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Paroxetine (Brisdelle) for Hot Flashes: Dosage & Side Effects

What is paroxetine (Brisdelle)? What is paroxetine used for?

  • Brisdelle (paroxetine) is a prescription medicine
    used to treat moderate to severe
    hot flashes associated with
    Brisdelle is a non-hormonal treatment for this condition. Paroxetine, the
    medicine in Brisdelle, is a selective serotonin reuptake inhibitor (SSRI).
    Brisdelle contains a low dose of paroxetine that is especially formulated to
    hot flashes associated with
    menopause. Higher doses of paroxetine have
    been used as an
    antidepressant for many years. How low doses of paroxetine help
    to treat hot flashes associated with
    menopause is not known. Brisdelle should
    not be used to treat
    depression or any other mood disorders.
  • The FDA approved Brisdelle in June 2013.

What brand names are available for paroxetine (Brisdelle)?


Is paroxetine (Brisdelle) available as a generic drug?


Do I need a prescription for paroxetine (Brisdelle)?


What are the uses for paroxetine (Brisdelle)?

  • Brisdelle is a prescription medicine used for the treatment
    of moderate to severe hot flashes associated with menopause.
  • Brisdelle should
    not be used to treat
    depression or other mood disorders. The drug is not
    indicated for pediatric use.

What are the side effects of paroxetine (Brisdelle)?

The most common side effects of Brisdelle are:

Other side effects include:

  • Restlessness
  • Constipation
  • Dry mouth
  • Diarrhea
  • Tremor

Possible serious side effects include:

  • Increased risk for suicidal thoughts
    or actions
  • Bone fracture

  • Seizure
  • Low salt (sodium) levels in the blood (hyponatremia)
  • Visual problems
  • Toxic epidermal necrolysis
  • Abnormal bleeding

  • Manic
  • Glaucoma
  • Restlessness

Numerous other side effects
may also occur infrequently.

What is the dosage for paroxetine (Brisdelle)?

  • The recommended dosage of Brisdelle is 7.5 mg by mouth once daily at
  • Brisdelle can be taken with or without food.

Which drugs or supplements interact with paroxetine (Brisdelle)?

  • Brisdelle should not be used with or within 14 days of taking a
    monoamine oxidase inhibitor (MAOI) due to the risk of serotonin syndrome, a rare, but
    potentially life-threatening condition caused by abnormally high levels of the
    chemical serotonin in the body. Similarly, due to a high risk of serotonin
    syndrome, Brisdelle should not be combined with
    linezolid (Zyvox) or intravenous
    methylene blue (Urolene Blue).
  • Other medications that also increase the risk of serotonin syndrome and
    should be used cautiously with Brisdelle include triptans (a type of
    antimigraine medication),
    lithium (Lithobid, Eskalith),
    tramadol (Ultram),
    John’s Wort, dextromethorphan (an over-the-counter
    common cold/cough
    medicine), and various classes of commonly used
    antidepressants including
    selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine
    reuptake inhibitors (SNRIs), and
    tricyclic antidepressants (TCAs).
  • Brisdelle should not be used with
    thioridazine (Mellaril) or
    pimozide (Orap).
    Thioridazine and pimozide are known to prolong the QT interval (a heart rhythm
    disorder). Because Brisdelle increases the concentration of these
    drugs in the
    blood, coadministration increases the risk of death.
  • Serotonin plays an important role in forming
    blood clots. SSRI’s, including
    Brisdelle may increase the risk of bleeding, especially if taken with the blood
    warfarin (Coumadin,
    aspirin, or non-steroidal
    anti-inflammatory drugs (NSAIDS) such as
    ibuprofen (Motrin),
    naproxen (Naprosyn),
    and indomethacin (Indocin).
  • Paroxetine, the medicine in Brisdelle, is a strong inhibitor of the CYP2D6
    enzymes. Taking Brisdelle with other drugs that are metabolized by this pathway
    may increase the risk for side effects. Therefore, Brisdelle should be used
    cautiously with
    nortriptyline (Pamelor),
    amitriptyline (Elavil),
    imipramine (Tofranil),
    desipramine (Norpramin),
    fluoxetine (Prozac),
    risperidone (Risperdal),
    flecainide (Tambocor), and others.
  • In addition to being a strong CYP2D6 inhibitor, paroxetine is also a CYP2D6
    substrate and is itself metabolized via this pathway. Consequently,
    administration with drugs that alter the activity of these enzymes may affect
    the concentration of Brisdelle in the body. Strong CYP2D6 inducers may decrease
    the blood levels of paroxetine, resulting in poor treatment outcomes. Examples
    of strong CYP2D6 inducers include rifampin (Rimactane),
    carbamazepine (Tegretol),
    and phenytoin (Dilantin).

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Is paroxetine (Brisdelle) safe to take if I’m pregnant or breastfeeding?

  • Brisdelle is classified as FDA
    pregnancy risk category X and
    should not be used during pregnancy because menopausal vasomotor symptoms do not
    occur during pregnancy, and Brisdelle can cause harm to the unborn baby.
  • Paroxetine is excreted in human milk. Due to the potential
    risk of causing harm to the
    nursing infant, Brisdelle should only be using by a
    nursing mother if clearly needed.

What else should I know about paroxetine (Brisdelle)?

What preparations of paroxetine (Brisdelle) are available?

Oral capsules: 7.5 mg

How should I keep paroxetine (Brisdelle) stored?

Tablets should be stored at room temperature between 15 C to 30 C
(59 F to 86 F).


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