"The U.S. Food and Drug Administration today approved Osphena (ospemifene) to treat women experiencing moderate to severe dyspareunia (pain during sexual intercourse), a symptom of vulvar and vaginal atrophy due to menopause.
- Clinician Information:
Brisdelle Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Brisdelle (paroxetine) is a selective serotonin reuptake inhibitor (SSRI) used to treat moderate to severe vasomotor menopausal symptoms (VMS) such as hot flashes and night sweats associated with menopause. Brisdelle is not intended to treat any psychiatric condition. Common side effects include headache, fatigue, nausea or vomiting.
The recommended dosage of Brisdelle for the treatment of moderate to severe VMS is 7.5 mg once daily, at bedtime, with or without food. Brisdelle may interact with thioridazine, pimozide, tamoxifen, other antidepressants, monoamine oxidase inhibitors (MAOIs), NSAIDs or aspirin, risperidone, atomoxetine, warfarin, digoxin, theophylline, phenytoin, fosamprenavir/ritonavir, or cimetidine. Tell your doctor all medications and supplements you use. Brisdelle is not recommended for use during pregnancy. It may cause fetal harm. Brisdelle passes into breast milk. Consult your doctor before breastfeeding.
Our Brisdelle (paroxetine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Brisdelle FDA Prescribing Information: Side Effects
The following serious adverse reactions are discussed elsewhere in labeling:
- Suicidality [see WARNINGS AND PRECAUTIONS]
- Serotonin syndrome [see WARNINGS AND PRECAUTIONS]
- Abnormal bleeding [see WARNINGS AND PRECAUTIONS]
- Hyponatremia [see WARNINGS AND PRECAUTIONS]
- Bone Fracture [see WARNINGS AND PRECAUTIONS]
- Mania/Hypomania [see WARNINGS AND PRECAUTIONS]
- Seizure [see WARNINGS AND PRECAUTIONS]
- Akathisia [see WARNINGS AND PRECAUTIONS]
Clinical 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 one 8-week Phase 2 randomized, placebo-controlled trial and the two Phase 3 randomized, placebo-controlled, 12-week and 24-week trials for the treatment of moderate to severe VMS [see Clinical Studies]. In these trials, a total of 635 women were exposed to BRISDELLE 7.5 mg administered orally once daily and 641 women received placebo. The majority of BRISDELLE-treated patients were Caucasian (68%) and African American (30%), with a mean age of 55 years (range 40 to 73 years). Women with a history of suicidal ideation or suicidal behavior were excluded from these studies.
Adverse Reactions Leading to Study Discontinuation
A total of 4.7% of women taking BRISDELLE discontinued from the clinical trials due to an adverse reaction, compared to 3.7% of women on placebo; the most frequent adverse reactions leading to discontinuation among paroxetine-treated women 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 women treated with BRISDELLE reported at least 1 adverse reaction in the three controlled studies. The most common adverse reactions ( ≥ 2% and more common among BRISDELLE-treated women) reported in these studies were headache, fatigue/malaise/lethargy, and nausea/vomiting. Of these commonly reported adverse reactions, nausea occurred primarily within the first 4 weeks of treatment and fatigue occurred primarily within the first week of treatment, and decreased in frequency with continued therapy.
The adverse reactions that occurred in at least 2% of patients in the BRISDELLE group and at a higher incidence than placebo are shown in Table 1 for the pooled Phase 2 and Phase 3 trials.
Table 1 : Frequency of Adverse Reactions in the Phase
2 and Phase 3 Trials ( ≥ 2% and at a higher incidence than placebo)
|Frequency n (%)|
(n = 635)
(n = 641)
|Nervous system disorders|
|Headache||40 (6.3)||31 (4.8)|
|General disorders and administration site conditions|
|Fatigue, malaise, lethargy||31 (4.9)||18 (2.8)|
|Nausea, vomiting||27 (4.3)||15 (2.3)|
Certain symptoms were seen more frequently in women at the time of discontinuation of BRISDELLE compared to women discontinuing placebo, and have also been reported upon discontinuation of other formulations of paroxetine, particularly when abrupt. These include increased dreaming/nightmares, muscle cramps/spasms/twitching, headache, nervousness/anxiety, fatigue/tiredness, restless feeling in legs, and trouble sleeping/insomnia. While these events are generally self-limiting, there have been reports of serious discontinuation symptoms with other formulations of paroxetine.
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.
The following adverse reactions have been identified from clinical studies of paroxetine and during post-approval use of other formulations of paroxetine. 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 causal relationship to drug exposure.
General Disorders and Administration Site Conditions: Death, Drug withdrawal syndrome, Malaise.
Investigations: Elevated liver tests (the most severe cases were deaths due to liver necrosis, and grossly elevated transaminases associated with severe liver dysfunction).
Psychiatric Disorders: Aggression, Agitation, Anxiety, Confusional state, Depression, Disorientation, Homicidal ideation, Insomnia, Restlessness. 9
Respiratory, Thoracic and Mediastinal Disorders: Pulmonary hypertension.
Read the entire FDA prescribing information for Brisdelle (Paroxetine Capsules 7.5 mg) »
Additional Brisdelle Information
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