Last reviewed · How we verify
Luvox (FLUVOXAMINE)
Luvox works by blocking the reabsorption of serotonin in the brain, allowing more of this neurotransmitter to be available for communication between nerve cells.
Fluvoxamine (Luvox) is a marketed selective serotonin reuptake inhibitor (SSRI) primarily indicated for the treatment of Obsessive Compulsive Disorder (OCD). Its key strength lies in its mechanism of action, which effectively blocks the reabsorption of serotonin, enhancing neurotransmitter availability and communication between nerve cells. The primary risk is the significant competition from off-patent generics, including fluoxetine, citalopram, sertraline, and escitalopram, which may erode market share despite Fluvoxamine's patent protection until 2028.
At a glance
| Generic name | FLUVOXAMINE |
|---|---|
| Sponsor | Ani Pharms |
| Drug class | Serotonin Reuptake Inhibitor |
| Target | Sodium-dependent serotonin transporter |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 1994 |
Mechanism of action
The mechanism of action of fluvoxamine maleate in obsessive compulsive disorder is presumed to be linked to its specific serotonin reuptake inhibition in brain neurons. Fluvoxamine has been shown to be potent inhibitor of the serotonin reuptake transporter in preclinical studies, both in-vitro and in-vivo.
Approved indications
- Obsessive Compulsive Disorder (OCD)
Boxed warnings
- 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. Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants for major depressive disorder and other psychiatric disorders ( 5.1 ).
Common side effects
- Nausea
- Somnolence
- Insomnia
- Asthenia
- Nervousness
- Dyspepsia
- Abnormal ejaculation
- Sweating
- Anorexia
- Tremor
- Vomiting
- Anorgasmia
Drug interactions
- Fluvoxamine
- Carbamazepine
- Sumatriptan
- Tacrine
- Tricyclic Antidepressants (TCAs)
- Tryptophan
- Diltiazem
- Propranolol or Metoprolol
Key clinical trials
- Mitigating Delirium With Fluvoxamine Treatment for Non-Cardiac Surgery (PHASE3)
- sElective Serotonin reuPtake inhibitoRs In posT-covid After COVID-19 (PHASE3)
- Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants
- Effect of SC-ICBT for Adults With OCD:A Three-Arm Randomized Controlled Trial (NA)
- Reducing Maximal Support in OCD: Efficacy of Stepped-Care Online CBT (NA)
- Fluvoxamine for Long COVID-19 (PHASE2,PHASE3)
- ACTIV-6: COVID-19 Study of Repurposed Medications (PHASE3)
- To Determine the Effect of KP-001 on Rosuvastatin, Caffeine PK and the Effect of Fluvoxamine on KP-001 PK in Volunteers (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |