Fluvoxamine
Fluvoxamine is a selective serotonin reuptake inhibitor (SSRI) antidepressant-type medicine used to treat obsessive compulsive disorder (OCD), available as tablets and extended-release capsules.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 27 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Fluvoxamine (Luvox) is an SSRI that treats obsessive compulsive disorder (OCD) by blocking serotonin reuptake (recycling), an older option on the market since about 1994, available as a generic and used less often than most other SSRIs. Most people settle in once early nausea and sleepiness ease, though sexual side effects can linger. Its boxed warning covers suicidal thoughts and behavior in children, teens and young adults up to age 24, so watch closely for worsening mood or unusual behavior, especially early on and after dose changes. It also slows the liver's handling of many other drugs, so every prescriber should know you take it.
Clinical pearls
- Doses start at bedtime, and extended-release capsules must be swallowed whole, never crushed or chewed.
- Never combine it with tizanidine, thioridazine, pimozide, alosetron or ramelteon, and warfarin users need extra clotting tests (prothrombin time).
- If you take theophylline for breathing, its dose needs to come down once fluvoxamine is started.
- Do not stop it suddenly; the dose should be lowered gradually to avoid withdrawal-type symptoms, and alcohol is best avoided.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Antidepressants, including fluvoxamine, can raise the risk of suicidal thoughts and behavior in children, teens and young adults (up to age 24). This was seen in short-term studies. It was not seen in adults over 24, and risk was lower in adults 65 and older.
Depression and other psychiatric conditions themselves raise suicide risk. Anyone starting an antidepressant should be watched closely for worsening mood, suicidal thoughts or unusual behavior changes. Families and caregivers should stay in close contact with the prescriber. Fluvoxamine tablets are not approved for children except those with OCD. Don't take other fluvoxamine-containing medicines at the same time.
Patient information guide A plain-language walkthrough of Fluvoxamine, written from its FDA label.
What Fluvoxamine is used for
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Fluvoxamine is used for one main condition, with product-specific details.
- Fluvoxamine maleate tablets: treat obsessions and compulsions in OCD in adults and in children and adolescents ages 8 to 17.
- Fluvoxamine maleate extended-release capsules: treat OCD.
How Fluvoxamine works
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Fluvoxamine is a selective serotonin reuptake inhibitor (SSRI). It blocks the serotonin transporter, which normally pulls serotonin back into nerve cells. Its benefit in OCD is thought to be linked to this action.
Fluvoxamine dosage
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Fluvoxamine is taken by mouth, usually starting at bedtime, with gradual increases as tolerated.
- Tablets: higher daily amounts are divided into two doses, with the larger one at bedtime.
- Extended-release capsules: do not crush or chew; food does not significantly change absorption.
- Stopping: lower the dose gradually rather than quitting suddenly.
Follow your prescriber's directions and your label.
Dosing details from the FDA-approved label
From the Fluvoxamine prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Adults (OCD)
- Starting dose 50 mg administered as a single daily dose at bedtime
- Increase in 50 mg increments every 4 to 7 days, as tolerated, until maximum therapeutic benefit is achieved
- 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
- Maximum: 300 mg per day
- Children and adolescents (ages 8 to 17 years)
- Starting dose 25 mg administered as a single daily dose at bedtime
- Increase in 25 mg increments every 4 to 7 days, as tolerated, until maximum therapeutic benefit is achieved
- Total daily dose of more than 50 mg should be given in two divided doses
- If not equal, the larger dose should be given at bedtime
- Maximum: 200 mg/day (8 to 11 years); 300 mg/day (12 to 17 years)
- Consider age and gender differences; therapeutic effect in female children may be achieved with lower doses.
- Elderly or hepatically impaired patients
- Decreased clearance has been observed
- It may be appropriate to modify the initial dose and the subsequent dose titration
- Decreased clearance in elderly and hepatic impairment
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION • Adults: Recommended starting dose is 50 mg at bedtime, with increases of 50 mg every 4 to 7 days as tolerated to maximum effect, not to exceed 300 mg/day. Daily doses over 100 mg should be divided ( 2.1 ). • Children and adolescents (8 to 17 years): Recommended starting dose is 25 mg at bedtime, with increases of 25 mg every 4 to 7 days as tolerated to maximum effect, not to exceed 200 mg/day (8 to 11 years) or 300 mg/day (12 to 17 years). Daily doses over 50 mg should be divided ( 2.2 ). • Hepatically impaired: Decreased clearance may require modified dose and titration ( 2.3 ). • Extended treatment: Adjust dose to maintain lowest effective dose; reassess patients periodically ( 2.6 ). • Discontinuation: Gradual dose reduction is recommended ( 2.7 , 5.9 ). 2.1 Adults The recommended starting dose for fluvoxamine maleate tablets in adult patients is 50 mg, administered as a single daily dose at bedtime. In the controlled clinical trials establishing the effectiveness of fluvoxamine maleate tablets in OCD, patients were titrated within a dose range of 100 to 300 mg/day. Consequently, the dose should be increased in 50 mg increments every 4 to 7 days, as tolerated, until maximum therapeutic benefit is achieved, not to exceed 300 mg per day. It is advisable that 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. 2.2 Pediatric Population (children and adolescents) The recommended starting dose for fluvoxamine maleate tablets in pediatric populations (ages 8 to 17 years) is 25 mg, administered as a single daily dose at bedtime. In a controlled clinical trial establishing the effectiveness of fluvoxamine maleate tablets in OCD, pediatric patients (ages 8 to 17) were titrated within a dose range of 50 to 200 mg/day. Physicians should consider age and gender differences when dosing pediatric patients. The maximum dose in children up to age 11 should not exceed 200 mg/day. Therapeutic effect in female children may be achieved with lower doses. Dose adjustment in adolescents (up to the adult maximum dose of 300 mg) may be indicated to achieve therapeutic benefit. The dose should be increased in 25 mg increments every 4 to 7 days, as tolerated, until maximum therapeutic benefit is achieved.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Fluvoxamine side effects
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The most common side effects in studies were:
Common side effects
- Nausea
- Diarrhea
- Sleepiness (somnolence)
- Weakness or lack of energy (asthenia)
- Loss of appetite
- Sweating
- Tremor (shaking)
- Sexual side effects such as abnormal ejaculation, anorgasmia or decreased libido
When to get medical help
- New or worsening depression, suicidal thoughts or behavior, or unusual changes in behavior, especially early in treatment or after a dose change
- Signs of serotonin syndrome, a dangerous reaction from too much serotonin, especially if you take other serotonin-affecting drugs
- Unusual bleeding or bruising, especially if you also take NSAIDs, aspirin or warfarin
- Symptoms of mania or hypomania (unusually high energy or elevated mood)
- New seizures, or seizures that become more frequent
- Symptoms of low sodium (hyponatremia), which may be more likely in older adults
- Eye pain or symptoms of angle closure glaucoma, particularly if you have narrow eye angles
- Withdrawal-type symptoms if the medicine is stopped suddenly
Fluvoxamine warnings and precautions
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- Boxed warning: antidepressants raise the risk of suicidal thoughts and behavior in children, teens and young adults.
- Serotonin syndrome, especially with other serotonin-affecting drugs.
- Increased bleeding risk, particularly with NSAIDs, aspirin or warfarin.
- Mania or hypomania, seizures and low sodium (hyponatremia).
- Angle closure glaucoma in people with narrow eye angles.
- Withdrawal-type symptoms if stopped abruptly.
Fluvoxamine interactions
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Fluvoxamine affects several liver enzymes, so it interacts with many drugs.
- Thioridazine, tizanidine, pimozide, alosetron, ramelteon: must not be combined.
- MAOIs, linezolid, IV methylene blue: serotonin syndrome risk.
- Warfarin: higher levels and longer clotting times.
- Theophylline: slower clearance, so lower dose needed.
- Methadone, clozapine, mexiletine, benzodiazepines: levels or effects can change.
- Triptans, lithium, tryptophan: more serotonin effects.
- Tricyclic antidepressants, carbamazepine, tacrine, diltiazem, propranolol, metoprolol: monitoring or dose changes.
- Alcohol: avoid.
Interactions listed in the FDA-approved label
From the Fluvoxamine prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Carbamazepine: Elevated carbamazepine levels and symptoms of toxicity have been reported with coadministration.
- Sumatriptan: Rare postmarketing reports of weakness, hyperreflexia, and incoordination following use of an SSRI and sumatriptan. If concomitant treatment is clinically warranted, appropriate observation of the patient is advised.
- Tacrine: Coadministration increased tacrine Cmax and AUC 5- and 8-fold and caused nausea, vomiting, sweating, and diarrhea.
- Tricyclic antidepressants (TCAs): Significantly increased plasma TCA levels have been reported with amitriptyline, clomipramine or imipramine. Use caution; plasma TCA concentrations may need to be monitored and the TCA dose may need to be reduced.
- Tryptophan: Severe vomiting has been reported with coadministration; tryptophan may enhance the serotonergic effects of fluvoxamine. Use the combination with caution.
- Diltiazem: Bradycardia has been reported with coadministration.
- Propranolol or metoprolol: Propranolol minimum plasma concentrations rose a mean five-fold; bradycardia and hypotension and orthostatic hypotension reported with metoprolol. Reduce the initial beta-blocker dose and titrate more cautiously.
- Lithium: Lithium may enhance the serotonergic effects of fluvoxamine; seizures have been reported with coadministration. Use the combination with caution.
- Lorazepam: No significant pharmacokinetic interaction; coadministration did not produce larger decrements in cognitive functioning than lorazepam alone.
- Atenolol: Did not affect the plasma concentrations of atenolol.
Read the label’s full interactions text
7 DRUG INTERACTIONS Drug Interactions (not described in Contraindications or Warnings and Precautions) include the following: Drugs Inhibiting or Metabolized by Cytochrome P450: Fluvoxamine inhibits several cytochrome P450 isoenzymes (CYP1A2, CYP2C9, CYP3A4, and CYP2C19) ( 7.1 ) . Carbamazepine: Elevated carbamazepine levels and symptoms of toxicity with coadministration ( 7.2 ) . Sumatriptan: Rare postmarketing reports of weakness, hyperreflexia, and incoordination following use of an SSRI and sumatriptan. Monitor appropriately if concomitant treatment is clinically warranted ( 7.2 ) . Tacrine: Coadministration increased tacrine C max and AUC five- and eight-fold and caused nausea, vomiting, sweating, and diarrhea ( 7.2 ). Tricyclic Antidepressants (TCAs): Coadministration significantly increased plasma TCA levels. Use caution; monitor plasma TCA levels; reduce TCA dose if indicated ( 7.2 ) . Tryptophan: Severe vomiting with coadministration ( 7.2 ) . Diltiazem: Bradycardia with coadministration ( 7.3 ) . Propranolol or Metoprolol : Reduce dose if coadministered with fluvoxamine and titrate more cautiously ( 7.3 ) . 7.1 Potential Interactions with Drugs that Inhibit or are Metabolized by Cytochrome P450 Isoenzymes Multiple hepatic cytochrome P450 isoenzymes are involved in the oxidative biotransformation of a large number of structurally different drugs and endogenous compounds. The available knowledge concerning the relationship of fluvoxamine and the cytochrome P450 isoenzyme system has been obtained mostly from pharmacokinetic interaction studies conducted in healthy volunteers, but some preliminary in vitro data are also available.
Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Fluvoxamine
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- Bipolar disorder: screen before starting.
- Epilepsy: avoid in unstable epilepsy.
- Liver problems: may need a lower dose and slower increases.
- Older adults: may need a lower starting dose and slow increases.
- Children: approved only for OCD; monitor weight and growth.
- Pregnancy: late-pregnancy use may cause newborn complications.
- Breastfeeding: passes into milk; watch the baby for diarrhea, vomiting, poor sleep and agitation.
Fluvoxamine overdose
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Overdose can cause nausea, vomiting, diarrhea, sleepiness, coma, low blood pressure, fast heart rate, breathing difficulty and seizures. Deaths have been reported, mostly with other drugs. Seek emergency care or call poison control right away. There is no specific antidote; treatment is supportive.
What Fluvoxamine does in the body
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In lab studies, fluvoxamine had no significant affinity for histamine, alpha or beta adrenergic, muscarinic or dopamine receptors. Blocking those receptors is linked to sedation, heart effects and other side effects of some psychiatric drugs.
How your body processes Fluvoxamine
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Fluvoxamine is extensively broken down by the liver and cleared mostly in urine as metabolites. Extended-release capsules had a lower peak level than tablets. The half-life after a single capsule dose was about 16 hours. Levels were higher in women and older adults. Steady state is reached within about a week.
How to store Fluvoxamine
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Keep out of reach of children. Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). Protect from high humidity and avoid exposure to temperatures above 30°C (86°F).
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Fluvoxamine
193 supplements and herbal products have documented interactions with Fluvoxamine in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 2
- Moderate · 151
- Minor · 40
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Nutrient depletion considerations
Fluvoxamine has been associated with lower levels of 1 nutrient in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.
Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.
Fluvoxamine: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Fluvoxamine — the kind of thing our pharmacy team would talk through with you at the counter.
What is fluvoxamine for?
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How should I take it?
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What side effects should I expect?
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Can I stop it when I feel better?
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Does it interact with my other medicines?
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Is it safe in pregnancy?
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Is Fluvoxamine available over the counter?
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When was Fluvoxamine first available?
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Who makes Fluvoxamine?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Fluvoxamine on HelloPharmacist
Fluvoxamine forms and strengths (how it comes)
Fluvoxamine is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Fluvoxamine maleate tablets are indicated for obsessions and compulsions in OCD.
- Fluvoxamine maleate tablets were studied in adults and in children and adolescents ages 8 to 17.
- Fluvoxamine maleate tablets are started at bedtime, with increases every several days as tolerated.
- Fluvoxamine maleate tablet doses above a set daily amount are split into two doses, with the larger dose at bedtime if unequal.
- Fluvoxamine maleate tablets should be lowered gradually when stopping.
Extended-release capsule
How this form is used
- Fluvoxamine maleate extended-release capsules are indicated for obsessive compulsive disorder (OCD).
- Fluvoxamine maleate extended-release capsules were shown effective in a 12-week adult trial.
- Fluvoxamine maleate extended-release capsules are started at bedtime, with weekly increases as tolerated.
- Fluvoxamine maleate extended-release capsules should not be crushed or chewed.
- Fluvoxamine maleate extended-release capsules can be taken with food; food does not significantly affect absorption.
- Fluvoxamine maleate extended-release capsules may need slower dose increases in older adults or people with liver problems.
Fluvoxamine on the U.S. market: products, makers and brands
How Fluvoxamine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
18 companies list 44 Fluvoxamine product records with the FDA, mostly as tablet, extended-release capsule; the earliest marketing or approval year on record is 1994. Brand names on the directory include Luvox, Luvox CR; the rest are generics.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (7) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Fluvoxamine is used (Medicaid data)
A general measure of how commonly Fluvoxamine is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Fluvoxamine is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Fluvoxamine prescribed? Of the 1,601 medications we measure, Fluvoxamine ranks #311 by Medicaid prescriptions — more than 81% of them.
Utilization by Fluvoxamine product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
fluvoxamine maleate 100 MG Oral Tablet Most dispensed
Summed across the 5 of 37 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 903884
fluvoxamine maleate 50 MG Oral Tablet
Summed across the 4 of 21 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 903891
fluvoxamine maleate 25 MG Oral Tablet
Summed across the 4 of 13 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 903887
24 HR fluvoxamine maleate 150 MG Extended Release Oral Capsule
Summed across the 4 of 10 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 903879
24 HR fluvoxamine maleate 100 MG Extended Release Oral Capsule
Summed across the 4 of 9 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 903873
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Fluvoxamine, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 21 of 90 listed Fluvoxamine NDCs with Medicaid activity.
Compare Fluvoxamine products
A representative set of FDA-listed product records for Fluvoxamine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Extended-release capsule | ||||
| 100 mg | Oral | Actavis Pharma, Inc. | ANDA | View NDC → |
| 150 mg | Oral | Actavis Pharma, Inc. | ANDA | View NDC → |
| 100 mg | Oral | Ajanta Pharma USA Inc. | ANDA | View NDC → |
| 150 mg | Oral | Ajanta Pharma USA Inc. | ANDA | View NDC → |
| 100 mg | Oral | AvKARE | ANDA | View NDC → |
| 150 mg | Oral | AvKARE | ANDA | View NDC → |
| 100 mg | Oral | Bionpharma Inc. | ANDA | View NDC → |
| 150 mg | Oral | Bionpharma Inc. | ANDA | View NDC → |
| 100 mg | Oral | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
| 150 mg | Oral | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
| 100 mg | Oral | Endo USA, Inc. | ANDA | View NDC → |
| 150 mg | Oral | Endo USA, Inc. | ANDA | View NDC → |
| 100 mg | Oral | Upsher-Smith Laboratories, LLC | ANDA | View NDC → |
| 150 mg | Oral | Upsher-Smith Laboratories, LLC | ANDA | View NDC → |
| 100 mg | Oral | Zydus Lifesciences Limited | ANDA | View NDC → |
| 150 mg | Oral | Zydus Lifesciences Limited | ANDA | View NDC → |
| 100 mg | Oral | Zydus Pharmaceuticals USA Inc. | ANDA | View NDC → |
| 150 mg | Oral | Zydus Pharmaceuticals USA Inc. | ANDA | View NDC → |
| 💊Tablet | ||||
| 100 mg | Oral | A-S Medication Solutions | ANDA | View NDC → |
| 100 mg | Oral | A-S Medication Solutions | NDA AUTHORIZED GENERIC | View NDC → |
| 50 mg | Oral | American Health Packaging | ANDA | View NDC → |
| 25 mg | Oral | ANI Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | View NDC → |
| 50 mg | Oral | ANI Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | View NDC → |
| 100 mg | Oral | ANI Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | View NDC → |
| 25 mg | Oral | Apotex Corp | ANDA | View NDC → |
| 50 mg | Oral | Apotex Corp | ANDA | View NDC → |
| 100 mg | Oral | Apotex Corp | ANDA | View NDC → |
| 25 mg | Oral | Bionpharma Inc. × 2 listings | ANDA | View NDC → |
| 50 mg | Oral | Bionpharma Inc. | ANDA | View NDC → |
| 100 mg | Oral | Bionpharma Inc. × 2 listings | ANDA | View NDC → |
| 50 mg | Oral | Bryant Ranch Prepack | ANDA | View NDC → |
| 100 mg | Oral | Bryant Ranch Prepack × 2 listings | ANDA | View NDC → |
| 25 mg | Oral | Chartwell RX, LLC | ANDA | View NDC → |
| 50 mg | Oral | Chartwell RX, LLC | ANDA | View NDC → |
| 100 mg | Oral | Chartwell RX, LLC | ANDA | View NDC → |
| 100 mg | Oral | PD-Rx Pharmaceuticals, Inc. | ANDA | View NDC → |
| 100 mg | Oral | Preferred Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | View NDC → |
| 100 mg | Oral | Preferred Pharmaceuticals Inc. × 2 listings | ANDA | View NDC → |
| 50 mg | Oral | Remedyrepack Inc. | NDA AUTHORIZED GENERIC | View NDC → |
| 100 mg | Oral | Remedyrepack Inc. | NDA AUTHORIZED GENERIC | View NDC → |
Showing 44 of 44 products — FDA National Drug Code Directory. See every product, package size and price: browse all 44 Fluvoxamine NDCs →
Fluvoxamine side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Fluvoxamine — a signal of what to watch for, not proof the drug caused it.
The effects most often named in FDA reports that mention Fluvoxamine are drug interaction, nausea, somnolence; about 78% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Fluvoxamine in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Fluvoxamine FDA approval history
How Fluvoxamine went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Fluvoxamine was first approved by the FDA in 1994 (Brand: LUVOX · Solvay); the first generic version was approved in 2000. It remains available in U.S. pharmacies today.
Source: Drugs@FDA.
Fluvoxamine recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Fluvoxamine recalls since July 2021.
✅No Fluvoxamine recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 42355 2 dose forms · 5 strengths
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Dose form (SCDF) Extended Release Oral Capsule RxCUI 790408In current FDA listingsClinical drug / strength (SCD) 24 HR fluvoxamine maleate 100 MGRxCUI 90387324 HR fluvoxamine maleate 150 MGRxCUI 903879 -
Dose form (SCDF) Oral Tablet RxCUI 372256In current FDA listingsClinical drug / strength (SCD) maleate 100 MGRxCUI 903884maleate 25 MGRxCUI 903887maleate 50 MGRxCUI 903891
Look up RxCUI 42355 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Fluvoxamine supply and shortage status
Whether Fluvoxamine is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
💵 What Fluvoxamine costs pharmacies (NADAC benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Capsule, Extended Release · Oral | 100 mg | $4.08 per capsule | NDC details & price history |
| Capsule, Extended Release · Oral | 150 mg | $3.97 per capsule | NDC details & price history |
| Tablet · Oral | 50 mg | $0.195 per tablet | NDC details & price history |
| Tablet · Oral | 25 mg | $0.151 per tablet | NDC details & price history |
| Tablet, Coated · Oral | 50 mg | $0.195 per tablet | NDC details & price history |
| Tablet, Coated · Oral | 25 mg | $0.151 per tablet | NDC details & price history |
| Tablet, Film Coated · Oral | 100 mg | $0.245 per tablet | NDC details & price history |
| Tablet, Film Coated · Oral | 25 mg | $0.151 per tablet | NDC details & price history |
| Tablet, Film Coated · Oral | 50 mg | $0.195 per tablet | NDC details & price history |
| Capsule, Extended Release | 150 mg | $3.97 per capsule | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Fluvoxamine brand names
Fluvoxamine is sold under 2 brand names in the FDA directory — Luvox, Luvox CR. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Fluvoxamine: manufacturers and labelers
18 companies list Fluvoxamine products with the FDA. By number of product records, the largest are Bionpharma Inc., ANI Pharmaceuticals, Inc., Apotex Corp. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Fluvoxamine drug class (RxNorm)
Fluvoxamine belongs to the Serotonin Reuptake Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Fluvoxamine page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. ANI Pharmaceuticals, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →