Luvox Side Effects
Generic name: fluvoxamine
Medically reviewed by Drugs.com. Last updated on Mar 5, 2024.
Note: This document provides detailed information about Luvox Side Effects associated with fluvoxamine. Some dosage forms listed on this page may not apply specifically to the brand name Luvox.
Applies to fluvoxamine: oral capsule extended release, oral tablet.
Important warnings
This medicine can cause some serious health issues
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 Luvox
Along with its needed effects, fluvoxamine (the active ingredient contained in Luvox) 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
- 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
- seizures
- 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
Incidence not known
- agitation
- anger
- bloating
- chest tightness
- constipation
- cough
- difficulty swallowing
- darkened urine
- fast heartbeat
- headache
- hostility
- indigestion
- irritability
- loss of appetite
- nausea
- pains in the stomach, side, or abdomen, possibly radiating to the back
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- swelling of the breasts or unusual milk production
- vomiting
- yellow eyes or skin
Other side effects of Luvox
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
- 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
Incidence not known
- decrease in smell
- loss of sense of smell
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]
References
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."
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Further information
Luvox 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.