Prescription medicine
Fluvoxamine First approved as Luvox
Fluvoxamine (Luvox) is a prescription medicine with an FDA approval on record since 1994. FDA's NDC Directory lists it from 16 generic labelers, and pharmacies paid $4.08 per fluvoxamine ER 100 mg capsule in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the fluvoxamine FDA label on DailyMed (effective June 27, 2026, Zydus Pharmaceuticals USA Inc.); the NDA 20243 record on Drugs@FDA; every fluvoxamine label on DailyMed.
Highlights of the record
FDA label of June 27, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS.
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 extended-release capsules 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. (See Warnings and Precautions-Clinical Worsening and Suicide Risk [ 5.1 ] and Use in Specific Populations-Pediatric Use [ 8.4 ].) WARNING: SUICIDALITY and ANTIDEPRESSANTS See full prescribing information for complete boxed warning. […]
Used for
From the label: indications and usageFluvoxamine maleate extended-release capsules are a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of obsessive compulsive disorder (OCD) ( 1 ).
Forms and strengths
- 25 mg
- 50 mg
- 100 mg
- 150 mg
Extended-release capsule; tablet; coated tablet; film-coated tablet.
On the market
- Earliest approval on file
- December 5, 1994 Luvox, Solvay; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 23 first November 29, 2000; 11 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 19 of which 16 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $4.08 per capsule Fluvoxamine ER 100 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 2,391 through July 30, 2026
What is fluvoxamine used for?
From the label: indications and usageFluvoxamine maleate extended-release capsules are a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of obsessive compulsive disorder (OCD) ( 1 ). Efficacy was demonstrated in: One 12-week study with fluvoxamine maleate extended-release capsules in adults ( 14.1 ). Two 10-week studies with immediate-release (IR) fluvoxamine tablets in adults and one 10-week study with IR fluvoxamine tablets in children and adolescents ( 14.1 , 14.3 ). One maintenance study with IR fluvoxamine tablets ( 14.2 ). 1.1 Obsessive Compulsive Disorder Fluvoxamine maleate extended-release capsules are indicated for the treatment of obsessive compulsive disorder (OCD), as defined in the DSM-IV. […]
FDA pharmacologic class: Serotonin Reuptake Inhibitor.
Source: FDA drug label (Fluvoxamine maleate extended-release), Zydus Pharmaceuticals USA Inc., effective June 27, 2026 (SPL set 6c71d4f6-54b5-4d3a-8d2f-b7773c92c32e), via openFDA; the full label on DailyMed
What does the patient leaflet for fluvoxamine say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about fluvoxamine maleate extended-release capsules?Fluvoxamine maleate extended-release capsules is the same kind of medicine as those used to treat depression. These medicines may cause serious side effects, including: 1 Suicidal thoughts or actions: Fluvoxamine maleate extended-release capsules and other antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers or young adults within the first few months of treatment or when the dose is changed. Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions. Watch for these changes and call your healthcare provider right away if you notice: New or sudden changes in mood, behavior, actions, thoughts or feelings, especially if severe. Pay particular attention to such changes when fluvoxamine maleate extended-release capsule is started or when the dose is changed. Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms. Call your healthcare provider right away if you have any of the following symptoms, or call 911 in an emergency, especially if they are new, worse, or worry you: attempts to commit suicide acting on dangerous impulses acting aggressive or violent thoughts about suicide or dying new or worse depression new or worse anxiety or panic attacks feeling agitated, restless, angry or irritable trouble sleeping an increase in activity or talking more than what is normal for you other unusual changes in behavior or mood Call your healthcare provider right away if you have any of the following symptoms or call 911 in an emergency. Fluvoxamine maleate extended-release capsules may be associated with these serious side effects: 2 Serotonin Syndrome. […]
From the patient leaflet: What should I avoid while taking fluvoxamine maleate extended-release capsules?Fluvoxamine maleate extended-release capsules can cause sleepiness or may affect your ability to make decisions, think clearly or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how fluvoxamine maleate extended-release capsules affect you. Do not drink alcohol while using fluvoxamine maleate extended-release capsules.
From the patient leaflet: How should I store fluvoxamine maleate extended-release capsules?Store fluvoxamine maleate extended-release capsules at 59°F to 86°F (15°C to 30°C). Keep fluvoxamine maleate extended-release capsules away from high temperatures (above 86°F or 30°C) and high humidity (dampness). Fluvoxamine maleate extended-release capsules comes in child resistant bottles of 30's. Keep the fluvoxamine maleate extended-release capsules bottle closed tightly. Keep fluvoxamine maleate extended-release capsules and all medicines out of the reach of children.
Source: FDA drug label (Fluvoxamine maleate extended-release), Zydus Pharmaceuticals USA Inc., effective June 27, 2026 (SPL set 6c71d4f6-54b5-4d3a-8d2f-b7773c92c32e), via openFDA; the full label on DailyMed
Is there a generic for fluvoxamine (Luvox)?
The FDA approved the first generic fluvoxamine on November 29, 2000. 23 generic applications are approved; 11 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists fluvoxamine from 16 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1994 earliest approval on file
- 2000 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for fluvoxamine (Luvox)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $4.08 per Fluvoxamine ER 100 mg capsule, down 21% from $5.18 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Fluvoxamine ER 150 mg capsule (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Fluvoxamine ER 100 mg capsule | Generic | $4.08 per capsule many times the lowest per-tablet cost; NADAC records the price, not why | $122.33 | -21% |
| Fluvoxamine ER 150 mg capsule | Generic | $3.97 per capsule many times the lowest per-tablet cost; NADAC records the price, not why | $119.21 | -25% |
| Fluvoxamine maleate 100 mg tablet | Generic | $0.245 per tablet | $7.34 | -6% |
| Fluvoxamine maleate 25 mg tablet | Generic | $0.151 per tablet | $4.54 | -24% |
| Fluvoxamine maleate 50 mg tablet | Generic | $0.195 per tablet | $5.86 | -17% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the fluvoxamine label say about other medicines?
The fluvoxamine label names 41 other medicines in its interaction, contraindication or warning sections. The labels of 39 other medicines name fluvoxamine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Alosetron | contraindications | CONTRAINDICATIONS Coadministration of thioridazine, tizanidine, pimozide, alosetron, or ramelteon with fluvoxamine maleate extended-release capsules is contraindicated (see Warnings and Precautions [ 5.4 to 5.8 ] ). |
| Alprazolam | drug interactions | CYP1A2 (e.g., warfarin, theophylline, propranolol, tizanidine), CYP2C9 (e.g., warfarin), CYP3A4 (e.g., alprazolam), and CYP2C19 (e.g., omeprazole). |
| Aminophylline | warnings and precautions | Theophylline: The effect of steady-state immediate-release fluvoxamine maleate tablets (50 mg tablets given twice daily) on the pharmacokinetics of a single dose of theophylline (375 mg as 442 mg aminophylline) was evaluated in 12 healthy non-smoking, male volunteers. |
| Amitriptyline | drug interactions | Tricyclic Antidepressants (TCAs): Significantly increased plasma TCA levels have been reported with the coadministration of immediate-release fluvoxamine maleate tablets and amitriptyline, clomipramine or imipramine. |
| Aspirin | drug interactions | Warfarin and Other Drugs that Interfere with Hemostasis (NSAIDs, Aspirin, etc.): See Warnings and Precautions ( 5.9 , 5.11 ). |
| Atenolol | drug interactions | Coadministration of immediate-release fluvoxamine maleate tablets 100 mg per day with atenolol 100 mg per day (N=6) did not affect the plasma concentrations of atenolol. |
| Buspirone | warnings and precautions | … (including triptans, tricyclic antidepressants, fentanyl, meperidine, methadone, lithium, tramadol, tryptophan, buspirone, amphetamines and St. John's Wort) and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid … |
| Carbamazepine | drug interactions | Carbamazepine: Elevated carbamazepine levels and symptoms of toxicity with coadministration ( 7.2 ). |
| Clomipramine | drug interactions | Tricyclic Antidepressants (TCAs): Significantly increased plasma TCA levels have been reported with the coadministration of immediate-release fluvoxamine maleate tablets and amitriptyline, clomipramine or imipramine. |
| Clozapine | warnings and precautions | Elevated serum levels of clozapine have been reported in patients taking immediate-release fluvoxamine maleate tablets and clozapine. |
| Dextromethorphan | drug interactions | Such individuals have been referred to as "poor metabolizers" (PM) of drugs such as debrisoquin, dextromethorphan and tricyclic antidepressants. |
| Diazepam | warnings and precautions | Because fluvoxamine reduces the clearance of both diazepam and its active metabolite, N-desmethyldiazepam, there is a strong likelihood of substantial accumulation of both species during chronic coadministration. |
| Digoxin | drug interactions | Administration of immediate-release fluvoxamine maleate tablets 100 mg daily for 18 days (N=8) did not significantly affect the pharmacokinetics of a 1.25 mg single intravenous dose of digoxin. |
| Diltiazem | drug interactions | Bradycardia has been reported with the coadministration of immediate-release fluvoxamine maleate tablets and diltiazem. |
Every other medicine the fluvoxamine label names
| Medicine named | Section | What the label says |
|---|---|---|
| Fentanyl | warnings and precautions | … serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, meperidine, methadone, lithium, tramadol, tryptophan, buspirone, amphetamines and St. … |
| Imipramine | drug interactions | … immediate-release fluvoxamine maleate tablets and amitriptyline, clomipramine or imipramine. |
| Ketoconazole | drug interactions | The metabolism of fluvoxamine has not been fully characterized and the effects of potent cytochrome P450 isoenzyme inhibition, such as the ketoconazole inhibition of CYP3A4, on fluvoxamine metabolism … |
| Linezolid | contraindications | Starting fluvoxamine maleate extended-release capsules in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased … |
| Lithium | drug interactions | As with other serotonergic drugs, lithium may enhance the serotonergic effects of fluvoxamine and, therefore, the combination should be used with caution. |
| Lorazepam | drug interactions | … twice daily) in healthy male volunteers (N=12) and a single dose of lorazepam (4 mg single dose) indicated no significant pharmacokinetic interaction. |
| Meperidine | warnings and precautions | … serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, meperidine, methadone, lithium, tramadol, tryptophan, buspirone, amphetamines and St. … |
| Methadone | warnings and precautions | … (including triptans, tricyclic antidepressants, fentanyl, meperidine, methadone, lithium, tramadol, tryptophan, buspirone, amphetamines and St. … |
| Methylene blue | contraindications | Starting fluvoxamine maleate extended-release capsules in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased … |
| Metoprolol | drug interactions | Propranolol or Metoprolol: Reduce dose if coadministered with fluvoxamine and titrate more cautiously ( 7.3 ). |
| Mexiletine | warnings and precautions | The clearance of mexiletine was reduced by 38% following coadministration with fluvoxamine compared to mexiletine alone. |
| Midazolam | warnings and precautions | Other Potentially Important Drug Interactions Benzodiazepines: Benzodiazepines metabolized by hepatic oxidation (e.g., alprazolam, midazolam, triazolam, etc.) should be used with caution because the … |
| Omeprazole | drug interactions | A clinically significant fluvoxamine interaction is possible with drugs having a narrow therapeutic ratio such as pimozide, warfarin, theophylline, certain benzodiazepines, omeprazole, and phenytoin. |
| Oxazepam | warnings and precautions | The clearance of benzodiazepines metabolized by glucuronidation (e.g., lorazepam, oxazepam, temazepam) is unlikely to be affected by fluvoxamine. |
| Phenytoin | drug interactions | A clinically significant fluvoxamine interaction is possible with drugs having a narrow therapeutic ratio such as pimozide, warfarin, theophylline, certain benzodiazepines, omeprazole, and phenytoin. |
| Pimozide | contraindications | CONTRAINDICATIONS Coadministration of thioridazine, tizanidine, pimozide, alosetron, or ramelteon with fluvoxamine maleate extended-release capsules is contraindicated (see Warnings and Precautions [ … |
| Propranolol | drug interactions | Propranolol or Metoprolol: Reduce dose if coadministered with fluvoxamine and titrate more cautiously ( 7.3 ). |
| Quinidine | drug interactions | Caution is indicated in patients known to have reduced levels of cytochrome P450 2D6 activity and those receiving concomitant drugs known to inhibit this cytochrome P450 isoenzyme (e.g., quinidine). |
| Ramelteon | contraindications | CONTRAINDICATIONS Coadministration of thioridazine, tizanidine, pimozide, alosetron, or ramelteon with fluvoxamine maleate extended-release capsules is contraindicated (see Warnings and Precautions [ … |
| Sumatriptan | drug interactions | Sumatriptan - There have been rare postmarketing reports describing patients with weakness, hyperreflexia and incoordination following the use of a selective serotonin reuptake inhibitor (SSRI) and … |
| Temazepam | warnings and precautions | The clearance of benzodiazepines metabolized by glucuronidation (e.g., lorazepam, oxazepam, temazepam) is unlikely to be affected by fluvoxamine. |
| Theophylline | drug interactions | A clinically significant fluvoxamine interaction is possible with drugs having a narrow therapeutic ratio such as pimozide, warfarin, theophylline, certain benzodiazepines, omeprazole, and phenytoin. |
| Thioridazine | contraindications | CONTRAINDICATIONS Coadministration of thioridazine, tizanidine, pimozide, alosetron, or ramelteon with fluvoxamine maleate extended-release capsules is contraindicated (see Warnings and Precautions [ … |
| Tizanidine | contraindications | CONTRAINDICATIONS Coadministration of thioridazine, tizanidine, pimozide, alosetron, or ramelteon with fluvoxamine maleate extended-release capsules is contraindicated (see Warnings and Precautions [ … |
| Tramadol | warnings and precautions | … tricyclic antidepressants, fentanyl, meperidine, methadone, lithium, tramadol, tryptophan, buspirone, amphetamines and St. … |
| Triazolam | warnings and precautions | Other Potentially Important Drug Interactions Benzodiazepines: Benzodiazepines metabolized by hepatic oxidation (e.g., alprazolam, midazolam, triazolam, etc.) should be used with caution because the … |
| Warfarin | drug interactions | A clinically significant fluvoxamine interaction is possible with drugs having a narrow therapeutic ratio such as pimozide, warfarin, theophylline, certain benzodiazepines, omeprazole, and phenytoin. |
Other labels that name fluvoxamine
Source: FDA drug label (Fluvoxamine maleate extended-release), Zydus Pharmaceuticals USA Inc., effective June 27, 2026 (SPL set 6c71d4f6-54b5-4d3a-8d2f-b7773c92c32e), via openFDA; the full label on DailyMed
What do FAERS reports show for fluvoxamine?
The FDA Adverse Event Reporting System holds 2,391 reports that list fluvoxamine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 256 are coded as a death and 908 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Alternatives to fluvoxamine
- medicines labeled for the same conditions
- Other serotonin reuptake inhibitors
- the pharmacologic class, with prices and generics
- Fluvoxamine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other