mifepristone-oral (cont.)
SIDE EFFECTS: Nausea, vomiting, diarrhea, headache, dizziness, and fatigue may occur. If these effects persist or worsen, notify your doctor promptly. Bleeding and cramping are expected during this treatment. Usually, the symptoms mean the drugs are working. However, sometimes you can have cramps and bleeding and still be pregnant. Therefore, you must return for all three of your doctor visits. Bleeding and spotting may last up to 30 days, and may be greater than a normal, heavy period. In a very few cases, this bleeding will need to be stopped by performing a surgical procedure. Seek immediate medical attention if you bleed enough to soak through two thick full-size sanitary pads per hour for two straight hours, or if you are concerned about heavy bleeding. Tell your doctor immediately if you have any of these unlikely but serious side effects: fever, fainting, vaginal discomfort or itching, unusual vaginal discharge, fast heartbeat, stomach/abdominal pain or tenderness, any other sign of infection. If you notice other effects not listed above, contact your doctor or pharmacist.
PRECAUTIONS: Tell your doctor your medical history, including: anemia, if you are a smoker 35 years of age or greater. This medication is not recommended for use if you have the following medical conditions: proven or possible pregnancy outside the womb (ectopic pregnancy), an undiagnosed abdominal growth, chronic adrenal gland failure, any allergies (including misoprostol or other prostaglandins), bleeding disorders, certain blood disorders (inherited porphyrias). This drug must be used where there is easy access to adequate emergency medical facilities in case problems develop. If you are using an IUD (intrauterine birth control device), it should be removed before mifepristone treatment begins. Another pregnancy can occur following this abortion treatment, and before your normal period begins again. Birth control can be started as soon as this treatment is successfully completed. Mifepristone usually causes fetal death. In the unlikely event you have an ongoing pregnancy after treatment, birth defects may result. It is not known whether this drug passes into breast milk. Since the effects of mifepristone on infants are unknown, breast- feeding women should consult their doctor and determine if they should discard their breast milk for a few days following this treatment.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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