Brisdelle belongs to a group of drugs called selective serotonin reuptake inhibitors (SSRIs).

Brisdelle is a prescription medicine used to reduce moderate to severe hot flashes related to menopause. The way Brisdelle treats hot flashes associated with menopause is not known.

Brisdelle is not to be used to treat psychiatric problems such as depression, obsessive compulsive disorder, panic disorder, generalized anxiety disorder, social anxiety disorder, or post-traumatic stress disorder.

You should not use Brisdelle if you are also taking pimozide or thioridazine.

Do not use Brisdelle within 14 days before or 14 days after you have used an MAO inhibitor, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Seek medical attention right away if you have symptoms such as: agitation, hallucinations, muscle stiffness, twitching, loss of coordination, dizziness, warmth or tingly feeling, nausea, vomiting, diarrhea, fever, sweating, tremors, racing heartbeats, or a seizure (convulsions).

Take Brisdelle exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

The recommended dosage of Brisdelle is 7.5 mg once daily, at bedtime.

Do not stop using Brisdelle suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine. Follow your doctor's instructions about tapering your dose.

Tell your doctor if you have any changes in sexual function, such as loss of interest in sex, trouble having an orgasm, Some sexual problems can be treated.

Store at room temperature away from moisture, heat, and light.

You should not use Brisdelle if you are allergic to paroxetine, or if you are also taking pimozide or thioridazine.

Do not use an MAO inhibitor within 14 days before or 14 days after you take paroxetine. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine. After you stop taking Brisdelle you must wait at least 14 days before you start taking an MAO inhibitor.

To make sure Brisdelle is safe for you, tell your doctor if you have:

• heart disease, high blood pressure, or a stroke;

• liver or kidney disease;

• a bleeding or blood clotting disorder;

• seizures or epilepsy;

• bipolar disorder (manic depression), drug addiction, or suicidal thoughts;

• sexual problems;

• narrow-angle glaucoma; or

• low levels of sodium in your blood.

Be sure your doctor knows if you also take stimulant medicine, opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. These medicines may interact with paroxetine and cause a serious condition called serotonin syndrome.

Do not use Brisdelle if you are pregnant.

Taking an SSRI during pregnancy may cause serious lung problems or other complications in the baby. Tell your doctor right away if you become pregnant.

You should not breastfeed while using paroxetine.

Brisdelle is not approved for use by anyone younger than 18 years old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of paroxetine can be fatal.

Avoid driving or hazardous activity until you know how paroxetine will affect you. Your reactions could be impaired.

Ask your doctor before taking a nonsteroidal anti-inflammatory drug (NSAID) such as aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib (Celebrex), diclofenac, indomethacin, meloxicam, and others. Using an NSAID with paroxetine may cause you to bruise or bleed easily.

Drinking alcohol with this medicine can cause side effects.

Get emergency medical help if you have signs of an allergic reaction to Brisdelle (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), 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 Brisdelle 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.

Using Brisdelle with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Tell your doctor about all your other medicines, especially:

• cimetidine (Tagamet), digoxin, St. John's wort, tamoxifen, theophylline, tryptophan (sometimes called L-tryptophan), warfarin (Coumadin, Jantoven);

• a diuretic or "water pill";

• heart rhythm medicine;

• HIV or AIDS medications;

• certain medicines to treat narcolepsy or ADHD - -amphetamine, atomoxetine, dextroamphetamine, Adderall, Dexedrine, Evekeo, Vyvanse, and others;

• narcotic pain medicine - fentanyl, tramadol;

• medicine to treat anxiety, mood disorders, thought disorders, or mental illness - such as buspirone, lithium, other antidepressants, or antipsychotics;

• migraine headache medicine - sumatriptan, rizatriptan, zolmitriptan, and others; or

• seizure medicine - phenobarbital, phenytoin.

This list is not complete. Other drugs may interact with paroxetine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.