ESTROGENS (Systemic)

Some commonly used brand names are:

In the U.S.?

• Alora ⁴
• Climara ⁴
• Congest ¹
• Delestrogen ⁴
• Depo-Estradiol ⁴
• Depogen ⁴
• Estinyl ⁷
• Estrace ⁴
• Estraderm ⁴
• Estragyn 5 ⁵
• Estragyn LA 5 ⁴
• Estrasorb ⁴
• Estro-L.A. ⁴
• Kestrone-5 ⁵
• Neo-Estrone ⁴
• Menest ³
• Ogen .625 ⁶
• Ogen 1.25 ⁶
• Ogen 2.5 ⁶
• Ortho-Est .625 ⁶
• Ortho-Est 1.25 ⁶
• Premarin ¹
• Premarin Intravenous ¹
• Valergen-10 ⁴
• Valergen-20 ⁴
• Valergen-40 ⁴
• Vivelle ⁴
• Vivelle-Dot ⁴

In Canada?

• C.E.S. ¹
• Delestrogen ⁴
• Estradot ⁴
• Estraderm ⁴
• Ogen ⁶
• Premarin ¹
• Premarin Intravenous ¹
• Vivelle ⁴

Other commonly used names are:

• DES
• Fosfestrol
• Oestradiol
• Oestrone
• Piperazine estrone sulfate
• Stilboestrol

Category

• Antineoplastic?Conjugated Estrogens; Diethylstilbestrol; Esterified Estrogens; Estradiol; Estradiol valerate; Estrone; Ethinyl Estradiol
• Estrogen,systemic?Conjugated Estrogens; Diethylstilbestrol; Esterified Estrogens; Estradiol; Estrone; Estropipate; Ethinyl Estradiol
• Osteoporosis prophylactic?ConjugatedEstrogens; Esterified Estrogens; Estradiol; Estropipate
• Ovarian hormone therapy?Conjugated Estrogens; Esterified Estrogens; Estradiol; Estropipate

Description

Estrogens (ES-troe-jenz) are female hormones. They are produced by thebody and are necessary for the normal sexual development of the female andfor the regulation of the menstrual cycle during the childbearing years.

The ovaries begin to produce less estrogen after menopause (the changeof life). This medicine is prescribed to make up for the lower amount of estrogen.Estrogens help relieve signs of menopause, such as hot flashes and unusualsweating, chills, faintness, or dizziness.

Estrogens are prescribed for several reasons:

• to provide additional hormone when the body does not produce enoughof its own, such as during menopause or when female puberty (development offemale sexual organs) does not occur on time. Other conditions include a genitalskin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis),or ovary problems (female hypogonadism or failure or removal of both ovaries).
• to help prevent weakening of bones (osteoporosis) in women past menopause.
• in the treatment of selected cases of breast cancer in men and women.
• in the treatment of cancer of the prostate in men.

Estrogens may also be used for other conditions as determined by your doctor.

There is no medical evidence to support thebelief that the use of estrogens will keep the patient feeling young, keepthe skin soft, or delay the appearance of wrinkles. Nor has it been proventhat the use of estrogens during menopause will relieve emotional and nervoussymptoms, unless these symptoms are caused by other menopausal symptoms, suchas hot flashes or hot flushes.

Estrogens are available only with your doctor's prescription, in the followingdosage forms:

Oral
• Conjugated Estrogens
  • Tablets (U.S. and Canada)
• Esterified Estrogens
  • Tablets (U.S. and Canada)
• Estradiol
  • Tablets (U.S.)
• Estropipate
  • Tablets (U.S. and Canada)
• Ethinyl Estradiol
  • Tablets (U.S.)

Parenteral
• Conjugated Estrogens
  • Injection (U.S. and Canada)
• Estradiol
  • Injection (U.S. and Canada)
• Estrone
  • Injection (U.S.)

Topical
• Estradiol
  • Emulsion (U.S.)
  • Transdermal system (skin patch) (U.S. and Canada)

Before Using This Medicine

In deciding to use a medicine,the risks of taking the medicine must be weighed against the good it willdo. This is a decision you and your doctor will make. For estrogens, the followingshould be considered:

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to estrogens. Also tell your health care professional ifyou are allergic to any other substances, such as foods, preservatives, ordyes.

Pregnancy?Estrogens are not recommended for use during pregnancyor right after giving birth. Becoming pregnant or maintaining a pregnancyis not likely to occur around the time of menopause.

Certain estrogens have been shown to cause serious birth defects in humansand animals. Some daughters of women who took diethylstilbestrol (DES) duringpregnancy have developed reproductive (genital) tract problems and, rarely,cancer of the vagina or cervix (opening to the uterus) when they reached childbearingage. Some sons of women who took DES during pregnancy have developed urinary-genitaltract problems.

Breast-feeding?Use of this medicine is not recommended in nursingmothers. Estrogens pass into the breast milk and their possible effect onthe baby is not known.

Children?Use of this medicine before puberty is not recommended.Growth of bones can be stopped early. Girls and boys may develop growth ofbreasts. Girls may have vaginal changes, including vaginal bleeding.

Adolescents?This medicine may be used to start puberty in teenagerswith some types of delayed puberty.

Older adults?Elderly people are especially sensitive to the effectsof estrogens. This may increase the chance of side effects during treatment,especially stroke, invasive breast cancer, and memory problems.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takingestrogens, it is especially important that your health care professional knowif you are taking any of the following:

• Acetaminophen (e.g., Tylenol) (with long-term, high-dose use) or
• Amiodarone (e.g., Cordarone) or
• Anabolic steroids (nandrolone [e.g., Anabolin], oxandrolone [e.g.,Anavar], oxymetholone [e.g., Anadrol], stanozolol [e.g., Winstrol]) or
• Androgens (male hormones) or
• Anti-infectives by mouth or by injection (medicine for infection)or
• Antithyroid agents (medicine for overactive thyroid) or
• Carbamazepine (e.g., Tegretol) or
• Carmustine (e.g., BiCNU) or
• Chloroquine (e.g., Aralen) or
• Dantrolene (e.g., Dantrium) or
• Daunorubicin (e.g., Cerubidine) or
• Disulfiram (e.g., Antabuse) or
• Divalproex (e.g., Depakote) or
• Etretinate (e.g., Tegison) or
• Gold salts (medicine for arthritis) or
• Hydroxychloroquine (e.g., Plaquenil) or
• Isoniazid or
• Mercaptopurine (e.g., Purinethol) or
• Methotrexate (e.g., Mexate) or
• Methyldopa (e.g., Aldomet) or
• Naltrexone (e.g., Trexan) (with long-term, high-dose use) or
• Oral contraceptives (birth control pills) containing estrogen or
• Phenothiazines (acetophenazine [e.g., Tindal], chlorpromazine [e.g.,Thorazine], fluphenazine [e.g., Prolixin], mesoridazine [e.g., Serentil],perphenazine [e.g., Trilafon], prochlorperazine [e.g., Compazine], promazine[e.g., Sparine], promethazine [e.g., Phenergan], thioridazine [e.g., Mellaril],trifluoperazine [e.g., Stelazine], triflupromazine [e.g., Vesprin], trimeprazine[e.g., Temaril]) or
• Phenytoin (e.g., Dilantin) or
• Plicamycin (e.g., Mithracin) or
• Valproic acid (e.g., Depakene)?Use of these medicines withestrogens may increase the chance of problems occurring that affect the liver

• Cyclosporine (e.g., Sandimmune)?Estrogens can prevent cyclosporine'sremoval from the body; this can lead to cyclosporine causing kidney or liverproblems

Other medical problems?The presence of other medicalproblems may affect the use of estrogens. Make sure you tell your doctor ifyou have any other medical problems, especially:

For all patients
• Blood clotting problems (or history of during previous estrogen therapy)?Estrogensusually are not used until blood clotting problems stop; using estrogens isnot a problem for most patients without a history of blood clotting problemsdue to estrogen use

• Asthma or
• Calcium, too much or too little in blood or
• Diabetes mellitus (sugar diabetes)
• Epilepsy (seizures) or
• Heart problems or
• Kidney problems or
• Liver tumors, benign or
• Lupus erythematosus, systemic or
• Migraine headaches?Estrogens may worsen these conditions.

• Breast cancer or
• Bone cancer or
• Cancer of the uterus or
• Fibroid tumors of the uterus?Estrogens may interfere with thetreatment of breast or bone cancer or worsen cancer of the uterus when theseconditions are present

• Changes in genital or vaginal bleeding of unknown causes?Useof estrogens may delay diagnosis or worsen condition. The reason for the bleedingshould be determined before estrogens are used

• Endometriosis or
• High cholesterol or triglycerides (or history of) or
• Gallbladder disease or gallstones (or history of) or
• Liver disease (or history of) or
• Pancreatitis (inflammation of pancreas) or
• Porphyria?Estrogens may worsen these conditions. Although estrogenscan improve blood cholesterol, they can worsen blood triglycerides for somepeople

• Hypothyroid (too little thyroid hormone)?Dose of thyroid medicinemay need to be increased.

• Vision changes, sudden onset including
• Bulging eyes or
• Double vision or
• Migraine headache or
• Vision loss, partial or complete?Estrogens may cause theseproblems. Tell your doctor if you have had any of these problems, especiallywhile taking estrogen or oral contraceptives (?birth control pills?).

For males treated for breast or prostate cancer
• Blood clots or
• Heart or circulation disease or
• Stroke?Males with these medical problems may be more likelyto have clotting problems while taking estrogens; the high doses of estrogensused to treat male breast or prostate cancer have been shown to increase thechances of heart attack, phlebitis (inflamed veins) caused by a blood clot,or blood clots in the lungs

Proper Use of This Medicine

Estrogensusually come with patient information or directions. Read them carefully beforetaking this medicine.

Take this medicine only as directed by your doctor.Do not take more of it and do not take or use it for a longer time than yourdoctor ordered. For patients taking any of the estrogens by mouth,try to take the medicine at the same time each day to reduce the possibilityof side effects and to allow it to work better.

For patients taking any of the estrogens by mouth or by injection:

• Nausea may occur during the first few weeks after you start takingestrogens. This effect usually disappears with continued use. If the nauseais bothersome, it can usually be prevented or reduced by taking each dosewith food or immediately after food.

For patients using the transdermal (skin patch) form of estradiol:

• Wash and dry your hands thoroughly before and after handling thepatch.
• Apply the patch to a clean, dry, nonoily skin area of your lowerabdomen, hips below the waist, or buttocks that has little or no hair andis free of cuts or irritation. The manufacturer of the 0.025-mg patch recommendsthat its patch be applied to the buttocks only. Furthermore, each new patchshould be applied to a new site of application. For instance, if the old patchis taken off the left buttock, then apply the new patch to the right buttock.
• Do not apply to the breasts. Also, donot apply to the waistline or anywhere else where tight clothes may rub thepatch loose.
• Press the patch firmly in place with the palm of your hand for about10 seconds. Make sure there is good contact, especially around the edges.
• If a patch becomes loose or falls off, you may reapply it or discardit and apply a new patch.
• Each dose is best applied to a different area of skin on your lowerabdomen, hips below the waist, or buttocks so that at least 1 week goes bybefore the same area is used again. This will help prevent skin irritation.

For patients using the topical emulsion (skin lotion) form of estradiol:

• Washing and drying hands thoroughly before each application.
• Apply while you are sitting comfortably. Apply one pouch to eachleg every morning.
• Apply the entire contents of one pouch to clean, dry skin on theleft thigh. Rub the emulsion into the entire thigh and calf for 3 minutesuntil thoroughly absorbed.
• Apply entire contents of the second pouch to clean, dry skin on theright thigh. Rub the emulsion into the entire thigh and calf for 3 minutesuntil thoroughly absorbed.
• Rub any remaining emulsion on both hands on the buttocks.
• Washing and drying hands thoroughly after application.
• To avoid transfer to other individuals, allow the application areasto dry completely before covering with clothing.

Dosing?The dose of these medicines will be differentfor different patients. Follow your doctor's orders orthe directions on the label. The following information includes onlythe average doses of these medicines. If your dose isdifferent, do not change it unless your doctor tells you to do so.

The number of tablets that you take or the amount of injection you usedepends on the strength of the medicine. Also, the numberof doses you take or use each day or patches you apply each week, the timeallowed between doses, and the length of time you take or use the medicinedepend on the medical problem for which you are taking, using, or applyingestrogen.

For conjugated estrogens
• For oral dosage form (tablets):
  • For treating breast cancer in women after menopause and in men:
    • Adults?10 milligrams (mg) three times a day for at least threemonths.
  • For treating a genital skin condition (vulvar atrophy), inflammationof the vagina (atrophic vaginitis), or symptoms of menopause:
    • Adults?0.3 mg a day. Your doctor may want you to take the medicineeach day or only on certain days of the month. Your doctor may change thedose based on how your body responds to the medication.
  • To prevent loss of bone (osteoporosis):
    • Adults?0.3 mg a day. Your doctor may want you to take the medicineeach day or only on certain days of the month. Your doctor may change thedose based on how your body responds to the medication.
  • For treating ovary problems (female hypogonadism or for startingpuberty):
    • Adults and teenagers?0.3 to 0.625 mg a day. Your doctor maywant you to take the medicine only on certain days of the month.
  • For treating ovary problems (failure or removal of both ovaries):
    • Adults?1.25 mg a day. Your doctor may want you to take themedicine each day or only on certain days of the month.
  • For treating prostate cancer:
    • Adults?1.25 to 2.5 mg three times a day.
• For injection dosage form:
  • For controlling abnormal bleeding of the uterus:
    • Adults?25 mg injected into a muscle or vein. This may be repeatedin six to twelve hours if needed.

For esterified estrogens
• For oral dosage form (tablets):
  • For treating breast cancer in women after menopause and in men:
    • Adults?10 milligrams (mg) three times a day for at least threemonths.
  • For treating a genital skin condition (vulvar atrophy) or inflammationof the vagina (atrophic vaginitis), or to prevent loss of bone (osteoporosis):
    • Adults?0.3 to 1.25 mg a day. Your doctor may want you to takethe medicine each day or only on certain days of the month.
  • For treating ovary problems (failure or removal of both ovaries):
    • Adults?1.25 mg a day. Your doctor may want you to take themedicine each day or only on certain days of the month.
  • For treating ovary problems (female hypogonadism):
    • Adults?2.5 to 7.5 mg a day. This dose may be divided up andtaken in smaller doses. Your doctor may want you to take the medicine eachday or only on certain days of the month.
  • For treating symptoms of menopause:
    • Adults?0.625 to 1.25 mg a day. Your doctor may want you totake the medicine each day or only on certain days of the month.
  • For treating prostate cancer:
    • Adults?1.25 to 2.5 mg three times a day.

For estradiol
• For oral dosage form (tablets):
  • For treating breast cancer in women after menopause and in men:
    • Adults?10 milligrams (mg) three times a day for at least threemonths.
  • For treating a genital skin condition (vulvar atrophy), inflammationof the vagina (atrophic vaginitis), ovary problems (female hypogonadism orfailure or removal of both ovaries), or symptoms of menopause:
    • Adults?0.5 to 2 mg a day. Your doctor may want you to takethe medicine each day or only on certain days of the month.
  • For treating prostate cancer:
    • Adults?1 to 2 mg three times a day.
  • To prevent loss of bone (osteoporosis):
    • Adults?0.5 mg a day. Your doctor may want you to take the medicineeach day or only on certain days of the month.
• For topical emulsion dosage form (skinlotion):
  • For treating symptoms of menopause:
    • Adults?1.74 grams (one pouch) applied to the skin of each leg(thigh and calf) once a day in the morning.
• For transdermal dosage form (skin patches):
  • For treating a genital skin condition (vulvar atrophy), inflammationof the vagina (atrophic vaginitis), symptoms of menopause, ovary problems(female hypogonadism or failure or removal of both ovaries), or to preventloss of bone (osteoporosis):
    For the Climara patches
    • Adults?0.025 to 0.1 milligram (mg) (one patch) applied to theskin and worn for one week. Then, remove that patch and apply a new one. Anew patch should be applied once a week for three weeks. During the fourthweek, you may or may not wear a patch. Your health care professional willtell you what you should do for this fourth week. After the fourth week, youwill repeat the cycle.
    For the Alora, Estraderm, Estradot, Vivelle, or Vivelle-Dot patches
    • Adults?0.025 to 0.1 mg (one patch) applied to the skin andworn for one half of a week. Then, remove that patch and apply and wear anew patch for the rest of the week. A new patch should be applied two timesa week for three weeks. During the fourth week, you may or may not apply newpatches. Your health care professional will tell you what you should do forthis fourth week. After the fourth week, you will repeat the cycle.

For estradiol cypionate
• For injection dosage form:
  • For treating ovary problems (female hypogonadism):
    • Adults?1.5 to 2 milligrams (mg) injected into a muscle oncea month.
  • For treating symptoms of menopause:
    • Adults?1 to 5 mg injected into a muscle every three to fourweeks.

For estradiol valerate
• For injection dosage form:
  • For treating a genital skin condition (vulvar atrophy), inflammationof the vagina (atrophic vaginitis), symptoms of menopause, or ovary problems(female hypogonadism or failure or removal of both ovaries):
    • Adults?10 to 20 milligrams (mg) injected into a muscle everyfour weeks as needed.
  • For treating prostate cancer:
    • Adults?30 mg injected into a muscle every one or two weeks.

For estrone
• For injection dosage form:
  • For controlling abnormal bleeding of the uterus:
    • Adults?2 to 5 milligrams (mg) a day, injected into a musclefor several days.
  • For treating a genital skin condition (vulvar atrophy), inflammationof the vagina (atrophic vaginitis), or symptoms of menopause:
    • Adults?0.1 to 0.5 mg injected into a muscle two or three timesa week. Your doctor may want you to receive the medicine each week or onlyduring certain weeks of the month.
  • For treating ovary problems (female hypogonadism or failure or removalof both ovaries):
    • Adults?0.1 to 1 mg a week. This is injected into a muscle asa single dose or divided into more than one dose. Your doctor may want youto receive the medicine each week or only during certain weeks of the month.
  • For treating prostate cancer:
    • Adults?2 to 4 mg injected into a muscle two or three timesa week.

For estropipate
• For oral dosage form (tablets):
  • For treating a genital skin condition (vulvar atrophy), inflammationof the vagina (atrophic vaginitis), or symptoms of menopause:
    • Adults?0.75 to 6 milligrams (mg) a day. Your doctor may wantyou to take the medicine each day or only on certain days of the month.
  • For treating ovary problems (female hypogonadism or failure or removalof both ovaries):
    • Adults?1.5 to 9 mg a day. Your doctor may want you to takethe medicine each day or only on certain days of the month.
  • To prevent loss of bone (osteoporosis):
    • Adults?0.75 mg a day. Your doctor may want you to take themedicine each day for twenty-five days of a thirty-one-day cycle.

For ethinyl estradiol
• For oral dosage form (tablets):
  • For treating breast cancer in women after menopause and in men:
    • Adults?1 milligram (mg) three times a day.
  • For treating ovary problems (female hypogonadism or failure or removalof both ovaries):
    • Adults?0.05 mg one to three times a day for three to six months.Your doctor may want you to take the medicine each day or only on certaindays of the month.
  • For treating prostate cancer:
    • Adults?0.15 to 3 mg a day.
  • For treating symptoms of menopause:
    • Adults?0.02 to 0.05 mg a day. Your doctor may want you to takethe medicine each day or only on certain days of the month.

For ethinyl estradiol and norethindrone
• For oral dosage form (tablets):
  • For treating symptoms of menopause:
    • Adults?1 tablet (5 mcg ethinyl estradiol and 1 mg of norethindrone)each day
  • To prevent loss of bone (osteoporosis):
    • Adults?1 tablet (5 mcg ethinyl estradiol and 1 mg of norethindrone)each day

Missed dose?

• For patients taking any of the estrogens by mouth: If you miss adose of this medicine, take it as soon as possible. However, if it is almosttime for your next dose, skip the missed dose and go back to your regulardosing schedule. Do not double doses.
• For patients using the topical emulsion (skin lotion) form of estradiol:If you forget to apply the emulsion when you are suppose to, apply it as soonas possible. However, if it is almost time for the next dose, skip the missedone and go back to your regular schedule. Do not apply more than once a day.
• For patients using the transdermal (skin patch) form of estradiol:If you forget to apply a new patch when you are supposed to, apply it as soonas possible. However, if it is almost time for the next patch, skip the missedone and go back to your regular schedule. Always remove the old patch beforeapplying a new one. Do not apply more than one patch at a time.

Storage?To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom medicine cabinet because the heat ormoisture may cause the medicine to break down.
• Keep the injection form of this medicine from freezing.
• Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

It is very important that your doctor check your progress atregular visits to make sure this medicine does not cause unwanted effects. These visits will usually be every year, but some doctors requirethem more often.

In some patients using estrogens, tenderness, swelling, or bleeding ofthe gums may occur. Brushing and flossing your teeth carefully and regularlyand massaging your gums may help prevent this. See your dentist regularlyto have your teeth cleaned. Check with your medical doctor or dentist if youhave any questions about how to take care of your teeth and gums, or if younotice any tenderness, swelling, or bleeding of your gums.

Although the incidence is low, the use of estrogensmay increase you chance of getting cancer of the breast, ovaries, or uterus(womb).. Therefore, it is very important thatyou regularly check your breasts for any unusual lumps or discharge. Reportany problems to your doctor. You should also have a mammogram (x-raypictures of the breasts) done if your doctor recommends it. Because breastcancer has occurred in men taking estrogens, regular breast self-exams andexams by your doctor for any unusual lumps or discharge should be done.

If your menstrual periods have stopped, they may startagain. This effect will continue for as long as the medicine is taken.However, if taking the continuous treatment (0.625 mg conjugated estrogensand 2.5 mg medroxyprogesterone once a day), monthly bleeding usually stopswithin 10 months.

Also, vaginal bleeding between your regular menstrual periods may occurduring the first 3 months of use. Do not stop taking your medicine. Check with your doctor if bleeding continues for an unusuallylong time, if your period has not started within 45 days of your last period,or if you think you are pregnant.

Tell the doctor in charge that you are taking this medicine before havingany laboratory test because some results may be affected.

Side Effects of This Medicine

Women rarely have severe side effects from taking estrogens to replaceestrogen. Discuss these possible effects with your doctor:

• The prolonged use of estrogens has been reported to increase therisk of endometrial cancer (cancer of the lining of the uterus) in women aftermenopause. This risk seems to increase as the dose and the length of use increase.When estrogens are used in low doses for less than 1 year, there is less risk.The risk is also reduced if a progestin (another female hormone) is addedto, or replaces part of, your estrogen dose. If the uterus has been removedby surgery (total hysterectomy), there is no risk of endometrial cancer.
• Although the incidence is low, the use of estrogens may increaseyou chance of getting cancer of the breast. Breast cancer has been reportedin men taking estrogens.

The following side effects may be caused byblood clots, which could lead to stroke, heart attack, or death. These sideeffects occur rarely, and, when they do occur, they occur in men treated forcancer using high doses of estrogens. Get emergency helpimmediately if any of the following side effects occur:

Rare?for males being treated for breast or prostate cancer only

Headache (sudden or severe); loss ofcoordination (sudden); loss of vision or change ofvision (sudden); pains in chest, groin, or leg, especiallyin calf of leg; shortness of breath (sudden and unexplained); slurring of speech (sudden); weakness or numbness in arm or leg

Also, check with your doctor as soon as possibleif any of the following side effects occur:

More common

Breast pain (in females and males); fast heartbeat; fever; hives; hoarseness; increasedbreast size (in females and males); irritation ofskin; itching of skin; joint pain, stiffness or swelling; rash; redness of skin; shortness of breath; swelling of eyelids, face, lips, hands, or feet; swelling of feet and lower legs; tightness in chest; troubled breathing or swallowing; weight gain (rapid); wheezing

Less common or rare

Changes in vaginal bleeding (spotting, breakthrough bleeding,prolonged or heavier bleeding, or complete stoppage of bleeding); chest pain; chills; cough; heavy nonmenstrual vaginal bleeding; lumps in, or discharge from, breast (in females and males); pains in stomach, side, or abdomen; yellow eyes or skin

Frequency not determined

Other side effects may occur that usually donot need medical attention. These side effects may go away during treatmentas your body adjusts to the medicine. However, check with your doctor if anyof the following side effects continue or are bothersome:

More common

Abnormal growth filled with fluid or semisolid material; accidental injury; bladder pain; bloated full feeling; bloody or cloudyurine; body aches or pain; coating or white patches on tongue; congestion; cough producing mucus; decrease in amountof urine; difficult, burning, or painful urination; discouragement; drynessof throat; ear congestion or pain; excess air or gas in stomach or intestines; fear; feeling of warmth; feelingsad or empty; frequent urge to urinate; general feeling of discomfort or illness; headache, severe and throbbing; increased clear orwhite vaginal discharge; irritability; itching of the vaginal, rectal or genital areas; lack of appetite; lack or loss of strength; loss of interest or pleasure; mild dizziness; neck pain; nervousness; pain; painduring sexual intercourse; painful or difficult urination; pain or tenderness around eyes and cheekbones; passing gas; redness of the face, neck,arms and occasionally, upper chest; runny nose; skin irritation or redness where skin patch was worn; shivering; sleeplessness; sneezing; sore mouth or tongue; stuffy nose; sudden sweating; tender, swollen glands in neck; thick,white vaginal discharge with no odor or with a mild odor; tiredness; trouble concentrating; trouble sleeping; unable to sleep; voice changes

Less common

Blemishes on the skin; burning, crawling,itching, numbness, prickling, "pins and needles" , or tingling feelings; burning or stinging of skin; diarrhea(mild); dizziness (mild); increased hair growth, especially on the face; lowerabdominal pain or pressure; mood or mental changes; muscle stiffness; difficultyin moving; painful cold sores or blisters on lips,nose, eyes, or genitals; pimples; pounding in the ears; slow heartbeat; problems in wearing contact lenses; tooth or gum pain; unusual decrease in sexual desire(in males); unusual increase in sexual desire (infemales); white or brownish vaginal discharge

Frequency not determined

abdominal pain; abnormal turning outof cervix; changes in appetite; dull ache or feeling of pressure or heaviness in legs; fatigue; flushed, dry skin; fruit-like breath odor; increased hunger; irritability; large amount of triglyceridein the blood; leg cramps; patchy brown or dark brown discoloration of skin; poor insight and judgment; problems with memory orspeech; trouble recognizing objects; trouble thinking and planning; troublewalking; twitching, uncontrolled movements of tongue,lips, face, arms, or legs; unexpected or excess milkflow from breasts

Also, many women who aretaking estrogens with a progestin (another female hormone) will start havingmonthly vaginal bleeding, similar to menstrual periods, again. This effectwill continue for as long as the medicine is taken. However, monthly bleedingwill not occur in women who have had the uterus removed by surgery (totalhysterectomy).

This medicine may cause loss or thinning of scalp hair in some people.

Other side effects not listed above may also occur insome patients. If you notice any other effects, check with your doctor.

Additional Information

Once a medicine has been approvedfor marketing for a certain use, experience may show that it is also usefulfor other medical problems. Although these uses are not included in productlabeling, estrogen is used in certain patients with the following medicalconditions:

• Gender identity disorder,male-to-female transsexualism (person who is born as a man but adapts to awoman's lifestyle, sees himself as a woman, and feels like a woman insteadof a man)
• Osteoporosis caused by lack of estrogen before menopause
• Turner's syndrome (a genetic disorder)

Other than the above information, there is no additional information relatingto proper use, precautions, or side effects for these uses.