Fluvoxamine maleate 100 mg Tablet, 30-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Serotonin Reuptake Inhibitor class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Fluvoxamine is used to treat obsessive-compulsive disorder (bothersome thoughts that won't go away and the need to perform certain actions over and over) and social anxiety disorder (extreme fear of interacting with others or performing in front of others that interferes with normal life). Fluvoxamine is in a class of medications called selective serotonin reuptake inhibitors (SSRIs). It works by increasing the amount of serotonin, a natural substance in the brain that helps maintain mental balance.
Read the full MedlinePlus article ↗- Great question. Fluvoxamine is in the SSRI family, which includes many antidepressants, but for these products it's specifically approved to treat obsessive-compulsive disorder (OC...
- What exactly does fluvoxamine treat — I thought it was an antidepressant?
- Fluvoxamine isn't a quick fix — it takes time. Doses start low and are increased gradually over several weeks, and meaningful symptom relief with OCD can take a number of weeks aft...
- Nausea is one of the most common early side effects and often improves as your body adjusts. You may also notice drowsiness, sweating, shakiness, diarrhea, or decreased appetite. T...
Patient education
Supplement & herbal interactions
Fluvoxamine may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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UNII 3OWL53L36A
A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
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UNII 7CV7WJK4UI
Sodium stearyl fumarate is a synthetic compound made from stearyl alcohol and fumaric acid. It acts as a lubricant and glidant in tablets and capsules, helping ingredients flow smoothly during manufacturing and preventing sticking.
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UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
3 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.3950 | $11.85 / 30 tablets |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Fluvoxamine maleate 100 mg 00832-1672-11 | Upsher-Smith | 100 tablets | $0.245 | AB | Discontinued | — |
| Fluvoxamine Maleate 100 mg 60505-0166-01 | Apotex | 100 tablets | $0.247 | AB | Availability likely | — |
| Fluvoxamine Maleate 100 mg 62135-0933-30 | Chartwell | 30 tablets | $0.247 | — | Availability likely | — |
| fluvoxamine maleate 100 mg 62559-0160-01 | ANI | 100 tablets | $0.247 | AB | Availability likely | — |
| Fluvoxamine maleate 100 mg 69452-0289-20 | Bionpharma | 100 tablets | $0.247 | AB | Availability likely | — |
| Fluvoxamine maleate 100 mg 69452-0455-20 | Bionpharma | 100 tablets | $0.247 | AB | Availability likely | — |
| fluvoxamine maleate 100 mg 50090-5988-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Fluvoxamine maleate 100 mg 50090-7728-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Fluvoxamine maleate 100 mg 68788-4011-03 | Preferred | 30 tablets | — | AB | FDA listed | — |
| fluvoxamine maleate 100 mg 68788-7219-03 | Preferred | 30 tablets | — | AB | FDA listed | — |
| Fluvoxamine Maleate 100 mg 68788-8175-03 | Preferred | 30 tablets | — | AB | FDA listed | — |
| fluvoxamine maleate 100 mg 70518-1057-00 | REMEDYREPACK | 30 tablets | — | AB | FDA listed | — |
| Fluvoxamine Maleate 100 mg 71335-2008-01 | Bryant | 90 tablets | — | AB | FDA listed | — |
| Fluvoxamine maleate 100 mgthis 71335-3006-02 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Fluvoxamine Maleate 100 mg 72789-0221-30 | PD-Rx | 30 tablets | — | AB | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 71335-3006-01 | 90 TABLET in 1 BOTTLE (71335-3006-1) | 2026-02-04 | Active |
| 71335-3006-02 You're viewing this | 30 TABLET in 1 BOTTLE (71335-3006-2) | 2026-02-04 | Active |
| 71335-3006-03 | 18 TABLET in 1 BOTTLE (71335-3006-3) | 2026-02-04 | Active |
| 71335-3006-04 | 28 TABLET in 1 BOTTLE (71335-3006-4) | 2026-02-04 | Active |
| 71335-3006-05 | 100 TABLET in 1 BOTTLE (71335-3006-5) | 2026-02-04 | Active |
You're viewing one of 5 pack sizes for this product.
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🧭 About this NDC listing & data coverage
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| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
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 tablets 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 years; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 years 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.
Fluvoxamine maleate tablets are not approved for use in pediatric patients except for patients with obsessive-compulsive disorder (OCD) [see Warnings and Precautions (5.1) ] . 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.
Fluvoxamine maleate tablets are not approved for use in pediatric patients except those with obsessive-compulsive disorder ( 5.1 ).
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Fluvoxamine maleate tablets are indicated for the treatment of obsessions and compulsions in patients with obsessive-compulsive disorder (OCD) ( 1 ).
1.1Obsessive-Compulsive Disorder Fluvoxamine maleate tablets are indicated for the treatment of obsessions and compulsions in patients with obsessive-compulsive disorder (OCD), as defined in DSM-III-R or DSM-IV. The obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning. Obsessive-compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses or images (obsessions) that are ego-dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable.
The efficacy of fluvoxamine maleate tablets was established in four trials in outpatients with OCD: two 10-week trials in adults, one 10-week trial in pediatric patients (ages 8 years to 17 years), and one maintenance trial in adults [see Clinical Studies (14) ] .
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Adults: Recommended starting dose is 50 mg at bedtime, with increases of 50 mg every 4 days 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 years to 17 years): Recommended starting dose is 25 mg at bedtime, with increases of 25 mg every 4 days to 7 days as tolerated to maximum effect, not to exceed 200 mg/day (8 years to 11 years) or 300 mg/day (12 years 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 ).
2.1Adults 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 mg/day to 300 mg/day. Consequently, the dose should be increased in 50 mg increments every 4 days 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.
2.2Pediatric Population (children and adolescents) The recommended starting dose for fluvoxamine maleate tablets in pediatric populations (ages 8 years 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 years to 17 years) were titrated within a dose range of 50 mg/day 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 days to 7 days, as tolerated, until maximum therapeutic benefit is achieved. It is advisable that a total daily dose of more than 50 mg should be given in two divided doses. If the two divided doses are not equal, the larger dose should be given at bedtime.
2.3Elderly or Hepatically Impaired Patients Elderly patients and those with hepatic impairment have been observed to have a decreased clearance of fluvoxamine maleate tablets. Consequently, it may be appropriate to modify the initial dose and the subsequent dose titration for these patient groups.
2.4Switching a Patient to or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with fluvoxamine maleate tablets. Conversely, at least 14 days should be allowed after stopping fluvoxamine maleate tablets before starting an MAOI intended to treat psychiatric disorders [see Contraindications (4) ] .
2.5Use of Fluvoxamine Maleate Tablets with Other MAOIs such as Linezolid or Methylene Blue Do not start fluvoxamine maleate tablets in a patient who is being treated with linezolid or intravenous methylene blue because there is an increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered [see Contraindications (4) ] . In some cases, a patient already receiving fluvoxamine maleate tablet therapy may require urgent treatment with linezolid or intravenous methylene blue.
If acceptable alternatives to linezolid or intrave…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Fluvoxamine maleate tablets, USP, for oral administration, are available as: 25 mg: White to off-white, round, biconvex, uncoated tablets, debossed “ F1 ” on one side and plain on the other side. 50 mg: White to off-white, round, biconvex, uncoated tablets, debossed “ F2 ” on one side and a functional score on the other side. 100 mg: White to off-white, round, biconvex, uncoated tablets, debossed “ F3 ” on one side and a functional score on the other side.
Tablets: 25 mg, 50 mg (functional scored), and 100 mg (functional scored) ( 3 ).
⛔ Contraindications ▾
4 CONTRAINDICATIONS Co-administration of tizanidine, thioridazine, alosetron, pimozide ( 4 ). Serotonin Syndrome and MAOIs: Do not use MAOIs intended to treat psychiatric disorders with fluvoxamine maleate tablets or within 14 days of stopping treatment with fluvoxamine maleate tablets. Do not use fluvoxamine maleate tablets within 14 days of stopping an MAOI intended to treat psychiatric disorders.
In addition, do not start fluvoxamine maleate tablets in a patient who is being treated with linezolid or intravenous methylene blue ( 4 ). Co-administration Co-administration of tizanidine, thioridazine, alosetron, or pimozide with fluvoxamine maleate tablets are contraindicated [see Warnings and Precautions (5.4 , 5.5 , 5.6 , 5.7) ] . Serotonin Syndrome and Monoamine Oxidase Inhibitors (MAOIs) The use of MAOIs intended to treat psychiatric disorders with fluvoxamine maleate tablets or within 14 days of stopping treatment with fluvoxamine maleate tablets are contraindicated because of an increased risk of serotonin syndrome.
The use of fluvoxamine maleate tablets within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated [see Dosage and Administration (2.4) , Warnings and Precautions (5.2) ] . Starting fluvoxamine maleate tablets in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome [see Dosage and Administration (2.5) , Warnings and Precautions (5.2) ] .
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Suicidality: Monitor for clinical worsening and suicide risk ( 5.1 ). Bipolar disorder: Screen for bipolar disorder ( 5.1 ). Serotonin Syndrome: Serotonin syndrome has been reported with SSRIs and SNRIs, including fluvoxamine maleate tablets, both when taken alone, but especially when co-administered with other serotonergic agents.
If such symptoms occur, discontinue fluvoxamine maleate tablets and serotonergic agents and initiate supportive treatment. If concomitant use of fluvoxamine maleate tablets 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. Co-administration with diazepam is generally not advisable ( 5.8 ).
Clozapine: Clozapine levels may be increased and produce orthostatic hypotension or seizures ( 5.8 ). Methadone: Co-administration may produce opioid intoxication. Discontinuation of fluvoxamine may produce opioid withdrawal ( 5.8 ).
Mexiletine: Monitor serum mexiletine levels ( 5.8 ). Ramelteon: Should not be used in combination with fluvoxamine ( 5.8 ). Theophylline: Clearance decreased; reduce theophylline dose by one-third ( 5.8 ).
Warfarin: Plasma concentrations increased and prothrombin times prolonged; monitor prothrombin time and adjust warfarin dose accordingly ( 5.8 ). Other Drugs Affecting Hemostasis: Increased risk of bleeding with concomitant use of NSAIDs, aspirin, or other drugs affecting coagulation ( 5.8 , 5.10 ) [see Contraindications (4) ] . Discontinuation: Symptoms associated with discontinuation have been reported ( 5.9 ).
Abrupt discontinuation not recommended [see Dosage and Administration (2.7) ]. Activation of mania/hypomania has occurred ( 5.11 ). Seizures: Avoid administering fluvoxamine in patients with unstable epilepsy; monitor patients with controlled epilepsy; discontinue treatment if seizures occur or frequency increases ( 5.12 ).
Hyponatremia: May occur with SSRIs and SNRIs, including fluvoxamine maleate tablets. The elderly may be at increased risk. Consider discontinuing in patients with symptomatic hyponatremia ( 5.13 ).
Concomitant Illness: Use caution in patients with diseases or conditions that affect hemodynamic responses or metabolism ( 5.14 ). Patients with impaired liver function may require a lower starting dose and slower titration ( 2.3 ). Sexual Dysfunction: Fluvoxamine maleate tablets may cause symptoms of sexual dysfunction ( 5.16 ).
5.1Clinical Worsening and Suicide Risk Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide.
There has been a long-standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18 years to 24 years) with major depressive disorder (MDD) and other psychiatric disorders.
Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24 years; there was a reduction with…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS 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 practice. Most common reactions in controlled trials with adult OCD and depression patients (incidence ≥ 5% and at least twice that for placebo) were nausea, somnolence, insomnia, asthenia, nervousness, dyspepsia, abnormal ejaculation, sweating, anorexia, tremor, and vomiting ( 6.2 ).
Using the above rule, the following events were also identified: anorgasmia, decreased libido, dry mouth, rhinitis, taste perversion, and urinary frequency in patients with OCD; and agitation, depression, dysmenorrhea, flatulence, hyperkinesia, and rash in pediatric patients with OCD. To report SUSPECTED ADVERSE REACTIONS, contact Bionpharma Inc. at 1-888-235-BION or 1-888-235-2466 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Adverse Reactions Leading to Treatment Discontinuation Of the 1,087 OCD and depressed patients treated with fluvoxamine maleate tablets in controlled clinical trials in North America, 22% discontinued due to an adverse reaction. Adverse reactions that led to discontinuation in at least 2% of fluvoxamine maleate tablets-treated patients in these trials were: nausea (9%), insomnia (4%), somnolence (4%), headache (3%), and asthenia, vomiting, nervousness, agitation, and dizziness (2% each).
6.2Incidence in Controlled Trials Commonly Observed Adverse Reactions in Controlled Clinical Trials Fluvoxamine maleate tablets have been studied in 10-week short-term controlled trials of OCD (N = 320) and depression (N = 1,350). In general, adverse reaction rates were similar in the two data sets as well as in the pediatric OCD study. The most commonly observed adverse reactions associated with the use of fluvoxamine maleate tablets and likely to be drug-related (incidence of 5% or greater and at least twice that for placebo) derived from Table 2 were: nausea, somnolence, insomnia, asthenia, nervousness, dyspepsia, abnormal ejaculation, sweating, anorexia, tremor, and vomiting .
In a pool of two studies involving only patients with OCD, the following additional reactions were identified using the above rule: anorgasmia, decreased libido, dry mouth, rhinitis, taste perversion, and urinary frequency . In a study of pediatric patients with OCD, the following additional reactions were identified using the above rule: agitation, depression, dysmenorrhea, flatulence, hyperkinesia, and rash . Adverse Reactions Occurring at an Incidence of 1% Table 2 enumerates adverse reactions that occurred in adults at a frequency of 1% or more, and were more frequent than in the placebo group, among patients treated with fluvoxamine maleate tablets in two short-term placebo-controlled OCD trials (10 weeks) and depression trials (6 weeks) in which patients were dosed in a range of generally 100 mg/day to 300 mg/day.
This table shows the percentage of patients in each group who had at least one occurrence of a reaction at some time during their treatment. Reported adverse reactions were classified using a standard COSTART-based Dictionary terminology. The prescriber should be aware that these figures cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors may differ from those that prevailed in the clinical trials.
Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and non-drug factors to the side-effect incidence rate in the population studied. Table 2: Treatment-Emergent Adverse Reaction Incidence Rates by Body System in Adult OCD and Depression Populatio…
🔄 Drug Interactions ▾
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). Carbamazepine: Elevated carbamazepine levels and symptoms of toxicity with co-administration ( 7.2 ). Sumatriptan: Rare post-marketing reports of weakness, hyperreflexia, and incoordination following use of an SSRI and sumatriptan.
Monitor appropriately if concomitant treatment is clinically warranted ( 7.2 ). Tacrine: Co-administration increased tacrine C max and AUC five- and eight-fold and caused nausea, vomiting, sweating, and diarrhea ( 7.2 ). Tricyclic Antidepressants (TCAs): Co-administration significantly increased plasma TCA levels.
Use caution; monitor plasma TCA levels; reduce TCA dose if indicated ( 7.2 ). Tryptophan: Severe vomiting with co-administration ( 7.2 ). Diltiazem: Bradycardia with co-administration ( 7.3 ).
Propranolol or metoprolol: Reduce dose if co-administered and titrate more cautiously ( 7.3 ).
7.1Potential 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.
Based on a finding of substantial interactions of fluvoxamine with certain of these drugs [see later parts of this section and also Warnings and Precautions (5) ] and limited in-vitro data for CYP3A4, it appears that fluvoxamine inhibits several cytochrome P450 isoenzymes that are known to be involved in the metabolism of other drugs such as: CYP1A2 (e.g., warfarin, theophylline, propranolol, tizanidine), CYP2C9 (e.g., warfarin), CYP3A4 (e.g., alprazolam), and CYP2C19 (e.g., omeprazole). In-vitro data suggest that fluvoxamine is a relatively weak inhibitor of CYP2D6.
Approximately 7% of the normal population has a genetic code that leads to reduced levels of activity of CYP2D6. Such individuals have been referred to as "poor metabolizers" (PM) of drugs such as debrisoquin, dextromethorphan, and tricyclic antidepressants. While none of the drugs studied for drug interactions significantly affected the pharmacokinetics of fluvoxamine, an in-vivo study of fluvoxamine single-dose pharmacokinetics in 13 PM subjects demonstrated altered pharmacokinetic properties compared to 16 "extensive metabolizers" (EM): mean C max , AUC, and half-life were increased by 52%, 200%, and 62%, respectively, in the PM compared to the EM group.
This suggests that fluvoxamine is metabolized, at least in part, by CYP2D6. Caution is indicated in patients known to have reduced levels of CYP2D6 activity and those receiving concomitant drugs known to inhibit this cytochrome P450 isoenzyme (e.g., quinidine). 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 have not been studied.
A clinically significant fluvoxamine interaction is possible with drugs having a narrow therapeutic ratio such as pimozide, warfarin, theophylline, certain benzodiazepines, omeprazole and phenytoin. If fluvoxamine maleate tablets are to be administered together with a drug that is eliminated via oxidative metabolism and has a narrow therapeutic window, plasma levels and/or pharmacodynamic effects of the latter drug should be monitored closely, at least until steady-state conditions are reached [see Contraindications (4) , Warnings and Precautions (5) ] .
7.2CNS Active Drugs Antipsychotics: [see Warnings and Precautions (5.2) ].…
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Specific populations not discussed in Dosage and Administration or Warnings and Precautions include: Pregnancy: Third-trimester use may increase risk for persistent pulmonary hypertension and symptoms of poor adaptation (respiratory distress, temperature instability, feeding difficulty, hypotonia, tremor, irritability) in the neonate ( 8.1 ). Pediatric: Monitor weight and growth; effects of long-term use on growth, cognitive behavioral development, and maturation have not been studied ( 8.4 ).
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 ).
8.1Pregnancy Pregnancy Exposure Registry 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/. Risk Summary Based on data from published observational studies, exposure to SSRIs, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage [see Warnings and Precautions (5.10) and Clinical Considerations].
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 ( see Data ). There are risks associated with untreated depression in pregnancy and risks of persistent pulmonary hypertension of the newborn (PPHN) and poor neonatal adaptation with exposure to selective serotonin reuptake inhibitors (SSRIs), including fluvoxamine, during pregnancy ( see Clinical Considerations ). When pregnant rats were treated orally with fluvoxamine throughout the period of organogenesis, increased embryofetal death and increased incidences of fetal eye abnormalities (folded retinas) was observed at doses ≥ 3 times the maximum recommended human dose (MRHD) of 300 mg/day given to adolescents on a mg/m 2 basis.
In addition, decreased fetal body weight was seen at a dose 6 times the MRHD given to adolescents on a mg/m 2 basis. There were no adverse developmental effects in rabbits treated with fluvoxamine during the period of organogenesis up to a dose 2 times the MRHD given to adolescents on a mg/m 2 basis. When fluvoxamine was administered orally to rats during pregnancy and lactation, increased pup mortality at birth was seen at a dose 2 times the MRHD given to adolescents on a mg/m 2 basis.
In addition, decreases in pup body weight and survival were observed at doses that are ≥ 0.13 times the MRHD given to adolescents ( see Data ). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Women who discontinue antidepressants during pregnancy are more likely to experience a relapse of major depression than women who continue antidepressants. This finding is from a prospective, longitudinal study that followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants at the beginning of pregnancy.
Consider the risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum. Maternal Adverse Reactions Use of fluvoxamine maleate tablets in the month before delivery may be associated with an increased risk…
🤰 Pregnancy ▾
8.1Pregnancy Pregnancy Exposure Registry 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/. Risk Summary Based on data from published observational studies, exposure to SSRIs, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage [see Warnings and Precautions (5.10) and Clinical Considerations].
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 ( see Data ). There are risks associated with untreated depression in pregnancy and risks of persistent pulmonary hypertension of the newborn (PPHN) and poor neonatal adaptation with exposure to selective serotonin reuptake inhibitors (SSRIs), including fluvoxamine, during pregnancy ( see Clinical Considerations ). When pregnant rats were treated orally with fluvoxamine throughout the period of organogenesis, increased embryofetal death and increased incidences of fetal eye abnormalities (folded retinas) was observed at doses ≥ 3 times the maximum recommended human dose (MRHD) of 300 mg/day given to adolescents on a mg/m 2 basis.
In addition, decreased fetal body weight was seen at a dose 6 times the MRHD given to adolescents on a mg/m 2 basis. There were no adverse developmental effects in rabbits treated with fluvoxamine during the period of organogenesis up to a dose 2 times the MRHD given to adolescents on a mg/m 2 basis. When fluvoxamine was administered orally to rats during pregnancy and lactation, increased pup mortality at birth was seen at a dose 2 times the MRHD given to adolescents on a mg/m 2 basis.
In addition, decreases in pup body weight and survival were observed at doses that are ≥ 0.13 times the MRHD given to adolescents ( see Data ). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Women who discontinue antidepressants during pregnancy are more likely to experience a relapse of major depression than women who continue antidepressants. This finding is from a prospective, longitudinal study that followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants at the beginning of pregnancy.
Consider the risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum. Maternal Adverse Reactions Use of fluvoxamine maleate tablets in the month before delivery may be associated with an increased risk of postpartum hemorrhage [see Warnings and Precautions (5.10) ]. Fetal/Neonatal adverse reactions Neonates exposed to fluvoxamine maleate tablets 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…
🧒 Pediatric Use ▾
8.4Pediatric Use The efficacy of fluvoxamine maleate tablets for the treatment of obsessive-compulsive disorder was demonstrated in a 10-week multicenter placebo-controlled study with 120 outpatients ages 8 years to 17 years. In addition, 99 of these outpatients continued open-label fluvoxamine maleate tablets treatment for up to another one to three years, equivalent to 94 patient years. The adverse event profile observed in that study was generally similar to that observed in adult studies with fluvoxamine [see Adverse Reactions (6.3) , Dosage and Administration (2.2) ] .
Decreased appetite and weight loss have been observed in association with the use of fluvoxamine as well as other SSRIs. Consequently, regular monitoring of weight and growth is recommended if treatment of a child with an SSRI is to be continued long term. The risks, if any, that may be associated with fluvoxamine's extended use in children and adolescents with OCD have not been systematically assessed.
The prescriber should be mindful that the evidence relied upon to conclude that fluvoxamine is safe for use in children and adolescents derives from relatively short-term clinical studies and from extrapolation of experience gained with adult patients. In particular, there are no studies that directly evaluate the effects of long-term fluvoxamine use on the growth, cognitive behavioral development, and maturation of children and adolescents. Although there is no affirmative finding to suggest that fluvoxamine possesses a capacity to adversely affect growth, development or maturation, the absence of such findings is not compelling evidence of the absence of the potential of fluvoxamine to have adverse effects in chronic use [see Warnings and Precautions (5.1) ] .
Safety and effectiveness in the pediatric population other than pediatric patients with OCD have not been established [see Boxed Warning , Warnings and Precautions (5.1) ] . Anyone considering the use of fluvoxamine maleate tablets in a child or adolescent must balance the potential risks with the clinical need.
🧓 Geriatric Use ▾
8.5Geriatric Use Approximately 230 patients participating in controlled pre-marketing studies with fluvoxamine maleate tablets were 65 years of age or over. No overall differences in safety were observed between these patients and younger patients. Other reported clinical experience has not identified differences in response between the elderly and younger patients.
However, SSRIs and SNRIs, including fluvoxamine maleate tablets, have been associated with several cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse event [see Warnings and Precautions (5.13) ] . Furthermore, the clearance of fluvoxamine is decreased by about 50% in elderly compared to younger patients [see Clinical Pharmacology (12.3) ] , and greater sensitivity of some older individuals also cannot be ruled out. Consequently, a lower starting dose should be considered in elderly patients and fluvoxamine maleate tablets should be slowly titrated during initiation of therapy.
🆘 Overdosage ▾
10 OVERDOSAGE The following have been reported with fluvoxamine tablet overdosage: Seizures, which may be delayed, and altered mental status including coma. Cardiovascular toxicity, which may be delayed, including QRS and QTc interval prolongation. Hypertension most commonly seen, but rarely can see hypotension alone or with co-ingestants including alcohol.
Serotonin syndrome (patients with a multiple drug overdosage with other pro-serotonergic drugs may have a higher risk). Gastrointestinal decontamination with activated charcoal should be considered in patients who present early after a fluvoxamine overdose. Consider contacting a poison center (1-800-221-2222) or a medical toxicologist for overdosage management recommendations.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action The mechanism of action of fluvoxamine maleate tablets 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 .
12.2Pharmacodynamics In in-vitro studies, fluvoxamine maleate tablets had no significant affinity for histaminergic, alpha or beta adrenergic, muscarinic, or dopaminergic receptors. Antagonism of some of these receptors is thought to be associated with various sedative, cardiovascular, anticholinergic, and extrapyramidal effects of some psychotropic drugs.
12.3Pharmacokinetics Absorption: The absolute bioavailability of fluvoxamine maleate tablets is 53%. Oral bioavailability is not significantly affected by food. In a dose proportionality study involving fluvoxamine maleate tablets at 100 mg/day, 200 mg/day and 300 mg/day for 10 consecutive days in 30 normal volunteers, steady state was achieved after about a week of dosing.
Maximum plasma concentrations at steady state occurred within 3 hours to 8 hours of dosing and reached concentrations averaging 88 ng/mL, 283 ng/mL and 546 ng/mL, respectively. Thus, fluvoxamine had nonlinear pharmacokinetics over this dose range, i.e., higher doses of fluvoxamine maleate tablets produced disproportionately higher concentrations than predicted from the lower dose. Distribution: The mean apparent volume of distribution for fluvoxamine is approximately 25 L/kg, suggesting extensive tissue distribution.
Approximately 80% of fluvoxamine is bound to plasma protein, mostly albumin, over a concentration range of 20 ng/mL to 2,000 ng/mL. Metabolism: Fluvoxamine maleate tablets are extensively metabolized by the liver; the main metabolic routes are oxidative demethylation and deamination. Nine metabolites were identified following a 5 mg radiolabelled dose of fluvoxamine maleate tablets, constituting approximately 85% of the urinary excretion products of fluvoxamine.
The main human metabolite was fluvoxamine acid which, together with its N-acetylated analog, accounted for about 60% of the urinary excretion products. A third metabolite, fluvoxethanol, formed by oxidative deamination, accounted for about 10%. Fluvoxamine acid and fluvoxethanol were tested in an in vitro assay of serotonin and norepinephrine reuptake inhibition in rats; they were inactive except for a weak effect of the former metabolite on inhibition of serotonin uptake (1 order to 2 orders of magnitude less potent than the parent compound).
Approximately 2% of fluvoxamine was excreted in urine unchanged [see Drug Interactions (7) ] . Elimination: Following a 14 C-labelled oral dose of fluvoxamine maleate tablets (5 mg), an average of 94% of drug-related products was recovered in the urine within 71 hours. The mean plasma half-life of fluvoxamine at steady state after multiple oral doses of 100 mg/day in healthy, young volunteers was 15.6 hours.
Elderly Subjects: In a study of fluvoxamine maleate tablets at 50 mg and 100 mg comparing elderly (ages 66 years to 73 years) and young subjects (ages 19 years to 35 years), mean maximum plasma concentrations in the elderly were 40% higher. The multiple dose elimination half-life of fluvoxamine was 17.4 hours and 25.9 hours in the elderly compared to 13.6 hours and 15.6 hours in the young subjects at steady state for 50 mg and 100 mg doses, respectively. In elderly patients, the clearance of fluvoxamine was reduced by about 50% and, therefore, fluvoxamine maleate tablets should be slowly titrated during initiation of therapy [see Dosage and Administration (2.3) ] .
Pediatric Subjects: The multiple-dose ph armacokinetics of fluvoxamine was determined in male and female children (ages 6 years to 11 years) and adolescents (ages 12 years to 17 years). Steady-state plasma fluvoxamine concentrations were 2-fold to 3-fold higher in ch…
🧬 Mechanism of Action ▾
12.1Mechanism of Action The mechanism of action of fluvoxamine maleate tablets 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 .
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Fluvoxamine maleate tablets, USP, for oral administration, are available as: 100 mg:White to off-white, round, biconvex, uncoated tablets, debossed “ F3” on one side and a functional score on the other side. NDC 71335-3006-1: 90 Tablets in a BOTTLE NDC 71335-3006-2: 30 Tablets in a BOTTLE NDC 71335-3006-3: 18 Tablets in a BOTTLE NDC 71335-3006-4: 28 Tablets in a BOTTLE NDC 71335-3006-5: 100 Tablets in a BOTTLE Fluvoxamine maleate tablets, USP should be protected from high humidity and stored at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].
Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure. Keep out of reach of children. Repackaged/Relabeled by: Bryant Ranch Prepack Burbank, CA 91504
📋 Description ▾
11 DESCRIPTION Fluvoxamine maleate is a selective serotonin (5-HT) reuptake inhibitor (SSRI) belonging to the chemical series, the 2-aminoethyl oxime ethers of aralkylketones. It is chemically unrelated to other SSRIs and clomipramine. It is chemically designated as 5-methoxy-4′-(trifluoromethyl)valerophenone-(E)-O-(2-aminoethyl) oxime maleate (1:1) and has the molecular formula C 19 H 25 F 3 N 2 O 6 .
Its molecular weight is 434.4 g/mol. The structural formula is: Fluvoxamine maleate, USP is a white to off-white, crystalline powder which is freely soluble in ethanol (96%) and chloroform, sparingly soluble in water, and practically insoluble in diethyl ether. Fluvoxamine maleate tablets, USP are available in 25 mg, 50 mg, and 100 mg strengths for oral administration.
In addition to the active ingredient, fluvoxamine maleate USP, each tablet contains the following inactive ingredients: corn starch, mannitol, and sodium stearyl fumarate. FDA approved dissolution test specifications differ from USP.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with fluvoxamine maleate tablets and should counsel them in the appropriate use. A patient Medication Guide about "Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions" is available for fluvoxamine maleate tablets.
The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document.
Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking fluvoxamine maleate tablets. Clinical Worsening and Suicide Risk Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down.
Families and caregivers of patients should be advised to look for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient's prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient's presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate the need for very close monitoring and possibly changes in the medication [see Boxed Warning , Warnings and Precautions (5.1) ] .
Serotonin Syndrome Patients should be cautioned about the risk of serotonin syndrome particularly with the concomitant use of fluvoxamine with other serotonergic agents (including triptans, tricyclic antidepressants, opioids, lithium, tryptophan, buspirone, amphetamines, and St. John's Wort) [see Warnings and Precautions (5.2) ] . Angle Closure Glaucoma Patients should be advised that taking fluvoxamine maleate tablets can cause mild pupillary dilation, which in susceptible individuals, can lead to an episode of angle closure glaucoma.
Pre-existing glaucoma is almost always open-angle glaucoma because angle closure glaucoma, when diagnosed, can be treated definitively with iridectomy. Open-angle glaucoma is not a risk factor for angle closure glaucoma. Patients may wish to be examined to determine whether they are susceptible to angle closure, and have a prophylactic procedure (e.g., iridectomy), if they are susceptible [see Warnings and Precautions (5.3) ] .
Interference with Cognitive or Motor Performance Since any psychoactive drug may impair judgment, thinking, or motor skills, patients should be cautioned about operating hazardous machinery, including automobiles, until they are certain that fluvoxamine maleate tablets therapy does not adversely affect their ability to engage in such activities. Pregnancy Advise pregnant women to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with fluvoxamine maleate tablets. Advise patients that fluvoxamine maleate tablets use late in pregnancy may lead to an increased risk for neonatal complications requiring prolonged hospitalization, respiratory support, tube feeding, and/or persistent pulmonary hypertension of the newborn (PPHN).
Advise women that there is a risk of relapse with discontinuation of antidepressants. Advise women tha…
💬 Medication Guide ▾
MEDICATION GUIDE Fluvoxamine (Flu-VOX-ah-meen) Maleate Tablets, USP Read the Medication Guide that comes with fluvoxamine maleate tablets before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment.
Talk with your healthcare provider if there is something you do not understand or want to learn more about. What is the most important information I should know about fluvoxamine maleate tablets? Fluvoxamine is the same kind of medicine as those used to treat depression and may cause serious side effects, including: 1.
Suicidal thoughts or actions: Fluvoxamine maleate tablets and 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 tablets are 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 if 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 Tell your healthcare provider right away if you have any of the following symptoms or call 911 if an emergency.
Fluvoxamine maleate tablets may be associated with these serious side effects: 2. Serotonin Syndrome: This condition can be life-threatening and may include: agitation, hallucinations, coma or other changes in mental status coordination problems or muscle twitching (overactive reflexes) racing heartbeat, high or low blood pressure sweating or fever nausea, vomiting, or diarrhea muscle rigidity 3. Visual problems eye pain changes in vision swelling or redness in or around the eye Only some people are at risk for these problems.
You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are. 4. Severe allergic reactions: trouble breathing swelling of the face, tongue, eyes, or mouth rash, itchy welts (hives) or blisters, alone or with fever or joint pain 5.
Abnormal bleeding: Fluvoxamine maleate tablets and antidepressant medicines may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin ® , Jantoven ® ), or a non-steroidal anti-inflammatory drug (NSAIDs, like ibuprofen, naproxen, or aspirin). 6. Seizures or convulsions 7.
Manic episodes: greatly increased energy severe trouble sleeping racing thoughts reckless behavior unusually grand ideas excessive happiness or irritability talking more or faster than usual 8. Changes in appetite or weight. Children and adolescents should have height and weight monitored during treatment.
9. Low salt (sodium) levels in the blood. Elderly people may be at greater risk for this.
Symptoms may include: headache weakness or feeling unsteady confusion, problems concentrating or thinking or memory problems 10. Sexual problems (dysfunction). Taking selective serotonin reuptake inhibitors (SSRIs), including fluvoxamine maleate tablets, may cause sexual problems.
Symptoms in males may include: Delayed ejaculation or inability to have an ejaculation Decreased sex drive Problems…