Many medications can cause side effects. A side effect is an unwanted response to a medication when it is used in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who uses Estrogel (Estradiol-topical). If you are concerned about side effects, discuss the risks and benefits of Estrogel (Estradiol-topical) with your doctor.

The following side effects have been reported by at least 1% of people taking Estrogel (Estradiol-topical). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• Acne
• breast pain
• darkening of the skin
• decreased interest in sexual activity
• fatigue
• fluid retention
• hair loss
• irritability
• migraine Headaches
• nausea
• nervousness
• stomach cramps and bloating

Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• abdominal tenderness, or persistent upper abdominal pain
• breast lumps
• changes in menstrual periods
• increased blood pressure
• nausea
• problems wearing contact lenses
• signs of Depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
• signs of liver problems (e.g., nausea, vomiting, Diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
• unexpected vaginal bleeding
• vomiting

Stop taking the medication and seek immediate medical attention if any of the following occur:

• headache (sudden or severe)
• irregular or fast, pounding heartbeat
• signs of a blood clot in the arm or leg (tenderness, pain, swelling, warmth, or redness in the arm or leg) or lungs (difficulty breathing, sharp chest pain that is worse when breathing in, coughing, coughing up blood, sweating, or passing out)
• signs of a heart attack (e.g., chest pain or pressure, pain extending through the shoulder and arm, nausea and vomiting, sweating)
• signs of stroke (e.g., sudden or severe headache; sudden loss of coordination; vision changes; sudden slurring of speech; or unexplained weakness, numbness, or pain in arm or leg)
• sudden vision changes (such as partial or complete loss of vision, double vision)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Estrogel (Estradiol-topical).

The transdermal gel contains estradiol-17β 0.06% in a specially formulated hydro-alcoholic gel to provide a sustained absorption of the active ingredient. Metered-dose pumps of 80 g. Each metered-actuation delivers 1.25 g of gel (0.75 mg of estradiol-17β). Nonmedicinal ingredients: carbopol 934, ethanol, purified water, and triethanolamine.

Do not use this medication if you:

• are allergic to estradiol gel or any ingredients of the medication
• are or may be pregnant or breast-feeding
• experience migraines that are accompanied by a visual aura or disturbance
• have active Phlebitis (inflamed Varicose Veins)
• have heart disease or have had a Stroke
• have had breast or endometrial cancer, except in special circumstances
• have liver dysfunction or disease, especially of the obstructive type
• have or have had Blood Clots in the legs (deep vein thrombosis), lungs (pulmonary Embolism), or heart (Heart Attack)
• have partial or complete loss of vision, or double vision from eye disease related to circulation problems
• have unusual vaginal bleeding and have not consulted a doctor about it
• have excessive growth of tissue in the uterus

There may be an interaction between estradiol gel and any of the following:

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. In many cases, interactions are intended or are managed by close monitoring. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Estrogel (Estradiol-topical). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Estrogel (Estradiol-topical).

Important information about estrogen:

• Estrogel (Estradiol-topical) should be used at the lowest dose that relieves your menopausal symptoms for the shortest time period possible.
• Estrogens should not be used to prevent heart disease, heart attacks, or strokes.

Allergy: Contact allergy, such as itching and redness, is known to occur with the application of estrogen to the skin. Although this allergy is extremely rare, people who develop skin reactions or contact sensitization to any component of the medication are at risk of developing a more Anaphylaxis (severe allergic reaction) with continued use.

Blood clotting disorders: Estrogens should not be used by people with active Thrombophlebitis (inflammation of a vein leading to a clot) or thromboembolic disorders (diseases of blood clotting and abnormal circulation). Some studies have suggested that there is an increased risk for healthy women to develop blood clots in the groin, legs, or lungs (conditions called deep vein thrombosis or pulmonary embolism) when taking hormone replacement therapy.

Women with severe varicose veins or severe Obesity (body mass index (BMI) more than 30 kg/m²), and those needing to stay in bed for 3 weeks or more, are generally considered to be at increased risk of blood clots.

If you have a family history of thromboembolic disorders (see above), or have experienced a blood clot either during pregnancy or while taking estrogens, inform your doctor so that you can be monitored closely. Women with cerebrovascular disease (such as stroke) or Coronary Artery Disease (such as Angina) should use estrogens with caution, and only if clearly needed.

Blood pressure: Increased blood pressure is not uncommon for women using Estrogel (Estradiol-topical). Blood pressure should be monitored with estrogen use, especially if high doses are used.

Bone disease: Estrogen can change the way your body uses calcium and phosphorus. If you have bone disease due to cancer or a metabolic condition causing too much calcium in your body, discuss with your doctor how Estrogel (Estradiol-topical) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Estrogel (Estradiol-topical), and whether any special monitoring is needed.

Breast Cancer: Studies indicate an increased risk of breast cancer with long-term use of estrogen replacement therapy. Women who have breast nodules, fibrocystic disease, abnormal mammograms, or a strong family history of breast cancer should approach the use of estrogens with caution. Women taking estrogens should have regular breast examinations and should be instructed in breast self-examination. Estrogel (Estradiol-topical) must not be applied to the breasts, as it may have harmful effects on the breast tissue.

Diabetes: Estradiol may cause a change in blood sugar levels and glucose tolerance. People with diabetes may find it necessary to monitor their blood sugar more frequently while using Estrogel (Estradiol-topical).

If you have diabetes or are at risk for developing diabetes, discuss with your doctor how Estrogel (Estradiol-topical) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Estrogel (Estradiol-topical), and whether any special monitoring is needed.

Dementia: Recent studies have indicated that the use of estrogen, with or without a progestin, may contribute to the development of dementia for women over the age of 65. If this is a concern, contact your doctor.

Endometrial cancer: There is evidence from several studies that estrogen replacement therapy, including estradiol, can increase the risk of cancer of the endometrium (lining of the uterus). Taking a progestin at the right time along with the estrogen reduces the risk of endometrial cancer to the same level as that of a woman who does not take estrogen. For this reason, all women who have not had their uterus removed should also take a progestin if they are using estrogens.

Endometriosis and fibroids: Estrogel (Estradiol-topical) may worsen fibroids, causing sudden enlargement, pain, or tenderness. It may also worsen symptoms of endometriosis. If you have had endometriosis or fibroids in the past, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Estrogel (Estradiol-topical), and whether any special monitoring is needed. If you notice any abdominal tenderness or pain, contact your doctor as soon as possible.

Fluid retention: Estrogen may cause fluid retention, which may worsen symptoms of heart or kidney dysfunction, or Asthma. If you have any of these conditions, discuss with your doctor how Estrogel (Estradiol-topical) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Gall bladder disease: Estrogen may increase the risk of gall bladder disease. If you have a history of gall bladder disease, discuss with your doctor how Estrogel (Estradiol-topical) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Estrogel (Estradiol-topical), and whether any special monitoring is needed.

Heart disease: There is evidence from recent studies that the use of estrogen plus progestin may increase the risk of heart disease. If you have heart disease or are at risk of heart disease, discuss with your doctor how Estrogel (Estradiol-topical) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Estrogel (Estradiol-topical), and whether any special monitoring is needed.

High Cholesterol or triglycerides: Estrogen may increase triglyceride levels in those who already have high levels. This has been observed particularly when estrogen is taken orally (by mouth); the risk is reduced with use of the gel. Ask your doctor to monitor your cholesterol levels.

Kidney function: Estrogen can affect how calcium and phosphorus are metabolized by your body, which may be a concern if you have Kidney Disease. If you have decreased kidney function or kidney disease, discuss with your doctor how Estrogel (Estradiol-topical) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Estrogel (Estradiol-topical), and whether any special monitoring is needed.

Liver function: Estrogen may cause liver problems or make existing liver problems worse. If you have a history of reduced liver function or liver disease, discuss with your doctor how Estrogel (Estradiol-topical) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Migraine headaches: Estrogen can cause an increase in migraine headaches or cause migraine headaches to develop. If you have a history of migraine headaches, discuss with your doctor how Estrogel (Estradiol-topical) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Estrogel (Estradiol-topical), and whether any special monitoring is needed. If you develop worsening symptoms of migraine headaches or develop headaches with an aura (flashes of light, halos), contact your doctor as soon as possible.

Ovarian Cancer: There is evidence from several studies that the use of estrogen replacement therapy for a long period of time (particularly 5 or more years) may increase the risk of cancer of the ovaries.

Seizures: Estrogen can increase the frequency of seizures for people with Epilepsy. If you have a seizure disorder such as epilepsy, discuss with your doctor how Estrogel (Estradiol-topical) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Estrogel (Estradiol-topical), and whether any special monitoring is needed.

Thyroid disease: Estrogen affects how your body uses thyroid hormone. If you take thyroid replacement therapy, discuss with your doctor how Estrogel (Estradiol-topical) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Estrogel (Estradiol-topical), and whether any special monitoring is needed.

Pregnancy: Estrogen should not be used during pregnancy, as it may be harmful to the developing baby. If you become pregnant while taking Estrogel (Estradiol-topical), contact your doctor immediately.

Breast-feeding: Taking estrogen while breast-feeding may decrease the amount and quality of breast milk. Estrogen is also passed through breast milk to your breast-feeding child. Women who are breast-feeding should not take Estrogel (Estradiol-topical).

Children: The safety and effectiveness of Estrogel (Estradiol-topical) have not been established for use by children.