Summary

Commonly reported side effects of fluvoxamine include: asthenia, diarrhea, dizziness, drowsiness, dyspepsia, insomnia, nausea, nervousness, constipation, headache, anorexia, and xerostomia. Other side effects include: anorgasmia, tremor, vomiting, diaphoresis, flushing, and ecchymoses. Continue reading for a comprehensive list of adverse effects.

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

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

• Decreased interest in sexual intercourse
• inability to have or keep an erection
• loss in sexual ability, desire, drive, or performance

Less common

• Behavior, mood, or mental changes
• delayed or inability to have an orgasm
• trouble with breathing
• trouble with urinating
• twitching

Rare

• Absence of or decrease in body movements
• agitation
• blurred vision
• chills
• clumsiness or unsteadiness
• confusion
• convulsions (seizures)
• diarrhea
• fever
• inability to move the eyes
• increase in body movements
• menstrual changes
• nosebleeds
• overactive reflexes
• poor coordination
• red or irritated eyes
• redness, tenderness, itching, burning, or peeling of the skin
• restlessness
• shivering
• skin rash
• sore throat
• sweating
• talking or acting with excitement you cannot control
• trembling or shaking
• unusual bruising
• unusual, incomplete, or sudden body or facial movements
• unusual secretion of milk (in females)
• weakness

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

• Change in sexual performance or desire
• constipation
• headache
• trouble sleeping
• unusual tiredness

Less common

• Change in sense of taste
• decreased appetite
• feeling of constant movement of self or surroundings
• frequent urination
• heartburn
• increased sweating
• stomach pain
• unusual weight gain or loss

For Healthcare Professionals

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

General

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

Gastrointestinal

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]

Psychiatric

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]

Metabolic

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]

Genitourinary

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]

Other

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]

Cardiovascular

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]

Respiratory

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]

Dermatologic

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]

Musculoskeletal

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]

Ocular

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]

Hepatic

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]

Immunologic

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

Frequency not reported: Infection^[Ref]

Hematologic

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]

Renal

Uncommon (0.1% to 1%): Cystitis

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

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

Endocrine

Uncommon (0.1% to 1%): Hypothyroidism

Rare (0.01% to 0.1%): Goiter

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

Hypersensitivity

Uncommon (0.1% to 1%): Allergic reaction

Postmarketing reports: Anaphylactic reaction, angioedema^[Ref]