Brisdelle is a brand-name prescription medication. It’s FDA-approved to treat moderate to severe vasomotor symptoms related to menopause. These symptoms are commonly referred to as hot flashes. For this purpose, Brisdelle should only be used in adult females.*

Brisdelle isn’t approved to treat any mental health condition. For more information on the uses of the drug, see the “Brisdelle uses” section below.

* Sex and gender exist on spectrums. Use of the term “female” in this article refers to sex assigned at birth.

Drug details

Brisdelle is currently the only nonhormonal brand-name medication approved to treat moderate to severe hot flashes during menopause.

Brisdelle contains the active drug paroxetine, which belongs to a class of medications known as selective serotonin reuptake inhibitors (SSRIs). A class of medications is a group of drugs that work in a similar way.

Brisdelle comes as capsules that you swallow. The capsules are available in one strength: 7.5 milligrams. Brisdelle is typically taken once per day, at bedtime.

Limitations of use

Brisdelle has certain limitations of use.

The active ingredient in Brisdelle, paroxetine, is often used as an antidepressant drug. (Paroxetine is also the active ingredient in the antidepressant Paxil.)

But the Food and Drug Administration (FDA) has approved Brisdelle only for treating hot flashes related to menopause. Brisdelle shouldn’t be used to treat any mental health condition, such as major depressive disorder or generalized anxiety disorder. For more information, see the “Brisdelle vs. Paxil” section below.

Effectiveness

For information about the effectiveness of Brisdelle, see the “Brisdelle uses” section below.

Brisdelle is a brand-name drug that contains the active drug paroxetine. This active drug is also available as a generic medication. A generic drug is an exact copy of the active drug in a brand-name medication.

The generic is considered to be as safe and effective as the original drug. Generics tend to cost less than brand-name drugs.

If you’re interested in using the generic form of Brisdelle, talk with your doctor. They can tell you if it comes in forms and strengths that can be used for your condition.

Brisdelle can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Brisdelle. These lists do not include all possible side effects.

For more information about the possible side effects of Brisdelle, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you’d like to notify the FDA about a side effect you’ve had with Brisdelle, you can do so through MedWatch.

Mild side effects

Mild side effects* of Brisdelle, which are discussed in “Side effect details” below, can include:

Most of these side effects may go away within a few days or a couple of weeks. But if they become more severe or don’t go away, talk with your doctor or pharmacist.

* This is a partial list of mild side effects from Brisdelle. To learn about other mild side effects, talk with your doctor or pharmacist or visit Brisdelle’s medication guide.

Serious side effects

Serious side effects from Brisdelle aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

  • Serotonin syndrome (high levels of the chemical serotonin). Symptoms can include:
    • hallucinations (seeing or hearing things that aren’t actually there)
    • nausea and vomiting
  • Bleeding or bruising more than usual. Symptoms can include:
    • discoloration of the skin
    • hematoma (leaking and pooling of blood around a blood vessel)
  • Problems with your vision. Symptoms can include:
    • changes in vision
    • eye pain
    • redness or swelling in or around your eye(s)
  • Hyponatremia (low levels of sodium) in your blood. Symptoms can include:
    • headache
    • trouble concentrating
    • memory problems
  • Bone fractures. Symptoms can include:
    • bruising or bone tenderness
    • swelling in or around the bone
  • Sexual problems.* Symptoms can include:
    • trouble having an orgasm, or inability to orgasm
  • Allergic reaction.†
  • Changes in behavior and feelings,† such as mood shifts, episodes of mania, or akathisia (an inner sense of restlessness).
  • Seizures.†
  • Risk of suicidal thoughts and behaviors.†‡

* Sexual dysfunction wasn’t reported in trials of Brisdelle, but it has occurred with the use of other selective serotonin reuptake inhibitors (SSRIs). Brisdelle is a type of SSRI.
† For more information about this side effect, see “Side effect details” below.
Brisdelle has a boxed warning for this side effect. This is the most serious warning from the FDA. For more information, see the “Suicidal thoughts and behaviors” section below.

Side effects in children

Brisdelle isn’t approved for use in children. It can increase their risk for suicidal thoughts and behaviors.* For more information, see “Suicidal thoughts and behaviors” in the “Side effect details” section below.

* Brisdelle has a boxed warning for this side effect. This is the most serious warning from the FDA. For more information, see the “Suicidal thoughts and behaviors” section below.

Side effect details

You may wonder how often certain side effects occur with this drug. Here’s some detail on certain side effects this drug may cause.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Brisdelle. It’s not known how many people taking Brisdelle in clinical trials may have had an allergic reaction.

Symptoms of a mild allergic reaction can include:

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your tongue, mouth, or throat
  • trouble breathing

Call your doctor right away if you have an allergic reaction to Brisdelle, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or you think you’re having a medical emergency.

Headache

Brisdelle may cause headache. Clinical trials compared Brisdelle with a placebo to treat moderate to severe hot flashes. (A placebo is a treatment with no active drug.) The results showed that:

  • 6.3% of females* who took Brisdelle had headache
  • 4.8% of females who took a placebo had headache

In these trials, 0.3% of females stopped taking Brisdelle due to this side effect. It’s not known how many stopped taking the placebo due to headache.

It’s also possible to experience headache after stopping treatment with Brisdelle. So, if you’re taking Brisdelle, it’s important that you don’t stop treatment without consulting your doctor first. For more information, see the “Brisdelle withdrawal and dependence” section below.

If you experience headache while taking Brisdelle, talk with your doctor. They may recommend a medication or other form of treatment for your headache. But if headache is interfering with your daily life, your doctor may suggest a different medication for treating your hot flashes.

* Sex and gender exist on spectrums. Use of the term “female” in this article refers to sex assigned at birth.

Fatigue

Fatigue (lack of energy) is a possible side effect of Brisdelle.

In clinical trials, females* took either Brisdelle or a placebo (treatment with no active drug). Researchers found that:

  • 4.9% of females who took Brisdelle had fatigue
  • 2.8% of females who took a placebo had fatigue

Most females who had fatigue in these trials developed it within the first week of treatment with Brisdelle. It isn’t known when females taking the placebo developed fatigue.

It’s also possible to have fatigue after stopping treatment with Brisdelle. So, if you’re taking Brisdelle, it’s important that you don’t stop treatment without consulting your doctor first. For more information, see the “Brisdelle withdrawal and dependence” section below.

If you have bothersome fatigue while taking Brisdelle, talk with your doctor. They may have you try a different medication for treating your condition.

* Sex and gender exist on spectrums. Use of the term “female” in this article refers to sex assigned at birth.

Nausea and vomiting

Nausea and vomiting were two common side effects in clinical trials of Brisdelle. In these trials, females took either Brisdelle or a placebo (treatment with no active drug). Researchers found that:

  • 4.3% of females* who took Brisdelle reported nausea or vomiting
  • 2.3% of females who took a placebo reported nausea or vomiting

Those who had nausea while taking Brisdelle in these trials were most likely to have it within the first 4 weeks of starting treatment. It wasn’t reported when vomiting was most likely to occur with Brisdelle. It also wasn’t reported when females taking the placebo were most likely to have nausea or vomiting.

If you experience nausea or vomiting while taking Brisdelle, talk with your doctor. They may recommend a medication or another treatment for either side effect. Or they may suggest a different drug for treating your hot flashes.

* Sex and gender exist on spectrums. Use of the term “female” in this article refers to sex assigned at birth.

Changes in behavior or feelings

Although it isn’t common, Brisdelle may cause changes in behavior.

The following changes in behavior or feeling have been reported in people taking paroxetine, which is the active drug in Brisdelle:

It’s not known how often these behavioral changes occurred in people taking paroxetine or a placebo. (A placebo is a treatment with no active drug.)

Akathisia is most likely to occur within the first few weeks of beginning treatment with Brisdelle. But these behavioral changes could occur at any time while taking the drug.

Note: Antidepressants may increase the risk of mixed or manic episodes in people with bipolar disorder. Brisdelle is a type of antidepressant, but it’s not approved to treat depression. Before taking Brisdelle, your doctor will likely check to see if you have a history of or are at risk for bipolar disorder or mania.

Also, because Brisdelle may impair judgment or thinking, it can affect your ability to drive or operate machinery. For this reason, you should avoid such activities until you know how Brisdelle affects you.

Seizures

Although rare, Brisdelle may cause seizures.

In clinical studies of paroxetine, the active drug in Brisdelle, seizures occurred in 0.1% of people who took the drug. It isn’t known if a placebo was used in these studies. (A placebo is a treatment with no active drug.)

Symptoms of seizure include loss of consciousness, convulsions (uncontrollable muscle spasms), and sudden rapid eye movements.

If you have a history of seizures or convulsions, be sure to tell your doctor before taking Brisdelle. For more information, see the “Brisdelle precautions” section below.

If you have a seizure while taking Brisdelle, tell your doctor right away. They may have you try a different medication to treat your condition.

Suicidal thoughts and behaviors

There have been reports of people having suicidal thoughts and behaviors within the first few months of taking Brisdelle. In fact, the drug has a boxed warning about the risk of this side effect. This is the most serious warning from the FDA. A boxed warning alerts doctors and patients about drug effects that may be dangerous.

Clinical studies have looked at antidepressants such as selective serotonin reuptake inhibitors (SSRIs). Brisdelle is a type of SSRI, but it’s not approved to treat depression. Researchers found that SSRIs can increase the risk for suicidal thoughts and behaviors in children and young adults up to age 24 years. The people in the study were taking the SSRIs for major depressive disorder and other mental health conditions. People with a history of mental health conditions weren’t included in Brisdelle clinical studies.

If you’re taking Brisdelle, your doctor will monitor you closely for any new or worsening symptoms of suicidal thoughts and behaviors. These can include any new or sudden changes in your behaviors, feelings, moods, or thoughts, such as:

  • aggressive or violent behavior
  • mania (elevated mood or racing thoughts)
  • feeling very agitated, irritated, or restless
  • new or worsening anxiety or depression
  • panic attacks
  • thoughts about dying or suicide
  • any other unusual changes in your mood or behavior

You, your family members, and your caregivers should watch closely for these symptoms as well. Be sure to call your doctor right away if you or someone else notices any changes.

Suicide prevention

If you know someone at immediate risk of self-harm, suicide, or hurting another person:

  • Ask the tough question: “Are you considering suicide?”
  • Listen to the person without judgment.
  • Call 911 or the local emergency number, or text TALK to 741741 to communicate with a trained crisis counselor.
  • Stay with the person until professional help arrives.
  • Try to remove any weapons, medications, or other potentially harmful objects.

If you or someone you know is having thoughts of suicide, a prevention hotline can help. The 988 Suicide and Crisis Lifeline is available 24 hours a day at 988. During a crisis, people who are hard of hearing can use their preferred relay service or dial 711 then 988.

Find more links and local resources.

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The Food and Drug Administration (FDA) approves prescription drugs such as Brisdelle to treat certain conditions. Brisdelle may also be used off-label for other conditions. Off-label drug use means using a drug for a purpose other than what it’s been approved for by the FDA.

Brisdelle for moderate to severe hot flashes during menopause

Brisdelle is FDA-approved to treat moderate to severe vasomotor symptoms related to menopause. These symptoms are commonly referred to as hot flashes. For this purpose, Brisdelle should only be used in adult females.*

* Sex and gender exist on spectrums. Use of the term “female” in this article refers to sex assigned at birth.

Limitations of use

Brisdelle isn’t approved to treat any mental health condition.

The active ingredient in Brisdelle, paroxetine, is often used as an antidepressant drug. But the amount of paroxetine in Brisdelle isn’t effective for treating certain mental health conditions. (Examples include major depressive disorder and generalized anxiety disorder.) So, Brisdelle shouldn’t be used for this purpose.

Paroxetine is the active ingredient in the antidepressant Paxil. For more information about how Brisdelle compares with Paxil, see the “Brisdelle vs. Paxil” section just below.

About menopause

According to the National Institute on Aging, menopause usually occurs between ages of 45 and 55 years. It begins when a female no longer has their period. During menopause, the body’s levels of the sex hormones estrogen and progesterone begin to decrease. This can lead to symptoms such as:

Effectiveness for hot flashes during menopause

Clinical studies have shown Brisdelle to be effective for treating hot flashes during menopause.

One study looked at females* who had had moderate to severe vasomotor symptoms (hot flashes) due to menopause. Each female had at least seven to eight hot flashes per day for 30 days leading up to the study. Over 12 weeks, the females took either Brisdelle or a placebo daily. (A placebo is a treatment with no active drug.)

Before the study, half of the females were experiencing at least 10.4 hot flashes per day. At the end of the 12 weeks:

  • half of the females taking Brisdelle had at least 5.9 fewer hot flashes each day
  • half of the females taking a placebo had at least 5 fewer hot flashes each day

Also, the severity of hot flashes decreased more in the females taking Brisdelle compared with those taking a placebo.

* Sex and gender exist on spectrums. Use of the term “female” in this article refers to sex assigned at birth.

Brisdelle and children

Brisdelle isn’t approved for use in children. It can increase their risk for suicidal thoughts and behaviors.* For more information, see “Suicidal thoughts and behaviors” in the “Brisdelle side effects” section above.

* Brisdelle has a boxed warning for this side effect. This is the most serious warning from the FDA.

You may wonder how Brisdelle compares with Paxil. Here, we look at how Brisdelle and Paxil are alike and different.

Ingredients

Brisdelle and Paxil both contain paroxetine as their active drug. Paroxetine belongs to a class of medications* called selective serotonin reuptake inhibitors (SSRIs).

But Brisdelle contains a lower dose of paroxetine than Paxil. This is because Brisdelle and Paxil are used to treat different conditions.

Note: Because these drugs contain different doses of paroxetine, if you’re taking Brisdelle, you shouldn’t switch to Paxil without speaking with your doctor first. And if you’re using Paxil, you shouldn’t take Brisdelle without first checking with your doctor.

* A class of medications is a group of drugs that work in a similar way.

Uses

Here is a list of symptoms and conditions that the Food and Drug Administration (FDA) has approved Brisdelle and Paxil to treat.

Drug forms and administration

Brisdelle comes as a capsule that you swallow. You’ll likely take Brisdelle once per day.

Paxil comes as a tablet as well as a liquid suspension, both of which you take by mouth. You’ll likely take Paxil once per day.

Side effects and risks

Brisdelle and Paxil both contain paroxetine. Therefore, these medications can cause very similar side effects. Because they each contain a different dose of paroxetine, they can also cause different side effects. Below are examples of these side effects.

Mild side effects

These lists contain up to 10 of the most common mild side effects that can occur with either Brisdelle or Paxil, as well as mild side effects that both drugs may share.

Serious side effects

These lists contain examples of serious side effects that both drugs share.

  • allergic reaction
  • bone fractures
  • changes in behaviors or feelings
  • akathisia (feeling an inner sense of restlessness)
  • hyponatremia (low levels of sodium in your blood)
  • seizures
  • serotonin syndrome (high levels of the chemical serotonin)
  • sexual problems
  • risk of suicidal thoughts and behaviors*
  • bleeding or bruising
  • vision problems

* Brisdelle and Paxil both have a boxed warning for this side effect. For more information, see “Suicidal thoughts and behaviors” in the “Brisdelle side effects” section above.

Effectiveness

These drugs are used to treat different conditions, so they haven’t been directly compared in clinical studies. But studies have found Brisdelle and Paxil to be effective for treating hot flashes and mental health issues, respectively.

Costs

Brisdelle and Paxil prices will vary depending on the condition you’re treating. The actual price you’ll pay for either drug depends on your insurance plan, your location, and the pharmacy you use.

Brisdelle and Paxil are both brand-name drugs. They’re also both available as the generic drug paroxetine. Brand-name medications usually cost more than generics.

The following information describes the dosage that is commonly used or recommended. But be sure to take the dosage your doctor prescribes for you. They’ll determine the best dosage to fit your needs.

Drug forms and strengths

Brisdelle comes in capsules that you swallow. These capsules are available in one strength: 7.5 milligrams (mg).

Dosage for moderate to severe hot flashes during menopause

The recommended dosage of Brisdelle for treating moderate to severe hot flashes during menopause is one 7.5-mg capsule per day. Brisdelle should be taken at bedtime. A clinical study found that taking Brisdelle before bed helped decrease the number of hot flashes that interrupted sleep.

Dosage questions

Below are answers to some questions you may have about using Brisdelle.

What if I miss a dose?

If you miss a dose of Brisdelle, try to take your missed dose as soon as you remember.

But if it’s almost time for your next dose, simply take your next dose at the regularly scheduled time. You shouldn’t take two doses to make up for your missed dose. This can increase your risk for side effects from the medication. (For more information, see the “Brisdelle side effects” section above.)

To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm on your phone or downloading a reminder app.

Will I need to use this drug long term?

Brisdelle is meant to be used as a long-term treatment. If you and your doctor determine that Brisdelle is safe and effective for you, you’ll likely take it long term.

Here are answers to some frequently asked questions about Brisdelle.

Is Brisdelle the same as Paxil?

No, Brisdelle isn’t the same as Paxil. Although Brisdelle and Paxil both contain the active drug paroxetine, they each have different amounts of it.

Brisdelle is approved by the Food and Drug Administration (FDA) to treat only hot flashes related to menopause. Paxil, on the other hand, is used to treat certain mental health conditions, such as depression, various anxiety disorders, and post-traumatic stress disorder.

Brisdelle and Paxil also have different dosages and side effects.

If you’re taking Brisdelle, you shouldn’t switch to Paxil without speaking with your doctor first. And if you’re using Paxil, you shouldn’t take Brisdelle without first checking with your doctor.

For more information about how Brisdelle compares with Paxil, see the “Brisdelle vs. Paxil” section above.

Will Brisdelle cure my hot flashes?

No, Brisdelle won’t cure your hot flashes. Currently, there isn’t a cure for hot flashes related to menopause. But there are numerous treatment options, including medications such as Brisdelle, for managing this effect.

Clinical studies have shown Brisdelle to be effective for treating moderate to severe hot flashes related to menopause.* Keep in mind that hot flashes could return if you stop taking Brisdelle.

If your hot flashes are bothering you, talk with your doctor about available treatment options.

* For more information about the effectiveness of Brisdelle for treating hot flashes, see the “Brisdelle uses” section above.

Will Brisdelle cause changes in my weight?

Brisdelle isn’t likely to cause changes in your weight.

But the hormone changes that occur during menopause may result in weight gain. These changes may cause certain areas of your body, such as your belly, to store more fat than before. They may also affect your appetite and how many calories you consume.

Paxil, an antidepressant that contains paroxetine, can rarely cause weight loss. Paroxetine is also the active drug in Brisdelle. But the dose of paroxetine in Brisdelle is lower, so taking Brisdelle likely won’t cause you to lose weight.*

If you have questions about managing your weight during menopause, talk with your doctor.

* For more information about how Brisdelle compares with Paxil, see the “Brisdelle vs. Paxil” section above.

Is Brisdelle a hormonal treatment for hot flashes?

No, Brisdelle isn’t a hormonal treatment for hot flashes. Hormonal treatments increase the levels of certain hormones in your body to help ease the symptoms of menopause, such as hot flashes.

Brisdelle is currently the only nonhormonal brand-name medication approved to treat moderate to severe hot flashes during menopause.

If you have questions about which treatment is best for your hot flashes, talk with your doctor. Together, you can review the pros and cons of available treatments and decide which is best for you.

How long do I need to take Brisdelle to know if it’s working?

How long Brisdelle takes to work will vary from person to person. For some people, the drug begins working about 30 days after they start taking it. But according to the manufacturer of Brisdelle, it may take up to 90 days before you notice Brisdelle working.

If you start taking Brisdelle and don’t notice any relief in your symptoms after 90 days, talk with your doctor. They can suggest other treatments to try to manage your hot flashes.

Can I use Brisdelle for hot flashes if I haven’t gone through menopause?

No, you shouldn’t use Brisdelle for hot flashes if you haven’t gone through menopause. Currently, Brisdelle is only approved by the FDA for treating hot flashes during menopause.

If you have questions about treating hot flashes not related to menopause, talk with your doctor. They can recommend treatment options for your situation.

There aren’t any known interactions between Brisdelle and alcohol.

But drinking alcohol while taking Brisdelle may make certain side effects of the drug* worse, including:

Also, drinking alcohol during menopause may trigger or worsen hot flashes and other menopause symptoms.

If you drink alcohol, talk with your doctor about how much is safe for you to drink while taking Brisdelle.

* For more information about the potential side effects of Brisdelle, see the “Brisdelle side effects” section above.

As with all medications, the cost of Brisdelle can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Keep in mind that you may be able to get a 90-day supply of Brisdelle. If approved by your insurance company, getting a 90-day supply of the drug could reduce your number of trips to the pharmacy and help lower the cost. If you’re interested in this option, check with your doctor or insurance company.

Before approving coverage for Brisdelle, your insurance company may require you to get prior authorization. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the prior authorization request and decide if the drug will be covered.

If you’re not sure if you’ll need to get prior authorization for Brisdelle, contact your insurance company.

Financial and insurance assistance

If you need financial support to pay for Brisdelle, or if you need help understanding your insurance coverage, help is available.

You can search Medicine Assistance Tool and NeedyMeds to find programs that may help decrease Brisdelle’s cost. To learn more, visit their websites.

Mail-order pharmacies

Brisdelle may be available through a mail-order pharmacy. Using this service may help lower the drug’s cost and allow you to get your medication without leaving home.

If recommended by your doctor, you may be able to receive a 90-day supply of Brisdelle. This would mean having less of a concern about running out of the medication. If you’re interested in this option, check with your doctor and insurance company. Some Medicare plans may help cover the cost of mail-order medications.

If you don’t have insurance, you can ask your doctor or pharmacist about online pharmacy options.

Generic version

Brisdelle is available in a generic form called paroxetine. A generic drug is an exact copy of the active drug in a brand-name medication. The generic is considered to be as safe and effective as the original drug. And generics tend to cost less than brand-name drugs.

If your doctor has prescribed Brisdelle and you’re interested in using paroxetine instead, talk with your doctor. They may have a preference for one version or the other. You’ll also need to check your insurance plan, as it may only cover one or the other.

You may be wondering if suddenly stopping Brisdelle will cause withdrawal symptoms, and if so, how to wean off Brisdelle.

Brisdelle contains the active drug paroxetine, which is also the active drug in Paxil.* People taking Paxil need to gradually reduce their dose instead of suddenly stopping treatment. (Gradually reducing a dose is known as drug tapering.) Otherwise, they may have symptoms of withdrawal. Withdrawal refers to symptoms that occur when you stop taking a drug that your body is dependent on.

According to the manufacturer of Brisdelle, you can stop taking the drug right away instead of reducing your dose over time. This is because the dose of paroxetine in Brisdelle is lower than it is in Paxil. It takes your body longer to get rid of higher doses of paroxetine.

But it’s still possible for you to have withdrawal symptoms when stopping Brisdelle treatment. These symptoms may include:

For most people who have these withdrawal symptoms, they are mild and will typically go away on their own. If you experience withdrawal symptoms that are moderate or severe or don’t go away, talk with your doctor right away.

* For more information about how Brisdelle compares with Paxil, see the “Brisdelle vs. Paxil” section above.

Menopause begins when a female* no longer has their period. According to the National Institute on Aging, menopause usually occurs between ages of 45 and 55 years. During menopause, the body’s levels of the sex hormones estrogen and progesterone begin to decrease. This can cause menopause symptoms such as hot flashes.

Brisdelle is currently the only nonhormonal brand-name medication approved to treat moderate to severe hot flashes during menopause. Brisdelle belongs to a class of medications known as selective serotonin reuptake inhibitors (SSRIs). A class of medications is a group of drugs that work in a similar way.

SSRIs are a type of antidepressant, but Brisdelle shouldn’t be used for treating any mental health condition, including depression. (For more information, see “Limitations of use” in the “Brisdelle uses” section above.)

It isn’t known how Brisdelle works for treating hot flashes due to menopause.

* Sex and gender exist on spectrums. Use of the term “female” in this article refers to sex assigned at birth.

How long does it take to work?

How long Brisdelle takes to work will vary from person to person. For some, Brisdelle begins working 30 days after starting the drug. But according to the manufacturer, it may take up to 90 days before Brisdelle begins to work.

If you start taking Brisdelle and don’t notice any relief in your symptoms after 90 days, talk with your doctor. They can suggest other treatments to try to manage your hot flashes.

Other drugs are available that can treat hot flashes during menopause. Some may be a better fit for you than others. If you’re interested in finding an alternative to Brisdelle, talk with your doctor. They can tell you about other medications that may work well for you.

Note: Some of the drugs listed here are used off-label to treat this specific condition. Off-label drug use means using a drug for a purpose other than what it’s been approved for by the FDA.

Alternatives for moderate to severe hot flashes during menopause

Examples of other drugs that may be used to treat moderate to severe hot flashes during menopause include:

  • Selective serotonin reuptake inhibitors (SSRIs)* other than Brisdelle. Examples include:
  • Serotonin-norepinephrine reuptake inhibitors (SNRIs).† Examples include:
  • Drugs that combine estradiol (a form of estrogen) with a progestin hormone. Examples include:
    • estradiol/drospirenone (Angeliq)
    • estradiol/levonorgestrel (Climara Pro)
    • estradiol/norethindrone (Activella, Amabelz)
    • estradiol/norgestimate
    • ethinyl estradiol/norethindrone (Fyavolv, Jinteli)
  • Different forms of estradiol. Examples include:
    • oral estradiol
    • estradiol topical gel (Divigel, Elestrin, EstroGel)
    • estradiol injection (Depo-Estradiol, Delestrogen)
    • estradiol topical spray (Evamist)
    • estradiol patch (Climara, Minivelle, Vivelle-Dot)
    • estradiol vaginal ring (Femring)
  • Other estrogen hormones. Examples include:
    • oral estrogen (Menest, Premarin)
    • estrogen/methyltestosterone (Covaryx)
    • estrogen/bazedoxifene (Duavee)
    • estrogen/medroxyprogesterone (Prempro, Premphase)
    • estropipate
  • Other nonhormonal prescription medications. Examples include:
    • clonidine (Catapres)

* SSRIs are a class of antidepressants. A class of medications is a group of drugs that work in a similar way.
† SNRIs are another class of antidepressants.

You should take Brisdelle according to your doctor’s or healthcare professional’s instructions.

Brisdelle comes as a capsule that you swallow.

When to take

You’ll likely take Brisdelle once per day. The recommended time of day to take Brisdelle is at bedtime. A clinical study found that taking Brisdelle before bed helped decrease the number of hot flashes that interrupted sleep.

To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm on your phone or downloading a reminder app. The timer on your phone or even a kitchen timer can also work.

Taking Brisdelle with food

You may take Brisdelle with or without food.

Can Brisdelle be crushed, split, or chewed?

No, you shouldn’t crush, split, or chew Brisdelle capsules. If you have trouble swallowing Brisdelle capsules, talk with your doctor. They may suggest a different medication for treating your condition.

Brisdelle can interact with several other medications. It can also interact with certain supplements.

Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase the number of side effects or make them more severe.

Brisdelle and other medications

Below are examples of medications that can interact with Brisdelle. This list does not contain all drugs that may interact with Brisdelle.

Before taking Brisdelle, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also, tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Brisdelle and certain drugs that affect serotonin

Brisdelle belongs to a group of medications known as selective serotonin reuptake inhibitors (SSRIs). This means that Brisdelle affects levels of the chemical serotonin in your body. Using Brisdelle with certain other medications that affect serotonin levels may increase your risk for serotonin syndrome (high levels of the chemical serotonin).*

Examples of these medications include:

If you’re taking any of these drugs, be sure to tell your doctor. They’ll monitor you for signs of serotonin syndrome, or they may suggest a treatment other than Brisdelle.

* For more information on serotonin syndrome, see the “Brisdelle side effects” section above.

Brisdelle and MAOIs

You shouldn’t use a monoamine oxidase inhibitor (MAOI) while taking Brisdelle. Doing so may increase your risk for serotonin syndrome (high levels of the chemical serotonin).* For the same reason, you shouldn’t start taking Brisdelle within 14 days of stopping an MAOI. And you shouldn’t start taking an MAOI within 14 days of stopping Brisdelle.

Examples of MAOIs include:

  • phenelzine (Nardil)
  • selegiline

* For more information on serotonin syndrome, see the “Brisdelle side effects” section above.

Brisdelle and drugs that can increase the risk of bleeding

Brisdelle can increase your risk for bleeding.* This risk may increase even more if you take Brisdelle with other medications that also increase your risk for bleeding.

Examples of these medications include:

If you use any of the drugs listed here, be sure to tell your doctor before taking Brisdelle. They’ll review your medications for interactions and recommend the right treatment for you.

* For more information, see “Serious side effects” in the “Brisdelle side effects” section above.

Brisdelle and certain drugs that are broken down by CYP2D6

CYP enzymes are special proteins that your body uses to metabolize (break down) medications. Brisdelle can inhibit (stop the action of) the CYP2D6 enzyme. As a result, Brisdelle can increase the blood level of drugs metabolized by CYP2D6. This can either decrease their effectiveness or increase the risk of side effects caused by these drugs.

Medications that may have decreased effectiveness if taken with Brisdelle include:

Medications that may cause an increased risk of side effects if taken with Brisdelle include:

  • risperidone (Risperdal), a drug used to treat certain mental health conditions
  • theophylline (Theo-24), an asthma drug

Before beginning treatment with Brisdelle, be sure to tell your doctor which medications you’re taking. They’ll be able to determine if any of your medications are broken down by CYP2D6, and they may adjust your dose if necessary.

Brisdelle and thioridazine and pimozide

You shouldn’t take either of these medications with Brisdelle.

Thioridazine and pimozide are used to treat certain mental health conditions. Both drugs are metabolized (broken down) by the CYP2D6 enzyme. (Enzymes are proteins that aid chemical changes in your body.)

Brisdelle can inhibit (stop the action of) the CYP2D6 enzyme. As a result, Brisdelle can increase the blood level of thioridazine and pimozide. This can increase the risk of side effects caused by these drugs.

Before beginning treatment with Brisdelle, be sure to tell your doctor if you’re taking either thioridazine or pimozidine. They’ll likely recommend a drug other than Brisdelle to treat your hot flashes.

Brisdelle and herbs and supplements

You shouldn’t use St. John’s wort while taking Brisdelle. This supplement may be used to treat depression and to ease symptoms of menopause.

Brisdelle and St. John’s wort both affect levels of serotonin in your body. Using Brisdelle with other medications or supplements that affect serotonin levels may increase your risk for serotonin syndrome. (For more information on serotonin syndrome, see the “Brisdelle side effects” section above.)

If you’re taking St. John’s wort, ask your doctor how else you can treat the condition you’re taking it for. Also, be sure to tell your doctor about any other herbs or supplements you’re using while taking Brisdelle.

Brisdelle and foods

There aren’t any foods that have been specifically reported to interact with Brisdelle. If you have any questions about eating certain foods with Brisdelle, talk with your doctor.

You shouldn’t take Brisdelle while pregnant. Brisdelle is approved only for treating hot flashes related to menopause, not those related to pregnancy.

The active drug in Brisdelle, paroxetine, can cause harm to a developing fetus. Studies have shown that taking paroxetine while pregnant can increase the risk of serious problems, such as heart abnormalities, for newborns.

If you’re pregnant or planning to become pregnant and are having hot flashes, talk with your doctor. They should be able to recommend a treatment other than Brisdelle.

Brisdelle isn’t safe to take during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re using Brisdelle.

For more information about taking Brisdelle during pregnancy, see the “Brisdelle and pregnancy” section above.

The active drug in Brisdelle, paroxetine, is known to pass into human breast milk. The presence of the drug has the potential to cause serious side effects in a breastfed child. These side effects include:

  • constant crying
  • insomnia (trouble sleeping)
  • lethargy (lack of energy)
  • reduced weight gain
  • restlessness

Because of this risk, if you’re breastfeeding or planning to breastfeed, you shouldn’t take Brisdelle to treat hot flashes related to menopause.

If you have questions about breastfeeding and treatments for hot flashes due to menopause, talk with your doctor. They should be able to recommend treatments other than Brisdelle.

This drug comes with several precautions.

FDA warning: Risk of suicidal thoughts and behaviors

Brisdelle has a boxed warning. This is the most serious warning from the Food and Drug Administration (FDA). A boxed warning alerts doctors and patients about drug effects that may be dangerous.

Clinical studies have looked at antidepressants such as selective serotonin reuptake inhibitors (SSRIs). Brisdelle is a type of SSRI, but it’s not approved to treat depression. Researchers found that SSRIs can increase the risk of suicidal thoughts and behaviors in children and young adults up to age 24 years. The people in the study were taking the SSRIs for major depressive disorder and other mental health conditions.

If you’re taking Brisdelle, your doctor will monitor you closely for any new or worsening symptoms of suicidal thoughts and behaviors. These can include any new or sudden changes in your behaviors, feelings, moods, or thoughts. You, your family members, and your caregivers should watch closely for these symptoms as well. Be sure to call your doctor right away if you or someone else notices any changes.

Other precautions

Before taking Brisdelle, talk with your doctor about your health history. Brisdelle may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

  • Liver or kidney problems. A few cases of liver failure and kidney failure have occurred in people taking paroxetine, which is the active drug in Brisdelle. These cases were rare and happened after paroxetine was released onto the market. Liver and kidney failure weren’t reported in actual clinical trials of Brisdelle. You should tell your doctor about any history of liver or kidney problems before taking Brisdelle.
  • Seizures or convulsions. In clinical studies of paroxetine, the active drug in Brisdelle, seizures occurred in a small number of people taking the medication. If you have a history of seizures or convulsions, be sure to tell your doctor before taking Brisdelle. Also, let your doctor know of any medications you take. Taking Brisdelle with certain drugs that can cause seizures could further increase your risk for this side effect.
  • Bipolar disorder or mania. Antidepressants may increase the risk of mixed or manic episodes in people with bipolar disorder. Brisdelle is a type of antidepressant, but it’s not approved to treat depression. Before taking Brisdelle, your doctor will likely check to see if you have a history of or are at risk for bipolar disorder or mania. If you have a history of either of these conditions, be sure to let your doctor know before taking Brisdelle. They may recommend a different treatment for your hot flashes.
  • Hyponatremia. Like other SSRIs, Brisdelle can cause hyponatremia. If you have hyponatremia or a history of this condition, be sure to talk with your doctor before you take Brisdelle. They may monitor you more closely than usual for signs of hyponatremia.
  • Bleeding problems. Drugs that affect serotonin levels, such as Brisdelle, may increase your risk for bleeding. This risk may be higher if you have other conditions that cause bleeding problems, including hemophilia and anemia. Before you take Brisdelle, tell your doctor about any history of bleeding problems you may have. They may monitor you more closely than usual for signs of bleeding.
  • Glaucoma. Brisdelle may trigger a sudden glaucoma attack in people with a type of glaucoma called angle-closure glaucoma. Be sure to tell your doctor if you have glaucoma or are at risk for this condition before you begin taking Brisdelle. They may recommend you be tested for this condition before starting Brisdelle.
  • Allergic reaction. If you’ve had an allergic reaction to Brisdelle or any of its ingredients, you shouldn’t take Brisdelle. Ask your doctor about which other medications are better options for you.
  • Pregnancy. You shouldn’t take Brisdelle while pregnant. For more information, see the “Brisdelle and pregnancy” section above.
  • Breastfeeding. You shouldn’t breastfeed while taking Brisdelle. For more information, see the “Brisdelle and breastfeeding” section above.

Note: For more information about the potential negative effects of Brisdelle, see the “Brisdelle side effects” section above.

Using more than the recommended dosage of Brisdelle can lead to serious side effects. Don’t use more Brisdelle than your doctor recommends.

Overdose symptoms

Symptoms of an overdose can include:

Symptoms of severe overdose can include:

What to do in case of overdose

If you think you’ve taken too much of this drug, call your doctor. You can also call the American Association of Poison Control Centers at 800-222-1222 or use their online tool. But if your symptoms are severe, call 911 or your local emergency number, or go to the nearest emergency room right away.

When you get Brisdelle from the pharmacy, the pharmacist will add an expiration date to the label on the package. This date is typically 1 year from the date they dispensed the medication.

The expiration date helps guarantee that the medication is effective during this time. The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. If you have unused medication that has gone past the expiration date, ask your pharmacist if you can still use it.

Storage

How long a medication remains good can depend on many factors, including how and where you store it.

Brisdelle capsules should be stored at a room temperature of 68°F to 77°F (20°C to 25°C) in a tightly sealed container away from light. For short periods of time, such as when traveling, you may store Brisdelle capsules at 59°F to 86°F (15°C to 30°C).

Avoid storing this medication in areas where it could get damp or wet, such as bathrooms.

Disposal

If you no longer need to take Brisdelle and have leftover medication, it’s important to dispose of it safely. This helps prevent others, including children and pets, from taking the drug by accident. It also helps keep the drug from harming the environment.

This article provides several useful tips on medication disposal. You can also ask your pharmacist for information about how to dispose of your medication.

Disclaimer: Medical News Today 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.

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