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Bravelle Consumer (continued)
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: unusual bleeding from the vagina/uterus, pain/redness/swelling of the calf muscles, cold/numb/pale skin of the arms/legs/hands/feet, swelling of ankles/hands/feet.
Seek immediate medical attention if any of these rare but very serious side effects occur: weakness on one side of the body, slurred speech, vision changes, sudden severe headache, chest pain, shortness of breath.
This medication may cause a condition known as ovarian hyperstimulation syndrome (OHSS). This condition may occur during treatment and after treatment has been stopped. Rarely, serious OHSS causes fluid to suddenly build up in the stomach, chest, and heart area. Seek immediate medical attention if you develop the following side effects: severe pain or swelling in the lower abdominal (pelvic) area, severe nausea/vomiting, sudden/rapid weight gain, difficult/painful breathing, change in the amount of urine.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the Bravelle (urofollitropin injection) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: other fertility problems (e.g., primary ovarian failure), abnormal bleeding from the vagina/uterus, thyroid problems, adrenal gland problems, cancer of the reproductive organs (e.g., breast, uterus, ovary), tumor in the brain (e.g., pituitary tumor), ovarian cysts or enlarged ovaries (not due to polycystic ovary syndrome), twisting of the ovary (ovarian torsion), personal/family history of blood clots, blood clotting disorders (such as thrombophilia), obesity, polycystic ovarian syndrome, stroke, certain heart diseases (e.g., angina, heart attack), lung problems (e.g., asthma).
Multiple births may occur as a result of this treatment. Discuss the risks and benefits of having such a pregnancy with your doctor.
Stop using this medication when you become pregnant. This medication must not be used during pregnancy. If you think you may be pregnant, tell your doctor immediately.
It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
Additional Bravelle Information
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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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