The short answer
Brisdelle is paroxetine 7.5 mg taken once at bedtime. It is the only SSRI FDA-approved to treat moderate-to-severe hot flashes associated with menopause and is not approved for any psychiatric condition. Like all antidepressants it carries a boxed warning about suicidal thoughts in young people, and it can reduce the effectiveness of tamoxifen.
Boxed warning and key interactions
Antidepressants increased suicidal thoughts and behaviors in children and young adults in studies; Brisdelle is not approved for anyone under 18 and patients should be monitored for mood worsening.
Contraindicated with MAO inhibitors (or within 14 days), thioridazine, pimozide, and pregnancy. Paroxetine strongly inhibits CYP2D6 and may reduce tamoxifen's effectiveness; the label advises considering alternatives. It raises bleeding risk with NSAIDs, aspirin, and anticoagulants, and can cause serotonin syndrome with other serotonergic drugs.
Current label check
The medication-specific claims on this page were checked against these current product labels on 2026-10-03.
| Product label | Label date | Boxed warning on that label |
|---|---|---|
| Brisdelle (paroxetine 7.5 mg) capsules | 2025-04-28 | Suicidal thoughts and behaviors |
Established evidence
What is Brisdelle?
Brisdelle contains paroxetine mesylate at 7.5 mg, a lower dose than paroxetine products used for depression and anxiety (such as Paxil). It was approved in 2013 as the first nonhormonal prescription for hot flashes. Higher-dose paroxetine used off-label for hot flashes is not the same approved product.
Limited human evidence
How it works
SSRIs increase serotonin signaling, which influences the hypothalamic temperature-control center. The exact mechanism for hot flash relief is not fully understood, and the effect appears at doses below those used for depression.
Established evidence
What the trials showed
Two 12- and 24-week randomized trials found modest but statistically significant reductions in hot flash frequency and severity compared with placebo. Benefit is generally smaller than with estrogen or neurokinin antagonists.
Established evidence
Common side effects
- Headache
- Fatigue
- Nausea and vomiting
- Possible low sodium, bone fracture risk, and abnormal bleeding as class warnings
Where it fits among nonhormonal options
| Medicine | FDA approved for hot flashes? |
|---|---|
| Paroxetine 7.5 mg (Brisdelle) | Yes |
| Fezolinetant (Veozah) | Yes |
| Elinzanetant (Lynkuet) | Yes |
| Venlafaxine, escitalopram, other SSRIs/SNRIs | No, off-label |
| Gabapentin, oxybutynin | No, off-label |
Questions to ask a healthcare professional
- I take tamoxifen; which option is safer for me?
- Could this interact with my migraine, pain, or mood medicines?
- How will we judge whether it is working?
Questions, answered
What people ask about Brisdelle
Is Brisdelle an antidepressant?+
It contains an SSRI antidepressant ingredient, but at 7.5 mg it is approved only for hot flashes and not for any psychiatric condition.
Can I take Brisdelle with tamoxifen?+
The label warns paroxetine may reduce tamoxifen's effectiveness; alternatives are generally preferred.
Is Brisdelle hormonal?+
No. It contains no estrogen or progesterone.
Does Kindr Health offer Brisdelle?+
This page is educational and does not state or imply availability through Kindr Health.
Kindr Health does not claim to offer Brisdelle on this page. Availability and prescribing are not implied.
A broader care pathway
Explore menopause care
Learn how Kindr Health care pathways work. An educational page is not a statement that this medication is available or appropriate for you.
SOURCES & REFERENCES
Every clinical claim on this page is sourced.
- BRISDELLE (paroxetine) capsules prescribing information (2025) — U.S. Food and Drug Administration. www.accessdata.fda.gov/drugsatfda_docs/label/2025/204516s009s014lbl.pdf
- The 2023 nonhormone therapy position statement of The North American Menopause Society (2023) — The Menopause Society (Menopause journal). menopause.org/wp-content/uploads/professional/2023-nonhormone-therapy-position-statement.pdf
This resource is educational and does not replace individualized medical advice. Do not start, stop, or change a prescription without guidance from a licensed healthcare professional.