Safety
General information, not medical advice
Your prescriber and the leaflet in your pack know your situation. This page does not.
- Follow your prescriber and the leaflet
- Don't start, stop, or change a dose on your own
- Doses and warnings differ by country and product
Brisdelle Capsule: Uses, Dosage, Side Effects, Precautions and Alternates
| Generic name | paroxetine |
|---|---|
| Drug class | Selective serotonin reuptake inhibitor (SSRI) |
| Forms | Capsules (7.5 mg) |
Quick overview
Brisdelle Capsule contains paroxetine, a selective serotonin reuptake inhibitor (SSRI). It is a prescription medicine used to reduce moderate to severe hot flashes related to menopause. It is not a hormone medicine, and it is not approved to treat any mental health condition such as depression or anxiety.
What is Brisdelle Capsule
Brisdelle is a prescription medicine used to reduce moderate to severe hot flashes related to menopause. It is not a hormone medicine, and it is not approved to treat any mental health condition such as depression or anxiety.
Brisdelle Capsule uses
- Treats moderate to severe hot flashes (also called vasomotor symptoms) related to menopause
- Not approved for treating depression, obsessive compulsive disorder, panic disorder, generalized anxiety disorder, social anxiety disorder, or post-traumatic stress disorder
- Only approved for use in adult women who have gone through menopause
Benefits of Brisdelle Capsule
- Helps reduce moderate to severe hot flashes associated with menopause
- Helps decrease the frequency and severity of night sweats
- Provides a non-hormonal treatment option for menopausal vasomotor symptoms
- May help improve sleep and daily comfort when hot flashes are disruptive
How Brisdelle Capsule works
Brisdelle is a selective serotonin reuptake inhibitor (SSRI), a type of medicine that raises serotonin levels in the body. Exactly how it reduces hot flashes isn't fully understood, but it may work partly by helping to lower body temperature.
Brisdelle Capsule dosage
Take it exactly as your doctor tells you to. Take it once a day at bedtime. You can take it with or without food. Do not crush, split, or chew the capsule; swallow it whole. If you have trouble swallowing the capsule, talk to your doctor about other options.
If you miss a dose, take it as soon as you remember, but if it's almost time for your next dose, skip the missed one — do not take two doses at once. Do not stop taking this medicine suddenly without talking to your doctor, since stopping abruptly can cause withdrawal symptoms. It may take up to several weeks or months to notice the full effect on hot flashes.
| Age group | Dose |
|---|---|
| Under 18 years | Not indicated; safety and effectiveness not established |
| 18+ years – Premenopausal women | Not routinely indicated for menopausal vasomotor symptoms |
| Postmenopausal women | 7.5 mg orally once daily at bedtime |
| 65–74 years | 7.5 mg once daily at bedtime |
| 75+ years | 7.5 mg once daily at bedtime; clinical experience is limited |
Available forms and strengths
- Capsules (7.5 mg)
Side effects of Brisdelle Capsule
Common
- Headache
- Tiredness/fatigue
- Nausea and vomiting
- Dizziness and drowsiness
- Sweating, anxiety, shaking
- Trouble sleeping (insomnia)
- Loss of appetite, diarrhea, constipation
- Dry mouth, yawning
- Vision changes
- Decreased sex drive, trouble having an orgasm
Serious
- Serotonin syndrome (agitation, hallucinations, fever, sweating, fast heartbeat, muscle stiffness or twitching, loss of coordination, nausea, vomiting, diarrhea)
- Suicidal thoughts or behaviors, especially in the first few months of treatment
- Severe allergic reaction (hives, trouble breathing, swelling of face, lips, tongue, or throat)
- Severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple rash with blistering or peeling)
- Abnormal bleeding or bruising (nosebleeds, blood in urine or stool, unusual bruising)
- Eye problems (eye pain, blurred vision, swelling or redness in or around the eye, seeing halos around lights)
- Low sodium levels in the blood (headache, confusion, weakness, unsteadiness, memory problems)
- Bone fractures (unusual bone pain, tenderness, swelling, or bruising)
- Manic episodes (racing thoughts, less need for sleep, unusual risk-taking, extreme happiness or irritability, talking more than usual)
- Seizures
- Akathisia (inner restlessness, inability to sit or stand still), most likely in the first few weeks of treatment
- Irregular or fast heartbeat
Warnings and precautions
- This medicine has a boxed warning, the most serious FDA warning, because it can increase the risk of suicidal thoughts and behaviors, especially within the first few months of treatment. Patients, families, and caregivers should watch closely for new or worsening mood or behavior changes.
- Do not take this medicine with, or within 14 days of taking, an MAO inhibitor (such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine). Combining them can cause a dangerous reaction.
- Do not take this medicine with pimozide or thioridazine, as this combination can cause serious heart rhythm problems or sudden death.
- This medicine can cause serotonin syndrome, a potentially life-threatening condition, especially when combined with other medicines that affect serotonin.
- This medicine may increase your risk of bleeding or bruising, especially if you also take blood thinners, aspirin, or NSAIDs like ibuprofen or naproxen.
- This medicine may reduce how well tamoxifen works if taken together. Tell your doctor if you are taking tamoxifen for breast cancer.
- This medicine can cause low sodium levels in the blood, which may be more likely in older adults. Symptoms include headache, confusion, and weakness.
- This medicine may raise the risk of bone fractures.
- If you have narrow-angle glaucoma, this medicine could trigger a sudden attack of vision loss due to pupil dilation.
- This medicine should be used cautiously in people with a history of seizures, since it may increase seizure risk.
- Before starting this medicine, your doctor should screen you for bipolar disorder, since antidepressants can trigger manic episodes in people at risk.
- Do not take Brisdelle if you are pregnant. It may cause serious harm to an unborn baby, including birth defects, especially heart defects, and other problems shortly after birth. Tell your doctor right away if you become pregnant.
- You should not breastfeed while using this medicine, since it passes into breast milk and could affect a nursing baby.
- Tell your doctor if you have kidney disease before starting this medicine. No dose change is generally needed, but your doctor should know about kidney problems.
- Tell your doctor if you have liver disease before starting this medicine. No dose change is generally needed, but your doctor should know about liver problems.
- Drinking alcohol while taking this medicine can make side effects like nausea, headache, and tiredness worse. Talk to your doctor about how much alcohol, if any, is safe for you.
- This medicine can affect your ability to make decisions, think clearly, or react quickly, and can cause sleepiness. Do not drive, operate heavy machinery, or do other dangerous activities until you know how it affects you.
Storage
- Store at 20–25°C (68–77°F) at controlled room temperature.
- Keep capsules in their original, tightly closed container until use.
- Protect from excessive heat, moisture, and direct sunlight.
- Avoid storing in bathrooms or other hot and humid areas.
- Keep out of reach and sight of children and pets.
When to see a doctor
- Get emergency help right away if you have signs of a severe allergic reaction, such as hives, trouble breathing, or swelling of your face or throat.
- Seek medical attention right away if you notice symptoms of serotonin syndrome, such as agitation, hallucinations, fever, sweating, fast heartbeat, muscle stiffness or twitching, loss of coordination, nausea, vomiting, or diarrhea.
- Call your doctor right away if you have new or worsening mood changes, agitation, panic attacks, trouble sleeping, or thoughts of suicide or self-harm.
- Call your doctor if you have signs of a manic episode, such as racing thoughts, less need for sleep, unusual risk-taking, or extreme mood swings.
- Call your doctor if you notice vision changes, eye pain or swelling, or seeing halos around lights.
- Call your doctor if you have unusual bone pain, tenderness, swelling, or bruising.
- Call your doctor if you notice easy bruising or unusual bleeding from the nose, mouth, vagina, or rectum, or if you cough up blood.
- Seek help if you have symptoms of low sodium levels, such as headache, confusion, slurred speech, severe weakness, loss of coordination, or feeling unsteady.
- If you think you've taken too much of this medicine, contact your doctor or your local poison control center right away, or go to the nearest emergency room.
Alternatives
- Desvenlafaxine
- Venlafaxine
- Gabapentin
- Lynkuet
- Veozah
Watch the video
FAQs
What is Brisdelle Capsule used for?
Brisdelle is used to treat moderate to severe hot flashes related to menopause. It is not a hormone medicine and is not approved for depression, anxiety, or other mental health conditions.
How should I take Brisdelle Capsule?
Take it exactly as prescribed, once a day at bedtime, with or without food. Swallow the capsule whole without crushing, splitting, or chewing it.
What is the dosage of Brisdelle Capsule?
The standard dose for postmenopausal women, including those 65 and older, is 7.5 mg orally once daily at bedtime. It is not indicated for use in people under 18 or in premenopausal women.
What are the common side effects of Brisdelle Capsule?
Common side effects include headache, tiredness, nausea, vomiting, dizziness, drowsiness, sweating, anxiety, trouble sleeping, dry mouth, and decreased sex drive.
Does Brisdelle Capsule have a boxed warning?
Yes, Brisdelle has a boxed warning because it can increase the risk of suicidal thoughts and behaviors, especially within the first few months of treatment.
General information, not medical advice
Your prescriber and the leaflet in your pack know your situation. This page does not.
- Follow your prescriber and the leaflet
- Don't start, stop, or change a dose on your own
- Doses and warnings differ by country and product
Sources
Video
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