Elestrin (estradiol gel) is indicated for the treatment of moderate-to-severe hot flashes and night sweats due to menopause. Estrogen therapy has serious risks, such as certain forms of cancer and heart disease. Please expand this section to read Important Risk Information.
- Using the female hormone estrogen, which is in Elestrin, raises your chance of getting cancer of the uterus (womb). This risk is the same for both natural and synthetic estrogens.
- Tell your doctor right away if you have any unusual bleeding from your vagina while you are using Elestrin. It may be a warning sign of cancer of the uterus (womb). Your doctor should check you to find out why you are bleeding.
- Do not use estrogens (alone or with other female hormones called progestins) to prevent heart disease, heart attacks, or strokes.
- Using estrogens alone or with progestins raises your chance of having heart attacks, strokes, breast cancer, and blood clots.
- Do not use estrogens alone or with progestins to prevent dementia (a disease where you cannot remember or think clearly).
- Using estrogens alone or with progestins raises your chance of getting dementia, based on a study of women who were 65 years old or older. It is not known whether this is true for younger women who have gone through the change of life (menopause).
- You should use the lowest dose of estrogens that helps your symptoms and use estrogen only as long as you need to use it. You should talk with your doctor often about whether you still need to use Elestrin.
Who should not use Elestrin?
- Do not use Elestrin if you:
- Have unusual bleeding from your vagina
- Have or had certain kinds of cancers. Elestrin may make it more likely that you will get some types of cancers, including breast cancer and cancer of the uterus (womb). If you have or had cancer, talk with your healthcare provider about whether you should use Elestrin.
- Had a stroke or heart attack
- Have or had blood clots
- Have or had liver problems
- Have been diagnosed with a bleeding disorder
- Are allergic to Elestrin or any of its ingredients. Elestrin contains the female hormone estrogen. Other ingredients in Elestrin are listed in the Patient Information section of the product label.
- Think you may be pregnant or are planning to be pregnant
- Tell your healthcare provider:
- About all of your health problems. Your healthcare provider may need to check you more carefully if you have certain conditions, such as asthma (wheezing or finding it hard to breathe), epilepsy (seizures), diabetes, migraine (very severe headaches), endometriosis (pain in your lower abdomen), lupus, or if you have problems with your heart, liver, thyroid, kidneys, or too much calcium in your blood.
- About all the medicines you take. This includes prescription and nonprescription medicines, vitamins, and herbal supplements. Some medicines may affect how Elestrin works. Elestrin may also affect how your other medicines work.
- If you are going to have an operation or will be on bed rest. You may need to stop using Elestrin.
- If you are breastfeeding. The hormone in Elestrin can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take Elestrin.
What are the possible side effects with Elestrin?
Serious but less common side effects include:
- Heart attack
- Stroke
- Blood clots
- Dementia
- Breast cancer
- Cancer of the lining of the uterus (womb)
- Cancer of the ovary
- High blood pressure
- High blood sugar
- Gallbladder disease
- Liver problems
- Enlargement of benign tumors of the uterus ("fibroids")
These are some of the warning signs of serious side effects: Breast lumps, unusual bleeding from your vagina, changes in vision or speech, very bad headaches, chest pain, being short of breath, pains in your legs,
Call your healthcare provider right away if you get any of these warning signs, or any other side effects that worry you.
The most common side effects in studies of patients taking Elestrin were irritated nose and throat; breast tenderness; colds and other illnesses of the nose, sinuses or throat; and irregular menstrual bleeding (periods). In studies, 1.8% of patients dropped out early because of side effects. These side effects included ovarian mass, thickening of the lining of the uterus, rash, limb discomfort, swelling of the limbs, and increased weight.
Other Important Risk Information
- Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Use Elestrin only as your healthcare provider tells you.
- If you have a uterus, talk to your healthcare provider about whether the addition of a progestin is right for you. The addition of a progestin is generally recommended for a woman with a uterus to reduce the chance of getting cancer of the uterus.
- Do not give Elestrin to other people, even if they have the same problems you have. It may harm them.
- Wash your hands with soap and water after applying the gel to reduce the chance that the medicine will be spread from your hands to other people. If someone else is exposed to Elestrin by direct contact with the gel, that person should wash the area of contact with soap and water as soon as possible. The longer the gel is in contact with the skin before washing, the greater is the chance that the other person will absorb some of the estrogen. This is especially important for men and children.
Do not use Elestrin on your breast or in or around your vagina. Read the Patient Instructions for Use.
These are not all of the possible side effects of Elestrin. Tell your doctor if you have any side effect that bothers you or does not go away. For more information about side effects, ask your doctor or pharmacist.
Call your doctor for medical advice about any side effects. You may report side effects to the FDA at 1-800-FDA-1088 or to Meda Pharmaceuticals Inc. at 1-877-999-8401.
Please see full Prescribing Information for additional Important Risk Information.
