estradiol emulsion - transdermal, Estrasorb (cont.)
SIDE EFFECTS: Dizziness, lightheadedness, headache, stomach upset, bloating, nausea, weight changes, increased/decreased interest in sex, breast tenderness, or skin redness/irritation at the application site may occur. If any of these effects persist or worsen, notify your doctor promptly.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: mental/mood changes (e.g., severe depression, memory loss), vision changes (e.g., change in contact lens fit), swelling of hands or feet, breast lumps, unusual vaginal bleeding (e.g., spotting, breakthrough bleeding, prolonged/recurrent bleeding), unusual vaginal discharge/itching/odor, stomach/abdominal/pelvic pain, yellowing of the eyes or skin.This medication may infrequently cause serious problems such as heart attacks, stroke, and blood clots. Seek immediate medical attention if you experience any of the following: chest/jaw/left arm pain, sudden severe headache, weakness on one side of the body, confusion, slurred speech, sudden vision changes (e.g., double vision, loss of vision), pain/redness/swelling of legs, trouble breathing, coughing up blood, sudden dizziness/fainting.A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: 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.
PRECAUTIONS: Before using estradiol, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: undiagnosed abnormal vaginal bleeding, certain cancers (e.g., breast cancer, especially non-metastatic type), current/history of blood clots, history of stroke or heart attack, liver disease.Before using this medication, tell your doctor or pharmacist your medical history, especially of: family medical history (especially breast lumps and cancer), asthma, diabetes, seizures, migraine headaches, heart disease (e.g., high blood pressure, congestive heart failure), kidney disease, low thyroid hormone (hypothyroidism), a certain hormone problem (hypoparathyroidism), abnormal calcium level in the blood, depression, high blood pressure during pregnancy (toxemia), yellowing of eyes and skin (cholestatic jaundice) during pregnancy or with past estrogen use, womb problems (e.g., uterine fibroids, endometriosis), cholesterol or lipid problems, gallbladder disease, overweight (obese), certain blood disorder (porphyria).If you will be having surgery or will be confined to a chair or bed for a long period of time (such as on a long plane flight), notify your doctor beforehand. Special precautions may need to be taken in these circumstances while you are using this drug.This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.This drug may cause a patchy darkening of the skin on the face (melasma). Sunlight may intensify this darkening and you may need to avoid prolonged sun exposure and sunlamps. Consult your doctor regarding use of sunscreens and protective clothing.Cigarette smoking can increase the chance of blood clots while using this medication (especially in women over the age of 35).If you go swimming after applying this medicine, allow enough time for the medicine to dry completely before swimming. This will decrease transferring this drug to others.If this medicine is used in children, their growth pattern should be monitored because it may stunt growth.This medication must not be used during pregnancy. It may result in birth defects or cancer later in the child's life. If you become pregnant or think you may be pregnant, tell your doctor immediately.This medication may pass into breast milk and may have undesirable effects on a nursing infant. Therefore, breast-feeding while using this medication is not recommended. Consult your doctor before breast-feeding.
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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