Brisdelle

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 10/4/2021
Brisdelle Side Effects Center

What Is Brisdelle?

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 of Brisdelle include:

What Are Side Effects of Brisdelle?

Dosage for Brisdelle

Brisdelle may cause thoughts of suicide. Tell your doctor if this happens while taking Brisdelle.

What Drugs, Substances, or Supplements Interact with Brisdelle?

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 During Pregnancy and Breastfeeding

Brisdelle is not recommended for use during pregnancy. It may cause fetal harm. Brisdelle passes into breast milk. Consult your doctor before breastfeeding. Withdrawal symptoms may occur if you suddenly stop taking Brisdelle.

Additional Information

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.

QUESTION

If menopause occurs in a woman younger than ___ years, it is considered to be premature. See Answer
Brisdelle Consumer Information

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Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

  • racing thoughts, decreased need for sleep, unusual risk-taking behavior, feelings of extreme happiness or sadness, being more talkative than usual;
  • blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • unusual bone pain or tenderness, swelling or bruising;
  • changes in weight or appetite;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), coughing up blood;
  • severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, fainting; or
  • low levels of sodium in the body--headache, confusion, slurred speech, severe weakness, loss of coordination, feeling unsteady.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Common side effects may include:

  • vision changes;
  • weakness, drowsiness, dizziness, tiredness;
  • sweating, anxiety, shaking;
  • sleep problems (insomnia);
  • loss of appetite, nausea, vomiting, diarrhea, constipation;
  • dry mouth, yawning;
  • infection;
  • headache; or
  • decreased sex drive, impotence, abnormal ejaculation, or difficulty having an orgasm.

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.

Read the entire detailed patient monograph for Brisdelle (Paroxetine Capsules 7.5 mg)

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Brisdelle Professional Information

SIDE EFFECTS

The following serious adverse reactions are discussed elsewhere in labeling:

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 Advers e Reactions in the Phas e 2 and Phas e 3 Trials (≥ 2% and at a higher incidence than placebo)

  Frequency n (%)
BRISDELLE (n = 635) Placebo (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)
Gastrointestinal disorders
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.

Postmarketing Experience

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.

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: Anaphylactoid reaction, 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.

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.

Read the entire FDA prescribing information for Brisdelle (Paroxetine Capsules 7.5 mg)

© Brisdelle Patient Information is supplied by Cerner Multum, Inc. and Brisdelle Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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