Menostar

Serious side effects have been reported with Menostar. See the “Menostar Precautions” section.

Common side effects of Menostar include the following:

• headache
• breast tenderness or pain
• irregular vaginal bleeding or spotting
• stomach or abdominal cramps, bloating
• nausea and vomiting
• hair loss
• fluid retention
• vaginal yeast infection
• redness or irritation at the patch placement site

This is not a complete list of Menostar side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Amiodarone (Cordarone, Pacerone)
• Antifungals such as itraconazole (Sporanox) and ketoconazole (Nizoral)
• Aprepitant (Emend)
• Carbamazepine (Carbatrol, Epitol, Tegretol)
• Cimetidine (Tagamet)
• Clarithromycin (Biaxin)
• Cyclosporine (Neoral, Sandimmune)
• Dexamethasone (Decadron, Dexpak)
• Diltiazem (Cardizem, Dilacor, Tiazac, others)
• Erythromycin (E.E.S, Erythrocin)
• Fluoxetine (Prozac, Sarafem)
• Fluvoxamine (Luvox)
• Griseofulvin (Fulvicin, Grifulvin, Gris-PEG)
• Lovastatin (Altocor, Mevacor)
• Medications for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) such as atazanavir (Reyataz), delavirdine (Rescriptor), efavirenz (Sustiva), indinavir (Crixivan), lopinavir (in Kaletra),nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir, in Kaletra), and saquinavir (Fortovase, Invirase)
• Medications for thyroid disease
• Nefazodone
• Other medications that contain estrogen
• Phenobarbital
• Phenytoin (Dilantin, Phenytek); rifabutin (Mycobutin)
• Rifampin 
• Sertraline (Zoloft)
• Troleandomycin (TAO)
• Verapamil (Calan, Covera, Isoptin, Verelan)
• Zafirlukast (Accolate)
• St. John's Wort

This is not a complete list of Menostar drug interactions. Ask your doctor or pharmacist for more information.

You should not use this medicine if you are allergic to estradiol, if you are pregnant, or if you have:

• unusual vaginal bleeding that a doctor has not checked;

• liver disease;

• a bleeding or blood-clotting disorder;

• a recent history of heart attack or stroke;

• a history of hormone-dependent cancer (such as breast, uterine, ovarian, or thyroid cancer); or

• if you have ever had a blood clot (especially in your lung or your lower body).

Estradiol should not be used to prevent heart disease, stroke, or dementia, because this medicine may actually increase your risk of developing these conditions.

To make sure estradiol is safe for you, tell your doctor if you have:

• heart disease;

• risk factors for coronary artery disease (such as diabetes, lupus, smoking, being overweight, having high blood pressure or high cholesterol, having a family history of coronary artery disease, or if you have had a hysterectomy);

• a history of jaundice caused by pregnancy or birth control pills;

• hereditary angioedema (an immune system disorder);

• a thyroid disorder;

• kidney disease;

• asthma;

• epilepsy or other seizure disorder;

• migraines;

• lupus;

• porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);

• endometriosis or uterine fibroid tumors;

• gallbladder disease;

• high or low levels of calcium in your blood; or

• if you have had your uterus removed (hysterectomy).

Long-term use of estradiol may increase your risk of breast cancer, heart attack, stroke, or blood clot. Talk with your doctor about your individual risks before using estradiol transdermal long term.

FDA pregnancy category X. Do not use estradiol if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use effective birth control while you are using this medicine.

Estradiol can pass into breast milk. This medicine may slow breast milk production. Do not use if you are breast-feeding a baby.

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:

• unusual vaginal bleeding;

• swelling or tenderness in your stomach;

• jaundice (yellowing of the skin or eyes);

• a lump in your breast;

• skin rash;

• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;

• signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;

• signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;

• signs of a blood clot in your leg--pain, swelling, warmth, or redness in one or both legs;

• low levels of calcium in your blood--numbness or tingly feeling around your mouth, fast or slow heart rate, muscle tightness or contraction, overactive reflexes; or

• high levels of calcium in your blood--nausea, vomiting, constipation, increased thirst or urination, muscle pain or weakness, joint pain, confusion, and feeling tired or restless.

Common side effects may include:

• headache;

• weight gain, bloating, stomach cramps, nausea, vomiting;

• fluid retention (swelling, rapid weight gain);

• thinning scalp hair;

• redness or irritation where the patch was worn;

• breast pain; or

• vaginal itching or discharge, changes in your menstrual periods, breakthrough bleeding.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In the U.S.

• Alora
• Cenestin
• Climara
• Divigel
• Elestrin
• Emcyt
• Enjuvia
• Esclim
• Estinyl
• EstroGel
• Evamist
• Femtrace
• Gynodiol
• Menest
• Menostar
• Minivelle
• Ogen .625
• Ogen 1.25
• Ogen 2.5
• Premarin
• Vivelle
• Vivelle-Dot

In Canada

• Estraderm
• Estradot Transdermal
• Estradot Transdermal Therapeutic System
• Estradot Transdermal Therapeutic System
• Estrogel
• Oesclim
• Rhoxal-Estradiol Derm 50
• Rhoxal-Estradiol Derm 75
• Roxal-Estradiol Derm 100
• Vivelle 100 Mcg
• Vivelle 25 Mcg

Available Dosage Forms:

• Tablet
• Cream
• Patch, Extended Release
• Gel/Jelly
• Spray
• Emulsion
• Tablet, Enteric Coated
• Capsule

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

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

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

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

Also, vaginal bleeding between your regular menstrual periods may occur during the first 3 months of use. Do not stop taking your medicine. Check with your doctor if bleeding continues for an unusually long 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 using this medicine before having any laboratory test because some results may be affected.

Check with your child's doctor right away if your child starts to have the following symptoms: nipple or breast swelling or tenderness in females, or enlargement of the breasts in males. Your child may have been exposed to Evamist® transdermal spray.

Do not allow your pets to lick or touch the arm where Evamist® transdermal spray was applied. Small pets may be sensitive to this medicine. Call your pet's veterinarian if your pet starts to have the following symptoms: nipple or breast enlargement, swelling of the vulva, or any signs of illness.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Do not take Menostar by mouth. Use on your skin only. Keep out of your mouth, nose, and eyes (may burn).
• Use this medicine at the same time of day.
• Do not use on skin that has any problems.
• Do not put on the face, breast, or vagina.
• Wash your hands before and after use.
• Put patch on clean, dry, healthy skin. Move the site with each new patch.
• Put patch on a site without hair.
• Do not place on breast. Place below waistline.
• Do not put the patch on the waistline.
• Do not use patches that are cut or do not look right.
• If the patch falls off, put a new one on.
• Wear only one patch at a time.

What do I do if I miss a dose?

• Put on a missed patch as soon as you think about it after taking off the old one.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Chest pain or pressure.
• Shortness of breath.
• Coughing up blood.
• Swelling, warmth, numbness, change of color, or pain in a leg or arm.
• Very bad headache.
• Very bad dizziness or passing out.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Very upset stomach or throwing up.
• Very bad belly pain.
• Back pain.
• Bulging eyes.
• Change in how contact lenses feel in the eyes.
• Loss of eyesight.
• Change in eyesight.
• A lump in the breast, breast soreness, or nipple discharge.
• Breast pain.
• Vaginal itching or discharge.
• Vaginal bleeding that is not normal.
• Low mood (depression).
• Mood changes.
• Memory problems or loss.
• Fever.
• Not able to pass urine or change in how much urine is passed.
• Pain when passing urine.
• Swelling.
• Very bad irritation where Menostar is used.

Menostar is a skin patch that contains estradiol, a form of estrogen. Estradiol is a female sex hormone produced by the ovaries that regulates many processes in the body.

Menostar skin patches are used to prevent postmenopausal osteoporosis.

Menostar may also be used for purposes not listed in this medication guide.

Common side effects of Menostar include: headache. Other side effects include: limb pain. See below for a comprehensive list of adverse effects.

Applies to estradiol: compounding powder, intramuscular solution, oral tablet, transdermal emulsion, transdermal film extended release, transdermal gel, transdermal spray, vaginal ring

Gastrointestinal

Cases of oral pigmentation and ischemic colitis have been reported rarely.[Ref]

Gastrointestinal side effects have included nausea, abdominal cramps, bloating and vomiting. Some studies have demonstrated a 2 to 4 fold increase in gallbladder disease in postmenopausal women taking estrogen therapy. Cholestatic jaundice, pancreatitis, and enlargement of hepatic hemangiomas have been reported. Postmarketing experience with the vaginal ring has included a few cases of bowel obstruction and vaginal ring use. Postmarketing side effects with Vivelle-Dot include nausea, vomiting, abdominal cramps, bloating, cholelithiasis and diarrhea.[Ref]

Oncologic

Oncologic side effects have included reports of an increased risk of endometrial carcinoma in patients with an intact uterus and less persuasively, with an increased risk of breast cancer.[Ref]

A number of studies have suggested that the risk of endometrial carcinoma is removed (or delayed) by the administration of progestins in combination with estrogen therapy.

The increased risk of breast cancer due to use of estrogens is controversial. Several studies have suggested that long-term estrogen therapy may be associated with a slightly increased risk of breast cancer. Meta analysis of 51 studies (epidemiological data) supports a modest risk increase associated with long-term hormone replacement therapy (HRT).

One study of Swedish women has reported that a 10% increase in the relative risk of breast cancer may occur and that the risk is related to increasing duration of estrogen therapy. In that study, women with more than nine years of estrogen use had a 70% greater relative risk of breast cancer than controls. That study, however, examined use of a variety of estrogen preparations of which estradiol was the most frequently prescribed. In addition, women who took progestins did not demonstrate a decreased risk of breast cancer and may even have been at higher risk.

The Toronto Breast Cancer Study has reported that women who receive unopposed conjugated estrogens for less than 15 years are not at increased risk of breast cancer. In that study, an increase in the risk of breast cancer for women who used conjugated estrogens for more than 15 years was not ruled out.

The Case-Control Surveillance Study has reported that there is "no evidence that the use of unopposed conjugated estrogens increases the risk of breast cancer, even after long duration of use or long latent intervals, but the possibility of a modest increase (less than a doubling) could not be excluded."

Follow-up to the Nurses' Health Study of 1992 concluded, however, that there is an increased risk of breast cancer in women taking estrogen replacement therapy and that the risk is not reduced by concurrent use of progestins. (In that study, greater risk was associated with advanced age and prolonged duration of hormonal therapy.)

A study of middle-aged women in the Puget Sound area concluded that "on the whole, the use of estrogen with progestin HRT [hormone replacement therapy] does not appear to be associated with an increased risk of breast cancer in middle-aged women."

A prospective cohort study (11 years) of 37,105 women by Gapstur et al evaluated the histology of the breast cancer in women who ever used HRT. No association was found between duration of ever HRT use and the incidence of ductal carcinoma in situ or invasive ductal/lobular carcinoma. The duration of ever HRT use was associated with risk of invasive carcinoma with a favorable prognosis (relative risk (RR) = 1.81, 95% confidence interval (CI), 1.07 to 3.07 for HRT use less than or equal to 5 yrs and RR = 2.65, CI, 1.32 to 5.23 for HRT use > 5 yrs, p = 0.005). The relative risk of invasive carcinoma with a favorable prognosis for current users (adjusted for age and other risk factors) was 4.42, CI, 2.00 to 9.76 for less than or equal to 5 yrs and 2.63, CI, 1.18 to 5.89 for > 5 yrs). Risk of invasive ductal or lobular carcinoma for current users less than or equal to 5 yrs was RR = 1.38, CI, 1.03 to 1.85.[Ref]

Cardiovascular

The reported effects of estrogens on cardiovascular activity are variable. Alterations in lipid profiles in treated women are thought to be responsible for reducing cardiovascular risks. Data suggest estrogen use may increase blood pressure, particularly in patients receiving high doses, decrease blood pressure, or result in no change. In addition, noncontraceptive use of estrogens in young women (particularly smokers) may substantially increase the risk of nonfatal myocardial infarction. Other studies have concluded that no increased risk of myocardial infarction exists.[Ref]

Cardiovascular side effects have included studies suggesting that unopposed estrogen therapy decreased the risk of coronary heart disease by as much as 35%. Combination therapy with a progestin may have also decreased coronary risk. However, the extent of risk reduction with combination therapy has not been determined. Data are available that suggest combination therapy does not reduce the overall rate of coronary heart disease in postmenopausal women with established coronary disease. Postmarketing side effects with Vivelle-Dot include deep vein thrombosis, pulmonary embolism and thrombophlebitis.[Ref]

Metabolic

Metabolic side effects have included reports of generally favorable alterations in plasma lipid profiles. Specifically, increased HDL and decreased cholesterol and LDL levels have occurred. Estrogen therapy may have led to increased serum triglyceride levels resulting in pancreatitis in patients with familial lipoprotein metabolic defects.

Metabolic adverse effects such as hypercalcemia have occurred in patients with breast cancer and bone metastases.[Ref]

Endocrine

Endocrine side effects have included increased levels of thyroxin-binding globulin which led to increased total thyroid serum levels and a decreased in resin uptake of T3. Free thyroid hormone levels remained unchanged. Other endocrine effects have included decreased fasting plasma glucose.[Ref]

General

General side effects have included fluid retention and mastodynia. Alterations in libido have occurred. Postmarketing experience with the vaginal ring has included a few cases of toxic shock syndrome. Postmarketing side effects with Vivelle-Dot include decrease in weight, reduced carbohydrate tolerance and edema.[Ref]

Hepatic

Hepatic side effects have included reports of focal nodular hyperplasia, liver cell adenomas, hepatic hemangiomas, and well-differentiated hepatocellular carcinomas. Aggravation of porphyria has been reported. Postmarketing side effects with Vivelle-Dot include abnormal liver function tests.[Ref]

Many of the reports of hepatic tumors have occurred in women taking long-term oral contraceptives. However, some tumors have been reported in women taking isolated estrogen therapy.[Ref]

Hematologic

Hematologic side effects have included hypercoagulability and an increase in venous thromboembolism.[Ref]

The clinical significance of such hypercoagulability in postmenopausal women taking estrogens has not been determined.[Ref]

Ocular

Ocular side effects have included alterations in corneal curvature and contact lens discomfort. Retinal vascular thrombosis has been reported. Postmarketing side effects with Vivelle-Dot include intolerance to contact lenses.[Ref]

Hypersensitivity

Hypersensitivity side effects have included reports of reactions including anaphylaxis. Some reports have implicated the dyes contained in some conjugated estrogen formulations. Urticaria and angioedema have also been reported.[Ref]

Postmarketing reports concerning a transdermal product (Climara) have included a few cases in which there were a combination of the symptoms of generalized hives or rash with swelling of the throat or eyelid edema.[Ref]

Other

Other side effects have included reports of a possible increase in the risk of "fibrocystic breast disease" by as much as twofold. Postmarketing side effects with Vivelle-Dot include breast enlargement and pain, nipple discharge, fibrocystic breast changes and breast cancer.[Ref]

Psychiatric

Psychiatric side effects have included case reports of rapid mood cycling in patients with severe depression. Postmarketing side effects with Vivelle-Dot include nervousness, affect liability and irritability.[Ref]

Nervous system

Nervous system side effects have included dementia, dizziness, mental depression, headache, nervousness, irritability exacerbation of epilepsy and new onset or exacerbation of migraine headaches. A case of chorea has been reported in association with estrogen therapy.[Ref]

Dermatologic

Dermatologic side effects have included chloasma or melasma, which did not always resolve following discontinuation of estrogen therapy. Scalp hair loss, hirsutism, erythema nodosum, and hemorrhagic eruptions have occurred. Postmarketing side effects with Vivelle-Dot include erythema multiforme, pruritus, purpura and rash.[Ref]

Genitourinary

Genitourinary side effects have included abnormal uterine bleeding and dysmenorrhea. In some cases, this was bleeding related to endometrial carcinoma. In addition, estrogens have increased the size of preexisting uterine leiomyomata. Postmarketing experience with the vaginal ring has included a few cases of ring adherence to the vaginal wall, making removal difficult. Postmarketing side effects with Vivelle-Dot include vaginal hemorrhage, abnormal withdrawal bleeding or flow, breakthrough bleeding, spotting, uterine leiomyomata, vaginitis, vaginal discharge, ovarian cancer and endometrial hyperplasia.[Ref]

Musculoskeletal

Musculoskeletal side effects have included arthralgias. Postmarketing side effects with Vivelle-Dot include leg cramps.[Ref]

Some side effects of Menostar may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.