Brisdelle (Paroxetine) - Oral

Warning:

Antidepressants may increase the risk of suicidal thinking and behavior (suicidality). If you’re considering using Brisdelle or any other antidepressant, it’s important to balance this possible risk with your current medical needs. When on antidepressant therapy, your healthcare provider will work with you to help look for any symptoms over time that may mean that your condition is worsening (e.g., suicidality, unusual behavior). It’s important that the individual on the medication, family members, and/or caregivers thoughtfully and carefully observe any changes and keep communication open with each other and the prescriber.

What Is Brisdelle?

Brisdelle is a medicine taken by mouth that contains paroxetine, a selective serotonin reuptake inhibitor (SSRI). It treats moderate to severe vasomotor symptoms (VMS) related to menopause.

SSRIs work by keeping certain chemicals (i.e., neurotransmitters, like serotonin) balanced in specific parts of the brain.

Brisdelle is currently the only nonhormonal brand-name medication approved for treating moderate to severe hot flashes related to menopause. It is a prescription-only medicine and should be used only by adults experiencing menopause.

Paroxetine is also available under other brand names (Pexeva and Paxil) for different indications. These formulations contain a higher dose of paroxetine than Brisdelle. Paxil and Pexeva are used to treat mental health conditions, such as depression, anxiety disorders, obsessive-compulsive disorder, and more.

Drug Facts

Generic Name: Paroxetine

Brand Name(s): Brisdelle, Pexeva, Paxil

Drug Availability: Prescription

Administration Route: Oral

Therapeutic Classification: Central nervous system agent

Available Generically: Yes

Controlled Substance: N/A

Active Ingredient: Paroxetine mesylate

Dosage Form(s): Capsule, tablet, suspension

What Is Brisdelle Used For?

Brisdelle is used to treat hot flashes during menopause in adults. The active ingredient in Brisdelle, paroxetine, is often used as an antidepressant. However, the Food and Drug Administration (FDA) approved the brand-name product Brisdelle, which contains a low dose of paroxetine, only for treating hot flashes related to menopause.

Brisdelle may be considered a first-line therapy option for hot flashes when hormonal therapy isn’t appropriate or isn’t well tolerated. Brisdelle should not be prescribed for mental health conditions.

Other forms of paroxetine, available under brand names such as Paxil and Pexeva, may be used for mental health conditions such as depression, obsessive-compulsive disorder, anxiety disorders, and panic disorders.

How to Take Brisdelle

Read the prescription label carefully before you start taking Brisdelle. Talk to your healthcare provider or pharmacist if you have any questions.

Take one capsule by mouth, with or without food, daily at bedtime or as directed by your prescriber.

Take Brisdelle regularly, and do not stop taking it without discussing any changes with your healthcare provider. When people suddenly stop taking their medicine, this may cause some conditions to get worse or may cause severe withdrawal symptoms. Contact your healthcare provider if your symptoms do not improve or if they get worse.

Do not take Brisdelle to treat a mental illness. If you think that you may have a mental illness, talk to your healthcare provider about treatment.

Storage

Store this medicine in a well-closed container away from direct light, heat, and moisture. Do not store it in the bathroom. Keep all medications locked away, out of the sight and reach of children.

Discard expired or unwanted medicines. Do not discard unwanted medication into a drain, down the toilet, or in the trash. The best way is to return the unwanted medicine through a drug take-back program. Ask your pharmacist or healthcare provider about drug take-back programs.

How Long Does Brisdelle Take to Work?

In clinical trials, people reported improvements in their VMS in about four weeks after starting therapy. Symptom improvement can be seen as early as one to two weeks.

What Are the Side Effects of Brisdelle?

This is not a complete list of side effects, and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your healthcare provider or pharmacist. You may report side effects to the FDA at fda.gov/medwatch or 1-800-FDA-1088.

Common Side Effects

Common side effects of Brisdelle are:

Contact your healthcare provider if any of these side effects become severe.

Severe Side Effects

Call your healthcare provider immediately if you have serious side effects. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency.

In rare cases, Brisdelle causes severe side effects, such as:

  • Allergic reaction
  • Akathisia (feeling a sense of restlessness)
  • Bleeding or bruising
  • Changes in behavior or feelings
  • Hyponatremia (lower salt levels in the blood)
  • Seizures
  • Serotonin syndrome (high serotonin levels)
  • Suicidal thoughts
  • Vision problems
  • Decreased sexual ability

Antidepressants may increase the risk of suicidal thinking and behavior (suicidality). If you’re considering using Brisdelle or any other antidepressant, it’s important to balance this possible risk with your current medical needs. When on antidepressant therapy, your healthcare provider will work with you to help look for any symptoms over time that may mean that your condition is worsening (e.g., suicidality, unusual behavior). It’s important that the individual on the medication, family members, and/or caregivers thoughtfully and carefully observe any changes and keep communication open with each other and the prescriber.

Report Side Effects

Brisdelle may cause other side effects. Call your healthcare provider if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your healthcare provider may send a report to the FDA's MedWatch Adverse Event Reporting Program online or by phone (800-332-1088).

Dosage: How Much Brisdelle Should I Take?

Drug Content Provided and Reviewed by IBM Micromedex®

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (capsules):
    • For moderate to severe hot flashes caused by menopause:
      • Adults—7.5 milligrams (mg) once a day, at bedtime.
      • Children—Use is not recommended.
  • For oral dosage form (suspension):
    • For depression:
      • Adults—At first, 20 milligrams (mg) (10 milliliters [mL]) once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 50 mg (25 mL) per day.
      • Older adults—At first, 10 mg (5 mL) once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 40 mg (20 mL) per day.
      • Children—Use and dose must be determined by your doctor.
    • For generalized anxiety disorder:
      • Adults—At first, 20 milligrams (mg) (10 milliliters [mL]) once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 50 mg (25 mL) per day.
      • Older adults—At first, 10 mg (5 mL) once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 40 mg (20 mL) per day.
      • Children—Use and dose must be determined by your doctor.
    • For obsessive-compulsive disorder:
      • Adults—At first, 20 milligrams (mg) (10 milliliters [mL]) once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 60 mg (30 mL) per day.
      • Older adults—At first, 10 mg (5 mL) once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 40 mg (20 mL) per day.
      • Children—Use and dose must be determined by your doctor.
    • For panic disorder:
      • Adults—At first, 10 milligrams (mg) (5 milliliters [mL]) once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 60 mg (30 mL) per day.
      • Older adults—At first, 10 mg (5 mL) once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 40 mg (20 mL) per day.
      • Children—Use and dose must be determined by your doctor.
    • For posttraumatic stress disorder:
      • Adults—At first, 20 milligrams (mg) (10 milliliters [mL]) once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 50 mg (25 mL) per day.
      • Older adults—At first, 10 mg (5 mL) once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose usually is not more than 40 mg (20 mL) per day.
      • Children—Use and dose must be determined by your doctor.
    • For social anxiety disorder:
      • Adults—At first, 20 milligrams (mg) (10 milliliters [mL]) once a day, usually taken in the morning.
      • Older adults—At first, 10 mg (5 mL) once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose usually is not more than 20 mg (10 mL) per day.
      • Children—Use and dose must be determined by your doctor.
  • For oral dosage form (tablets):
    • For depression:
      • Adults—At first, 20 milligrams (mg) once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 50 mg per day.
      • Older adults—At first, 10 mg once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 40 mg per day.
      • Children—Use and dose must be determined by your doctor.
    • For generalized anxiety disorder:
      • Adults—At first, 20 milligrams (mg) once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 50 mg per day.
      • Older adults—At first, 10 mg once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose usually is not more than 40 mg per day.
      • Children—Use and dose must be determined by your doctor.
    • For obsessive-compulsive disorder:
      • Adults—At first, 20 milligrams (mg) once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose usually is not more than 60 mg per day.
      • Older adults—At first, 10 mg once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 40 mg per day.
      • Children—Use and dose must be determined by your doctor.
    • For panic disorder:
      • Adults—At first, 10 milligrams (mg) once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 60 mg per day.
      • Older adults—At first, 10 mg once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 40 mg per day.
      • Children—Use and dose must be determined by your doctor.
    • For posttraumatic stress disorder:
      • Adults—At first, 20 milligrams (mg) once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose usually is not more than 50 mg per day.
      • Older adults—At first, 10 mg once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 40 mg per day.
      • Children—Use and dose must be determined by your doctor.
    • For social anxiety disorder:
      • Adults—At first, 20 milligrams (mg) once a day, usually taken in the morning.
      • Older adults—At first, 10 mg once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 20 mg per day.
      • Children—Use and dose must be determined by your doctor.
  • For oral dosage form (extended-release tablets):
    • For depression:
      • Adults—At first, 25 milligrams (mg) once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose usually is not more than 62.5 mg per day.
      • Older adults—At first, 12.5 mg once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 50 mg per day.
      • Children—Use and dose must be determined by your doctor.
    • For panic disorder:
      • Adults—At first, 12.5 milligrams (mg) once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose usually is not more than 75 mg per day.
      • Older adults—At first, 12.5 mg once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 50 mg per day.
      • Children—Use and dose must be determined by your doctor.
    • For premenstrual dysphoric disorder:
      • Adults—At first, 12.5 milligrams (mg) once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 25 mg per day.
      • Older adults and children—Use and dose must be determined by your doctor.
    • For social anxiety disorder:
      • Adults—At first, 12.5 milligrams (mg) once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 37.5 mg per day.
      • Older adults—At first, 12.5 mg once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 37.5 mg per day.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of Brisdelle, take it as soon as you remember. If it is almost the time of the next dose, skip the missed dose. Take the next dose at the scheduled time. Don't take a double dose to make up for a missed one.

Overdose: What Happens If I Take Too Much Brisdelle?

An overdose of Brisdelle may cause the following:

  • Seizures
  • Cardiovascular toxicity, which may be delayed, such as high blood pressure
  • Serotonin syndrome

What Happens If I Overdose on Brisdelle?

If you think you or someone else may have overdosed on Brisdelle, call a healthcare provider or the Poison Control Center (800-222-1222).

If someone collapses or isn't breathing after taking Brisdelle, call 911 immediately.

Precautions

Drug Content Provided and Reviewed by IBM Micromedex®

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Do not take paroxetine with a monoamine oxidase (MAO) inhibitor (eg, isocarboxazid [Marplan®], linezolid [Zyvox®], methylene blue injection, phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]). Do not start taking paroxetine during the 2 weeks after you stop a MAO inhibitor and wait 2 weeks after stopping paroxetine before you start taking a MAO inhibitor. If you take them together or do not wait 2 weeks, you may develop confusion, agitation, restlessness, stomach or intestinal symptoms, a sudden high body temperature, an extremely high blood pressure, or severe convulsions.

Do not take pimozide (Orap®) or thioridazine (Mellaril®) while you are taking this medicine. Using these medicines together can cause very serious heart problems.

Paroxetine may cause a serious condition called serotonin syndrome if taken together with some medicines. Do not use paroxetine with buspirone (Buspar®), fentanyl (Abstral®, Duragesic®), lithium (Eskalith®, Lithobid®), tryptophan, St. John's wort, amphetamines, or some pain or migraine medicines (eg, rizatriptan, sumatriptan, tramadol, Frova®, Imitrex®, Maxalt®, Relpax®, Ultram®, Zomig®). Check with your doctor first before taking any other medicines with paroxetine.

This medicine may decrease the amount of sperm men make and affect their ability to have children. If you plan to have children, talk with your doctor before using this medicine.

Paroxetine may cause some teenagers and young adults to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Some people may have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. If you or your caregiver notice any of these unwanted effects, tell your doctor right away. Let the doctor know if you or anyone in your family has bipolar disorder (manic-depressive) or has tried to commit suicide.

Do not suddenly stop taking this medicine without checking first with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This will decrease the chance of having withdrawal symptoms such as agitation, breathing problems, chest pain, confusion, diarrhea, dizziness or lightheadedness, fast heartbeat, headache, increased sweating, muscle pain, nausea, restlessness, runny nose, trouble in sleeping, trembling or shaking, unusual tiredness or weakness, vision changes, or vomiting.

Check with your doctor right away if you develop the following symptoms during the first few weeks of treatment with paroxetine: inability to sit still, need to keep moving, or restlessness.

The use of alcohol is not recommended in patients who are taking paroxetine.

Paroxetine may cause some people to become drowsy or have blurred vision. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert or able to see clearly.

Hyponatremia (low sodium in the blood) may occur with this medicine. Check with your doctor right away if you have confusion, difficulty concentrating, headaches, memory problems, weakness, and unsteadiness.

This medicine may increase your risk for bleeding problems. Make sure your doctor knows if you are also taking other medicines that thin the blood, such as aspirin, nonsteroidal antiinflammatory agents, also called NSAIDs (eg, diclofenac, ibuprofen, naproxen, Advil®, Aleve®, Celebrex®, Voltaren®), or warfarin (Coumadin®, Jantoven®).

This medicine may increase the risk of bone fractures. Tell your doctor if you have unexplained bone pain, tenderness, swelling, or bruising. Also, ask your doctor about ways to keep your bones strong to help prevent fractures.

Check with your doctor right away if you have decreased interest in sexual intercourse, delayed or inability to have an orgasm in women, inability to have or keep an erection in men, or loss in sexual ability, desire, drive, or performance. These could be symptoms of sexual dysfunction.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

What Are Reasons I Shouldn’t Take Brisdelle?

You should not take Brisdelle if you:

  • Are allergic to paroxetine or any other ingredients in the capsule
  • Are taking other antidepressants
  • Take monoamine oxidase inhibitors (MAOIs), such as Nardil (phenelzine), Matulane (procarbazine), Azilect (rasagiline), and Xadago (safinamide). MAOI use with Brisdelle can cause severe serotonin syndrome. Do not use Brisdelle within 14 days of stopping an MAOI. Similarly, do not use an MAOI within 14 days of stopping Brisdelle. 
  • Are on Mellaril (thioridazine) or Orap (pimozide), as Brisdelle increases the levels of these drugs in the body
  • Are pregnant or breastfeeding. It can cause harm to the fetus and a breastfeeding baby

What Other Medications Interact With Brisdelle?

Severe, potentially deadly reactions may occur when taking MAOIs. MAOIs should be stopped at least 14 days before starting Brisdelle treatment. Any paroxetine drug should be stopped at least 14 days before beginning MAOIs.

Brisdelle may decrease metabolism and increase the effects of certain drugs metabolized by the liver (CYP2D6 inhibitors), including:

Using Brisdelle with 5-HT1 agonists may increase serotonin levels and lead to serotonin syndrome. These medications include:

  • Frova (frovatriptan)
  • Amerge (naratriptan)
  • Tosymra (sumatriptan)
  • Maxalt (rizatriptan)
  • Zomig (zolmitriptan)
  • Fentanyl
  • Lithobid (lithium)
  • Conzip (tramadol)

Using Brisdelle with pimozide or thioridazine may increase the risk of changes in the heart’s electrical activity (QT interval prolongation). Avoid using Brisdelle with pimozide or thioridazine.

Side effects like serotonin syndrome may happen if you take Brisdelle with herbs and supplements like St. John's wort, SAMe, and tryptophan. Speak with your healthcare provider about any herbs or supplements you are using or are thinking about using.

Avoid using alcohol when taking Brisdelle.

What Medications Are Similar?

Other drugs belonging to the class of SSRIs are: 

These drugs treat mental health disorders, including major depressive disorder, panic disorder, social phobia, generalized anxiety disorder, and others, along with some off-label uses.

Brisdelle, Pexeva, and Paxil all contain paroxetine, but Brisdelle contains a lower dose of paroxetine. Paxil and Prexeva are used to treat different conditions than Brisdelle.

Frequently Asked Questions

  • What is Brisdelle used for?

    It is used to treat hot flashes related to menopause.

  • How does Brisdelle work?

    Brisdelle is a selective serotonin reuptake inhibitor (SSRI) that helps with the balance of chemicals (specifically serotonin) in the brain. SSRIs are thought lower core body temperature by widening the blood vessels (vasodilation) and decreasing blood flow to the skin, which reduces hot flashes.

  • What drugs should not be taken with Brisdelle?

    MAOIs should be stopped at least 14 days before starting Brisdelle treatment. Any paroxetine drug should be stopped at least 14 days before starting MAOIs. Ask your healthcare provider or pharmacist for a complete list of drugs you should not take with Brisdelle.

  • How long does it take for Brisdelle to work?

    Brisdelle helps reduce hot flash severity. You’ll normally see improvements in your symptoms in about four weeks, although some individuals notice improvement sooner or later than that.

  • What are the side effects of Brisdelle?

    Common side effects of Brisdelle are headache, fatigue, nausea, vomiting, and dry mouth, among others. Talk to your healthcare provider about what to expect when starting Brisdelle treatment.

  • How do I stop taking Brisdelle?

    Do not stop taking the medication without speaking with your healthcare provider, as it may cause severe withdrawal symptoms.

How Can I Stay Healthy While Taking Brisdelle?

While taking Brisdelle, do not switch between the different brands of paroxetine. Keep taking the brand prescribed for you. Brisdelle is specifically formulated with a lower dose of paroxetine than Paxil or Pexeva.

After starting treatment, wait before you drive or operate machinery until you know how Brisdelle will affect you. Additionally, watch for any changes in behavior or suicidal thoughts or tendencies. Immediately contact your healthcare provider if you feel that Brisdelle is affecting your mental health.

While waiting for your treatment to take effect, there are at-home ways you can manage VMS related to menopause and find some comfort.

For hot flashes:

  • Avoid hot places, such as a sauna, or sunbathing.
  • Avoid hot or spicy foods that may trigger a flash.
  • Turn down the heat if possible.
  • Dress in layers so that you can easily remove clothing if needed.

If your symptoms persist or do not improve after treatment, talk to your healthcare provider about other options for finding relief.

Medical Disclaimer

Verywell Health's drug information is meant for educational purposes only and is not intended to replace medical advice, diagnosis, or treatment from a healthcare provider. Consult your healthcare provider before taking any new medication(s). IBM Watson Micromedex provides some of the drug content, as indicated on the page.

6 Sources
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
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  2. David PS, Smith TL, Nordhues HC, Kling JM. A clinical review on paroxetine and emerging therapies for the treatment of vasomotor symptoms. Int J Womens Health. 2022;14:353-361. doi:10.2147/IJWH.S282396

  3. DailyMed. Label: Paxil- paroxetine hydrochloride suspension. Paxil-paroxetine hydrochloride tablet, film coated.

  4. DailyMed. Label: Pexeva- paroxetine mesylate tablet, film coated.

  5. Simon JA, Portman DJ, Kaunitz AM, et al. Low-dose paroxetine 7.5 mg for menopausal vasomotor symptoms: two randomized controlled trials. Menopause. 2013;20(10):1027-1035. doi: 10.1097/GME.0b013e3182a66aa7

  6. Carroll DG, Lisenby KM, Carter TL. Critical appraisal of paroxetine for the treatment of vasomotor symptoms. Int J Womens Health. 2015;7:615-624. doi:10.2147/IJWH.S50804