Paroxetine (Oral Route)

US Brand Name

1. Brisdelle

2. Paxil

3. Paxil CR

4. Pexeva

Descriptions

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.

This product is available in the following dosage forms:

• Tablet

• Capsule

• Suspension

• Tablet, Extended Release

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

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