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Luvox CR Side Effects

Generic name: fluvoxamine

Medically reviewed by Drugs.com. Last updated on Mar 2, 2025.

Note: This document provides detailed information about Luvox CR Side Effects associated with fluvoxamine. Some dosage forms listed on this page may not apply specifically to the brand name Luvox CR.

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.

Precautions

It is very important that your doctor check your progress at regular visits. This will allow for changes in the dose and to help reduce any side effects. Blood tests may be needed to check for unwanted effects.

Do not take alosetron (Lotronex®), pimozide (Orap®), ramelteon (Rozerem®), thioridazine (Mellaril®), or tizanidine (Zanaflex®) while you are taking fluvoxamine (the active ingredient contained in Luvox CR) /i>. You could have more side effects than usual if you use these medicines together.

Do not take fluvoxamine with a monoamine oxidase (MAO) inhibitor (eg, isocarboxazid [Marplan®], linezolid [Zyvox®], methylene blue injection, phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]). Do not start taking fluvoxamine during the 2 weeks after you stop a MAO inhibitor and wait 2 weeks after stopping fluvoxamine before you start taking a MAO inhibitor. If you take them together or do not wait 2 weeks, you may develop confusion, agitation, restlessness, stomach or intestinal symptoms, a sudden high body temperature, an extremely high blood pressure, or severe seizures.

Fluvoxamine may cause a serious condition called serotonin syndrome if taken together with some medicines. Do not use fluvoxamine with buspirone (Buspar®), fentanyl (Abstral®, Duragesic®), lithium (Eskalith®, Lithobid®), tryptophan, St. John's wort, amphetamines, or some pain or migraine medicines (eg, meperidine, methadone, rizatriptan, sumatriptan, tramadol, Demerol®, Methadose®, Frova®, Imitrex®, Maxalt®, Relpax®, Ultram®, Zomig®). Check with your doctor first before taking any other medicines with fluvoxamine.

Fluvoxamine may cause some people to be agitated, irritable or display other abnormal behaviors. It may also cause some children, teenagers, and young adults to have suicidal thoughts and tendencies or to become more depressed. Some people may have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. If you, or your caregiver notice any of these side effects, tell your doctor right away. Let the doctor know if you or anyone in your family has bipolar disorder (manic-depressive) or has tried to commit suicide.

Avoid drinking alcohol with fluvoxamine.

This medicine may cause some people to become drowsy, less able to think clearly, or to have blurred vision or poor muscle control. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert or able to see clearly.

Do not suddenly Stop taking fluvoxamine without checking with your doctor first. Your doctor may want you to gradually reduce the amount you are taking before stopping it completely. This is to decrease the chance of having withdrawal symptoms such as agitation, confusion, headache, irritability, numbness or tingling, restlessness, trouble sleeping, or unusual drowsiness or weakness.

This medicine may increase your risk for bleeding problems. Make sure your doctor knows if you are also taking other medicines that thin the blood, including aspirin, NSAIDs (eg, diclofenac, ibuprofen, naproxen, Advil®, Aleve®, Celebrex®, Voltaren®), or warfarin (Coumadin®, Jantoven®).

Hyponatremia (low sodium in the blood) may occur with this medicine. Check with your doctor right away if you have confusion, difficulty concentrating, headaches, memory problems, weakness, and unsteadiness.

Tell your doctor right away if you develop a rash or hives, swelling of the face, eyes, or mouth, or trouble breathing after taking this medicine.

Check with your doctor right away if you have decreased interest in sexual intercourse, delayed or inability to have an orgasm in women, inability to have or keep an erection in men, or loss in sexual ability, desire, drive, or performance. These could be symptoms of sexual dysfunction.

Some men and women who use this medicine have become infertile (unable to have children). Talk with your doctor before using this medicine if you plan to have children.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

Serious side effects of Luvox CR

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 side effects

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

Less common side effects

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

Rare side effects

  • 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 CR

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 side effects

  • change in sexual performance or desire
  • trouble sleeping
  • unusual tiredness

Less common side effects

  • 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 adverse events

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

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

See also:

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."

Frequently asked questions

Further information

Luvox CR 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.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.