Brisdelle Warnings and Precautions

Before using Brisdelle, you should be aware that this medicine could make certain health conditions worse, such as certain types of glaucoma. Warnings and precautions with Brisdelle also apply to women who have bipolar disorder, a history of seizures, or osteoporosis. You should not use this drug if you are pregnant or are taking certain medications.


What Should I Tell My Healthcare Provider?

You should talk with your healthcare provider prior to taking Brisdelle™ (paroxetine mesylate capsules) if you have:
  • Kidney disease, such as kidney failure (renal failure)
  • Liver disease, such as hepatitis, cirrhosis, or liver failure
  • Ever had a seizure
  • Bipolar disorder, a family member with bipolar disorder, or ever had an abnormally high mood (mania)
  • Ever tried to commit suicide, or have had thoughts of suicide or of harming yourself
  • Breast cancer or a history of it
  • Low blood sodium levels (hyponatremia)
  • Osteoporosis or have broken a bone
  • Glaucoma
  • Ever had bleeding problems
  • Any allergies, including to foods, dyes, or preservatives.
Also, let your healthcare provider know if you are:
  • Pregnant or thinking of becoming pregnant
  • Breastfeeding.
Make sure to tell your healthcare provider about all other medications you are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Specific Precautions and Warnings for Brisdelle

Some warnings and precautions to be aware of prior to taking this drug include the following:
  • Studies have shown that medications used to treat depression may increase suicidal thoughts or actions in children, adolescents, and young adults (see Brisdelle and Suicide for more information). Although Brisdelle is not approved to treat depression, it contains the antidepressant paroxetine, which is also an active ingredient in several antidepressant medicines. There is little information on whether Brisdelle increases the risk for suicidal thoughts and actions in women using it for hot flashes.

    However, you should contact your healthcare provider immediately if you experience any unusual changes in your mood or behavior during Brisdelle treatment, such as:
    • Thoughts of suicide or of harming yourself
    • New or worsening depression
    • Feelings of anxiety or panic
    • Agitation, irritability, hostility, or aggressiveness
    • Difficulty sleeping
    • Being overly impulsive or wanting to act on dangerous impulses
    • Internal restlessness
    • An overly inflated sense of happiness or elation.
  • Like other medicines that affect serotonin, Brisdelle has the potential to cause a rare but potentially life-threatening condition known as serotonin syndrome. Serotonin syndrome occurs when levels of serotonin in the body are too high. Taking Brisdelle with other medications that affect serotonin levels can increase your risk for serotonin syndrome (see Brisdelle Drug Interactions). Contact your healthcare provider immediately if you develop symptoms of serotonin syndrome, which may include:
    • Agitation
    • Confusion
    • Seeing or hearing things that are not real (hallucinations)
    • A fast heartbeat (tachycardia)
    • High or low blood pressure
    • Dizziness
    • Sweating
    • Flushing
    • Fever
    • Tremor
    • Stiff or twitching muscles
    • Overactive reflexes
    • Problems with walking or coordination
    • Nausea and vomiting
    • Diarrhea
    • Coma.
  • Tamoxifen (Nolvadex®) is a prescription medication used to treat and prevent breast cancer. Brisdelle can make tamoxifen less effective. Talk to your healthcare provider about the risks and benefits of using Brisdelle if you are taking tamoxifen.
  • This medication may increase your risk for bruising and bleeding, including serious bleeding in the stomach or intestines. People who take medicines that thin the blood or that can cause bleeding, such as warfarin (Coumadin®), aspirin, or nonsteroidal anti-inflammatory drugs (NSAID), have a higher risk for bleeding events from Brisdelle (see Brisdelle Drug Interactions). Contact your healthcare provider right away if you experience any unusual bruising or bleeding during treatment.
  • This medicine may cause low blood sodium (salt) levels in the blood (known medically as hyponatremia). Older adults, people who are dehydrated, and people who take diuretics ("water pills") have a greater chance of developing this side effect. Let your healthcare provider know if you have signs of hyponatremia during treatment, such as:
    • Headache
    • Confusion
    • Problems concentrating
    • Memory problems
    • Weakness
    • Unsteadiness or falling
    • Dizziness or fainting
    • Hallucinations (seeing or hearing things that aren't real)
    • Seizures
    • Coma.
  • In certain studies, people taking medications like Brisdelle have been reported to have a higher risk for bone fracture (breaking a bone). Let your healthcare provider know if you break a bone during treatment. Also let your healthcare provider know if you experience unexplained bone pain or bruising, tenderness, or swelling of an area of the body, as these could be signs of fracture. Finally, talk to your healthcare provider about ways you can keep your bones healthy and strong during Brisdelle treatment, such as consuming adequate amounts of calcium and vitamin D.  
  • Before you start Brisdelle, your healthcare provider will want to make sure you don't have bipolar disorder or a risk for bipolar disease. Bipolar disorder is a psychiatric condition characterized by alternating cycles of depression and mania (an overly excited or elevated mood). Although Brisdelle is not approved to treat psychiatric conditions, it contains the antidepressant paroxetine. There is a concern that antidepressants, including paroxetine, may trigger mania in people with bipolar disorder.
  • Although rare, seizures have been reported in people taking this medication. Make sure your healthcare provider knows if you have a seizure disorder before starting treatment. Also, tell your healthcare provider right away if you have a seizure while taking Brisdelle.
  • You may develop a side effect called akathisia while taking this medicine. Akathisia causes an uncomfortable inner sense of restlessness, making it quite difficult to sit or stand still. Akathisia is most likely to occur within the first few weeks of treatment. Let your healthcare provider know if you develop symptoms of this side effect.
  • This medicine could worsen certain types of glaucoma (an eye condition). Let your healthcare provider know if you have any changes in vision during treatment.
  • Suddenly stopping Brisdelle can cause uncomfortable withdrawal-type symptoms known as discontinuation syndrome. Do not stop taking this medication without first talking to your healthcare provider. Let him or her know if you develop discontinuation symptoms while stopping this medication, such as:
    • Low, abnormally high, or unstable mood
    • Irritability
    • Agitation
    • Anxiety
    • Confusion
    • Dizziness
    • Burning or prickling sensations
    • Headache
    • Fatigue
    • Insomnia
    • Ringing in the ears
    • Seizures.
  • Brisdelle may affect your judgment, thinking, or motor skills. Do not drive, perform activities requiring mental or motor concentration, or make important decisions until you know how this medication affects you.
  • This medicine is a pregnancy Category X medication, which means it should not be used by women who are pregnant. Talk to your healthcare provider about the risks and benefits of using this medication during pregnancy (see Brisdelle and Pregnancy for more information).
  • Brisdelle passes through breast milk. Therefore, if you are breastfeeding or plan to start, make sure to talk with your healthcare provider about using Brisdelle (see Brisdelle and Breastfeeding).
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Brisdelle Medication Information

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