Paroxetine hcl er

Paroxetine Side Effects

In Summary

Commonly reported side effects of paroxetine include: asthenia, constipation, diarrhea, dizziness, drowsiness, ejaculatory disorder, erectile dysfunction, insomnia, male genital disease, nausea, headache, decreased libido, delayed ejaculation, diaphoresis, and xerostomia. Other side effects include: infection, blurred vision, female genital tract disease, impotence, lack of concentration, orgasm disturbance, tremor, vasodilation, visual disturbance, anxiety, paresthesia, abnormal dreams, decreased appetite, and yawning. See below for a comprehensive list of adverse effects.

For the Consumer

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

Along with its needed effects, paroxetine 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 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 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 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

For Healthcare Professionals

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

General

Side effects are generally reported as mild. The most common side effects associated with treatment discontinuation in clinical trials included somnolence, insomnia, agitation, tremor, anxiety, dizziness, headache, constipation, nausea, diarrhea, dry mouth, vomiting, flatulence, asthenia, abnormal ejaculation, sweating, impotence, and decreased libido.

The most common dose-dependent side effects associated with treatment discontinuation in clinical trials for the treatment of premenstrual dysphoric disorder with controlled-release paroxetine 25 mg compared with 12.5 mg included nausea, somnolence, impaired concentration, dry mouth, dizziness, decreased appetite, sweating, tremor, and yawn.

The most common side effects associated with treatment discontinuation in the treatment of vasomotor symptoms in clinical trials included abdominal pain, attention disturbances, headache, and suicidal ideation.

In a placebo-controlled study in elderly patients with major depressive disorder, the most common side effects associated with treatment discontinuation of controlled-release paroxetine included nausea, headache, depression, and abnormal LFTs.

There may be adaptation to some side effects (such as nausea and dizziness) but not to others (such as dry mouth, somnolence, and asthenia) with continued therapy. Paroxetine is less likely than tricyclic antidepressants to be associated with dry mouth, constipation, and somnolence.

Psychiatric

Very common (10% or more): Insomnia

Common (1% to 10%): Abnormal dreams, agitation, anxiety, depersonalization, depression, drugged feeling, emotional lability, lack of emotion, nervousness

Uncommon (0.1% to 1%): Abnormal thinking, alcohol abuse, bruxism, euphoria, hallucinations, hostility, lack of emotion, manic reaction, neurosis, paranoid reaction

Rare (less than 0.1%): Abnormal electroencephalogram, antisocial reaction, bulimia, delirium, delusions, drug dependence, hysteria, irritability, manic-depressive reaction, panic attacks, psychosis, psychotic depression, stupor, withdrawal syndrome

Frequency not reported: Suicidal ideation and behavior

Postmarketing reports: Confusional state, disorientation, homicidal ideation, restlessness

Antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. An increased risk of suicidal thinking and behavior in children, adolescents, and young adults (aged 18 to 24 years) with major depressive disorder (MDD) and other psychiatric disorders has been reported with short-term use of antidepressant drugs.

Adult and pediatric patients receiving antidepressants for MDD, as well as for psychiatric and nonpsychiatric indications, have reported symptoms that may be precursors to emerging suicidality, including anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, and mania. Causality has not been established.

Pooled results from clinical trials report hallucinations in 22 of 9089 patients who received paroxetine and 4 of 3187 patients who received placebo.

Nervous system

Extrapyramidal symptoms such as akathisia, bradykinesia, cogwheel rigidity, dystonia, hypertonia, and oculogyric crisis have been associated with concomitant pimozide therapy.

Potentially life-threatening serotonin syndrome has been reported with SSRIs and SNRIs as monotherapy, but particularly with concomitant use of other serotonergic drugs and drugs that impair the metabolism of serotonin. Signs and symptoms associated with serotonin syndrome or neuroleptic malignant syndrome included agitation, confusion, diaphoresis, diarrhea, fever, hypertension, rigidity, and tachycardia, and were in some cases associated with concomitant use of serotonergic drugs.

Very common (10% or more): Dizziness, headache, somnolence, tremor

Common (1% to 10%): Amnesia, anxiety, CNS stimulation, confusion, hypertonia, impaired concentration, migraine, myoclonus, paresthesia, taste perversion

Uncommon (0.1% to 1%): Ataxia, convulsion, dyskinesia, dystonia, hyperesthesia, hyperkinesia, hypokinesia, incoordination, neuralgia, neuropathy, nystagmus, paralysis, syncope

Rare (less than 0.1%): Abnormal gait, adrenergic syndrome, akathisia, akinesia, anticholinergic syndrome, aphasia, cerebral ischemia, cerebrovascular accident, choreoathetosis, circumoral paresthesia, dysarthria, extrapyramidal syndrome, fasciculations, grand mal convulsions, hyperalgesia, meningitis, myelitis, peripheral neuritis, reflexes decreased, reflexes increased, taste loss, torticollis, trismus, vascular headache

Postmarketing reports: Eclampsia, Guillain-Barre syndrome, neuroleptic malignant syndrome, restless legs syndrome, serotonin syndrome, status epilepticus

Metabolic

The results of one study appear to indicate that treatment with selective serotonin reuptake inhibitors (i.e., paroxetine, 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.

Common (1% to 10%): Decreased appetite, increased appetite, increases in cholesterol levels, weight gain, weight loss

Uncommon (0.1% to 1%): Hypoglycemia, hypokalemia, thirst

Rare (less than 0.1%): Alkaline phosphatase increased, creatinine phosphokinase increased, dehydration, diabetes mellitus, gamma globulins increased, gout, hypercalcemia, hypercholesteremia, hyperglycemia, hyperkalemia, hyperphosphatemia, hypocalcemia, hyponatremia, ketosis, lactic dehydrogenase increased, non-protein nitrogen increased, obesity

Postmarketing reports: Porphyria

Cardiovascular

Common (1% to 10%): Chest pain, edema, palpitation, peripheral edema, tachycardia, vasodilation (usually flushing)

Uncommon (0.1% to 1%): Abnormal electrocardiogram, angina pectoris, bradycardia, conduction abnormalities, hematoma, hypertension, hypotension, palpitation, postural hypotension, sinus tachycardia, supraventricular tachycardia

Rare (less than 0.1%): Arrhythmia, arrhythmia nodal, atrial arrhythmia, atrial fibrillation, bundle branch block, cellulitis, congestive heart failure, extrasystoles, heart block, low cardiac output, myocardial infarct, myocardial ischemia, pallor, phlebitis, substernal chest pain, supraventricular extrasystoles, thrombophlebitis, thrombosis, varicose vein, ventricular extrasystoles

Postmarketing reports: Atrial fibrillation, pulmonary edema, ventricular fibrillation, ventricular tachycardia (including torsades de pointes)

Other

Fatigue, malaise, and lethargy were very commonly reported in Phase 2 and 3 clinical trials with paroxetine for treatment of vasomotor symptoms in postmenopausal women.

Very common (10% or more): Asthenia

Common (1% to 10%): Chills, pain, tinnitus, trauma, vertigo

Uncommon (0.1% to 1%): Ear pain, fever, malaise, otitis media, overdose

Rare (less than 0.1%): Abscess, deafness, hypothermia, otitis externa, sepsis, ulcer, abnormal laboratory value, cyst, hernia, intentional overdose

Postmarketing reports: Death

Genitourinary

Very common (10% or more): Decreased libido, ejaculation disturbance, other male genital disorders (primarily ejaculatory delay)

Common (1% to 10%): Female genital disorders (primarily anorgasmia and difficulty reaching climax/orgasm), dysmenorrhea, impotence, menorrhagia, menstrual disorder, urinary disorder (primarily difficulty with micturition and urinary hesitancy), urinary frequency, urination impaired, urinary tract infection, vaginal moniliasis, vaginitis

Uncommon (0.1% to 1%): Albuminuria, amenorrhea, breast pain, cystitis, dysuria, hematuria, increased libido, nocturia, ovarian cyst, polyuria, pyuria, pregnancy and puerperal disorders, testes pain, urinary incontinence, urinary retention, urinary urgency,

Rare (0.01% to 0.1%): Abortion, breast atrophy, breast enlargement, endometrial disorder, epididymitis, female lactation, fibrocystic breast, kidney calculus, kidney pain, leukorrhea, mastitis, metrorrhagia, nephritis, oliguria, pelvic pain, salpingitis, urethritis, urinary abnormality, urinary casts, uterine spasm, urolith, vaginal hemorrhage

Very rare (less than 0.01%): Priapism

Postmarketing reports: Premature births in pregnant women, symptoms suggestive of galactorrhea

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

In placebo-controlled clinical trials, ejaculatory disturbance in men was reported in 13% to 28% of men taking paroxetine, compared to 0% to 2% in the placebo group. Decreased libido was reported in 6% to 15% in men treated with paroxetine, compared to 0% to 5% in the placebo group, and in 0% to 9% in women treated with paroxetine, compared with 0% to 2% in placebo patients. The estimates of the incidence of untoward sexual experience and performance may underestimate their actual incidence, partly because patients and physicians may be reluctant to discuss this issue.

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 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.

Very common (10% or more): Sweating

Common (1% to 10%): Eczema, hypertension, photosensitivity, pruritus, rash, sweat gland disorder

Uncommon (0.1% to 1%): Acne, alopecia, contact dermatitis, dry skin, ecchymosis, furunculosis, purpura, urticaria

Rare (0.01% to 0.1%): Angioedema, erythema multiforme, erythema nodosum, exfoliative dermatitis, fungal dermatitis, hirsutism, maculopapular rash, pustular rash, seborrhea, skin discoloration, skin hypertrophy, skin ulcer, sweating decreased, vesiculobullous rash

Very rare (less than 0.01%): Severe cutaneous reactions such as Stevens Johnson syndrome and toxic epidermal necrolysis)

Postmarketing reports: Vasculitic syndromes (such as Henoch-Schonlein purpura)

Endocrine

Rare (less than 0.1%): Goiter, hyperthyroidism, hypothyroidism, thyroiditis

Postmarketing reports: Syndrome of inappropriate antidiuretic hormone secretion, symptoms suggestive of prolactinemia

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.

Very common (10% or more): Constipation, diarrhea, dry mouth, nausea

Common (1% to 10%): Abdominal pain, dyspepsia, flatulence, gastrointestinal disorder, gingivitis, stomatitis, tooth disorder, vomiting

Uncommon (0.1% to 1%): Buccal cavity disorders, colitis, dysphagia, eructation, gastritis, gastroenteritis, gastroesophageal reflux, gastrointestinal flu, gingivitis, glossitis, increased salivation, melena, pancreatitis, rectal hemorrhage, toothache, ulcerative stomatitis

Rare (less than 0.1%): Aphthous stomatitis, bloody diarrhea, cardiospasm, cholelithiasis, duodenitis, enteritis, esophagitis, fecal impaction, fecal incontinence, gum hemorrhage, gum hyperplasia, hematemesis, ileitis, ileus, intestinal obstruction, mouth ulceration, peptic ulcer, peritonitis, salivary gland enlargement, sialadenitis, stomach ulcer, tooth caries, tongue discoloration, tongue edema, tooth malformation

Postmarketing reports: Acute pancreatitis, pancreatitis hemorrhagic

Hematologic

Uncommon (0.1% to 1%): Anemia, eosinophilia, hypochromic anemia, leukocytosis, leukopenia, lymphadenopathy, WBC abnormality

Rare (less than 0.1%): Abnormal erythrocytes, abnormal lymphocytes, anisocytosis, basophilia, bleeding time increased, iron deficiency anemia, lymphedema, lymphocytosis, lymphopenia, microcytic anemia, monocytosis, normocytic anemia, thrombocytopenia, thrombocythemia,

Postmarketing reports: Events related to impaired hematopoiesis (including aplastic anemia, pancytopenia, bone marrow aplasia, agranulocytosis), hemolytic anemia, idiopathic thrombocytopenic purpura

Hepatic

Uncommon (0.1% to 1%): Abnormal liver function tests, SGOT increased, SGPT increased

Rare (less than 0.1%): Bilirubinemia, hepatitis, hepatosplenomegaly, jaundice

Postmarketing reports: Drug-induced liver injury, elevated liver function tests, hepatic failure

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.

Hypersensitivity

Uncommon (0.1% to 1%): Allergic reaction, face edema

Rare (less than 0.1%): Anaphylactoid reaction

Postmarketing reports: Anaphylaxis

Immunologic

Common (1% to 10%): Infection

Uncommon (0.1% to 1%): Flu syndrome, herpes simplex

Rare (less than 0.1%): Herpes zoster, moniliasis

Musculoskeletal

Epidemiological studies, primarily in patients aged 50 years or older, have shown an increased risk of bone fractures in patients receiving SSRIs or TCAs.

Common (1% to 10%): Arthralgia, back pain, migraine, myalgia, myasthenia, myopathy

Uncommon (0.1% to 1%): Arthritis, arthrosis, bursitis, myositis, neck pain, tendonitis, traumatic fracture

Rare (less than 0.1%): Cartilage disorder, generalized spasm, myositis, neck rigidity, osteoporosis, tenosynovitis, tetany

Ocular

Common (1% to 10%): Abnormality of accommodation, abnormal vision, blurred vision

Uncommon (0.1% to 1%): Conjunctivitis, eye pain, keratoconjunctivitis, mydriasis, photophobia, retinal hemorrhage

Rare (less than 0.1%): Anisocoria, blepharitis, cataract, conjunctival edema, corneal lesion, corneal ulcer, diplopia, exophthalmos, eye hemorrhage, glaucoma, hyperacusis, night blindness, ptosis, visual field defect

Frequency not reported: Angle-closure glaucoma, eye pain

Postmarketing reports: Acute glaucoma, optic neuritis

Renal

Rare (less than 0.1%): Abnormal kidney function, BUN increased

Postmarketing reports: Acute renal failure

Respiratory

Common (1% to 10%): Bronchitis, cough increased, oropharynx disorder, pharyngitis, respiratory disorder, rhinitis, sinusitis, yawn

Uncommon (0.1% to 1%): Asthma, dyspnea, epistaxis, hyperventilation, laryngitis, pneumonia, respiratory flu

Rare (less than 0.1%): Dysphonia, emphysema, hemoptysis, hiccups, lung fibrosis, parosmia, pulmonary edema, pulmonary embolus, sputum increased, stridor, throat tightness, voice alteration

Postmarketing reports: Allergic alveolitis, laryngismus, pulmonary hypertension