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What is Paxil?

Paxil (paroxetine) is an antidepressant in a group of drugs called selective serotonin reuptake inhibitors (SSRIs). Paroxetine affects chemicals in the brain that may become unbalanced.

Paxil is used to treat depression, obsessive-compulsive disorder, anxiety disorders, post-traumatic stress disorder (PTSD), and premenstrual dysphoric disorder (PMDD).

Paxil may also be used for purposes not listed in this medication guide.

Important information about Paxil

You should not use Paxil if you are also taking pimozide or thioridazine, or if you are being treated with methylene blue injection. Do not start or stop taking this medicine during pregnancy without your doctor's advice.

Do not use an MAO inhibitor within 14 days before or after you take Paxil. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

Some young people have thoughts about suicide when first taking an antidepressant. Your doctor will need to check your progress at regular visits while you are using Paxil. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Do not give Paxil to anyone younger than 18 years old without the advice of a doctor. Paxil is not approved for use in children.

Before taking Paxil

You should not use Paxil if you are allergic to paroxetine, or if:

  • you are also taking pimozide or thioridazine; or

  • you are being treated with methylene blue injection.

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

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

  • liver or kidney disease;

  • a bleeding or blood clotting disorder;

  • seizures or epilepsy;

  • bipolar disorder (manic depression), or a history of drug abuse or suicidal thoughts;

  • narrow-angle glaucoma; or

  • if you take warfarin (Coumadin) to prevent blood clots.

Some young people have thoughts about suicide when first taking an antidepressant. Your doctor will need to check your progress at regular visits while you are using Paxil. Your family or other caregivers should also be alert to changes in your mood or symptoms.

FDA pregnancy category D. Taking an SSRI antidepressant during pregnancy may cause heart defects, serious lung problems, or other complications in the baby. However, you may have withdrawal symptoms or a relapse of depression if you stop taking your antidepressant. Tell your doctor right away if you become pregnant while taking Paxil. Do not start or stop taking this medicine during pregnancy without your doctor's advice.

Paroxetine can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

Do not give Paxil to anyone younger than 18 years old without the advice of a doctor. Paxil is not approved for treating depression in children.

How should I take Paxil?

Take Paxil exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

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

Shake the oral suspension (liquid) well just before you measure a dose. Measure the liquid with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

It may take up to 4 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

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

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

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

What should I avoid while taking Paxil?

Ask your doctor before taking a nonsteroidal anti-inflammatory drug (NSAID) for pain, arthritis, fever, or swelling. This includes aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib (Celebrex), diclofenac, indomethacin, meloxicam, and others. Using an NSAID with Paxil may cause you to bruise or bleed easily.

Drinking alcohol can increase some of the side effects of Paxil.

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Paxil side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Paxil: skin rash or hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

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:

  • unusual bone pain or tenderness, swelling or bruising;

  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), coughing up blood;

  • high levels of serotonin in the body--agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting;

  • low levels of sodium in the body--headache, confusion, slurred speech, severe weakness, loss of coordination, feeling unsteady;

  • severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, fainting; or

  • severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common Paxil side effects may include:

  • mild headache, drowsiness, dizziness, tired feeling;

  • sleep problems (insomnia), feeling restless or nervous;

  • mild nausea, constipation, weight changes;

  • decreased sex drive, impotence, or difficulty having an orgasm; or

  • dry mouth, yawning, or ringing in your ears.

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 other drugs will affect Paxil?

Taking Paxil with other drugs that make you sleepy or slow your breathing can increase these effects. Ask your doctor before taking Paxil with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety or seizures.

Many drugs can interact with paroxetine. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with Paxil, especially:

  • any other antidepressant;

  • tamoxifen;

  • tramadol;

  • tryptophan (sometimes called L-tryptophan); or

  • medicine to treat mental illness--lithium, thioridazine, and others.

This list is not complete and many other drugs can interact with Paxil. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

For the Consumer

Applies to paroxetine: oral capsule, oral suspension, oral tablet, oral tablet extended release

Along with its needed effects, paroxetine (the active ingredient contained in Paxil) 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 while taking paroxetine:

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
  • inability to move the arms and legs
  • inability to sit still
  • increased thirst
  • incremental or ratchet-like movement of the muscle
  • itching skin
  • joint pain
  • light-colored stools
  • lockjaw
  • loss of appetite
  • loss of bladder control
  • low blood pressure
  • 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 of paroxetine 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 in urinating
  • runny or stuffy nose
  • sexual problems, especially ejaculatory disturbances
  • sleepiness or unusual drowsiness
  • stomach discomfort or upset
  • trouble with 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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Applies to paroxetine: oral capsule, oral suspension, oral tablet, oral tablet extended release

Gastrointestinal

A study of 26,005 antidepressant users has reported 3.6 times more upper GI bleeding episodes with the use of SSRIs relative to the population who did not receive antidepressant medications. Upper gastrointestinal tract bleeding was observed up to 3.2 times more frequently in patients receiving paroxetine (the active ingredient contained in Paxil)

Gastrointestinal side effects have frequently included nausea (15% to 36%), dry mouth (4% to 36%), constipation (5% to 16%), diarrhea (6% to 19%), increased appetite (3%), decreased appetite (2% to 12%), flatulence (4% to 8%), vomiting (2% to 3%), oropharynx disorder (2%), taste perversion (2%), gingivitis (1%), and dyspepsia (2% to 13%). Bruxism, upper GI bleeding, colitis, dysphagia, eructation, gastritis, gastroenteritis, glossitis, increased salivation, rectal hemorrhage, ulcerative stomatitis, aphthous stomatitis, bloody diarrhea, bulimia, cholelithiasis, duodenitis, enteritis, esophagitis, fecal impaction, fecal incontinence, gum hemorrhage, hematemesis, ileitis, ileus, intestinal obstruction, melena, mouth ulceration, peptic ulcer, peritonitis , salivary gland enlargement, sialadenitis, stomach ulcer, stomatitis, tongue discoloration, tongue edema, loss of taste, and tooth caries have also been reported.

Nervous system

Chorea has been reported in 13 patients. One incidence of chorea occurred after a single dose of paroxetine (the active ingredient contained in Paxil)

Severe psychomotor retardation and stupor have been reported in one patient.

According to the manufacturer, one study reported that seizures occurred in 0.26% of patients treated with other commonly used antidepressants.

In one study, paroxetine was found to decrease rapid eye movement (REM) sleep, increase REM latency, increase awakenings, and reduce actual sleep time. Another study found a decreased amount of REM sleep without a detrimental effect on subjective sleep quality.

Nearly all selective serotonin reuptake inhibitors, mixed serotonin/norepinephrine reuptake inhibitors, and tricyclic antidepressants cause sleep abnormalities to some extent. These antidepressants have marked dose-dependent effects on rapid eye movement (REM) sleep, causing reductions in the overall amount of REM sleep over the night and delays the first entry into REM sleep (increased REM sleep onset latency (ROL)), both in healthy subjects and depressed patients. The antidepressants that increase serotonin function appear to have the greatest effect on REM sleep. The reduction in REM sleep is greatest early in treatment, but gradually returns towards baseline during long-term therapy; however, ROL remains long. Following discontinuation of therapy the amount of REM sleep tends to rebound. Some of these drugs (i.e., bupropion, mirtazapine, nefazodone, trazodone, trimipramine) appear to have a modest or minimal effect on REM sleep.

Nervous system side effects have frequently included somnolence (9% to 24%), dizziness (7% to 14%), insomnia (8% to 24%), tremor (4% to 11%), nervousness (2% to 9%), paresthesia (1% to 4%), decreased libido in both male and female patients (3% to 15%), 'drugged' feeling (2%), confusion (1%), sleep abnormalities, abnormal dreams (1% to 4%), impaired concentration (2% to 4%), myoclonus (1% to 3%), amnesia (1% to 2%), tremor (4% to 8%), hypertonia (2% to 3%), and vertigo (2%). Abnormal thinking, alcohol abuse, ataxia, dystonia, dyskinesia, hypesthesia, hypokinesia, incoordination, paralysis, abnormal gait, akinesia, antisocial reaction, aphasia, choreoathetosis, circumoral paresthesias, convulsion, delirium, delusions, dysarthria, extrapyramidal syndrome, fasciculations, grand mal convulsions, hyperalgesia, meningitis, myelitis, neuralgia, neuropathy, nystagmus, peripheral neuritis, decreased reflexes, increased reflexes, stupor, torticollis, trismus, tardive dyskinesia, seizures, status epilepticus, serotonin syndrome, extrapyramidal symptoms (including akathisia, bradykinesia, cogwheel rigidity, dystonia, and hypertonia), changes in rapid eye movement (REM) sleep, chorea, psychomotor retardation, and stupor have also been reported.

Psychiatric

Other commonly used antidepressants induced mania in 11% of patients in one study.

Pooled results from clinical trials report hallucinations in 22 of 9089 patients who received paroxetine (the active ingredient contained in Paxil) and 4 of 3187 patients who received placebo.

Psychiatric side effects have frequently included anxiety (2% to 5%), agitation (2% to 5%), depersonalization (3%), depression (2%), lack of emotion (2%), and emotional lability. Euphoria, hallucinations, hostility, increased libido, neurosis, paranoid reaction, antisocial reaction, delusions, drug dependence, hysteria, manic-depressive reaction, psychotic depression, and psychosis. Mania has been reported in up to 2% of bipolar patients.

Dermatologic

Seven cases of alopecia have been reported. In all cases, hair loss was eventually reversible.

A case of cutaneous leukocytoclastic vasculitis has been reported following treatment with paroxetine (the active ingredient contained in Paxil) The patient originally developed the lesions after treatment with escitalopram. The lesions disappeared one week following discontinuation of escitalopram and reappeared upon rechallenge. When the patient was switched to paroxetine a similar reaction occurred.

Dermatologic side effects have frequently included sweating (5% to 34%), rash (2% to 3%), photosensitivity (2%), eczema (1%), and pruritus. Acne, alopecia, contact dermatitis, dry skin, ecchymosis, herpes simplex, urticaria, erythema nodosus, erythema multiforme, exfoliative dermatitis, fungal dermatitis, furunculosis, herpes zoster, hirsutism, maculopapular rash, seborrhea, skin discoloration, skin hypertrophy, skin ulcer, decreased sweating, vesiculobullous rash, and toxic epidermal necrolysis have also been reported. Two cases of cutaneous vasculitis have also been reported. Dermatologic side effects reported postmarketing have included Stevens-Johnson syndrome.

Genitourinary

There are no controlled clinical data regarding sexual dysfunction with paroxetine (the active ingredient contained in Paxil) use.

There are several reports of priapism associated with paroxetine use. In cases in which outcome was reported, all patients fully recovered.

Genitourinary side effects reported in males have included ejaculatory disturbance (13% to 28%), impotence (2% to 9%), and priapism. Genitourinary side effects reported in females have included anorgasmia, orgasmic disturbance, dysmenorrhea, eclampsia, menstrual disorder (2%), vaginitis (2%), amenorrhea, menorrhagia, abortion, endometrial disorder, female lactation, leukorrhea, mastitis, salpingitis, uterine spasm, vaginal hemorrhage, metrorrhagia, and vaginal moniliasis. Urinary tract infection (3%), sexual dysfunction, urinary frequency, urinary disorder, difficulty with micturition, urinary hesitancy, breast pain, breast atrophy, breast enlargement, fibrocystic breast, cystitis, dysuria, hematuria, nocturia, polyuria, pyuria, urinary incontinence, urinary retention, urinary urgency, epididymitis, kidney calculus, kidney pain, nephritis, oliguria, urethritis, urinary casts, and urolith have also been reported.

Cardiovascular

The effects on blood pressure have been reported to be inconsistent.

Cardiovascular side effects have frequently included palpitation (2% to 3%), vasodilation (2% to 4%), hypertension (2%), and tachycardia (including torsade de pointes). Bradycardia, hematoma, hypotension, postural hypotension, syncope, angioedema, angina pectoris, nodal arrhythmia, atrial fibrillation, bundle branch block, cerebral ischemia, cerebrovascular accident, congestive heart failure, heart block, low cardiac output, myocardial infarct, myocardial ischemia, phlebitis, supraventricular extrasystoles, thrombophlebitis, thrombosis, varicose vein, supraventricular tachycardia, vascular headache, vasculitic syndromes (including Henoch-Schonlein purpura), ventricular extrasystoles, and ventricular fibrillation have also been reported.

Endocrine

Paroxetine- induced hyponatremia may be more common in elderly female patients and those who are volume depleted or are receiving concomitant diuretic therapy.

Endocrine side effects have included diabetes mellitus, goiter, hyperthyroidism, hypothyroidism, and thyroiditis. Hyperprolactinemia, hyponatremia, and the syndrome of inappropriate antidiuretic hormone (SIADH) are increasingly being associated with selective serotonin reuptake inhibitors including paroxetine. A case of severe life-threatening hyponatremia in a patient receiving paroxetine has been reported.

Hematologic

The mechanism of paroxetine- induced bleeding may be related to drug-induced platelet dysfunction.

Hematologic side effects have included anemia, leukopenia, lymphadenopathy, purpura, abnormal erythrocytes, basophilia, increased bleeding time, eosinophilia, hypochromic anemia, iron deficiency anemia, leukocytosis, lymphedema, abnormal lymphocytes, lymphocytosis, microcytic anemia, monocytosis, normocytic anemia, thrombocythemia, thrombocytopenia, hemolytic anemia, and events related to impaired hematopoiesis (including aplastic anemia, pancytopenia, bone marrow aplasia, and agranulocytosis). Several cases have also been reported suggesting that paroxetine may cause bleeding in patients with normal bleeding times, platelet counts, prothrombin times, and partial thromboplastin times.

Other

A withdrawal syndrome, similar to that seen in other selective serotonin reuptake inhibitors, has been reported. Recent clinical trials by the manufacturer reported withdrawal events to be serious in 0.3% of patients who discontinued therapy with controlled-release paroxetine (the active ingredient contained in Paxil) tablets. Patients discontinuing paroxetine have complained of vertigo, lightheadedness, gait instability, malaise, myalgia, middle insomnia, nausea, emesis, diarrhea, and/or visual phenomena (similar to that associated with migraine) during withdrawal. Two cases of behavioral syndromes including severe aggressive and suicidal impulsivity following paroxetine withdrawal have been reported. One case of withdrawal hypomania has been reported. One case of unilateral facial numbness with blurred peripheral vision has also been reported upon withdrawal.

In one retrospective chart review of 352 patients who were supervised during tapering and discontinuation from serotonin reuptake inhibitor therapy, dizziness, lethargy, paresthesia, nausea, vivid dreams, irritability, and lowered mood were the most common symptoms reported. Patients with at least one qualitatively new symptom were defined in the paroxetine group at a rate of 17.2%.

Patients should be monitored for symptoms when discontinuing treatment. A gradual reduction in dosage rather than abrupt discontinuation of therapy is recommended when possible. If intolerable symptoms occur following discontinuation of therapy, then resumption of the previous dose may be considered. Subsequently, discontinuation of therapy may be retried at a more gradual rate.

Other side effects have frequently included headache (15% to 27%), asthenia (14% to 22%), infection (6% to 8%), abdominal pain (4% to 7%), chest pain (3%), back pain (3% to 5%), chills (2%), migraine (1%), and trauma (3% to 8%). Face edema, withdrawal syndrome, malaise, neck pain, adrenergic syndrome, cellulitis, moniliasis, neck rigidity, pelvic pain, sepsis, ulcer, ear pain, tinnitus, otitis media, deafness, pallor, hyperacusis, otitis externa, parosmia, Guillain-Barre syndrome, and neuroleptic malignant syndrome- like reaction.

Renal

Renal side effects have included acute renal failure.

Respiratory

Respiratory side effects have frequently included respiratory disorder (7%), sinusitis (4% to 8%), yawn (2% to 5%), rhinitis (3% to 4%), increased cough (1% to 2%), bronchitis (1% to 2%), and pharyngitis (4%). Asthma, dyspnea, epistaxis, hyperventilation, pneumonia, respiratory flu, emphysema, hemoptysis, hiccups, lung fibrosis, pulmonary edema, pulmonary embolus, increased sputum, stridor, porphyria, laryngismus, and alteration in voice have also been reported.

Hypersensitivity

Hypersensitivity side effects have included allergic reactions in up to 2% of patients including allergic alveolitis and anaphylaxis.

Hepatic

Hepatic side effects have included a single case of severe hepatotoxicity with jaundice. Hepatitis and abnormal liver function tests have been reported rarely.

The manufacturer states that in placebo-controlled clinical trials patients receiving paroxetine experienced abnormal values on liver function tests at a rate equal to or less than that reported in patients receiving placebo. However, there have been postmarketing reports of patients developing elevated serum transaminases resulting in severe liver dysfunction, as well as, a few cases of elevated liver function tests resulting in death secondary to liver necrosis.

Ocular

Ocular side effects have frequently included blurred vision (4%), abnormality of accommodation (2%), and abnormal vision (2% to 5%). Conjunctivitis, eye pain, keratoconjunctivitis, mydriasis, amblyopia, anisocoria, blepharitis, cataract, conjunctival edema, corneal ulcer, diplopia, exophthalmos, eye hemorrhage, glaucoma, night blindness, photophobia, ptosis, retinal hemorrhage, optic neuritis, and visual field effect have also been reported.

Musculoskeletal

Musculoskeletal side effects have frequently included myopathy (2%), myalgia (2% to 5%), myasthenia (1%), and arthralgia (2%). Arthritis, arthrosis, bursitis, myositis, osteoporosis, generalized spasm, tenosynovitis, and tetany have also been reported. A single case of bruxism has been reported. Postmarketing reports have included restless legs syndrome.

In one study using the healthcare data from the providence of Ontario, Canada reviewing 8239 patients treated for hip fractures, the adjusted odds ratio for hip fracture was 2.4 for exposure to selective serotonin reuptake inhibitors (including fluoxetine, fluvoxamine, paroxetine, and sertraline), compared to participants who had no exposure to antidepressants.

Metabolic

Controlled studies reported an average weight loss of approximately 1 pound per patient versus smaller changes reported with placebo.

The results of one study appear to indicate that treatment with selective serotonin reuptake inhibitors (i.e., paroxetine (the active ingredient contained in Paxil) sertraline, citalopram) may cause an increase in serum total cholesterol, HDL cholesterol, and/or LDL cholesterol. However, additional studies are necessary to confirm these findings.

Numerous cases of hyponatremia have been reported following treatment with a selective serotonin reuptake inhibitor (SSRI). Risk factors for the development of SSRI- associated hyponatremia including advanced age, female gender, concomitant use of diuretics, low body weight, and lower baseline serum sodium levels have been identified. Hyponatremia tends to develop within the first few weeks of treatment (range 3 to 120 days) and typically resolves within 2 weeks (range 48 hours to 6 weeks) after therapy has been discontinued with some patients requiring treatment. The proposed mechanism for the development of hyponatremia involves the syndrome of inappropriate secretion of antidiuretic hormone (SIADH) via release of antidiuretic hormone.

Metabolic side effects have frequently included weight gain (3%) and weight loss (1%). Edema, peripheral edema, thirst, bilirubinemia, dehydration, gout, hypercalcemia, hypercholesteremia, hyperglycemia, hyperkalemia, hyperphosphatemia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, porphyria, and ketosis have also been reported. In addition, increased levels of SGOT, SGPT, alkaline phosphatase, BUN, creatinine phosphokinase, gamma globulins, lactic dehydrogenase, and non- protein nitrogen (NPN) have been reported. An increase in serum cholesterol has been reported following use of paroxetine.

General

General side effects including abnormal bleeding have been reported.