Fluvoxamine

Pronunciation: floo-VOX-a-meen.

Generic name
fluvoxamine
Drug class
Selective serotonin reuptake inhibitor (SSRI) antidepressant
Form
Tablet (immediate-release, 25 mg/50 mg/100 mg); a separate extended-release capsule (Luvox CR, 100 mg/150 mg) is a distinct US product with a broader indication
Route
Oral
Legal status
Prescription-only in every market with a confirmed classification

Availability and supply rules vary by country

Trade names by country: Canada

Australia: · Full directory

What fluvoxamine is and how it works

Fluvoxamine is a prescription antidepressant belonging to the SSRI (selective serotonin reuptake inhibitor) class, first approved in the United States in 1994. In its plain (immediate-release) tablet form, the US FDA label restricts its approved use specifically to obsessive-compulsive disorder (OCD) -- it is not approved for depression or any other use in that tablet form in the US. A separate extended-release capsule product (Luvox CR) is additionally approved in the US for Social Anxiety Disorder. In the UK and Australia, the plain tablet is approved for both major depressive disorder and OCD. (1)

Fluvoxamine carries a genuine safety warning shared with all antidepressants: in short-term studies, antidepressants were linked to an increased risk of suicidal thinking and behaviour in children, adolescents, and young adults under 25. This risk was not seen in older adults, and was actually lower with antidepressant treatment in adults 65 and older. Anyone starting fluvoxamine, at any age, should be watched closely for worsening mood or new suicidal thoughts, especially in the first few weeks or after a dose change, and should know to contact their prescriber immediately if these appear.

Mechanism of action: how fluvoxamine works

Fluvoxamine is a selective serotonin reuptake inhibitor (SSRI) that blocks the reuptake transporter for serotonin at the presynaptic neuron. It is a potent inhibitor of several cytochrome P450 isoenzymes (CYP1A2, CYP2C9, CYP3A4, CYP2C19), which underlies many of its clinically significant drug interactions (carbamazepine, tricyclic antidepressants, theophylline, warfarin, and others). (1)

What fluvoxamine is used for

Obsessive-compulsive disorder (OCD)

Used to treat obsessions and compulsions in OCD, in adults and (in the US, UK, and Australian sources reviewed) children and adolescents aged 8-17. This is the sole approved use of the plain (immediate-release) tablet in the United States. Health Canada's product monograph states fluvoxamine is not indicated below age 18 -- a more restrictive paediatric position than the US, UK, and Australian sources. (1) (3) (5) (6)

Major depressive disorder (depression)

Used to treat major depressive disorder in adults -- confirmed as an indication for the plain tablet in the UK, Canadian, and Australian sources reviewed. This is NOT an approved indication for the plain immediate-release tablet in the specific US label reviewed for this dossier (the US plain-tablet label covers OCD only). (3) (5) (6)

Social anxiety disorder (SAD) -- Luvox CR extended-release capsule only

The separate Luvox CR extended-release capsule product is FDA-approved in the US for Social Anxiety Disorder in adults, in addition to OCD. This is a distinct product/formulation from the plain immediate-release tablet reviewed as the primary source for this dossier, and this indication is kept scoped specifically to that product -- not presented as a use of ordinary fluvoxamine tablets. (2)

Before taking fluvoxamine

Do not take / not appropriate for

  • Do not take fluvoxamine together with tizanidine, thioridazine, alosetron, or pimozide -- coadministration is contraindicated in the US source reviewed due to serious interaction risks. (United States) (1)
  • Do not take fluvoxamine together with tizanidine or pimozide. (United Kingdom) (3)
  • Do not take fluvoxamine if you are taking, or have taken within the last 14 days, a monoamine oxidase inhibitor (MAOI) intended to treat a psychiatric disorder -- combining these can cause a serious reaction (serotonin syndrome). A 14-day gap is required in both directions. (United States, United Kingdom) (1) (3)
  • Do not start fluvoxamine if you are being treated with linezolid or intravenous methylene blue, due to an increased risk of serotonin syndrome. (United States) (1)
  • Do not take fluvoxamine if you have a known hypersensitivity to fluvoxamine or its excipients. (United Kingdom) (3)

Tell your clinician about

  • Any history of suicidal thoughts, self-harm, or bipolar disorder (screen for bipolar disorder before starting).
  • Any history of untreated anatomically narrow angles (risk of angle-closure glaucoma).
  • Any history of seizures/epilepsy.
  • Any history of low blood sodium (hyponatraemia), especially if elderly.
  • Any history of bleeding problems, or if you take anticoagulants (including warfarin), aspirin, or NSAIDs.
  • Any liver problems -- clearance of fluvoxamine is decreased in hepatic impairment.
  • All other medicines, especially MAOIs, other antidepressants or serotonergic medicines, tricyclic antidepressants, benzodiazepines, clozapine, methadone, mexiletine, carbamazepine, theophylline, tryptophan, diltiazem, propranolol, metoprolol, ramelteon, or sumatriptan.
  • Whether you smoke -- smoking increases fluvoxamine metabolism by about 25%, per the US source reviewed.
  • Whether you are pregnant, plan to become pregnant, or are breastfeeding.
(1) (3)

How to take fluvoxamine

  • Usually taken once daily at bedtime; a total daily dose over 100 mg (US) or 50 mg in children (US) should be divided, with the larger portion given at bedtime.
  • It can take several weeks of treatment before the full effect is felt -- do not expect an immediate result.
  • Any change in dose, or a decision to stop fluvoxamine, should always be made together with your prescriber, not on your own.
  • Gradual dose reduction is recommended when stopping, per the US source reviewed -- abrupt discontinuation is not recommended.
(1) (3)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5) (6)

Missed dose

If you miss a dose, ask your prescriber or pharmacist for guidance on the best next step rather than doubling your next dose. Contact your prescriber if you are unsure.

Overdose

Seek urgent medical attention if you think you or someone else has taken too much fluvoxamine. Take the medicine packaging with you if possible. (1)

Side effects

Side effects and their urgency vary; report severe, persistent, or concerning symptoms.

Nausea.

What to notice: Nausea.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1) (3)

Somnolence (sleepiness).

What to notice: Somnolence (sleepiness).

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1) (3)

Insomnia.

What to notice: Insomnia.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1) (3)

Asthenia (weakness/fatigue) and nervousness.

What to notice: Asthenia (weakness/fatigue) and nervousness.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Dyspepsia (indigestion) and dry mouth.

What to notice: Dyspepsia (indigestion) and dry mouth.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Abnormal ejaculation and other sexual dysfunction.

What to notice: Abnormal ejaculation and other sexual dysfunction.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1) (3)

Sweating, anorexia (reduced appetite), tremor, and vomiting.

What to notice: Sweating, anorexia (reduced appetite), tremor, and vomiting.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Headache and dizziness.

What to notice: Headache and dizziness.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (3)

Agitation and withdrawal symptoms on discontinuation.

What to notice: Agitation and withdrawal symptoms on discontinuation.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (3)

Serious warnings

Worsening depression or emergence of suicidal thoughts (especially in children, adolescents, and young adults under 25) — boxed_warning

Symptoms: New or worsening depression, suicidality, or unusual changes in behaviour, particularly in the first few weeks of treatment or after a dose change.

Action: Contact your prescriber immediately, or seek emergency help if there is any immediate danger. Families and caregivers should watch closely for these signs, especially early in treatment. (1)

Signs of serotonin syndrome — emergency

Symptoms: Agitation, hallucinations, fast heartbeat, high body temperature, muscle rigidity or twitching, loss of coordination, sweating, shivering, diarrhoea -- especially if combined with another serotonergic medicine or an MAOI.

Action: Seek emergency medical help immediately. If symptoms occur, the prescriber will discontinue fluvoxamine and other serotonergic drugs and start supportive treatment. (1) (3)

Signs of angle-closure glaucoma — high caution

Symptoms: Eye pain, vision changes, or swelling/redness in or around the eye.

Action: Seek prompt medical attention. This has occurred in patients with untreated anatomically narrow angles treated with antidepressants. (1)

Signs of low blood sodium (hyponatraemia) — high caution

Symptoms: Headache, confusion, weakness, unsteadiness, or in severe cases seizures -- more common in elderly patients.

Action: Contact your prescriber promptly for assessment. (1)

Unusual bleeding or bruising — high caution

Symptoms: Nosebleeds, easy bruising, blood in vomit or stool -- risk is higher when combined with NSAIDs, aspirin, or anticoagulants such as warfarin.

Action: Contact your prescriber for assessment, particularly if you also take a blood-thinning or anti-inflammatory medicine. (1)

Signs of mania or hypomania — high caution

Symptoms: Unusually elevated mood, racing thoughts, or impulsive behaviour.

Action: Contact your prescriber for assessment before continuing treatment as before. (1)

New or worsening seizures — high caution

Symptoms: Seizure activity or an increase in seizure frequency, particularly in patients with unstable epilepsy.

Action: Contact your prescriber promptly; fluvoxamine should be used cautiously in patients with controlled epilepsy and discontinued if seizures occur or frequency increases. (1)

Interactions

  • Monoamine oxidase inhibitors (MAOIs) intended to treat psychiatric disorders, and linezolid or intravenous methylene blue: must not be combined with fluvoxamine due to risk of a serious, potentially fatal reaction (serotonin syndrome). A 14-day washout is required in both directions between fluvoxamine and an MAOI. (1)
  • Tizanidine, thioridazine, alosetron, pimozide: contraindicated in combination with fluvoxamine in the US source reviewed (tizanidine and pimozide also contraindicated in the UK source reviewed). (1) (3)
  • Other serotonergic medicines (triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, amphetamines, St John's Wort): increase the risk of serotonin syndrome. (1)
  • Carbamazepine: fluvoxamine can elevate carbamazepine levels and symptoms of toxicity. (1)
  • Sumatriptan: rare postmarketing reports of weakness, hyperreflexia, and incoordination when used with an SSRI; monitor if concurrent use is clinically warranted. (1)
  • Tricyclic antidepressants: fluvoxamine significantly increases plasma TCA levels -- use caution, monitor levels, and reduce the TCA dose if indicated. (1)
  • Tryptophan: severe vomiting reported with coadministration. (1)
  • Diltiazem: bradycardia reported with coadministration. (1)
  • Propranolol or metoprolol: fluvoxamine may increase these drugs' levels -- dose reduction may be needed if coadministered. (1)
  • Ramelteon: should not be used in combination with fluvoxamine. (1)
  • Theophylline: fluvoxamine decreases clearance -- theophylline dose reduction is typically needed. (1)
  • Warfarin and other drugs affecting hemostasis (including NSAIDs and aspirin): fluvoxamine increases prothrombin time and bleeding risk -- monitor and adjust warfarin dose accordingly. (1)
  • Benzodiazepines (e.g. diazepam): use with caution -- coadministration with diazepam is generally not advisable. (1)
  • Clozapine: levels may be increased, with a risk of orthostatic hypotension or seizures. (1)
  • Methadone: coadministration may produce opioid intoxication; discontinuation of fluvoxamine may produce opioid withdrawal. (1)
  • Mexiletine: monitor serum mexiletine levels if coadministered. (1)
  • Smoking: smokers had a 25% increase in fluvoxamine metabolism in the US source reviewed. (1)
  • Electroconvulsive therapy (ECT): use caution, per the US source reviewed. (1)

Pregnancy, breastfeeding, kidney/liver function, age

Pregnancy

Fluvoxamine is used in pregnancy only when the clinical need justifies the risk, decided together with your prescriber. Neonates exposed late in the third trimester to fluvoxamine or other SSRIs/SNRIs have developed complications requiring prolonged hospitalisation, respiratory support, and tube feeding, and may be at risk for persistent pulmonary hypertension of the newborn (PPHN) -- reported at approximately 5 per 1,000 pregnancies versus a 1-2 per 1,000 baseline in the UK source reviewed. The prescribing physician should carefully consider risks and benefits when treating during the third trimester. Health Canada's product monograph states safe use in pregnancy has not been established. (1) (2) (3) (4) (5) (6)

Breastfeeding

Fluvoxamine is secreted in human breast milk. The UK source reviewed advises against use while breastfeeding; discuss the balance of risks and benefits with your prescriber. (1) (2) (3) (4) (5) (6)

Children

Approved for OCD from age 8 in the US, UK, and Australian sources reviewed, with a lower starting dose and slower titration than adults, and specific attention to age/gender differences in dosing. Health Canada's product monograph states fluvoxamine is not indicated below age 18 -- always follow local prescribing guidance. (1) (2) (3) (4) (5) (6)

Elderly

Decreased clearance of fluvoxamine has been observed in elderly patients -- the prescriber may modify the initial dose and titration schedule. Elderly patients may also be at higher risk of hyponatraemia. (1) (2) (3) (4) (5) (6)

Hepatic_impairment

Decreased clearance has been observed in patients with hepatic impairment -- the prescriber may modify the initial dose and subsequent titration. (1) (2) (3) (4) (5) (6)

Renal_impairment

Not specifically detailed with a dose adjustment in the sources reviewed for this dossier. (1) (2) (3) (4) (5) (6)

Source_ids

US-DAILYMED-FLUVOXAMINE-2026,UK-EMC-FAVERIN-2026,CA-HC-FLUVOXAMINE-PM-2026 (1) (2) (3) (4) (5) (6)

Monitoring

Before starting

  • Screening for bipolar disorder or family history of mania
  • Assessment for personal or family history of suicidal thoughts
  • Review of all other medicines for MAOI or serotonergic interactions
  • Assessment for untreated narrow anatomical angles (angle-closure glaucoma risk)
  • Baseline liver function assessment where relevant

During treatment

  • Close monitoring for worsening mood or emergence of suicidal thoughts, especially in the first few weeks of treatment or after a dose change, and especially in patients under 25.
  • Monitoring for signs of serotonin syndrome if other serotonergic medicines are used concurrently.
  • Monitoring prothrombin time/INR if taking warfarin or other anticoagulants.
  • Growth and development monitoring in children and adolescents, where prescribed.
(1)

Storage

Store at room temperature, away from moisture and direct light, out of reach of children.

Study the drug class: SSRI antidepressants

Professional information

Clinician-facing context only, sourced from the current US FDA prescribing information, UK emc SmPC, and Health Canada product monograph reviewed for this dossier; verify against the current full label before prescribing.

United States

Indication: OCD only (plain tablet); SAD + OCD for the separate Luvox CR extended-release capsule

Dose summary: OCD (adults): 50 mg/day initial, increase by 50 mg q4-7 days, max 300 mg/day (divided if >100 mg). OCD (8-17 years): 25 mg/day initial, increase by 25 mg q4-7 days, max 200 mg/day (up to 11 years) or up to 300 mg/day (adolescents), divided if >50 mg.

Renal context: Not specifically detailed in the source reviewed. (1)

United Kingdom

Indication: MDD, OCD

Dose summary: Depression: 50-100 mg/day (evening), max 300 mg/day. OCD (adults): 50 mg/day initial, range 100-300 mg/day. OCD (8+): 25 mg/day initial, max 200 mg/day.

Renal context: Not specifically dose-adjusted per the source reviewed. (3)

Canada

Indication: MDD, OCD (adults only -- not indicated under 18)

Dose summary: 50 mg/day initial, increase in 50 mg increments q4-7 days, usual range 100-300 mg/day.

Renal context: Not specifically detailed in the source reviewed. (5)

Australia

Indication: MDD (adults), OCD (adults and children 8+)

Dose summary: Schedule 4 (Prescription Only Medicine); PBS-subsidised. Dosing generally follows the UK/US pattern per the ARTG entries reviewed.

Renal context: Not specifically detailed in the source reviewed. (6)

Mechanism of action

Hepatic guidance

Decreased clearance observed in hepatic impairment; the prescriber may modify the initial dose and titration schedule.

Overdose note

Manage with supportive care; no specific antidote described in the sources reviewed. (1)

Frequently asked questions

Is fluvoxamine available in the US, UK, Europe, Canada, Australia, and New Zealand?

Confirmed authorised in five of these six markets via live regulator sources this session: the United States (as generic fluvoxamine maleate tablets and the extended-release Luvox CR), United Kingdom (as Faverin), European Union (nationally authorised, e.g. as Dumirox), Canada (as Luvox and generics), and Australia (as Luvox and Faverin). New Zealand's current status could not be confirmed -- an official 2012 Medsafe committee document references an actively-maintained New Zealand data sheet, but an official 2004 Medsafe media release stated the product was 'not marketed', and no current live source was found this session. This is disclosed honestly as Unable to verify rather than guessed. (1) (3) (4) (5) (6) (7)

Why does fluvoxamine have a boxed warning about suicidal thoughts?

Because in short-term clinical trials, antidepressants as a class -- including fluvoxamine -- were linked to a higher rate of suicidal thinking and behaviour in children, adolescents, and young adults under 25, compared with placebo. This risk was not seen in older adults, and was actually lower with antidepressant treatment in adults 65 and older. Anyone starting fluvoxamine at any age should be watched closely for worsening mood or new suicidal thoughts, especially early in treatment, and should contact their prescriber immediately if these appear. (1)

Is fluvoxamine approved for depression, or only for OCD?

This depends on the country and the specific product. In the United States, the plain (immediate-release) fluvoxamine tablet is approved for OCD only -- it is not FDA-approved for depression in that form. A separate extended-release product, Luvox CR, is FDA-approved for Social Anxiety Disorder in addition to OCD. In the United Kingdom, Canada, and Australia, the plain tablet is approved for both major depressive disorder and OCD. Always check which indication applies to the specific product and country. (1) (2) (3) (5) (6)

Can I take fluvoxamine with an MAOI or with linezolid?

No. Fluvoxamine must never be combined with a monoamine oxidase inhibitor (MAOI) intended to treat a psychiatric disorder, and a 14-day gap is required in both directions. Fluvoxamine also must not be started in a patient currently being treated with linezolid or intravenous methylene blue, due to the serious, potentially fatal risk of serotonin syndrome. Never start, stop, or combine antidepressants without medical guidance. (1)

What is the mechanism of action of fluvoxamine?

Fluvoxamine is a selective serotonin reuptake inhibitor (SSRI) that blocks the reuptake transporter for serotonin at the presynaptic neuron. It is a potent inhibitor of several cytochrome P450 isoenzymes (CYP1A2, CYP2C9, CYP3A4, CYP2C19), which underlies many of its clinically significant drug interactions (carbamazepine, tricyclic antidepressants, theophylline, warfarin, and others). (1)

What is the generic name of Fluvoxamine?

The generic name is fluvoxamine. (1) (3)

What class of drug is fluvoxamine?

Fluvoxamine is classed as: Selective serotonin reuptake inhibitor (SSRI) antidepressant. (1) (3)

References

  1. FLUVOXAMINE MALEATE Tablets -- full prescribing information (Rev 1/2017)U.S. Food and Drug Administration (FDA) / DailyMed · United States · dated 2017-01 · accessed 2026-07-30 · source 1
  2. FDA approval of LUVOX CR (fluvoxamine maleate) Extended-Release Capsules for Social Anxiety Disorder (SAD) and OCDU.S. Food and Drug Administration (FDA) via Jazz Pharmaceuticals investor announcement and FDA label · United States · dated 2008-02-28 · accessed 2026-07-30 · source 2
  3. Faverin 50 mg Film-coated Tablets -- Summary of Product Characteristics (SmPC)electronic medicines compendium (emc), United Kingdom -- Faverin 50mg Summary of Product Characteristics · United Kingdom · accessed 2026-07-30 · source 3
  4. Fluvoxamine: list of nationally authorised medicinal products (PSUSA/00001458/202207)European Medicines Agency (EMA) -- PSUSA list of nationally authorised medicinal products · European Union · accessed 2026-07-30 · source 4
  5. LUVOX (fluvoxamine maleate) Product MonographHealth Canada -- Product Monograph (Luvox / generic fluvoxamine maleate tablets) · Canada · accessed 2026-07-30 · source 5
  6. LUVOX / FAVERIN (fluvoxamine maleate) -- ARTG registration entriesTherapeutic Goods Administration (TGA), Australia -- ARTG registration · Australia · accessed 2026-07-30 · source 6
  7. MARC Minutes, 151st Meeting (13 September 2012) -- fluvoxamine and QT prolongation/Torsades de Pointes reviewMedsafe (New Zealand) -- Medicines Adverse Reactions Committee (MARC), 151st meeting minutes · New Zealand · dated 2012-09-13 · accessed 2026-07-30 · source 7
  8. Media Releases for 2004 (SSRI medicines list, includes fluvoxamine/Luvox marketing-status note)Medsafe (New Zealand) -- official media release archive · New Zealand · dated 2004-10-21 · accessed 2026-07-30 · source 8

Brand names by country

Single-ingredient fluvoxamine names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries

Canada

  • LUVOX
  • RIVA-FLUVOX
View brands in additional countries.

This page provides general reference information about fluvoxamine and is not a substitute for advice from the prescriber managing your treatment. All dosing and treatment decisions, including starting, changing, or stopping this medicine, should be made with your prescriber.

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