fluvoxamine (Rx)

Brand and Other Names:Luvox, Luvox CR (DSC)
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Dosing & Uses


Dosage Forms & Strengths


  • 25mg
  • 50mg
  • 100mg

Obsessive-Compulsive Disorder

Conventional tablets

  • 50 mg qHS initially; may increase by 50 mg/day q4-7Days up to 100-300 mg/day
  • Dose >100 mg/day should be divided q12hr

Social Phobia (Off-label)

Immediate release

  • 50 mg PO qDay; may increase by 50 mg at 1 week interval; usual dose range is 100-300 mg/day

Panic Disorder (Off-label)

25-50 mg PO qDay; after several days, gradually increase to 100-200 mg/day; may increase to 300 mg/day for patients who fail to respond after several weeks of treatment

Dosing considerations

  • Continue therapy for 1-2 years, and consider discontinuation with close supervision; when discontinuing therapy, a slow taper over 2-6 months is recommended

Posttraumatic Stress Disorder (Off-label)

50 mg/day PO initially; may increase dose to 100-250 mg in adults and 100 mg in older adults; not to exceed 300 mg/day

Dosing considerations

  • Patients who respond to therapy may need to continue therapy indefinitely
  • May attempt tapering after 6-12 months in patients with acute PTSD; tapering should occur gradually over 2 weeks to 1 month to avoid withdrawal symptoms; tapering should take place over 4-12 weeks in patients at risk of relapse

Dosing Modifications

Hepatic impairment: Decrease dose

Therapy discontinuation

  • To discontinue therapy, gradually taper the dose to minimize the incidence of withdrawal symptoms and allow for detection of re-emerging symptoms

Dosage Forms & Strengths


  • 25mg
  • 50mg
  • 100mg

Obsessive-Compulsive Disorder

<8 years: Safety and efficacy not established

Ages 8-17 years (conventional tablets): 25 mg PO qHS initially; may titrate by 25 mg/day increments every 4-7 days to 50-200 mg/day

Not to exceed 200 mg (for ages 8-11 years) or 300 mg for adolescents

Give doses >50 mg/day divided q12hr

The elderly are prone to SSRI/SNRI-induced hyponatremia; monitor closely

Obsessive-Compulsive Disorder

Conventional tablets: 25 mg qHS initially; may increase by 50 mg/day q4-7days up to 100-300 mg/day; dose >100 mg/day should be divided q12hr

Social Phobia (Off-label)

Conventional tablets: 50 mg PO qDay initially; may increase by 50 mg at 1 week interval; usual dose range is 100-300 mg/day



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            Adverse Effects


            Nausea (40%)

            Headache (22-35%)

            Somnolence (22-27%)

            Weakness (14-26%)

            Insomnia (20-35%)

            Diarrhea (11-18%)

            Dizziness (11-15%)

            Xerostomia (10-14%)

            Anorexia (6-14%)

            Abnormal ejaculation (8-11%)


            Pain (10%)

            Dyspepsia (8-10%)

            Constipation (4-10%)

            Decreased libido (2-10%)

            Upper respiratory infections (9%)

            Anxiety (5-8%)

            Tremor (5-8%)

            Sweating (6-7%)

            Vomiting (4-6%)

            Abdominal pain (5%)

            Myalgia (5%)

            Abnormal taste (2-5%)

            Bruising (4%)

            Abnormal dreams (3%)

            Abnormal thinking (3%)

            Chest pain (3%)

            Palpitation (3%)

            Agitation (2-3%)

            Vasodilation (2-3%)

            Hypertension (1-2%)

            Increased LFTs (1-2%)

            Weight change (1-2%)

            Manic reaction


            Activation of mania/hypomania, seizures (discontinue)


            Frequency Not Defined







            Dry mouth





            Black Box Warnings

            In short-term studies, antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults (<24 years) taking antidepressants for major depressive disorders and other psychiatric illnesses

            This increase was not seen in patients aged >24 years; a slight decrease in suicidal thinking was seen in adults >65 years

            In children and young adults, risks must be weighed against the benefits of taking antidepressants

            Patients should be monitored closely for changes in behavior, clinical worsening, and suicidal tendencies; this should be done during initial 1-2 months of therapy and dosage adjustments

            The patient’s family should communicate any abrupt changes in behavior to the healthcare provider

            Worsening behavior and suicidal tendencies that are not part of the presenting symptoms may require discontinuation of therapy

            This drug is not approved for use in pediatric patients



            Coadministration with serotonergic drugs

            • Concomitant use or within 14 days of MAOIs increases risk of serotonin syndrome
            • Reactions to concomitant administration with MAOIs include tremor, myoclonus, diaphoresis, nausea, vomiting, flushing, dizziness, hyperthermia with features resembling neuroleptic malignant syndrome, seizures, rigidity, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes (including extreme agitation progressing to delirium and coma)
            • Starting fluvoxamine in a patient who is being treated with linezolid or IV methylene blue is contraindicated because of an increased risk of serotonin syndrome
            • If linezolid or IV methylene blue must be administered, discontinue SSRI immediately and monitor for CNS toxicity; may resume 24 hr after last linezolid or methylene blue dose, or after 2 weeks of monitoring (5 weeks for fluoxetine), whichever comes first


            Conflicting evidence regarding use of SSRIs during pregnancy and increased risk of persistent pulmonary hypertension of the newborn (see Pregnancy)

            In neonates exposed to SNRIs/SSRIs late in third trimester: Risk of complications such as feeding difficulties, irritability, and respiratory problems

            Risk of mydriasis; may trigger angle closure attack in patients with angle closure glaucoma with anatomically narrow angles without a patent iridectomy

            May need to modify dose for hepatic impairment; titrate at smaller increments and longer intervals

            Clinical worsening and suicide ideation may occur despite medication in adolescents and young adults (18-24 years); prescriptions should be written for the smallest quantity consistent with good patient care

            May worsen mania symptoms or precipitate mania in patients with bipolar disorder

            May impair platelet aggregation; increases risk of bleeding in patients taking anticoagulants/antiplatelets concomitantly

            Do not use concurrently with alosetron, astemizole, cisapride, pimozide, terfenadine, or tizanidine due to QT prolongation risk

            Potentially life-threatening serotonin syndrome has been reported with drugs that impair serotonin metabolism (in particular, MAOIs, including nonpsychiatric MAOIs, such as linezolid and IV methylene blue); it has also been reported with reported with SNRIs and SSRIs, including fluvoxamine, alone but particularly with concomitant use of serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John's Wort (see Contraindications)

            May impair ability to operate heavy machinery and other tasks requiring mental alertness

            Bone fractures have been associated with antidepressant treatment; consider possibility of fragility fracture if patient presents with pain, joint tenderness, or swelling

            Impaired glucose control (hyperglycemia or hypoglycemia) reported; monitor for signs/symptoms of loss of glucose control, especially in patients with diabetes

            May cause or exacerbate sexual dysfunction

            Syndrome of inapropriate antidiuretic hormone and hyponatremia reported with SSRI and SNRI use; volume deplretion and/or concurrent use of diuretics may increase risk; consider discontinuing therapy if symptomatic hyponatremia occurs

            Use caution in patients with cardiovascular disease or history of seizure disorder


            Pregnancy & Lactation


            There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy; healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants

            Prolonged experience with fluvoxamine in pregnant women over decades, based on published observational studies, have not identified a clear drug-associated risk of major birth defects or miscarriage; there are risks associated with untreated depression in pregnancy and risks of persistent pulmonary hypertension of newborn (PPHN) and poor neonatal adaptation with exposure to selective serotonin reuptake inhibitors (SSRIs), including fluvoxamine, during pregnancy

            Women who discontinue antidepressants during pregnancy are more likely to experience a relapse of major depression than women who continue antidepressants; consider risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum

            Neonates exposed to therapy and other SSRIs or SNRIs late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding; such complications can arise immediately upon delivery; reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying; these features are consistent with either a direct toxic effect of SSRIs and SNRIs or, possibly, a drug discontinuation syndrome; it should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome

            Animal findings suggest fertility may be impaired while taking fluvoxamine

            Animal data

            • Pregnant rats treated orally with throughout period of organogenesis, increased embryofetal death and increased incidences of fetal eye abnormalities (folded retinas) was observed at doses ≥3 times maximum recommended human dose (MRHD) of 300 mg/day given to adolescents on a mg/m2 basis; in addition, decreased fetal body weight was seen at a dose 6 times MRHD given to adolescents on a mg/m2 basis
            • There were no adverse developmental effects in rabbits treated with fluvoxamine during period of organogenesis up to a dose 2 times MRHD given to adolescents on a mg/m2 basis; when drug was administered orally to rats during pregnancy and lactation, increased pup mortality at birth was seen at dose 2 times MRHD given to adolescents on a mg/m2 basis; in addition, decreases in pup body weight and survival were observed at doses that are ≥0.13 times MRHD given to adolescents

            Persistent pulmonary hypertension of the newborn

            • Potential risk of persistent pulmonary hypertension of the newborn when used during pregnancy
            • Initial Public Health Advisory in 2006 was based on a single published study; since then, there have been conflicting findings from new studies, making it unclear whether use of SSRIs during pregnancy can cause PPHN
            • FDA has reviewed the additional new study results and has concluded that, given the conflicting results from different studies, it is premature to reach any conclusion about a possible link between SSRI use in pregnancy and PPHN
            • FDA recommendation: FDA advises healthcare professionals not to alter their current clinical practice of treating depression during pregnancy and to report any adverse events to the FDA MedWatch program
            • A meta-analysis of 7 observational studies, found exposure to SSRIs in late pregnancy (ie, >20 weeks' gestation) more than doubled the risk of PPHN that could not be explained by other etiologies (eg, congenital malformations, meconium aspiration) (BMJ 2014;348:f6932)


            Data from published literature report presence of drug in human milk; no adverse effects on breastfed infant have been reported in most cases of maternal use of fluvoxamine during breastfeeding; however, there are reports of diarrhea, vomiting, decreased sleep, and agitation; there are no data on effect of fluvoxamine on milk production

            Developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for fluvoxamine and any potential adverse effects on breastfed child from drug or from the underlying maternal condition

            Monitor infants exposed to fluvoxamine through breast milk for diarrhea, vomiting, decreased sleep, and agitation

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.



            Mechanism of Action

            Selective serotonin reuptake inhibitor; little or no affinity for dopamine, alpha-adrenergic histamine, or cholinergic receptor


            Bioavailability: 53%

            Peak plasma time: 3-8 hr

            Peak plasma concentration: 88-546 ng/mL (nonlinear)


            Protein bound: 80%

            Vd: 25 L/kg


            Metabolism: Hepatic oxidative demethylation, deamination

            Metabolites: Inactive

            Enzymes inhibited: Hepatic CYP1A2, CYP2C9, CYP3A4


            Half-life: 15.6 hr; 17.4-25.9 hr (elderly)

            Dialyzable: No

            Excretion: Urine (85%)


            Several SSRIs (eg, fluoxetine, fluvoxamine, paroxetine, sertraline) are metabolized by CYP2D6

            CYP2D6 is involved in the metabolism of approximately 20% of drugs in clinical use and displays large individual-to-individual variability in activity due to genetic polymorphisms

            More than 80 CYP2D6 variant alleles have been identified; however, 4 of the most prevalent alleles, CYP2D6*3, *4, *5, and *6, account for 93-97% of CYP2D6 poor metabolizers (PMs)

            CYP2D6*4, the most common variant (~25% frequency in whites), causes a splicing defect; CYP2D6*3 (2.7% frequency) causes a frameshift mutation; and CYP3D6*5 (2.6%) is an entire deletion of the CYP2D6 gene; individuals homozygous for these alleles have no CYP2D6 activity

            The impact of CYP2D6 activity is further complicated in some SSRIs (eg, fluoxetine, fluvoxamine, paroxetine, sertraline) that, in addition to being substrates for CYP2D6, are also known to moderately inhibit CYP2D6 activity

            Genetic testing laboratories

            • Genotyping tests for CYP2D6 variants are commercially available through Applied Biosystems (http://www.appliedbiosystems.com/) and GenPath Diagnostics (http://www.genpathdiagnostics.com/)


            Oral Administration

            May take with or without food





            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.