Brisdelle (paroxetine) is a prescription oral capsule used to help treat hot flashes related to menopause. Brisdelle can cause side effects that range from mild to serious. These include nausea and headache.

Keep reading to learn about common, mild, and serious side effects that Brisdelle can cause. For a general overview of the drug, including details about its uses, see this in-depth Brisdelle article.

Brisdelle has a boxed warning about the risk of suicidal thoughts and actions. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For details, see the “Side effects explained” section.

Some people may experience mild to serious side effects during Brisdelle treatment. Examples of the drug’s commonly reported side effects include:

Mild side effects have been reported with Brisdelle. These include:

In most cases, these side effects should be temporary. And some may be easily managed. But if you have symptoms that are ongoing or bothersome, talk with your doctor or pharmacist. And do not stop Brisdelle treatment unless your doctor recommends it.

Brisdelle may cause mild side effects other than those listed above. See the drug’s prescribing information for details.

Serious side effects have been reported with Brisdelle. These include:

If you develop serious side effects while taking Brisdelle, call your doctor right away. If the side effects seem life threatening or you think you’re having a medical emergency, immediately call 911 or your local emergency number.

* To learn more about this side effect, see the “Side effects explained” section.

Note: After the FDA approves a drug, it tracks and reviews side effects of the medication. If you’d like to notify the FDA about a side effect you’ve had with Brisdelle, visit MedWatch.

ALLERGIC REACTION

For some people, Brisdelle can cause an allergic reaction. But it’s not known how often this occurred in the drug’s studies.

In general, symptoms of allergic reaction can be mild or serious.

What might help

If you have mild symptoms of an allergic reaction, such as a mild rash, call your doctor right away. They may suggest a treatment to manage your symptoms and can determine whether you should continue Brisdelle treatment.

If you have symptoms of a severe allergic reaction, such as swelling or difficulty breathing, call 911 or your local emergency number right away. These symptoms could be life threatening and require immediate medical care.

If your doctor confirms you’ve had a serious allergic reaction to Brisdelle, they may have you switch to a different treatment.

Get answers to some frequently asked questions about Brisdelle’s side effects.

Brisdelle vs Paxil: how do side effects compare?

Brisdelle and Paxil contain the same active ingredient (paroxetine). Brisdelle is only approved to treat hot flashes from menopause. Paxil is approved to treat mental health conditions such as depression, panic disorder, anxiety disorders, post-traumatic stress disorder (PTSD) and premenstrual dysphoric disorder.

These medications are not interchangeable.

Although they have the same active ingredient, Brisdelle contains a lower amount of paroxetine than Paxil. Because of this, it’s possible that you may have a lower risk of side effects with Brisdelle compared to Paxil. But this depends on your response to Brisdelle and other factors, such as other conditions you have or other medications you take.

Both medications have some similar and some different side effects.

Loss of appetite, dry mouth, and weight gain are side effects associated more with Paxil than Brisdelle. Common side effects of both drugs include sleepiness, nausea, and vomiting. And they share similar serious side effects. (See the “What are the serious side effects of Brisdelle?” section to learn more.)

To learn more about how side effects of Brisdelle and Paxil compare, talk with your doctor or pharmacist.

Does Brisdelle help with anxiety or depression? Are these side effects of Brisdelle?

Brisdelle is only approved to treat vasomotor symptoms such as hot flashes from menopause in females.* Brisdelle is not used to treat depression or types of anxiety.

Brisdelle comes in one dose of 7.5 milligrams (mg). But its active ingredient (paroxetine) is available in generic and brand name versions (Paxil, Paxil CR, Pexeva) in higher doses. These medications are used to treat types of anxiety disorders and depression. But Brisdelle isn’t likely to help treat anxiety or depression because of its low dose.

Note: Some rare side effects reported in studies of people taking Brisdelle include anxiety and nervousness. They also include serious mood changes, such as suicidal thoughts and behavior (for which Brisdelle has a boxed warning).

If you’ve been prescribed Brisdelle for vasomotor symptoms of menopause, do not take it for other conditions such as depression or anxiety. Talk with your doctor about your symptoms. They can discuss your treatment options with you.

* In this article, we use the term ”female” to refer to someone’s sex assigned at birth. To learn more about this topic, see this article comparing sex and gender.

Keeping track of side effects

During your Brisdelle treatment, consider taking notes on any side effects you’re having. You can then share this information with your doctor. This is especially helpful when you first start a new drug or combination of treatments.

Your side effect notes can include things such as:

  • what dose of the drug you were taking when you had the side effect
  • how soon you had the side effect after starting that dose
  • what your symptoms were
  • how your symptoms affected your daily activities
  • what other medications you were taking
  • any other information you feel is important

Sharing notes with your doctor will help them learn more about how Brisdelle affects you. They can then use this information to adjust your treatment plan if needed.

Learn more about some of the side effects Brisdelle may cause.

Sexual side effects

While they were rarely reported in the drug’s studies, treatment with Brisdelle may cause sexual side effects.

Symptoms of sexual side effects may include:

What might help

If you experience sexual side effects during Brisdelle treatment which don’t go away or are bothersome, talk with your doctor. They can discuss your symptoms and suggest other treatment options for you to consider.

Boxed warning: Risk of suicidal thoughts and behavior

Brisdelle has a boxed warning about the risk of suicidal thoughts and actions. A boxed warning is the most serious warning from the FDA. It alerts doctors and patients about drug effects that may be dangerous.

Suicidal thoughts and behavior: Studies of antidepressant medications including selective serotonin reuptake inhibitors (SSRIs) have shown they may, in rare cases, increase the risk of suicidal thoughts and behaviors in children and adolescents up to 24 years of age. (Brisdelle is an SSRI.)

What might help

When you begin treatment with Brisdelle, your doctor will monitor you closely for changes in mood, emotions, thoughts, and behavior, including those related to suicide. You have a higher risk of these side effects during the first few months of Brisdelle treatment. Tell your doctor right away if you or someone else notices a sudden worsening in your mood, especially if it includes thoughts of suicide.

Help is out there

If you or someone you know is in crisis and considering suicide or self-harm, please seek support:

  • Call or text the 988 Suicide and Crisis Lifeline at 988 or chat at 988lifeline.org. Caring counselors are available to listen and provide free and confidential support 24/7.
  • Text HOME to the Crisis Text Line at 741741 to connect with a volunteer crisis counselor for free and confidential support 24/7.
  • Not in the United States? Find a helpline in your country with Befrienders Worldwide.
  • Call 911 or your local emergency services number if you feel safe to do so.

If you’re calling on behalf of someone else, stay with them until help arrives. You may remove weapons or substances that can cause harm if you can do so safely.

If you’re not in the same household, stay on the phone with them until help arrives.

Below is important information you should consider before taking Brisdelle.

Boxed warning: Risk of suicidal thoughts and behavior

Brisdelle has a boxed warning about the risk of suicidal thoughts and behavior. A boxed warning is the most serious warning from the FDA. For details, see the “Side effects explained” section.

Other warnings

Brisdelle can sometimes cause harmful effects in people with certain conditions. This is known as a drug-condition interaction. Other factors may also affect whether this drug is a good treatment option for you.

Talk with your doctor about your health history before starting Brisdelle. Be sure to tell them if any of the following factors apply to you:

Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.