Note: This document contains side effect information about paroxetine. Some dosage forms listed on this page may not apply to the brand name Pexeva.

Summary

Common side effects of Pexeva 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. Continue reading for a comprehensive list of adverse effects.

Applies to paroxetine: oral conventional tablets, oral extended-release tablets, oral suspension.

Side effects include:

Nervous system effects (e.g., asthenia, somnolence, dizziness, insomnia, tremor, nervousness), GI effects (e.g., nausea, decreased appetite, constipation, dry mouth), impotence, ejaculatory dysfunction, female genital disorders (e.g., anorgasmia or difficulty reaching climax/orgasm), sweating.

For Healthcare Professionals

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

General

HYDROCHLORIDE IR/MESYLATE TABLET FORMULATIONS: The most commonly reported side effects included nausea, ejaculation disturbance/abnormal ejaculation, somnolence, and asthenia.

HYDROCHLORIDE CR FORMULATIONS: The most commonly reported side effects included headache, ejaculation disturbance, nausea, and somnolence.

MESYLATE CAPSULES: The most commonly reported side effects included headache, fatigue, lethargy, and malaise.^[Ref]

Gastrointestinal

HYDROCHLORIDE IR/MESYLATE TABLET FORMULATIONS:

Very common (10% or more): Nausea (up to 36.3%), dry mouth (up to 20.6%), diarrhea (up to 19.2%), constipation (up to 16%)

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

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

Rare (0.01% to 0.1%): Aphthous stomatitis, bloody diarrhea, cardiospasm, circumoral paresthesias, duodenitis, enteritis, esophagitis, fecal impactions, fecal incontinence, gum hemorrhage, hematemesis, ileitis, ileus, intestinal obstruction, melena, mouth ulceration, peptic ulcer, salivary gland enlargement, sialadenitis, stomach ulcer, stomatitis, tongue discoloration, tongue edema, tooth caries

Very rare (less than 0.01%): Gastrointestinal bleeding

Postmarketing reports: Acute pancreatitis

HYDROCHLORIDE CR FORMULATIONS:

Very common (10% or more): Nausea (up to 23%), diarrhea (up to 18%), dry mouth (up to 18%), constipation (up to 13%), dyspepsia (up to 13%)

Common (1% to 10%): Abdominal pain, flatulence

Frequency not reported: Vomiting

Postmarketing reports: Acute pancreatitis

MESYLATE CAPSULES:

Common (1% to 10%): Nausea, vomiting

Uncommon (0.1% to 1%): Abdominal pain

Postmarketing reports: Pancreatitis, pancreatitis hemorrhage^[Ref]

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 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.^[Ref]

HYDROCHLORIDE IR/MESYLATE TABLET FORMULATIONS:

Very common (10% or more): Somnolence (up to 24%), headache (up to 18%), tremor (up to 14.7%), dizziness (up to 14%)

Common (1% to 10%): Amnesia, central nervous system (CNS) stimulation, drugged feeling, hyperesthesia, impaired concentration, myoclonus, paresthesia, sensory disturbance, syncope, taste perversion, vertigo

Uncommon (0.1% to 1%): Ataxia, convulsion, dystonia, dyskinesia, extrapyramidal disorders, hyperkinesia, hypertonia, hypesthesia, hypokinesia, incoordination, migraine, paralysis

Rare (0.01% to 0.1%): Abnormal electroencephalogram, abnormal gait, adrenergic syndrome, akathisia, akinesia, aphasia, cerebral ischemia, cerebrovascular accident, choreoathetosis, decreased reflexes, dysarthria, extrapyramidal syndrome, fasciculations, grand mal convulsion, hyperalgesia, increased reflexes, meningitis, myelitis, neuralgia, neuropathy, nystagmus, parosmia, peripheral neuritis, restless legs syndrome (RLS), stupor, taste loss, vascular headache, visual field defect

Very rare (less than 0.01%): Serotonin syndrome

Frequency not reported: Electric shock sensation, hyperreflexia, orofacial dystonia

Postmarketing reports: Bradykinesia, cogwheel rigidity, extrapyramidal symptoms, Guillain-Barre syndrome, optic neuritis, status epilepticus

HYDROCHLORIDE CR FORMULATIONS:

Very common (10% or more): Headache (up to 27%), somnolence (up to 22%), dizziness (up to 14%)

Common (1% to 10%): Concentration impaired, tremor

Uncommon (0.1% to 1%): Convulsion, akathisia

Frequency not reported: Hyperkinesia, hypertonia, migraine, myoclonus, paresthesia, seizures, serotonin syndrome, taste perversion

Postmarketing reports: Bradykinesia, cogwheel rigidity, dystonia, extrapyramidal syndrome, Guillain-Barre syndrome, hypertonia, optic neuritis, RLS, status epilepticus

MESYLATE CAPSULES:

Common (1% to 10%): Headache, lethargy

Uncommon (0.1% to 1%): Attention disturbances

Frequency not reported: Akathisia, restless feeling in legs, seizure, serotonin syndrome, tiredness, trouble sweeping

Postmarketing reports: Neuroleptic malignant syndrome, paresthesia, somnolence, tremor^[Ref]

Genitourinary

HYDROCHLORIDE IR/MESYLATE TABLET FORMULATIONS:

Very common (10% or more): Ejaculation disturbance (up to 28%), abnormal ejaculation (up to 25%), other male genital disorders (up to 10%)

Common (1% to 10%): Female genital disorder, impotence, sexual dysfunction, urinary frequency, urinary tract infection (UTI), urination impaired

Uncommon (0.1% to 1%): Abnormal gynecological bleeding, amenorrhea, breast pain, cystitis, dysuria, hematuria, menorrhagia, nocturia, polyuria, pyuria, urinary incontinence, urinary retention, urinary urgency, vaginitis

Rare (0.01% to 0.1%): Breast atrophy, breast enlargement, delayed menstruation, endometrial disorder, epididymitis, female lactation, fibrocystic breast, irregular menstruation, leukorrhea, mastitis, metrorrhagia, pelvic pain, salpingitis, urethritis, uterine spasm, urolith, vaginal hemorrhage, vaginal moniliasis

Frequency not reported: Delayed ejaculation, dysmenorrhea, erectile difficulties, micturition difficulty, sexual dysfunction, urinary hesitancy, vaginal bleeding

Postmarketing reports: Galactorrhea, menstrual disorders, priapism

HYDROCHLORIDE CR FORMULATIONS:

Very common (10% or more): Ejaculation disturbance (up to 27%)

Common (1% to 10%): Female genital disorder, impotence

Uncommon (0.1% to 1%): Urinary retention

Rare (0.01% to 0.1%): Urinary incontinence

Frequency not reported: Delayed ejaculation, impaired urination, menstrual disorder, priapism, untoward sexual experience/performance, urinary disorder, urinary frequency, UTI, vaginitis

Postmarketing reports: Galactorrhea^[Ref]

There are several reports of priapism associated with use.^[Ref]

Psychiatric

HYDROCHLORIDE IR/MESYLATE TABLET FORMULATIONS:

Very common (10% or more): Insomnia (up to 24%), decreased libido (up to 15%)

Common (1% to 10%): Abnormal dreams, agitation, anxiety, confusion, depersonalization, depression, emotional lability, nervousness, nightmares, orgasmic disturbance, sleep disturbance

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

Rare (0.01% to 0.1%): Antisocial reaction, bulimia, delirium, delusions, drug dependence, hysteria, manic-depressive reaction, panic attacks, psychotic depression, psychosis, withdrawal syndrome

Frequency not reported: Aggression, anorgasmia, delayed orgasm, difficulty reaching climax/orgasm, intense dreams, mood fluctuations, self-harm, suicidal behavior, suicidal ideation/thoughts, suicide attempts

HYDROCHLORIDE CR FORMULATIONS:

Very common (10% or more): Insomnia (up to 20%), decreased libido (up to 13%)

Common (1% to 10%): Anxiety, depression, nervousness, orgasmic disturbance

Uncommon (0.1% to 1%): Hallucinations, manic reaction

Frequency not reported: Agitation, anorgasmia, confusion, delayed orgasm, difficulty achieving orgasm, hypomania activation, mania activation, suicidal behaviors, suicidal thoughts

MESYLATE CAPSULES:

Uncommon (0.1% to 1%): Suicidal ideation

Frequency not reported: Anxiety, hypomania, increased dreaming, insomnia, mania, nervousness, nightmares, suicidality, suicide attempt

Postmarketing reports: Aggression, agitation, confusional state, depression, disorientation, drug withdrawal syndrome, homicidal ideation, restlessness^[Ref]

Other

HYDROCHLORIDE IR/MESYLATE TABLET FORMULATIONS:

Very common (10% or more): Asthenia (up to 22%)

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

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

Rare (0.01% to 0.1%): Abnormal laboratory value, abortion, chills and fever, cyst, deafness, hernia, hyperacusis, intentional overdose, otitis externa, ulcer

Frequency not reported: Crying, lump in throat

Postmarketing reports: Eclampsia, elevated phenytoin level, premature birth

HYDROCHLORIDE CR FORMULATIONS:

Very common (10% or more): Asthenia (up to 18%)

Frequency not reported: Discontinuation syndrome, embryofetal toxicity, neonatal toxicity

Postmarketing reports: Eclampsia

MESYLATE CAPSULES:

Common (1% to 10%): Fatigue, malaise

Postmarketing reports: Death^[Ref]

Dermatologic

HYDROCHLORIDE IR/MESYLATE TABLET FORMULATIONS:

Very common (10% or more): Sweating/diaphoresis (up to 14%)

Common (1% to 10%): Pruritus, rash/skin rash

Uncommon (0.1% to 1%): Abnormal skin bleeding, acne, alopecia, contact dermatitis, dry skin, ecchymosis, eczema, face edema, herpes simplex, photosensitivity, purpura, urticaria

Rare (0.01% to 0.1%): Decreased sweating, erythema nodosum, erythema multiforme, exfoliative dermatitis, fungal dermatitis, furunculosis, hirsutism, maculopapular rash, seborrhea, skin discoloration, skin hypertrophy, skin ulcer, vesicobullous rash

Very rare (less than 0.01%): Severe cutaneous adverse reactions, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN)

Postmarketing reports: Henoch-Schonlein purpura

HYDROCHLORIDE CR FORMULATIONS:

Very common (10% or more): Sweating (up to 14%)

Common (1% to 10%): Rash

Uncommon (0.1% to 1%): Urticaria

Rare (0.01% to 0.1%): Erythema multiforme

Frequency not reported: Eczema, photosensitivity

Postmarketing reports: Henoch-Schonlein purpura, SJS, TEN

MESYLATE CAPSULES:

Postmarketing reports: Hyperhidrosis, SJS, TEN^[Ref]

Metabolic

HYDROCHLORIDE IR/MESYLATE TABLET FORMULATIONS:

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

Uncommon (0.1% to 1%): Altered glycemic control, hyperglycemia, obesity, thirst

Rare (0.01% to 0.1%): Dehydration, diabetes mellitus, hypercalcemia, hypercholesterolemia, hyperglycemia, hyperkalemia, hyperphosphatemia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, ketosis, lactic dehydrogenase increased, tetany

Postmarketing reports: Porphyria

HYDROCHLORIDE CR FORMULATIONS:

Very common (10% or more): Decreased appetite (up to 12%)

Uncommon (0.1% to 1%): Hypercholesterolemia

Frequency not reported: Hyponatremia, weight gain, weight loss

Postmarketing reports: Porphyria

MESYLATE CAPSULES:

Frequency not reported: Hyponatremia

Postmarketing reports: Diabetes mellitus inadequate control, type 2 diabetes mellitus^[Ref]

Cardiovascular

HYDROCHLORIDE IMMEDIATE-RELEASE (IR)/MESYLATE TABLET FORMULATIONS:

FORMULATIONS:

Common (1% to 10%): Chest pain, hypertension, palpitation, postural hypotension, sinus tachycardia/tachycardia, vasodilation

Uncommon (0.1% to 1%): Abnormal ECG, abnormal mucous membrane bleeding, bradycardia, edema, hematoma, hypotension, peripheral edema, transient decreases/increases in blood pressure

Rare (0.01% to 0.1%): Angina pectoris, arrhythmia/arrhythmia nodal, atrial arrhythmia, atrial fibrillation, bundle branch block, conduction abnormalities, congestive heart failure, extrasystoles, heart block, low cardiac output, lymphedema, myocardial infarction, myocardial ischemia, pallor, phlebitis, substernal chest pain, supraventricular extrasystoles, thrombophlebitis, thrombosis, varicose vein, ventricular extrasystoles

Postmarketing reports: Severe hypotension, torsade de pointes, vasculitic syndrome, ventricular fibrillation, ventricular tachycardia

HYDROCHLORIDE CONTROLLED-RELEASE (CR) FORMULATIONS:

Uncommon (0.1% to 1%): Postural hypotension, generalized edema

Frequency not reported: Tachycardia, hypertension, vasodilation

Postmarketing reports: Torsade de pointes, vasculitic syndromes, ventricular fibrillation, ventricular tachycardia

MESYLATE CAPSULES:

Postmarketing reports: Atrial fibrillation, ventricular fibrillation, ventricular tachycardia, torsade de pointes^[Ref]

Respiratory

HYDROCHLORIDE IR/MESYLATE TABLET FORMULATIONS:

Common (1% to 10%): Oropharynx disorder, respiratory disorder, rhinitis, sinusitis, yawn

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

Rare (0.01% to 0.1%): Emphysema, hemoptysis, hiccups, increased sputum, lung fibrosis, pulmonary edema, pulmonary embolus, stridor, voice alteration

Frequency not reported: Cough increased, pharyngitis, throat tightness, upper respiratory infection (URI)

Postmarketing reports: Allergic alveolitis, laryngismus, pulmonary hypertension

HYDROCHLORIDE CR FORMULATIONS:

Common (1% to 10%): Sinusitis, yawn

Frequency not reported: Bronchitis, increased cough, rhinitis

Postmarketing reports: Allergic alveolitis, laryngismus, pulmonary hypertension

MESYLATE CAPSULES:

Postmarketing reports: Pulmonary edema, pulmonary hypertension^[Ref]

Musculoskeletal

HYDROCHLORIDE IR/MESYLATE TABLET FORMULATIONS:

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

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

Rare (0.01% to 0.1%): Bursitis, cartilage disorder, creatinine phosphokinase increased, generalized spasm, myositis, neck rigidity, osteoporosis, tenosynovitis, torticollis, trismus

Frequency not reported: Shivering

Postmarketing reports: Bone fracture

HYDROCHLORIDE CR FORMULATIONS:

Common (1% to 10%): Back pain, myalgia

Frequency not reported: Bone fracture

Postmarketing reports: Trismus

MESYLATE CAPSULES:

Frequency not reported: Bone fractures, muscle cramps/spasms/twitching^[Ref]

Patients 50 years or older receiving selective serotonin reuptake inhibitors (SSRIs) have shown an increased risk of bone fractures.^[Ref]

Ocular

HYDROCHLORIDE IR/MESYLATE TABLET FORMULATIONS:

Common (1% to 10%): Abnormal vision, blurred vision

Uncommon (0.1% to 1%): Accommodation abnormal, conjunctivitis, eye pain, keratoconjunctivitis, mydriasis

Rare (0.01% to 0.1%): Amblyopia, anisocoria, blepharitis, cataract, conjunctival edema, corneal lesion, corneal ulcer, diplopia, exophthalmos, eye hemorrhage, glaucoma, night blindness, photophobia, ptosis, retinal hemorrhage, specified cataract

Postmarketing reports: Oculogyric crisis

HYDROCHLORIDE CR FORMULATIONS:

Common (1% to 10%): Abnormal vision

Frequency not reported: Angle-closure glaucoma

MESYLATE CAPSULES:

Frequency not reported: Angle-closure glaucoma^[Ref]

Immunologic

HYDROCHLORIDE IR/MESYLATE TABLET FORMULATIONS:

Common (1% to 10%): Infection

Uncommon (0.1% to 1%): Candidiasis, moniliasis

Rare (0.01% to 0.1%): Abscess, cellulitis, herpes zoster, peritonitis, sepsis

Frequency not reported: Cold symptoms, flu syndrome

HYDROCHLORIDE CR FORMULATIONS:

Common (1% to 10%): Infection^[Ref]

Hepatic

HYDROCHLORIDE IR/MESYLATE TABLET FORMULATIONS:

Uncommon (0.1% to 1%): Abnormal liver function tests, ALT increased, AST increased

Rare (0.01% to 0.1%): Alkaline phosphatase increased, bilirubinemia, cholelithiasis, elevation of liver enzymes, gamma globulins increased, hepatitis, jaundice

Very rare (less than 0.01%): Hepatic events, liver failure

Postmarketing reports: Fatal liver necrosis, grossly elevated transaminases with severe liver dysfunction, liver necrosis

HYDROCHLORIDE CR FORMULATIONS:

Common (1% to 10%): Abnormal liver function tests

Postmarketing reports: Elevated liver function tests, fatal liver necrosis, grossly elevated transaminases associated with severe liver dysfunction, liver necrosis

MESYLATE CAPSULES:

Postmarketing reports: Drug-induced liver injury, elevated liver tests, fatal liver necrosis, grossly elevated transaminases associated with severe liver dysfunction, hepatic failure, jaundice, liver necrosis^[Ref]

Hematologic

HYDROCHLORIDE IR/MESYLATE TABLET FORMULATIONS:

Uncommon (0.1% to 1%): Abnormal bleeding, anemia, leukopenia, lymphadenopathy, white blood cell abnormality

Rare (0.01% to 0.1%): Abnormal erythrocytes, abnormal lymphocytes, basophilia, bleeding time increased, eosinophilia, hypochromic anemia, iron deficiency anemia, leukocytosis, lymphocytosis, microcytic anemia, monocytosis, normocytic anemia, thrombocythemia, thrombocytopenia

Postmarketing reports: Agranulocytosis, aplastic anemia, bone marrow aplasia, hematopoiesis impaired, hemolytic anemia, pancytopenia

HYDROCHLORIDE CR FORMULATIONS:

Rare (0.01% to 0.1%): Thrombocytopenia

Frequency not reported: Increased bleeding risk

Postmarketing reports: Agranulocytosis, aplastic anemia, bone marrow aplasia, hemolytic anemia, impaired hematopoiesis, pancytopenia

MESYLATE CAPSULES:

Frequency not reported: Abnormal bleeding

Postmarketing reports: Agranulocytosis, aplastic anemia, bone marrow aplasia, impaired hematopoiesis, idiopathic thrombocytopenic purpura, pancytopenia^[Ref]

Hypersensitivity

HYDROCHLORIDE IR/MESYLATE TABLET FORMULATIONS:

Uncommon (0.1% to 1%): Allergic reaction

Rare (0.01% to 0.1%): Angioedema

Very rare (less than 0.01%): Anaphylactoid reactions, fatal allergic reactions/severe allergic reactions

Postmarketing reports: Anaphylaxis

HYDROCHLORIDE CR FORMULATIONS:

Rare (0.01% to 0.1%): Angioedema

Frequency not reported: Allergic reaction, hypersensitivity reactions

Postmarketing reports: Anaphylaxis

MESYLATE CAPSULES:

Postmarketing reports: Anaphylactoid reaction, angioedema^[Ref]

Renal

HYDROCHLORIDE IR/MESYLATE TABLET FORMULATIONS:

Rare (0.01% to 0.1%): Blood urea nitrogen (BUN) increased, kidney calculus, kidney pain, nephritis, non-protein nitrogen (NPN) increased, oliguria, urinary casts

Postmarketing reports: Acute renal failure

HYDROCHLORIDE CR FORMULATIONS:

Postmarketing reports: Acute renal failure^[Ref]

Endocrine

HYDROCHLORIDE IR/MESYLATE TABLET FORMULATIONS:

Rare (0.01% to 0.1%): goiter, Hyperprolactinemia, hyperthyroidism, hypothyroidism, thyroiditis

Very rare (less than 0.01%): Syndrome of inappropriate antidiuretic hormone (SIADH) secretion

Postmarketing reports: Prolactinemia symptoms

HYDROCHLORIDE CR FORMULATIONS:

Postmarketing reports: Prolactinemia, SIADH secretion^[Ref]