pharmacopeia
GET
/api/v1/drug/fluvoxamine

Boxed 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.

2D structure
2-[(E)-[5-methoxy-1-[4-(trifluoromethyl)phenyl]pentylidene]amino]oxyethanamine
SMILES COCCCC/C(=N\OCCN)/C1=CC=C(C=C1)C(F)(F)F
InChIKey CJOFXWAVKWHTFT-XSFVSMFZSA-N

Mechanism of action

Sourced from openFDA

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 a potent inhibitor of the serotonin reuptake transporter in preclinical studies, both in vitro and in vivo .

Monoamine OxidaseSerotonin Uptake

Indications

Sourced from openFDA
  • Fluvoxamine maleate extended-release capsules is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of obsessive compulsive disorder (OCD) ( 1 ). Efficacy was demonstrated in: One 12-week study fluvoxamine maleate extended-release capsules in adults ( 14.1 ).ICD-10: F42.9

Contraindications

Sourced from openFDA
  • Coadministration of thioridazine, tizanidine, pimozide, alosetron, or ramelteon with fluvoxamine maleate extended-release capsules is contraindicated ( see WARNINGS AND PRECAUTIONS [ 5.4 - 5.8 ] ) . Coadministration of thioridazine, tizanidine, pimozide, alosetron, or ramelteon ( 4 ).contraindicated

Dosage & administration

Sourced from openFDA

Adults: Recommended starting dose is 100 mg at bedtime, with weekly increases of 50 mg as tolerated to maximum effect, not to exceed 300 mg/day ( 2.1 ) . Pediatric patients naïve to fluvoxamine maleate: The lowest available dose of fluvoxamine maleate extended-release capsules may not be appropriate ( 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 ( 2.4 ) . Discontinuation: Gradual dose reduction is recommended ( 2.7 , see Warnings and Precautions [ 5.10 ] ). 2.1 OCD (Obsessive Compulsive Disorder) The recommended starting dose is 100 mg at bedtime, with weekly increases of 50 mg as tolerated to maximum therapeutic benefit, not to exceed 300 mg per day. Capsules should not be crushed or chewed. 2.2 Pediatric Patients Naïve to Fluvoxamine Maleate Physicians should consider that the lowest available dose of fluvoxamine maleate extended-release capsules may not be appropriate for pediatric patients naïve to fluvoxamine maleate. 2.3 Dosage for Elderly or Hepatically Impaired Patients Elderly patients and those with hepatic impairment have been observed to have a decreased clearance of fluvoxamine maleate. Consequently, it may be appropriate to titrate slowly following the initial dose of 100 mg in these patient groups.

Warnings & precautions

Sourced from openFDA

Clinical Worsening/Suicide Risk: Monitor for clinical worsening of suicidal thoughts/behaviors especially during the initial months of therapy and at times of dose changes ( 5.1 ). Bipolar Disorder: Screen for bipolar disorder ( 5.1 ). Serotonin Syndrome: Serotonin syndrome has been reported with SSRIs and SNRIs, including fluvoxamine maleate extended-release capsules, both when taken alone, but especially when co-administered with other serotonergic agents. If such symptoms occur, discontinue fluvoxamine maleate extended-release capsules and serotonergic agents and initiate supportive treatment. If concomitant use of fluvoxamine maleate extended-release capsules with other serotonergic drugs is clinically warranted, patients should be made aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases ( 5.2 ). Angle Closure Glaucoma: Angle closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants ( 5.3 ). Other Potentially Important Drug Interactions: Benzodiazepines : Use with caution. Coadministration with diazepam is generally not advisable ( 5.9 ). Clozapine: Clozapine levels may be increased and produce orthostatic hypotension or seizures ( 5.9 ). Methadone: Coadministration may produce opioid intoxication. Discontinuation of fluvoxamine may produce opioid withdrawal ( 5.9 ). Mexiletine: Monitor serum mexiletine levels ( 5.9 ). Theophylline: Clearance decreased; reduce theophylline dose by one-third ( 5.9 ).

Adverse reactions

Sourced from openFDA

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Most common reactions in controlled trials with OCD patients and patients from another studied population (incidence ≥5% and at least twice that for placebo) were abnormal ejaculation, anorexia, anorgasmia, asthenia, diarrhea, nausea, somnolence, sweating and tremor ( 6.2 ) . The following additional reactions occurred: anxiety, decreased libido, myalgia, pharyngitis, and vomiting in the OCD population; and dyspepsia, dizziness, insomnia, and yawning in another studied population. To report SUSPECTED ADVERSE REACTIONS, contact Ajanta Pharma USA Inc., at 855-664-7744 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Data Sources Fluvoxamine maleate extended-release capsules were studied in one 12-week controlled trial in patients with OCD (N = 124; mean exposure 66.6 days) and in two 12-week controlled trials for another condition (N = 279; mean exposure 59.2 days). Patients in these trials were initiated on 100 mg/day and were titrated in 50 mg increments over the first 6 weeks to within a range of 100 mg/day to 300 mg/day. The reactions listed in Table 2 show reactions from the two populations separately. Table 3 shows reactions from the three controlled studies combined.

Use in specific populations

Sourced from openFDA

Specific populations not discussed in Dosage and Administration or Warnings and Precautions include: Pregnancy: Consider both potential risks and benefits when treating a pregnant woman. Infants exposed to SSRIs in pregnancy have developed various complications and may be at risk for persistent pulmonary hypertension of the newborn (PPHN) ( 2.7 , 8.1 ). Nursing mothers: Fluvoxamine is secreted in human breast milk ( 8.3 ). Geriatric: Use of a lower starting dose may be warranted. Titrate slowly during initiation of therapy ( 2.3 , 8.5 ). Smokers: Smokers had a 25% increase in fluvoxamine metabolism ( 7.4 ). 8.1 Pregnancy Teratogenic Effects: When pregnant rats were given daily doses of fluvoxamine (60 mg/kg, 120 mg/kg, or 240 mg/kg) orally throughout the period of organogenesis, developmental toxicity in the form of increased embryofetal death and increased incidences of fetal eye abnormalities (folded retinas) was observed at doses of 120 mg/kg or greater. Decreased fetal body weight was seen at the high dose. The no effect dose for developmental toxicity in this study was 60 mg/kg (approximately 2 time the maximum recommended human dose [MRHD] on a mg/m 2 basis).

Pharmacokinetics

Sourced from openFDA
Metabolism
Bioavailability: A single-dose crossover study in 28 healthy subjects was conducted to compare the pharmacokinetics of fluvoxamine after administration of fluvoxamine maleate extended-release capsules and immediate-release fluvoxamine maleate tablets. In the single-dose crossover study, mean C max was 38% lower and relative bioavailability was 84% for fluvoxamine maleate extended-release capsules versus immediate-release fluvoxamine maleate tablets.

Overdosage

Sourced from openFDA

10.1 Human Experience Exposure to immediate-release fluvoxamine maleate tablets includes over 45,000 patients treated in clinical trials and an estimated exposure of 50,000,000 patients treated during worldwide marketing experience (end of 2005). Of the 539 cases of deliberate or accidental overdose involving fluvoxamine reported from this population, there were 55 deaths. Of these, 9 were in patients thought to be taking immediate-release fluvoxamine tablets alone and the remaining 46 were in patients taking fluvoxamine along with other drugs. Among non-fatal overdose cases, 404 patients recovered completely. Five patients experienced adverse sequelae of overdosage, to include persistent mydriasis, unsteady gait, hypoxic encephalopathy, kidney complications (from trauma associated with overdose), bowel infarction requiring a hemicolectomy, and vegetative state. In 13 patients, the outcome was provided as abating at the time of reporting. In the remaining 62 patients, the outcome was unknown. The largest known ingestion of fluvoxamine immediate-release tablets involved 12,000 mg (equivalent to 2 months to 3 months' dosage). The patient fully recovered.

Approval history

Sourced from openFDA
  • Nov 29, 2000ANDAANDA075888Aiping Pharm Inc
  • May 7, 2001ANDAANDA075902Apotex
  • Feb 23, 2006ANDAANDA075900Chartwell Rx
  • Dec 20, 2007NDANDA021519Ani Pharms
  • Mar 13, 2013ANDAANDA091476Ph Health
  • Apr 23, 2013ANDAANDA091482Actavis Elizabeth
  • May 11, 2020ANDAANDA212182Bionpharma
  • Jan 22, 2024ANDAANDA217917Bionpharma

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
2,340 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Interaction2179.3%
  2. 2Drug Ineffective1375.9%
  3. 3Nausea1245.3%
  4. 4Somnolence1144.9%
  5. 5Anxiety1084.6%
  6. 6Suicidal Ideation974.1%
  7. 7Depression944.0%
  8. 8Dizziness923.9%
  9. 9Headache913.9%
  10. 10Fatigue873.7%
  11. 11Insomnia843.6%
  12. 12Serotonin Syndrome813.5%
  13. 13Tremor813.5%
  14. 14Condition Aggravated803.4%
  15. 15Pyrexia803.4%

Literature

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Recent PubMed references pinned to Fluvoxamine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 103 ClinicalTrials.gov registrations naming Fluvoxamine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Pharmacogenomics

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CPIC-curated drug–gene pairs for Fluvoxamine. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

Frequently asked questions

How does Fluvoxamine work?
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 a potent inhibitor of the serotonin reuptake transporter in preclinical studies, both in vitro and in vivo .
What is Fluvoxamine used for?
According to FDA labeling, Fluvoxamine carries indications including: Fluvoxamine maleate extended-release capsules is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of obsessive compulsive disorder (OCD) ( 1 ). Efficacy was demonstrated in: One 12-week study fluvoxamine maleate extended-release capsules in adults ( 14.1 ).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Fluvoxamine?
Fluvoxamine is classified as Selective serotonin reuptake inhibitors, Serotonin Reuptake Inhibitor, Monoamine Oxidase Inhibitors, Serotonin Uptake Inhibitors, Increased Central Nervous System Serotonin Activity.
What are the contraindications for Fluvoxamine?
Fluvoxamine labeling lists contraindications including: Coadministration of thioridazine, tizanidine, pimozide, alosetron, or ramelteon with fluvoxamine maleate extended-release capsules is contraindicated ( see WARNINGS AND PRECAUTIONS [ 5.4 - 5.8 ] ) . Coadministration of thioridazine, tizanidine, pimozide, alosetron, or ramelteon ( 4 ).. Always consult the full prescribing information and a clinician.
Note. Data for fluvoxamine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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