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Luvox CR Side Effects

Generic Name: fluvoxamine

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

In Summary

Common side effects of Luvox CR include: asthenia, diarrhea, drowsiness, nausea, headache, and anorexia. Other side effects include: anorgasmia, tremor, diaphoresis, and ecchymoses. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to fluvoxamine: oral capsule extended release, oral tablet

Along with its needed effects, fluvoxamine (the active ingredient contained in Luvox CR) 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:

Less common
  • Behavior, mood, or mental changes
  • 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

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
  • Abdominal or stomach pain
  • change in sense of taste
  • decreased appetite
  • feeling of constant movement of self or surroundings
  • frequent urination
  • heartburn
  • increased sweating
  • 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]

References

1. Cerner Multum, Inc. "Australian Product Information." O 0

2. "Product Information. Luvox (fluvoxamine)." Solvay Pharmaceuticals Inc, Marietta, GA.

3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

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.

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