SIDE-EFFECTS
Please keep in mind that, just because a side effect is listed here does not mean that all people using this medicine will experience any side effect – we are all different.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
- unusual bleeding such as nosebleeds, bleeding gums, or any bleeding that will not stop;
- pale skin, fever, easy bruising, purple or red spots under your skin;
- jaundice (yellowing of the skin or eyes);
- unexpected vaginal bleeding;
- feeling very weak or dizzy;
- blood in your urine or stools, black or tarry stools;
- coughing up blood or vomit that looks like coffee grounds;
- chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
- sudden numbness or weakness, especially on one side of the body;
- sudden headache, confusion, problems with vision, speech, or balance.
Less serious side effects may include:
- mild headache or dizziness;
- back pain, minor chest pain;
- cough;
- nausea;
- tired feeling.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects – especially when they are persistent.
SAFETY
Before you begin taking 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 this medication.
You should not use Effient if you are allergic to prasugrel, or if you have:
- any active bleeding such as a stomach ulcer or bleeding in the brain (such as from a head injury);
- a history of stroke, including TIA ("mini-stroke"); or
- if you are scheduled to have surgery, especially heart bypass surgery (coronary artery bypass graft, or CABG).
To make sure Effient is safe for you, tell your doctor if you have:
- a stomach ulcer;
- stomach or intestinal bleeding;
- a history of surgery, injury, or medical emergency;
- liver or kidney disease;
- if you weigh less than 132 pounds;
- if you also use other medicines to treat or prevent blood clots; or
- if you have ever had a severe allergic reaction to clopidogrel (Plavix) or ticlopidine (Ticlid).
Effient is not expected to be harmful to an unborn baby. However, aspirin is usually given with Effient, and aspirin can cause bleeding when it is taken during the last 3 months of pregnancy. Aspirin can also cause side effects in a newborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.
It is not known whether Effient passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.
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 this medication, and whether any special monitoring is needed.
Thrombotic thrombocytopenic purpura (TTP) is a rare condition that may occur while taking Effient 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.
Heart problems: There is an increased risk of bleeding if Effient 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, this risk does not affect your situation and you should not stop taking the medication without first speaking to your doctor.
Lactose intolerance: This medication contains lactose. If you have galactose intolerance (galactosemia, glucose-galactose malabsorption, or Lapp lactase deficiency) you should not take this medication.
Liver function: If you have decreased liver function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. People with severely reduced liver function should not take Effient.
Stomach problems: Since Effient 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: Do not stop taking Effient suddenly as this increases the risk of blood clots, heart attack, and death. If you need to stop taking Effient due to bleeding problems, your doctor should monitor you for any blood clots.
Surgery: Your doctor may want you to stop taking Effient at least 7 days prior to any planned surgery to prevent any unnecessary bleeding. However, you should not stop taking Effient without talking to your doctor first. It is important to tell any doctors including your dentist that you are taking Effient if you plan to have any surgery or dental procedure.
Children: The safety and effectiveness of using this medication 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 this medication, Effient is not recommended for people over 75 years of age unless the benefits outweigh the risks.
Can Other Medicines Affect Effient?
There may be an interaction between Effient and any of the following:
- acetylsalicylic acid (ASA);
- alteplase "azole" antifungals (e.g., itraconazole, ketoconazole, voriconazole);
- boceprevir;
- clarithromycin;
- conivaptan;
- dabigatran;
- dasatinib;
- delaviridine;
- dipyridamole;
- glucosamine;
- heparin;
- herbs with anticoagulant properties (e.g., alfalfa, chamomile, garlic, ginger, ginkgo biloba, ginseng, SAMe);
- HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir);
- low weight heparins (e.g., dalteparin, enoxaparin, tinzaparin);
- multivitamins with vitamin A, E;
- nefazodone;
- nelfinavir;
- nonsteroidal anti-inflammatory drugs (NSAIDs; e.g., ibuprofen, diclofenac, ketorolac, naproxen);
- omega-3-fatty acids;
- other antiplatelet medications (e.g., clopidogrel, pentoxifylline, ticlopidine);
- ranitidine;
- rifampin;
- rivaroxaban;
- selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, duloxetine, fluoxetine, paroxetine, sertraline);
- telaprevir;
- urokinase;
- vitamin E;
- Warfarin.
If you are taking any of these medications, then tell 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 this medication. Tell your doctor about all prescriptions, over-the-counter (non-prescription), and herbal medications you are taking – not forgetting 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 doctor know if you use them.