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Fluvoxamine is a selective serotonin reuptake inhibitor (SSRI) antidepressant. Fluvoxamine affects chemicals in the brain that may be unbalanced in people with obsessive-compulsive symptoms.
Fluvoxamine is used to treat social anxiety disorder (social phobia), or obsessive-compulsive disorders involving recurring thoughts or actions.
Fluvoxamine may also be used for purposes not listed in this medication guide.
You should not take fluvoxamine if you are also using alosetron, pimozide, ramelteon, thioridazine, or tizanidine.
Do not use fluvoxamine within 14 days before or 14 days after you have taken an MAO inhibitor, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, and tranylcypromine.
Some young people have thoughts about suicide when first taking an antidepressant. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.
Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.
Do not stop using desvenlafaxine without first talking to your doctor.
You should not take fluvoxamine if you are allergic to it, or if you are also using alosetron, pimozide, ramelteon, thioridazine, or tizanidine.
Do not use fluvoxamine within 14 days before or 14 days after you have taken an MAO inhibitor. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.
To make sure fluvoxamine is safe for you, tell your doctor if you have ever had:
liver or kidney disease;
narrow-angle glaucoma;
heart disease, high blood pressure, or a stroke;
a bleeding or blood clotting disorder;
seizures or epilepsy;
bipolar disorder (manic depression); or
low levels or sodium in your blood (an electrolyte imbalance).
Some medicines can interact with fluvoxamine and cause a serious condition called serotonin syndrome. Be sure your doctor knows if you also take stimulant medicine, opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. Ask your doctor before making any changes in how or when you take your medications.
Some young people have thoughts about suicide when first taking an antidepressant. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.
Tell your doctor right away if you become pregnant while taking fluvoxamine. Fluvoxamine may cause serious lung problems or other complications in a newborn if you take the medication during late pregnancy. However, you may have a relapse of OCD symptoms if you stop taking fluvoxamine. Do not start or stop taking this medicine during pregnancy without your doctor's advice.
Fluvoxamine can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using fluvoxamine.
Do not give this medicine to anyone under 18 years old without medical advice.
Fluvoxamine is usually taken at night. Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not take this medicine in larger or smaller amounts or for longer than recommended.
You may take fluvoxamine with or without food.
Do not crush, chew, break, or open an extended-release capsule. Swallow it whole.
You should not stop using fluvoxamine suddenly. Follow your doctor's instructions about tapering your dose.
Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Drinking alcohol can increase certain side effects of fluvoxamine.
Ask your doctor before taking a nonsteroidal anti-inflammatory drug (NSAID) for pain, arthritis, fever, or swelling. This includes aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib (Celebrex), diclofenac, indomethacin, meloxicam, and others. Using an NSAID with fluvoxamine may cause you to bruise or bleed easily.
Fluvoxamine may impair your thinking or reactions. Avoid driving or operating machinery until you know how fluvoxamine will affect you.
Get emergency medical help if you have signs of an allergic reaction: skin rash, blisters, or hives; fever, joint pain; difficult breathing; swelling of your face, lips, tongue, or throat.
Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.
Call your doctor at once if you have;
anxiety, racing thoughts, risk-taking behavior, sleep problems (insomnia), feelings of extreme happiness or irritability;
blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
seizure (convulsions);
changes in weight or appetite;
easy bruising or unusual bleeding;
low levels of sodium in the body--headache, confusion, memory problems, severe weakness, loss of coordination, feeling unsteady; or
severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.
Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea
Common side effects may include:
drowsiness, dizziness;
shaking, feeling anxious;
depressed mood;
sleep problems (insomnia);
upset stomach, gas, loss of appetite;
nausea, vomiting, diarrhea;
dry mouth, yawning;
sore throat;
muscle pain;
sweating, rash;
heavy menstrual periods; or
decreased sex drive, abnormal ejaculation, trouble having an orgasm.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Usual Adult Dose for Obsessive Compulsive Disorder:
Initial immediate-release tablet dose: 50 mg orally once a day at bedtime
Initial extended-release capsule dose: 100 mg orally once a day at bedtime
Maintenance dose: 100 to 300 mg orally per day
Maximum dose: 300 mg/day
Comments:
-The dose may be increased in 50 mg increments every 4 to 7 days, as tolerated, until maximum therapeutic benefit is achieved.
-A total daily dose of more than 100 mg should be given in two divided doses. If the doses are not equal, the larger dose should be given at bedtime.
Use: Treatment of obsessions and compulsions in patients with obsessive compulsive disorder (OCD), as defined in DSM-III-R or DSM-IV
Usual Pediatric Dose for Obsessive Compulsive Disorder:
8 to 11 years:
-Initial dose: 25 mg orally once a day at bedtime
-Maintenance dose: 25 to 200 mg orally per day
-Maximum dose: 200 mg/day
11 to 17 years:
-Initial dose: 25 mg orally once a day at bedtime
-Maintenance dose: 25 to 300 mg orally per day
-Maximum dose: 300 mg/day
Comments:
The dose may be increased in 25 mg increments every 4 to 7 days, as tolerated, up to a maximum daily dose.
-Total daily doses of more than 50 mg should be given in two divided doses. If the two divided doses are not equal, the larger dose should be given at bedtime.
-Lower doses may be effective in female versus male patients.
Use: Treatment of obsessions and compulsions in patients with OCD, as defined in DSM-III-R or DSM-IV
Taking fluvoxamine with other drugs that make you sleepy can worsen this effect. Ask your doctor before taking a sleeping pill, opioid medication, muscle relaxer, or medicine for anxiety, depression, or seizures.
Many drugs can interact with fluvoxamine. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any you start or stop using, especially:
methadone, mexiletine, St. John's wort, theophylline, tramadol, tryptophan (also called L-tryptophan);
a diuretic or "water pill";
a blood thinner--warfarin, Coumadin, Jantoven;
medicine to treat anxiety, mood disorders, thought disorders, or mental illness--such as clozapine, lithium, antidepressants, or antipsychotics;
migraine headache medicine--sumatriptan, rizatriptan, zolmitriptan, and others; or
a sedative--diazepam, alprazolam, midazolam, triazolam, Valium, Xanax.
This list is not complete and many other drugs can interact with fluvoxamine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.
Further informationRemember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Fluvoxamine Maleate Er (www.drugs.com/mtm/fluvoxamine.html).
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. See below for a comprehensive list of adverse effects.
For the ConsumerApplies to fluvoxamine: oral capsule extended release, oral tablet
Oral route (Capsule, Extended Release; Tablet)
Antidepressants can increase the risk of suicidal thinking and behavior in children, adolescents, and young adults with major depressive disorder and other psychiatric disorders. This risk was not observed in patients older than 24 years, and the risk was reduced in patients 65 years or younger. Closely monitor patients of all ages for clinical worsening and emergence of suicidal thoughts and behaviors.. Fluvoxamine maleate tablets are not approved for use in pediatric patients except for patients with obsessive compulsive disorder.
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:
Less common
Rare
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
For Healthcare Professionals
Applies to fluvoxamine: oral capsule extended release, oral tablet
GeneralThe most commonly reported side effects included nausea, headache, insomnia, and somnolence.
GastrointestinalVery 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
Nervous systemVery 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
PsychiatricVery 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
MetabolicVery 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
GenitourinaryVery 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
OtherVery 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
CardiovascularCommon (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
RespiratoryCommon (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
DermatologicCommon (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
MusculoskeletalCommon (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
OcularCommon (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
HepaticCommon (1% to 10%): Abnormal liver function, elevated liver transaminases
Rare (0.01% to 0.1%): Biliary pain, cholecystitis, cholelithiasis, jaundice
Postmarketing reports: Hepatitis
ImmunologicCommon (1% to 10%): Flu syndrome, viral infection
Frequency not reported: Infection
HematologicUncommon (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
RenalUncommon (0.1% to 1%): Cystitis
Rare (0.01% to 0.1%): Kidney calculus, oliguria
Postmarketing reports: Acute renal failure, renal impairment
EndocrineUncommon (0.1% to 1%): Hypothyroidism
Rare (0.01% to 0.1%): Goiter
Frequency not reported: Hyperprolactinemia, inappropriate antidiuretic hormone secretion/SIADH
HypersensitivityUncommon (0.1% to 1%): Allergic reaction
Postmarketing reports: Anaphylactic reaction, angioedema
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Fluvoxamine Maleate Er (www.drugs.com/mtm/fluvoxamine.html).
October 19, 2020
October 19, 2020
October 19, 2020
October 19, 2020
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