Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Brisdelle and some medicines may interact with each other, may not work as well, or may cause serious side effects when taken together.
Especially tell your healthcare provider if you take:
- triptans used to treat migraine headache such as sumatriptan (Imitrex), rizatriptan (Maxalt), zolmitriptan (Zomig), and eletriptan (Relpax)
- medicines used to treat mood, anxiety, psychotic or thought disorders, including MAOIs, SSRIs, tricyclic antidepressants, lithium, buspirone, or antipsychotics
- tramadol (Ultram), fentanyl (Actiq, Duragesic, Fentanyl, others) or over-the-counter supplements such as tryptophan or St. John’s wort
- thioridazine (Mellaril)
- pimozide (Orap)
- tamoxifen (Nolvadex)
- atomoxetine (Strattera)
- cimetidine (Tagamet)
- digoxin (Lanoxin)
- theophylline (Theolair)
- medicines to treat irregular heart rate (like propafenone, flecainide, and encainide)
- medicines used to treat schizophrenia
- certain medicines used to treat HIV infection
- the blood thinner warfarin (Coumadin, Jantoven)
- nonsteroidal anti-inflammatory drugs (NSAIDs) (like ibuprofen, naproxen, or aspirin)
- certain medicines used to treat seizures (like phenobarbital and phenytoin)
- other drugs containing paroxetine, the medicine in Brisdelle
Ask your healthcare provider if you are not sure if you are taking any of these medications.
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
Brisdelle (generic: paroxetine) is a prescription medication used to treat hot flashes associated with menopause. Brisdelle contains paroxetine, a selective serotonin reuptake inhibitor (SSRI) and is the only non-hormonal treatment for hot flashes approved by the FDA. The exact way it works to treat symptoms of menopause is unknown.
This medication comes in capsule form and is taken once daily, at bedtime. Brisdelle can be taken with or without food.
Common side effects of Brisdelle include headache, fatigue, nausea, and vomiting. Brisdelle can cause sleepiness. Do not drive or operate heavy machinery until you know how Brisdelle affects you.
- Store Brisdelle at room temperature between 68°F to 77°F (20°C to 25°C).
- Keep Brisdelle out of the light.
- Keep Brisdelle dry.
- Keep Brisdelle and all medicines out of the reach of children.
If you take too much Brisdelle, call your healthcare provider or poison control center right away, or go to the nearest emergency room right away.
Active ingredient: paroxetine
Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Brisdelle there are no specific foods that you must exclude from your diet when receiving Brisdelle.
Take Brisdelle exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.
The recommended dosage of Brisdelle for the treatment of moderate to severe hot flashes associated with menopause is 7.5 mg once daily, at bedtime, with or without food.
Tell your doctor if you are pregnant or plan to become pregnant. Brisdelle is approved to treat the symptoms of menopause. This medication should not be used by pregnant women.
The FDA categorizes medications based on safety for use during pregnancy. Five categories – A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.
Brisdelle falls into category X.
It has been shown that women taking Brisdelle during pregnancy may have babies with problems. There are no situations where the benefits of the medication for the mother outweigh the risks of harm to the baby. These medicines should never be used by pregnant women.
Brisdelle may cause serious side effects. Call your healthcare provider right away if you have any of the following symptoms, or go to the nearest emergency room:
- New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe.
- Pay particular attention to such changes when Brisdelle is started.
Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms.
- attempts to commit suicide
- acting on dangerous impulses
- acting aggressive or violent
- thoughts about suicide or dying
- new or worse depression
- new or worse anxiety or panic attacks
- feeling agitated, restless, angry or irritable
- trouble sleeping
- an increase in activity or talking more than what is normal for you
- other unusual changes in behavior or mood.
2. Serotonin Syndrome. This condition can be life-threatening and may include:
- agitation (nervousness), hallucinations, coma or other changes in mental status
- coordination problems or muscle twitching (small movements of the muscles that you cannot control)
- racing heartbeat, high or low blood pressure
- sweating or fever
- nausea, vomiting, or diarrhea
- muscle rigidity
- dizziness
- flushing
- tremors
- seizures
3. Reduced effectiveness of tamoxifen. Tamoxifen (a medicine used to treat breast cancer) may not work as well if it is taken while you take Brisdelle. If you are taking tamoxifen, tell your healthcare provider before starting Brisdelle.
- headache
- weakness or feeling unsteady
- confusion, problems concentrating or thinking or memory problems
6. Bone Fractures. Women who take Brisdelle may have a higher risk of bone fractures. Contact your healthcare provider if you have pain in a bone.
7. Manic episodes:
- greatly increased energy
- severe trouble sleeping
- racing thoughts
- reckless behavior
- unusually grand ideas
- excessive happiness or irritability
- talking more or faster than usual
8. Seizures or convulsions.
- take a Monoamine Oxidase Inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid.
- Do not take an MAOI within 14 days of stopping Brisdelle unless directed to do so by your healthcare provider.
- Do not start Brisdelle if you stopped taking an MAOI in the last 14 days unless directed to do so by your healthcare provider.
- People who take Brisdelle close in time to an MAOI may have serious or lifethreatening side effects. Get medical help right away if you have any of these symptoms:
- high fever
- uncontrolled muscle spasms
- stiff muscles
- rapid changes in heart rate or blood pressure
- confusion
- loss of consciousness (pass out)
- take thioridazine. Do not take thioridazine together with Brisdelle because this can cause serious heart rhythm problems or sudden death.
- take the antipsychotic medicine pimozide. Do not take pimozide together with Brisdelle because this can cause serious heart problems.
- are allergic to paroxetine or any of the ingredients in Brisdelle.
- are pregnant. Brisdelle is not for pregnant women. Paroxetine, the active ingredient in Brisdelle, can harm your unborn baby. Risks to your unborn baby include an increased risk of birth defects, particularly heart defects. Your baby may also have certain other serious symptoms shortly after birth.
Brisdelle may cause serious side effects. See “Drug Precautions” section.
The most common side effects of Brisdelle include:
- headache
- tiredness
- nausea and vomiting
Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Brisdelle. For more information, ask your healthcare provider or pharmacist.
Tell your doctor if you are breastfeeding or plan to breastfeed.
Brisdelle has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from Brisdelle, a choice should be made whether to stop nursing or to stop use of Brisdelle. Determining the importance of the drug to the mother should be considered.
Brisdelle is a prescription medicine used to reduce moderate to severe hot flashes associated with menopause.
This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
- Take Brisdelle exactly as your healthcare provider tells you to take it.
- Take Brisdelle 1 time each day at bedtime.
- Brisdelle may be taken with or without food.
- If you miss a dose of Brisdelle, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Brisdelle at the same time.
Before starting Brisdelle, tell your healthcare provider if you:
- have liver problems
- have kidney problems
- have or had seizures or convulsions
- have bipolar disorder or mania
- have low sodium levels in your blood
- have or had bleeding problems
- have glaucoma (high pressure in the eye)
- have any other medical conditions
- are pregnant or breastfeeding
Tell your healthcare provider about all the medicines that you take, including prescription and over-thecounter medicines, vitamins, and herbal supplements