Femhrt (ethinyl estradiol / norethindrone) is a combination medication that works well to treat symptoms of low estrogen levels in women, such as hot flashes and night sweats, related to menopause (the end of monthly menstrual periods). It can also be used to prevent bone loss (osteoporosis) in women who've reached menopause. This medication is available by prescription only.
In women who have a healthy uterus:
Moderate-to-severe symptoms of menopause (hot flashes and night sweats)
Prevention of osteoporosis in women who've reached menopause
Femhrt (ethinyl estradiol / norethindrone) is a combination of two medications that act as natural hormones to balance hormonal changes your body goes through during menopause.
Ethinyl estradiol is a synthetic (man-made) estrogen replacement. It relieves symptoms of low estrogen that happen during menopause, such as hot flashes and night sweats. Estrogen also helps prevent bone loss and improve bone mineral density (BMD), which is a measure of how dense your bones are. A higher BMD means your bones are stronger, which helps lower your risk of bone fractures.
Norethindrone is a progestin. It acts like progesterone in your body and helps balance the effect of estrogen on the growth of your uterine lining. Without progesterone around in your body, estrogen can cause an overgrowth of cells in your uterus that can raise your risk of endometrial (lining of your uterus) cancer.
Source: DailyMed
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Incidence not known
Absent, missed, or irregular menstrual periods
change in vision
changes in skin color
chest pain or discomfort
chills
clay-colored stools
dark urine
dizziness or lightheadedness
fainting
fast heartbeat
headache
hives or welts
itching skin
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
loss of appetite
medium to heavy, irregular vaginal bleeding between regular monthly periods, which may require the use of a pad or a tampon
pain or discomfort in the arms, jaw, back, or neck
pain, tenderness, or swelling of the foot or leg
pains in the chest, groin, or legs, especially in the calves of the legs
pounding in the ears
rash
redness of the skin
severe headaches of sudden onset
slow or fast heartbeat
stomach pain
sudden loss of coordination or slurred speech
sweating
troubled breathing
unusual tiredness or weakness
vomiting
vomiting of blood
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Incidence not known
blotchy spots on the exposed skin
breast enlargement or tenderness
discouragement
feeling sad or empty
irritability
itching of the vagina or outside genitals
loss of interest or pleasure
pain during sexual intercourse
stomach cramps
thick, white curd-like vaginal discharge without odor or with mild odor
tiredness
trouble concentrating
trouble sleeping
trouble wearing contact lenses
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Works well to relieve menopausal symptoms, like hot flashes and night sweats
Lowers your risk of fractures by keeping your bones healthy
Only need to take it once daily
Available as a lower-cost, generic medication
Available by prescription only
Raises your risk of blood clots, heart attack, and stroke
Not first-choice treatment for osteoporosis in women who have reached menopause
Raises risk of dementia in women 65 years and older
Take Femhrt (ethinyl estradiol / norethindrone) at the same time every day to keep your hormone levels stable.
If you experience unwanted side effects, let your provider know so you can discuss the best dose of this medication for you.
Speak to your provider regularly (every 3 to 6 months) about your dose of Femhrt (ethinyl estradiol / norethindrone) and whether or not you still need to keep taking it. You should take this medication at the lowest dose and for the shortest time possible to avoid side effects.
If you experience unusual vaginal bleeding while taking Femhrt (ethinyl estradiol / norethindrone), tell your provider. This could be a sign of cancer of your uterus.
Tell your provider if you're planning to have surgery or need to be on bed rest, since Femhrt (ethinyl estradiol / norethindrone) can raise your risk of blood clots.
Tell your provider all of the medications you're taking, including over-the-counter and prescription medications, vitamins, and supplements. Your other medications might affect how well Femhrt (ethinyl estradiol / norethindrone) works.
Femhrt (ethinyl estradiol / norethindrone) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Risk factors: Personal or family history of blood clots | High blood pressure | Diabetes | High cholesterol | Tobacco use | Obesity | Systemic lupus erythematosus (SLE)
Estrogen/progestin combination therapies, such as Femhrt (ethinyl estradiol / norethindrone), and estrogen-only therapy can raise your risk of blood clots. These blood clots can travel anywhere in your body and block bloodflow, including your legs or arms (deep vein thrombosis, DVT) and your lungs (pulmonary embolism, PE), which can be life-threatening. They can also travel to your heart, which can lead to a heart attack, or your brain, which can lead to a stroke. Because of this risk, estrogen/progestin and estrogen-only therapies shouldn't be used to prevent heart disease. You're at higher risk of blood clots if you or anyone in your family has had them in the past, if you use tobacco, or if you have certain conditions, like high blood pressure, diabetes, or high cholesterol.
Let your healthcare provider know you're using Femhrt (ethinyl estradiol / norethindrone). Because of the risk of developing blood clots, you'll need to stop using Femhrt (ethinyl estradiol / norethindrone) before certain types of surgeries or periods of time when you won't be moving much. Your provider will let you know how long before the surgery you need to stop using Femhrt (ethinyl estradiol / norethindrone). To lower your risk of blood clots, wear compression leggings or get up and stretch often on long car or plane trips.
Let your provider know if you have pain or swelling in your legs or arms, as this can be a sign of a blood clot. Call 911 and get medical help right away if you have trouble breathing, chest or arm pain, facial drooping, weakness on one side of the body, severe headaches, or sudden changes in your speech or vision, since these can be signs of life-threatening complications of blood clots.
Risk factors: Personal or family history of breast cancer | Using hormonal therapy for a long period of time
Estrogen/progestin combination therapies like Femhrt (ethinyl estradiol / norethindrone) can raise your risk of breast cancer. This risk might be higher compared to estrogen-only therapy. Don't use Femhrt (ethinyl estradiol / norethindrone) if you currently have or have had breast cancer in the past. You're also at greater risk if you've used Femhrt (ethinyl estradiol / norethindrone) or similar medications for a long period of time. To lower your risk of breast cancer, your provider will prescribe the lowest dose of estrogen for the shortest period of time possible. It's important that you regularly check your breasts for any changes and get breast scans (mammograms) done. Let your healthcare provider know if you notice any unusual changes in breast shape, size, or color.
Risk factors: Estrogen therapy without progestin use | Women with a healthy uterus | Using estrogen therapy for more than 1 year | High estrogen dose
Femhrt (ethinyl estradiol / norethindrone) contains ethinyl estradiol, which works like estrogen in your uterus. It can thicken and change the lining of your uterus, called the endometrium. Uncontrolled growth of the uterus lining can cause uterine or endometrial cancer in people with a healthy uterus. This risk is especially high in people taking estrogen therapy without a progestin to balance out estrogen's effect on the growth of the uterine lining. Your risk is higher if you use estrogen therapy for more than 1 year and if you use high doses. You can still have the risk of uterine cancer several years after stopping estrogen therapy.
People using Femhrt (ethinyl estradiol / norethindrone) might have a lower risk of uncontrolled endometrial growth compared to those taking estrogen-only therapy, since Femhrt (ethinyl estradiol / norethindrone) contains a progestin. Regardless of the hormonal therapy you're taking, it's important to be aware of the warning signs of uterine (endometrial) cancer, including vaginal bleeding that doesn't go away or keeps coming back. Let your healthcare provider know if you notice any unusual vaginal bleeding. If you're worried about getting uterine cancer, talk to your provider.
Risk factors: Age 65 years or older
Women taking estrogen/progestin combinations or estrogen-only therapy might be at greater risk for dementia, especially if hormonal therapy is started after age 65. Estrogen/progestin combination and estrogen-only therapies shouldn't be used to prevent dementia. Symptoms of dementia include forgetfulness, confusion, getting lost, and trouble with names of familiar objects or people. If the risk of dementia worries you, speak to your provider.
Estrogen/progestin combinations and estrogen-only therapy can potentially raise the risk of ovarian cancer in women using hormonal therapy for menopausal symptoms. If you notice any unusual vaginal bleeding, vaginal discharge, or pelvic pain, talk to your healthcare provider. These can be signs of ovarian cancer.
Risk factors: History of liver disease or jaundice
Estrogen therapy can raise the risk of gallbladder disease. Let your healthcare provider know if you've had jaundice (yellowing of your skin or eyes, or dark urine) in the past. If your jaundice comes back while using Femhrt (ethinyl estradiol / norethindrone), stop the medication and talk to your provider. These can be signs of liver damage or gallbladder disease.
Risk factors: Breast cancer | Cancer that has spread to the bones | Low parathyroid hormone levels
Estrogen therapy can change the calcium levels in your blood. Women with breast cancer and cancer that's spread to the bones are at higher risk of extremely high calcium levels while taking estrogens. Symptoms of high calcium levels include muscle weakness, nausea, vomiting, or constipation.
On the other hand, women with low parathyroid hormone levels from the parathyroid gland are at higher risk of low calcium levels during estrogen therapy. Symptoms of low calcium levels include muscle spasms or twitching and numbness and tingling in your fingers, toes, or around your mouth.
Let your provider know if you notice any of these symptoms. You might need regular blood tests done so that your provider can check your calcium levels while you're taking Femhrt (ethinyl estradiol / norethindrone).
Although rare, some people taking estrogens have had vision problems due to blood clot formation in the eyes. If you have sudden, partial or complete vision loss, bulging eyes, double vision, or migraines, stop Femhrt (ethinyl estradiol / norethindrone) and tell your provider.
Risk factors: History of high triglyceride levels in the blood
Estrogen therapy might raise the triglyceride (fat) levels in your blood. Too much triglyceride in your blood can lead to problems in your pancreas, including swelling (pancreatitis). You might need to get blood tests done regularly while taking Femhrt (ethinyl estradiol / norethindrone) so your provider can make sure your pancreas is healthy. If you experience signs of pancreatitis, like stomach pain, nausea, or vomiting, let your provider know right away.
Risk factors: Conditions that cause low thyroid hormone levels
Estrogens can cause changes in the thyroid hormone levels in your body. If you have conditions that cause low thyroid hormone levels, your body can't adjust these levels to keep them in the normal range. If you're taking thyroid replacement medication for your thyroid condition, you might need to take a higher dose. You also might need to get regular blood tests done while using Femhrt (ethinyl estradiol / norethindrone) to make sure your thyroid hormone levels are normal.
Risk factors: Certain heart conditions | Kidney damage
Estrogen/progestin combination therapies can cause excess fluids to build up inside your body. Signs of fluid retention include swelling of your hands and ankles. You're at higher risk of fluid retention if you have certain heart conditions, like heart failure, or kidney damage. If you have these conditions, let your provider know if you notice any signs of worsening fluid retention while using Femhrt (ethinyl estradiol / norethindrone).
Risk factors: Asthma | Diabetes | Seizures | Migraine | Blood problems | Lupus | Liver problems
Estrogen therapy might cause worsening of certain health conditions, including asthma, diabetes, seizures, migraine, blood problems (e.g., porphyria), systemic lupus erythematosus, and liver problems. Make sure your provider knows your full medical history so you can discuss if estrogen therapy is a good option for you.
The typical dose is 1 tablet by mouth once daily.
Each tablet of Femhrt and Fyavolv contains 2.5 mcg of ethinyl estradiol and 1 mg of norethindrone. A higher strength with tablets containing 5 mcg of ethinyl estradiol and 1 mg of norethindrone is available for brands Fyavolv and Jinteli. Ask your provider if the higher strength of this medication is right for you.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Undiagnosed unusual vaginal bleeding
History of breast cancer
History of other estrogen-sensitive cancer or tumor
History of blood clots traveling to your arms or legs (DVT) or lungs (PE)
History of heart attack or stroke
Liver disease
Blood-clotting conditions
Currently pregnant
In women who have a healthy uterus:
Moderate-to-severe symptoms of menopause (hot flashes and night sweats)
Prevention of osteoporosis in women who've reached menopause
Hot flashes, night sweats, and flushes caused by menopause
Vaginal dryness and burning caused by menopause
Prevention of postmenopausal osteoporosis (not a first-choice)
Moderate-to-severe vasomotor symptoms (VMS) of menopause, like hot flashes and night sweats
Moderate-to-severe symptoms of vulvar and vaginal atrophy, like vaginal dryness
Prevention of osteoporosis in females who've reached menopause
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