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Fluvoxamine Side Effects

Medically reviewed by Last updated on May 26, 2023.

Applies to fluvoxamine: oral capsule extended release, oral tablet.


Oral route (Capsule, Extended Release; Tablet)

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of fluvoxamine maleate or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber.. Fluvoxamine maleate tablets are not approved for use in pediatric patients except for patients with obsessive compulsive disorder.

Serious side effects of Fluvoxamine

Along with its needed effects, fluvoxamine 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 fluvoxamine:

More common

Less common


Incidence not known

Other side effects of Fluvoxamine

Some side effects of fluvoxamine 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

Less common

Incidence not known

For Healthcare Professionals

Applies to fluvoxamine: oral capsule extended release, oral tablet.


The most commonly reported side effects included nausea, headache, insomnia, and somnolence.[Ref]


Very common (10% or more): Nausea (up to 40%), diarrhea (up to 18%), dry mouth (up to 14%), constipation (up to 10%), dyspepsia (up to 10%)

Common (1% to 10%): Abdominal pain, abscess, caries, dysphagia, flatulence, gingivitis, toothache, tooth extraction, tooth disorder, vomiting

Uncommon (0.1% to 1%): Colitis, eructation, esophagitis, gastritis, gastroenteritis, gastrointestinal hemorrhage, gastrointestinal ulcer, glossitis, hemorrhoids, increased salivation, melena, rectal hemorrhage, stomatitis

Rare (0.01% to 0.1%): Fecal incontinence, hematemesis, intestinal obstruction

Frequency not reported: Dental pain

Postmarketing reports: Gastroesophageal reflux disease, glossodynia, ileus, pancreatitis[Ref]

Nervous system

Very common (10% or more): Headache (up to 35%), somnolence (up to 27%), asthenia (up to 26%), dizziness (up to 15%)

Common (1% to 10%): Amnesia, central nervous system (CNS) stimulation, hyperkinesia, hypokinesia, hypertonia, myoclonus, paresthesia, syncope, tremor

Uncommon (0.1% to 1%): Akathisia, ataxia, CNS depression, convulsion, dyskinesia, dystonia, extrapyramidal syndrome, hemiplegia, hypersomnia, hypotonia, incoordination, paralysis, parosmia, stupor, taste loss, unsteady gait, vertigo, visual field defect

Rare (0.01% to 0.1%): Akinesia, cerebrovascular accident, coma, decreased reflexes, fibrillations, slurred speech, tardive dyskinesia

Frequency not reported: Dysgeusia, electric shock sensation, neuroleptic malignant syndrome-like events, psychomotor restlessness, sensory disturbance, serotonin syndrome, taste perversion

Postmarketing reports: Dysarthria, gait disturbance, lethargy, loss of consciousness, neonatal somnolence, Parkinsonism[Ref]


Very common (10% or more): Insomnia (up to 35%), nervousness (up to 12%), decreased male libido (up to 10%)

Common (1% to 10%): Abnormal dreams, abnormal thinking, agitation, anorgasmia, anxiety, apathy, decreased female libido, decreased libido, depression, female anorgasmia, male anorgasmia, manic reaction, neuroses, psychotic reaction

Uncommon (0.1% to 1%): Aggression, agoraphobia, confusion/confusional state, delirium, delusion, depersonalization, emotional instability/lability, euphoria, hallucinations, hostility, hypochondriasis, hysteria, increased libido, paranoid reaction, phobia, psychosis, sleep disorder, suicidal tendency, suicide attempt

Rare (0.01% to 0.1%): Mania, mutism, obsessions, withdrawal syndrome

Frequency not reported: Hypomania, intense dreams, irritability, sleep disturbances, suicidal behavior, suicidal ideation

Postmarketing reports: Activation syndrome, anger, bruxism, homicidal ideation, impulsive behavior, self-injurious behavior[Ref]


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

Common (1% to 10%): Decreased appetite, loss of appetite, weight gain, weight loss

Uncommon (0.1% to 1%): Dehydration, hypercholesterolemia

Rare (0.01% to 0.1%): Diabetes mellitus, hyperglycemia, hyperlipidemia, hypoglycemia, hypokalemia, increased lactate dehydrogenase

Frequency not reported: Hyponatremia, increased appetite, porphyria, thirst[Ref]


Very common (10% or more): Abnormal ejaculation (up to 11%)

Common (1% to 10%): Abnormal female sexual function, abnormal male sexual function, delayed ejaculation, impotence, menorrhagia, polyuria, urinary frequency, urinary retention, urinary tract infection

Uncommon (0.1% to 1%): Anuria, delayed menstruation, dysuria, female lactation, hematospermia, hematuria, impaired urination, menopause, metrorrhagia, nocturia, premenstrual syndrome, vaginal hemorrhage, vaginitis

Rare (0.01% to 0.1%): Galactorrhea

Frequency not reported: Amenorrhea, dysmenorrhea, enuresis, gynecological hemorrhage, hypomenorrhea, menstrual disorders, micturition disorder, pollakiuria, priapism, urinary incontinence[Ref]


Very common (10% or more): Pain (up to 10%)

Common (1% to 10%): Accidental injury, asthenia, chills, malaise

Uncommon (0.1% to 1%): Otitis media, overdose

Rare (0.01% to 0.1%): Sudden death

Frequency not reported: Body aches, ear pain, neonatal drug withdrawal syndrome, pain from surgery, unspecified pain

Postmarketing reports: Crying, fall, feeling drunk, feeling jittery, fatigue, pyrexia[Ref]


Common (1% to 10%): Chest pain, edema, feeling hot, feeling warm, flushing, hypertension, hypotension, palpitations, tachycardia, vasodilation

Uncommon (0.1% to 1%): Angina pectoris, bradycardia, cardiomyopathy, cardiovascular disease, cold extremities, conduction delay, hypotension, irregular pulse, myocardial infarction, orthostatic hypotension, pallor, ST segment changes

Rare (0.01% to 0.1%): Atrioventricular (AV) block, embolus, pericarditis, phlebitis, supraventricular extrasystoles

Frequency not reported: Hemorrhage

Postmarketing reports: Cardiac arrest/fatal cardiac arrest, cardiorespiratory arrest, electrocardiogram QT prolonged, shock, Torsade de pointes, vasculitis, ventricular arrhythmia, ventricular tachycardia[Ref]


Common (1% to 10%): Bronchitis, cough increased, dyspnea, epistaxis, laryngitis, pharyngitis, sinusitis, upper respiratory infection, yawn

Uncommon (0.1% to 1%): Asthma, hoarseness, hyperventilation

Rare (0.01% to 0.1%): Apnea, hemoptysis, hiccups, laryngismus, obstructive pulmonary disease, pneumonia, pulmonary infarction, upper airway congestion

Frequency not reported: Rhinitis

Postmarketing reports: Interstitial lung disease[Ref]


Common (1% to 10%): Acne, ecchymosis, hyperhidrosis, sweating

Uncommon (0.1% to 1%): Alopecia, angioneurotic edema, cutaneous hypersensitivity reactions, dry skin, eczema, exfoliative dermatitis, furunculosis, photosensitivity reaction, pruritus, rash, seborrhea, skin discoloration, urticaria

Postmarketing reports: Bullous eruption, Henoch-Schonlein purpura, Stevens-Johnson syndrome, toxic epidermal necrolysis[Ref]


Common (1% to 10%): Myalgia, twitching

Uncommon (0.1% to 1%): Arthralgia, arthritis, bursitis, generalized muscle spasm, myasthenia, neck pain, neck rigidity

Rare (0.01% to 0.1%): Myopathy, torticollis, trismus

Frequency not reported: Back pain, bone fractures, general pain secondary to injuries (sprains, fractures), leg cramps

Postmarketing reports: Muscular weakness, rhabdomyolysis[Ref]


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

Uncommon (0.1% to 1%): Abnormal accommodation, conjunctivitis, diplopia, dry eyes, eye pain, mydriasis, photophobia

Rare (0.01% to 0.1%): Corneal ulcer

Frequency not reported: Glaucoma, visual disturbance[Ref]


Common (1% to 10%): Abnormal liver function, elevated liver transaminases

Rare (0.01% to 0.1%): Biliary pain, cholecystitis, cholelithiasis, jaundice

Postmarketing reports: Hepatitis[Ref]


Common (1% to 10%): Flu syndrome, viral infection

Frequency not reported: Infection[Ref]


Uncommon (0.1% to 1%): Anemia, leukocytosis, lymphadenopathy, thrombocytopenia

Rare (0.01% to 0.1%): Leukopenia, purpura

Postmarketing reports: Agranulocytosis, aplastic anemia, decreased white blood cell count[Ref]


Uncommon (0.1% to 1%): Cystitis

Rare (0.01% to 0.1%): Kidney calculus, oliguria

Postmarketing reports: Acute renal failure, renal impairment[Ref]


Uncommon (0.1% to 1%): Hypothyroidism

Rare (0.01% to 0.1%): Goiter

Frequency not reported: Hyperprolactinemia, inappropriate antidiuretic hormone secretion/SIADH[Ref]


Uncommon (0.1% to 1%): Allergic reaction

Postmarketing reports: Anaphylactic reaction, angioedema[Ref]

Frequently asked questions


1. (2001) "Product Information. Luvox (fluvoxamine)." Solvay Pharmaceuticals Inc

2. Cerner Multum, Inc. "UK Summary of Product Characteristics."

3. Cerner Multum, Inc. "Australian Product Information."

Further information

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.