Paroxetine Side Effects

Medically reviewed by Drugs.com. Last updated on Apr 4, 2024.

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

Common side effects of paroxetine

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:

Serious side effects of paroxetine

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:

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

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]

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]

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]

Frequently asked questions

• SSRIs vs SNRIs - What's the difference between them?
• What are some common side effects of antidepressants?

Further information

Paroxetine side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer