Specifically, the Food and Drug Administration (FDA) has approved Prempro to:

treat moderate to severe hot flashes and night sweats due to menopause
treat moderate to severe vaginal dryness and irritation due to menopause
prevent osteoporosis after menopause

This article describes possible side effects of Prempro. You can learn more about Prempro by talking with your doctor.

Prempro is a brand-name medication that comes as a tablet that you swallow. It isn’t available in a generic version. This article describes possible side effects of Prempro.

Prempro has boxed warnings. A boxed warning is the most serious warning from the FDA. For details, see the “Side effects of Prempro in detail” section below.

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More common side effects of Prempro

Prempro may cause mild or serious side effects. Below are some of the more common side effects of this medication.

Commonly reported side effects of Prempro include:

abdominal pain
weakness
back pain
headache
gas

Mild side effects of Prempro

Prempro may cause certain mild side effects. Most often, mild side effects are temporary and can be easily managed. Tell your doctor or pharmacist if you have side effects that don’t go away or become bothersome.

Mild side effects of Prempro that occurred in studies include:

abdominal pain
weakness
back pain
headache
gas
nausea
itchiness
breast pain
painful menstrual periods
vaginal discharge

Prempro may cause more mild side effects than those listed above. For details, see the drug’s prescribing information.

Serious side effects of Prempro

Prempro may cause certain serious side effects. If you have any serious side effects from Prempro, call your doctor right away. But if you think you’re having a medical emergency or your side effects feel life threatening, take immediate action. Call 911 or a local emergency number, or go to the nearest emergency room.

After the FDA approves a drug, it tracks and reviews side effects of the medication. Visit MedWatch’s website if you’d like to notify the FDA about a side effect you’ve had with Prempro.

Serious side effects of Prempro that occurred in studies include:

heart and blood vessel problems*†
breast cancer*†
endometrial cancer*†
dementia*†
gallbladder problems
high blood calcium
vision problems, including partial or complete loss of vision
water retention

Prempro may cause more serious side effects than those listed above. For details, see the drug’s prescribing information.

* To learn more about this side effect, see the “Side effects of Prempro in detail” section below.
† Prempro has a boxed warning for this side effect. A boxed warning is the most serious warning from the FDA. For details, see the “Side effects of Prempro in detail” section below.

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Allergic reaction

For some people, Prempro can cause an allergic reaction.

But it’s not clear whether this side effect occurred in the drug’s studies.

In general, symptoms of allergic reaction can be mild or serious. You can learn more about possible symptoms in this article.

Ways to manage

For mild allergic reaction symptoms, such as a mild rash, call your doctor right away. They may recommend treatments to help manage your symptoms. They’ll also let you know whether you should keep taking the medication.

For severe allergic reaction symptoms, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms require immediate medical care because they can become life threatening. If you’ve had a serious allergic reaction to Prempro, your doctor may recommend taking a different medication instead.

Common questions about side effects of Prempro

Here are answers to some common questions about side effects of Prempro. If you have other questions, talk with your doctor or pharmacist.

Can Prempro cause weight loss?

It’s not likely. Weight loss wasn’t a side effect seen during studies of Prempro. Some people experienced weight gain in studies of the drug.

There have also been reports of weight loss in people taking Prempro, but it’s unclear how often this has happened or if Prempro was the cause.

If you have concerns about this or have experienced weight changes while taking Prempro, talk with your doctor.

Does Prempro cause long-term side effects?

Yes, in some cases Prempro may cause long-term side effects. These can occur if you take the drug for a long time.

Examples of long-term side effects reported with Prempro include:

Talk with your doctor to learn more about these side effects and how to manage them. Ask your doctor for more information about how long these side effects of Prempro may last.

Does Prempro cause withdrawal?

It’s not likely. Withdrawal wasn’t a side effect seen during studies of Prempro. Withdrawal symptoms are side effects that can occur when you stop taking a drug that your body has become dependent on.

But there is some evidence that suddenly stopping hormone replacement therapy may cause temporary withdrawal symptoms.

Talk with your doctor to learn more about the risk of withdrawal from Prempro.

Side effects of Prempro in detail

Below you’ll find details on some of the side effects of Prempro.

Heart and blood vessel problems

Prempro has a boxed warning for the risk of cardiovascular (heart and blood vessel) problems. A boxed warning is the most serious warning from the FDA. This side effect may be serious.

Prempro can increase your risk of heart and blood vessel problems, including stroke, heart attack, and pulmonary embolism (blood clot in your lungs). These conditions can cause side effects including:

shortness of breath
chest pain or discomfort
lightheadedness
difficulty speaking
confusion
fast heart rate

Certain factors can increase the risk of heart and blood vessel problems with Prempro. These include smoking, high cholesterol, high blood pressure, and diabetes.

Ways to manage

Heart and blood vessel problems can be life threatening and require immediate medical care. If you experience symptoms of heart and blood vessel problems, call 911 to get emergency medical help right away. They’ll likely recommend that you stop taking Prempro.

Certain cancers

Prempro also has a boxed warning for the risk of certain cancers, including breast and endometrial cancer. This side effect may be serious.

Prempro can increase your risk of breast cancer. And this risk increases the longer you take the medication. Symptoms of breast cancer may include:

breast pain
nipple discharge
a breast lump or thickened tissue in the breast
a lump or swelling under your arm

Prempro also can increase your risk of endometrial cancer. This risk also increases the longer you take Prempro. Symptoms of endometrial cancer can include:

vaginal bleeding after menopause
changes in the length or heaviness of your period
pain in the lower abdomen or pelvis

Ways to manage

Due to this risk, your doctor will prescribe Prempro for the shortest amount of time needed. If you experience symptoms of breast or endometrial cancer, tell your doctor. They’ll likely recommend you stop taking Prempro and seek treatment from a cancer specialist.

Dementia

Prempro also has a boxed warning for the risk of dementia. This side effect may be serious.

With dementia, you experience a decline in your brain function. You may also have difficulty remembering things and speaking, and experience changes in your behavior. Older adults (ages 65 years and older) have a higher risk of dementia.

Ways to manage

If you experience symptoms of dementia, tell your doctor. They’ll likely recommend you stop taking Prempro and recommend treatment to help manage your symptoms.

Warnings for Prempro

Below are some factors you may want to discuss with your doctor before taking Prempro.

Boxed warning

Prempro has boxed warnings. A boxed warning is the most serious warning from the FDA.

For details, see the “Side effects of Prempro in detail” section above.

Other warnings

It may not be safe for you to take Prempro if you have specific health conditions. These are sometimes called drug-condition interactions. Other things may also affect whether Prempro is a safe treatment option for you.

Before taking Prempro, tell your doctor about your health and any medications you take. Things to consider include:

unusual vaginal bleeding
history of stroke, heart attack, or blood clots
liver problems
bleeding disorder
planned surgery
pregnancy or breastfeeding
past allergic reaction to Prempro

Prempro and pregnancy

Prempro should not be taken during pregnancy. If you’re planning a pregnancy or can become pregnant, talk with your doctor before taking this medication. Your doctor may suggest birth control options to use during treatment with Prempro.

Prempro and breastfeeding

Prempro should not be taken while breastfeeding. If you’re currently breastfeeding or planning to do so, talk with your doctor before taking this medication. Your doctor may recommend other ways to feed your child during treatment with Prempro.

Prempro and alcohol

Prempro isn’t known to interact with alcohol.

If you drink alcohol, talk with your doctor about whether it’s safe to consume it during your treatment with Prempro.

Disclaimer: Optum Perks has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.