Generic Name
Paroxetine
Brand Names
Brisdelle, Paxil
FDA approval date: July 30, 2003
Classification: Serotonin Reuptake Inhibitor
Form: Tablet, Suspension, Capsule
What is Brisdelle (Paroxetine)?
Paroxetine Capsules are indicated for the treatment of moderate to severe vasomotor symptoms associated with menopause. Limitation of Use: Paroxetine capsules are not indicated for the treatment of any psychiatric condition. Paroxetine capsules contain a lower dose of paroxetine than that used to treat depression, obsessive compulsive disorder, panic disorder, generalized anxiety disorder, social anxiety disorder, and post-traumatic stress disorder. The safety and efficacy of this lower dose of paroxetine in paroxetine capsules have not been established for any psychiatric condition. Patients who require paroxetine for treatment of a psychiatric condition should discontinue paroxetine capsules and initiate a paroxetine-containing medication that is indicated for such use. Paroxetine capsules are a selective serotonin reuptake inhibitor indicated for the treatment of moderate to severe vasomotor symptoms associated with menopause Limitation of Use: Paroxetine capsules are not indicated for the treatment of any psychiatric condition
Approved To Treat
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Brand Information
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
Selective serotonin reuptake inhibitors (SSRIs) increased the risk of suicidal thoughts and behavior in pediatric and young adult patients in short-term trials for the treatment of major depressive disorder and other psychiatric disorders. Because BRISDELLE is an SSRI, closely monitor BRISDELLE-treated patients closely for emergence of suicidal thoughts and behaviors
1INDICATIONS AND USAGE
BRISDELLE is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.
Limitations of Use:
BRISDELLE is not indicated for the treatment of any psychiatric condition. BRISDELLE has a lower recommended paroxetine dosage than that used to treat major depressive disorder, obsessive compulsive disorder, panic disorder, generalized anxiety disorder, social anxiety disorder, and post-traumatic stress disorder. The safety and effectiveness of the lower BRISDELLE dosage has not been established for any psychiatric condition. Patients who require paroxetine for treatment of a psychiatric condition should discontinue BRISDELLE and initiate a paroxetine-containing product that is indicated for such use.
2DOSAGE FORMS AND STRENGTHS
BRISDELLE is available as 7.5 mg pink capsules printed with black edible ink with “BRISDELLE” and “7.5 mg” on the capsule. Each capsule contains 9.69 mg of paroxetine mesylate equivalent to 7.5 mg paroxetine base.
3CONTRAINDICATIONS
BRISDELLE is contraindicated in patients:
- Taking, or within 14 days of stopping, MAOIs (including the MAOIs linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome
- Taking thioridazine because of risk of QT prolongation
- Taking pimozide because of risk of QT prolongation
- With known hypersensitivity (e.g., anaphylaxis, angioedema, Stevens-Johnson syndrome) to paroxetine or to any of the inactive ingredients in BRISDELLE
- Who are or become pregnant because menopausal VMS does not occur during pregnancy and BRISDELLE may cause fetal harm
4ADVERSE REACTIONS
The following serious adverse reactions are discussed elsewhere in labeling:
- Suicidality
- Serotonin syndrome
- Abnormal bleeding
- Angle-Closure Glaucoma
- Hyponatremia
- Bone Fracture
- Mania/Hypomania
- Seizure
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot directly be compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data described below reflect exposure to BRISDELLE in the following randomized, placebo-controlled trials for the treatment of moderate to severe VMS associated with menopause
Serious Adverse Reactions:
In the pooled Phase 2 and Phase 3 trials, three BRISDELLE-treated patients reported a serious adverse reaction of suicidal ideation and one BRISDELLE-treated patient reported a serious adverse reaction of suicide attempt. There were no serious adverse reactions of suicidal ideation or suicide attempt reported among the placebo-treated patients.
Adverse Reactions Leading to Study Discontinuation:
A total of 4.7% of females taking BRISDELLE discontinued from the clinical trials due to an adverse reaction, compared to 3.7% of females on placebo; the most frequent adverse reactions leading to discontinuation among paroxetine-treated females were: abdominal pain (0.3%), attention disturbances (0.3%), headache (0.3%), and suicidal ideation (0.3%).
Common Adverse Reactions:
Overall, based on investigators’ determinations about what events were likely to be drug-related, about 20% of postmenopausal females treated with BRISDELLE reported at least 1 adverse reaction in the three controlled trials. The most common adverse reactions (≥ 2% and at a higher incidence in BRISDELLE-treated females compared to placebo-treated females) reported in these trials were headache, fatigue/malaise/lethargy, and nausea/vomiting. Of these commonly reported adverse reactions, nausea occurred primarily within the first 4 weeks of BRISDELLE treatment and fatigue occurred primarily within the first week of BRISDELLE treatment, and decreased in frequency with continued therapy.
The adverse reactions that occurred in ≥ 2% of BRISDELLE-treated patients and at a higher incidence in BRISDELLE-treated females compared to placebo-treated females are shown in Table 1 for the pooled Phase 2 and Phase 3 trials.
Table 1: Incidence of Common Adverse Reactions in the Phase 2 and Phase 3 Trials of Postmenopausal Females with Moderate to Severe VMS
1 ≥ 2% BRISDELLE-treated patients and at a higher incidence in BRISDELLE-treated females compared to placebo-treated females.
Adverse Reactions After Discontinuing BRISDELLE
Certain symptoms were seen more frequently in postmenopausal females at the time of discontinuation of BRISDELLE compared to discontinuation of placebo and have also been reported upon discontinuation of other paroxetine products, particularly after abrupt discontinuation. Adverse reactions reported after discontinuation of BRISDELLE included increased dreaming/nightmares, muscle cramps/spasms/twitching, headache, nervousness/anxiety, fatigue/tiredness, restless feeling in legs, and trouble sleeping/insomnia. While these adverse reactions were generally self-limiting, there have been reports of serious discontinuation symptoms with other paroxetine products.
4.2Postmarketing Experience
The following adverse reactions have been identified during post-approval use of this and other paroxetine products. Because some of these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a
Blood and Lymphatic System Disorders: Idiopathic thrombocytopenic purpura, Events related to impaired hematopoiesis (including aplastic anemia, pancytopenia, bone marrow aplasia, agranulocytosis).
Cardiac Disorders: Atrial fibrillation, Pulmonary edema, Ventricular fibrillation, Ventricular tachycardia (including torsades de pointes).
Gastrointestinal Disorders: Pancreatitis, Pancreatitis hemorrhagic, Vomiting.
General Disorders and Administration Site Conditions: Death, Drug withdrawal syndrome, Malaise.
Hepatobiliary Disorders: Drug-induced liver injury, Hepatic failure, Jaundice.
Immune System Disorders: Anaphylaxis, Angioedema, Toxic epidermal necrolysis.
Investigations: Elevated liver tests (the most severe cases were deaths due to liver necrosis, and grossly elevated transaminases associated with severe liver dysfunction).
Metabolism and Nutrition Disorders: Diabetes mellitus inadequate control, Type 2 diabetes mellitus.
Nervous System Disorders: Neuroleptic malignant syndrome, Paresthesia, Somnolence, Tremor, Anosmia, Hyposmia
Psychiatric Disorders: Aggression, Agitation, Anxiety, Confusional state, Depression, Disorientation, Homicidal ideation, Insomnia, Restlessness.
Respiratory, Thoracic and Mediastinal Disorders: Pulmonary hypertension.
Skin and Subcutaneous Tissue Disorders: Hyperhidrosis, Stevens-Johnson syndrome, Drug reaction with eosinophilia and systemic symptoms (DRESS).
5OVERDOSAGE
The following have been reported with paroxetine tablets overdose:
- Seizures, which may be delayed, and altered mental status including coma.
- Cardiovascular toxicity, which may be delayed, including QRS and QTc interval prolongation. Hypertension most commonly seen, but rarely can see hypotension alone or with co-ingestants including alcohol.
- Serotonin syndrome (patients with a multiple drug overdosage with other pro-serotonergic drugs may have a higher risk).
Consider contacting the Poison Help Line (1-800-221-2222) or a medical toxicologist for overdose management recommendations.
6DESCRIPTION
BRISDELLE (paroxetine) is an orally administered selective serotonin reuptake inhibitor (SSRI) for the treatment of moderate to severe VMS associated with menopause. It is identified chemically as (-)-
The mesylate salt of paroxetine is an odorless, off-white powder, having a melting point range of 147° to 150°C and a solubility of more than 1 g/mL in water.
Each pink capsule contains 9.69 mg of paroxetine mesylate equivalent to 7.5 mg paroxetine base.
Inactive ingredients consist of: dibasic calcium phosphate, sodium starch glycolate, magnesium stearate, gelatin, titanium dioxide, FD&C Yellow #6, FD&C Red #3, FD&C Red #40, shellac, and black iron oxide.
7CLINICAL STUDIES
The effectiveness of BRISDELLE as a treatment for moderate to severe vasomotor symptoms (VMS) associated with menopause was established in two Phase 3 randomized, double-blind, placebo-controlled clinical trials in 1,174 postmenopausal females. In these trials, patients must have had a minimum of 7-8 moderate to severe VMS per day at baseline (≥ 50 per week) for 30 days prior to receiving study drug. Patients were randomized to BRISDELLE 7.5 mg orally once daily or daily placebo:
- Trial 1 was a 12-week trial with a total of 606 postmenopausal females (average age 55 years; 65% White, 33% Black or African American, and 2% other races; 10.6% were Hispanic/Latina and 89.4% were not Hispanic/Latina; 18% surgically menopausal and 82% naturally menopausal).
- Trial 2 was a 24-week trial with a total of 568 postmenopausal females (average age 54 years; 76% White, 22% Black or African American, and 2% other races; 6.5% were Hispanic/Latina and 93.5% were not Hispanic/Latina; 20% surgically menopausal and 81% naturally menopausal).
The co-primary efficacy endpoints for both trials were the reduction from baseline in VMS frequency and VMS severity at Weeks 4 and 12.
- Data from Trial 1 showed a statistically significant reduction from baseline in the frequency of moderate to severe VMS at Week 4 and Week 12 and a statistically significant reduction in the severity of moderate to severe VMS at Week 4 in the BRISDELLE group compared to the placebo group (Table 4).
- Data from Trial 2 showed a statistically significant reduction from baseline in the frequency and severity of moderate to severe VMS at Week 4 and Week 12 in the BRISDELLE group compared to placebo group (Table 5).
Table 4: Trial 1: Changes in the Daily Frequency and Daily Severity of VMS at Weeks 4 and 12 in Postmenopausal Females with Moderate to Severe VMS (MITT Population)
MITT population: all consented and randomized patients with valid baseline daily hot flash diary data who had taken at least 1 dose of study drug and had at least 1 day of on-treatment daily hot flash diary data.
Table 5: Trial 2: Changes in the Daily Frequency and Daily Severity of VMS at Weeks 4 and 12 in Postmenopausal Females with Moderate to Severe VMS (MITT Population)
MITT population: all consented and randomized patients with valid baseline daily hot flash diary data who had taken at least 1 dose of study drug and had at least 1 day of on-treatment daily hot flash diary data.
Persistence of benefit at 24 weeks in Trial 2 was evaluated with a responder analysis where responders were defined as those patients who achieved ≥ 50% reduction from baseline in the frequency of moderate to severe VMS at Week 24. The proportion of patients who achieved a ≥ 50% reduction in the frequency of moderate to severe VMS from baseline to Week 24 was 48% in the BRISDELLE group and 36% in the placebo group at Week 24.
8HOW SUPPLIED/STORAGE AND HANDLING
BRISDELLE (paroxetine) capsules is available as 7.5 mg pink capsules printed with black edible ink with “BRISDELLE” and “7.5 mg”.
NDC 83107-027-30 blister packs of 30
Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). Protect from light and humidity.
9PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Instruct patients to read the Medication Guide before starting therapy with BRISDELLE and to reread it each time the prescription is renewed.
Suicidal Thoughts and Behaviors
Advise patients, their families, and their caregivers to look for the emergence of suicidal thoughts and behaviors, especially early during treatment and to alert the health care provider if such changes occur
Serotonin Syndrome
Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of BRISDELLE with triptans, tricyclic antidepressants, opioids, linezolid, tramadol, amphetamines, St. John’s Wort, lithium, tryptophan supplements, other serotonergic agents, or antipsychotic drugs. Instruct patients to contact their health care provider, or report to the emergency room, should they experience signs or symptoms of serotonin syndrome
Potential Impact on Tamoxifen Efficacy
Caution patients that efficacy of tamoxifen may be reduced when administered concomitantly and counsel them about the likely benefit of paroxetine for treating VMS vs. the risk of possible decreased tamoxifen effectiveness
Increased Risk of Bleeding
Caution patients about the concomitant use of BRISDELLE and NSAIDs, aspirin, warfarin, and other anticoagulants because combined use of drugs that interfere with serotonin reuptake has been associated with an increased risk of bleeding
Angle-Closure Claucoma
Advise patients that taking BRISDELLE can cause mild pupillary dilation, which in susceptible individuals, can lead to an episode of angle-closure glaucoma -existing
Hyponatremia
Caution patients about the risk of hyponatremia, particularly elderly patients and those who are taking diuretics or are volume-depleted
Bone Fracture
Inform patients that there is the possibility for an increased risk of fracture
Screening Patients for Bipolar Disorder and Monitoring for Mania/Hypomania
Advise patients, their families, and their caregivers to observe for signs of activation of mania/hypomania
Pregnancy
Advise patients to notify their physician if they become pregnant during therapy
Drug Interactions
Advise patients to inform their healthcare provider if they are taking, or plan to take, any prescription or over-the-counter drugs, including herbal supplements, because there is a potential for interaction with paroxetine
Sexual Dysfunction
Advise patients that use of BRISDELLE may cause symptoms of sexual dysfunction in female patients. Inform patients that they should discuss any changes in sexual function and potential management strategies with their healthcare provider
Allergic Reactions
Advise patients to seek medical attention if they develop an allergic reaction such as rash, hives, swelling, or difficulty breathing
BRISDELLE is a registered trademark of Legacy Pharma Inc.
©2025 Legacy Pharma Inc. All rights reserved.
Manufactured for:
10PRINCIPAL DISPLAY PANEL
BRISDELLE (paroxetine) Capsules is available as 7.5 mg - NDC 83107-027-30 - 30 Caps Blister Label
BRISDELLE (paroxetine) Capsules is available as 7.5 mg - NDC 83107-027-30 - 30 Caps Blister Carton
