Paroxetine is used to treat depression, obsessive-compulsive disorder (OCD), panic disorder, generalized anxiety disorder (GAD), social anxiety disorder (also known as social phobia), premenstrual dysphoric disorder (PMDD), and posttraumatic stress disorder (PTSD). Brisdelle™ is used only to treat moderate to severe hot flashes caused by menopause.

Paroxetine belongs to a group of medicines known as selective serotonin reuptake inhibitors (SSRIs). These medicines are thought to work by increasing the activity of the chemical called serotonin in the brain.

This medicine is available only with your doctor's prescription.

Take this medicine only as directed by your doctor to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine should come with a Medication Guide. Follow the instructions carefully. Ask your doctor if you have any questions.

Paroxetine may be taken with or without food.

You may have to take paroxetine for a month or longer before you begin to feel better.

If you are taking the oral suspension, shake the bottle well before measuring each dose. Use a small measuring cup or a measuring spoon to measure each dose. The teaspoons and tablespoons that are used for serving and eating food do not measure exact amounts.

Swallow the tablet or extended-release tablet whole. Do not crush, break, or chew it.

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Agitation

chest congestion

chest pain

chills

cold sweats

confusion

difficulty with breathing

dizziness, faintness, or lightheadedness when getting up from a lying or sitting position

fast, pounding, or irregular heartbeat or pulse

muscle pain or weakness

skin rash

Rare

Absence of or decrease in body movements

bigger, dilated, or enlarged pupils (black part of the eye)

convulsions (seizures)

difficulty with speaking

dry mouth

fever

inability to move the eyes

incomplete, sudden, or unusual body or facial movements

increased sensitivity of the eyes to light

poor coordination

red or purple patches on the skin

restlessness

shivering

sweating

talking, feeling, and acting with excitement and activity you cannot control

trembling or shaking, or twitching

Incidence not known

Back, leg, or stomach pains

blindness

blistering, peeling, or loosening of the skin

blue-yellow color blindness

blurred vision

constipation

cough or hoarseness

dark urine

decreased frequency or amount of urine

decreased vision

difficulty with swallowing

electric shock sensations

eye pain

fainting

general body swelling

headache

high fever

hives or itching skin

inability to move the arms and legs

inability to sit still

increased thirst

incremental or ratchet-like movement of the muscle

joint pain

light-colored stools

lockjaw

loss of appetite

loss of bladder control

lower back or side pain

muscle spasm, especially of the neck and back

muscle tension or tightness

painful or difficult urination

painful or prolonged erection of the penis

pale skin

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

raised red swellings on the skin, the buttocks, legs, or ankles

red, irritated eyes

sensitivity to the sun

skin redness or soreness

slow heart rate

sores, ulcers, or white spots on the lips or in the mouth

spasms of the throat

stiff muscles

stomach pain

sudden numbness and weakness in the arms and legs

swelling of the breasts

swelling of the face, fingers, or lower legs

swollen or painful glands

tightness in the chest

unexpected or excess milk flow from the breasts

unusual bleeding or bruising

unusual tiredness or weakness

vomiting

weight gain

yellowing of the eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Acid or sour stomach

belching

decreased appetite

decreased sexual ability or desire

heartburn

pain or tenderness around the eyes and cheekbones

passing gas

problems with urinating

runny or stuffy nose

sexual problems, especially ejaculatory disturbances

sleepiness or unusual drowsiness

stomach discomfort or upset

trouble sleeping

Less common

Abnormal dreams

change in sense of taste

congestion

discouragement, feeling sad, or empty

drugged feeling

fast or irregular breathing

feeling of unreality

headache, severe and throbbing

increased appetite

itching of the vagina or genital area

itching, pain, redness, or swelling of the eye or eyelid

lack of emotion

loss of interest or pleasure

lump in the throat

menstrual changes

pain during sexual intercourse

problems with memory

sense of detachment from self or body

sneezing

thick, white vaginal discharge with no odor or with a mild odor

tightness in the throat

tingling, burning, or prickling sensations

trouble concentrating

voice changes

watering of the eyes

weight loss

yawn

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

It is important that your doctor check your progress at regular visits to allow changes in your dose and help reduce any side effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Do not take paroxetine with a monoamine oxidase (MAO) inhibitor (eg, isocarboxazid [Marplan®], linezolid [Zyvox®], methylene blue injection, phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]). Do not start taking paroxetine during the 2 weeks after you stop a MAO inhibitor and wait 2 weeks after stopping paroxetine before you start taking a MAO inhibitor. If you take them together or do not wait 2 weeks, you may develop confusion, agitation, restlessness, stomach or intestinal symptoms, a sudden high body temperature, an extremely high blood pressure, or severe convulsions.

Do not take pimozide (Orap®) or thioridazine (Mellaril®) while you are taking this medicine. Using these medicines together can cause very serious heart problems.

Paroxetine may cause a serious condition called serotonin syndrome if taken together with some medicines. Do not use paroxetine with buspirone (Buspar®), fentanyl (Abstral®, Duragesic®), lithium (Eskalith®, Lithobid®), tryptophan, St. John's wort, amphetamines, or some pain or migraine medicines (eg, rizatriptan, sumatriptan, tramadol, Frova®, Imitrex®, Maxalt®, Relpax®, Ultram®, Zomig®). Check with your doctor first before taking any other medicines with paroxetine.

This medicine may decrease the amount of sperm men make and affect their ability to have children. If you plan to have children, talk with your doctor before using this medicine.

Paroxetine may cause some teenagers and young adults to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Some people may have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. If you or your caregiver notice any of these unwanted effects, tell your doctor right away. Let the doctor know if you or anyone in your family has bipolar disorder (manic-depressive) or has tried to commit suicide.

Do not suddenly stop taking this medicine without checking first with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This will decrease the chance of having withdrawal symptoms such as agitation, breathing problems, chest pain, confusion, diarrhea, dizziness or lightheadedness, fast heartbeat, headache, increased sweating, muscle pain, nausea, restlessness, runny nose, trouble in sleeping, trembling or shaking, unusual tiredness or weakness, vision changes, or vomiting.

Check with your doctor right away if you develop the following symptoms during the first few weeks of treatment with paroxetine: inability to sit still, need to keep moving, or restlessness.

The use of alcohol is not recommended in patients who are taking paroxetine.

Paroxetine may cause some people to become drowsy or have blurred vision. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert or able to see clearly.

Hyponatremia (low sodium in the blood) may occur with this medicine. Check with your doctor right away if you have confusion, difficulty concentrating, headaches, memory problems, weakness, and unsteadiness.

This medicine may increase your risk for bleeding problems. Make sure your doctor knows if you are also taking other medicines that thin the blood, such as aspirin, nonsteroidal antiinflammatory agents, also called NSAIDs (eg, diclofenac, ibuprofen, naproxen, Advil®, Aleve®, Celebrex®, Voltaren®), or warfarin (Coumadin®, Jantoven®).

This medicine may increase the risk of bone fractures. Tell your doctor if you have unexplained bone pain, tenderness, swelling, or bruising. Also, ask your doctor about ways to keep your bones strong to help prevent fractures.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.