranes, yellowish color of the skin or eyes, Fever, confusion, headache, extreme tiredness)
• speech or vision changes
• sudden severe headache

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Effient (Prasugrel).

Each 10 mg, beige, elongated hexagonal, film-coated, unscored tablet, debossed with "10 mg" on one side and "4759" on the other side, contains 10.98 mg Effient (Prasugrel) hydrochloride equivalent to 10 mg of Effient (Prasugrel). Nonmedicinal ingredients: croscarmellose sodium, hypromellose, mannitol, microcrystalline cellulose, and vegetable magnesium stearate; color coatings: hypromellose, iron oxide red, iron oxide yellow, lactose, titanium dioxide, and triacetin.

Do not take Effient (Prasugrel) if you:

• are allergic to Effient (Prasugrel) or any ingredients of Effient (Prasugrel)
• have a history of stroke or a mini-stroke (also called a Transient Ischemic Attack or TIA)
• have an active bleeding condition, such as stomach or intestinal bleeding (e.g., a stomach ulcer) or bleeding in the brain
• have significant liver disease

There may be an interaction between Effient (Prasugrel) and any of the following:

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Effient (Prasugrel). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Effient (Prasugrel).

Bleeding problems: Effient (Prasugrel) increases the risk of bleeding because it reduces the ability of your blood to clot. People who weigh less than 60 kg (132 pounds) should not use Effient (Prasugrel) due to an increased risk of bleeding. Using other blood thinners (e.g., Warfarin, NSAIDs) and blood clot dissolving drugs (e.g., alteplase) may further increase the risk of bleeding.

If you experience signs of serious or excessive bleeding (easy bruising, bleeding from the rectum, red or black stools, bloody urine, persistent abdominal pain and vomiting, coughing up blood), contact your doctor immediately.

If you have a history of bleeding disorders, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Effient (Prasugrel), and whether any special monitoring is needed.

Thrombotic thrombocytopenic purpura (TTP) is a rare condition that may occur while taking Effient (Prasugrel) and that requires immediate medical attention. Signs include decreased number of blood cells, reduced kidney function, and fever. Your doctor will order blood tests to monitor for this condition while you are taking Effient (Prasugrel).

Heart problems: There is an increased risk of bleeding if Effient (Prasugrel) is started in the hospital before your doctor checks the heart arteries with a procedure known as an angiogram. This risk is something that your doctor will consider before starting the medication.

If you are already taking Effient (Prasugrel), this risk does not affect your situation and you should not stop taking the medication without first speaking to your doctor.

Lactose intolerance: Effient (Prasugrel) contains lactose. If you have galactose intolerance (galactosemia, glucose-galactose malabsorption, or Lapp lactase deficiency) you should not take Effient (Prasugrel).

Liver function: If you have decreased liver function, discuss with your doctor how Effient (Prasugrel) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Effient (Prasugrel), and whether any special monitoring is needed. People with severely reduced liver function should not take Effient (Prasugrel).

Stomach problems: Since Effient (Prasugrel) can increase the risk of bleeding, it is important to remind your doctor if you have had stomach ulcers, and have the doctor or pharmacist review your medications to determine if they may cause stomach ulcers (e.g., NSAIDs such as Ibuprofen, Naproxen, and others). Bleeding in the digestive system is a medical emergency. If you experience signs of bleeding in the stomach, intestines, or rectum, such as black and tarry stools, vomiting blood, or blood in the stools, seek medical help immediately.

Stopping Effient (Prasugrel): Do not stop taking Effient (Prasugrel) suddenly as this increases the risk of Blood Clots, heart attack, and death. If you need to stop taking Effient (Prasugrel) due to bleeding problems, your doctor should monitor you for any blood clots.

Surgery: Your doctor may want you to stop taking Effient (Prasugrel) at least 7 days prior to any planned surgery to prevent any unnecessary bleeding. However, you should not stop taking Effient (Prasugrel) without talking to your doctor first. It is important to tell any doctors including your dentist that you are taking Effient (Prasugrel) if you plan to have any surgery or dental procedure.

Pregnancy: The medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Effient (Prasugrel), contact your doctor immediately.

Breast-feeding: It is not known if Effient (Prasugrel) passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Effient (Prasugrel) have not been established for children.

Seniors: Seniors are generally at increased risk for bleeding with or without medications. Because of the increased risk of bleeding with Effient (Prasugrel), Effient (Prasugrel) is not recommended for people over 75 years of age unless the benefits outweigh the risks.