Fluvoxamine Maleate

Fluvoxamine Maleate is an FDA-registered drug product whose active ingredient is FLUVOXAMINE MALEATE. It is labelled by Par Health USA, LLC taken by oral and marketed as a human prescription drug product. Identifiers on file: NDC 10370-175, application ANDA091476, label effective 20260624. It is one of 5 FDA drug label records sharing the active ingredient FLUVOXAMINE MALEATE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing FLUVOXAMINE MALEATE are most often described in connection with: fluvoxamine maleate, extended-release capsules, obsessive compulsive, one week, disorder ocd, maintenance study, see clinical, selective serotonin. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE Fluvoxamine 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. 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 obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning. The efficacy of fluvoxamine maleate extended-release capsules was demonstrated in one 12-week trial in adults with fluvoxamine maleate extended-release capsules as well as in two 10-week trials in adults and in one 10-week trial in children and adolescents (ages 8 to 17 years) with immediate-release fluvoxamine tablets in outpatients with the diagnosis of OCD as defined in DSM-IV or DSM-III-R ( see CLINICAL STUDIES [ 14.1 , 14.3 ] ). The efficacy of fluvoxamine for long-term use was established in one maintenance study in adults with immediate-release fluvoxamine tablets ( see CLINICAL STUDIES [ 14.2 ] ). The health care provider who elects to prescribe fluvoxamine maleate extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient ( see DOSAGE AND ADMINISTRATION [ 2.4 ] ).

2 DOSAGE AND ADMINISTRATION 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. 2.4 Maintenance/Continuation of Extended Treatment Although the efficacy of fluvoxamine maleate extended-release capsules beyond 12 weeks of dosing has not been documented in controlled trials, OCD is a chronic condition, and it is reasonable to consider continuation for a responding patient. The benefit of maintaining patients with OCD on immediate-release fluvoxamine maleate tablets after achieving a response for an average duration of about 4 weeks in a 10-week single-blind phase during which patients were titrated to effect was demonstrated in a controlled trial ( see CLINICAL TRIALS [ 14.2 ]). Dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for continued treatment. 2.5 Switching 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 extended-release capsules. Conversely, at least 14 days should be allowed after stopping fluvoxamine maleate extended-release capsules before starting an MAOI intended to treat psychiatric disorders (see CONTRAINDICATIONS [ 4.1 ] ). 2.6 Use of Fluvoxamine Maleate Extended-Release Capsules with Other MAOIs such as Linezolid or Methylene Blue Do not start fluvoxamine maleate extended-release capsules 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 [ 4.1 ] ). In some cases, a patient already receiving fluvoxamine maleate extended-release capsules therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, fluvoxamine maleate extended-release capsules should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for two weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with fluvoxamine maleate extended-release capsules may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue (see WARNINGS AND PRECAUTIONS [ 5.2 ] ). The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with fluvoxamine maleate extended-release capsules are unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use (see WARNINGS AND PRECAUTIONS [ 5.2 ] ). 2.7 Discontinuation of Treatment with Fluvoxamine Maleate Extended-Release Capsules Symptoms associated with discontinuation of other SSRIs or SNRIs have been reported (see WARNINGS AND PRECAUTIONS [ 5.10 ] ). Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the health care provider may continue decreasing the dose but at a more gradual rate.

4 CONTRAINDICATIONS 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 ). Serotonin Syndrome and MAOIs: Do not use MAOIs intended to treat psychiatric disorders with fluvoxamine maleate extended-release capsules or within 14 days of stopping treatment with fluvoxamine maleate extended-release capsules. Do not use fluvoxamine maleate extended-release capsules within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start fluvoxamine maleate extended-release capsules in a patient who is being treated with linezolid or intravenous methylene blue ( 4.1 ). 4.1 Monoamine Oxidase Inhibitors (MAOIs) The use of MAOIs intended to treat psychiatric disorders with fluvoxamine maleate extended-release capsules or within 14 days of stopping treatment with fluvoxamine maleate extended-release capsules are contraindicated because of an increased risk of serotonin syndrome. The use of fluvoxamine maleate extended-release capsules within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated (see DOSAGE AND ADMINISTRATION [ 2.5 ] and WARNINGS AND PRECAUTIONS [ 5.2 ] ) . 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 risk of serotonin syndrome (see DOSAGE AND ADMINISTRATION [ 2.6 ] and WARNINGS AND PRECAUTIONS [ 5.2 ]).

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 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 Par Health at 1-800-828-9393 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 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. 6.2 Adverse Reactions Observed in Controlled Trials Adverse Reactions Associated with Discontinuation of Treatment: Of the 124 patients with OCD and 279 patients in other studies treated with fluvoxamine maleate extended-release capsules in controlled clinical trials, 19% and 26% discontinued treatment due to an adverse reaction. The most common reactions (≥1%) associated with discontinuation and considered to be drug related (i.e., those reactions associated with dropout at a rate at least twice that of placebo) were anorexi a (including, but not limited to, loss of appetite and decreased appetite) (1%), anxiety (3%), asthenia (3%), diarrhea (2%), dizziness (4%), headache (2%), insomnia (5%), nausea (7%), nervousness (1%), somnolence (5%), and thinking abnormal (1%) . Commonly Observed Adverse Reactions: Fluvoxamine maleate extended-release capsules have been studied in one controlled trial in patients with OCD (N = 124) and two controlled trials for another condition (N = 279). In general, adverse reaction rates were similar in the two data sets as well as in a study of pediatric patients with OCD treated with immediate-release fluvoxamine maleate tablets. The most commonly observed treatment-emergent adverse reactions associated with the use of fluvoxamine maleate extended-release capsules and likely to be drug-related (incidence of 5% or greater and at least twice that for placebo) and derived from Table 2 were: abnormal ejaculation, anorexia, anorgasmia, asthenia, diarrhea, nausea, somnolence, sweating, and tremor . In the one controlled trial in patients with OCD, the following additional reactions occurred at an incidence of 5% or greater and at least twice that for placebo: anxiety, decreased libido, myalgia, pharyngitis, and vomiting . The following additional reactions occurred in another studied population: dyspepsia, dizziness, insomnia, and yawning . In a study evaluating immediate-release fluvoxamine maleate tablets in 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 ≥ 2%: Table 2 enumerates adverse reactions that occurred in adults at a frequency of 2% or more, and were more frequent than in the placebo group, among patients treated with fluvoxamine maleate extended-release capsules in two short-term, placebo-controlled trials (12 weeks) in another population and one short-term placebo-controlled OCD trial (12 weeks) and in which patients were dosed once-a-day in a range of 100 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 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 health care provider 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 PATIENTS AND ANOTHER STUDIED POPULATION 1 PERCENTAGE OF PATIENTS REPORTING REACTION OBSESSIVE COMPULSIVE DISORDER OTHER STUDIED POPULATION BODY SYSTEM/ ADVERSE REACTION FLUVOXAMINE MALEATE EXTENDED-RELEASE CAPSULES N = 124 PLACEBO N = 124 FLUVOXAMINE MALEATE EXTENDED-RELEASE CAPSULES N = 279 PLACEBO N = 276 BODY AS A WHOLE Headache 32 31 35 30 Asthenia 26 8 24 10 Pain 2 10 8 -- -- Abdominal Pain -- -- 5 4 Accidental Injury 5 3 – – Chest Pain -- -- 3 1 Viral Infection 2 <1 -- -- CARDIOVASCULAR Palpitation -- -- 3 1 Vasodilatation -- -- 2 <1 Hypertension 2 <1 -- -- DIGESTIVE SYSTEM Nausea 34 13 39 11 Diarrhea 18 8 14 5 Anorexia 3 13 5 14 1 Dyspepsia 8 5 10 4 Constipation 4 <1 6 5 Vomiting 6 2 -- -- Tooth Disorder 2 <1 -- -- Liver Function Test Abnormal -- -- 2 <1 Gingivitis 2 0 -- -- HEMIC AND LYMPHATIC Ecchymosis 4 2 -- -- METABOLIC AND NUTRITIONAL DISORDERS Weight Loss 2 <1 -- -- MUSCULOSKELETAL Myalgia 5 2 -- -- NERVOUS SYSTEM Insomnia 35 20 32 13 Somnolence 27 11 26 9 Dizziness 12 10 15 7 Dry Mouth 10 9 11 8 Nervousness -- -- 10 9 Libido Decreased 6 2 6 4 Male 10 5 8 6 Female 4 1 4 3 Anxiety 6 2 8 5 Tremor 6 0 8 <1 Abnormal Thinking 3 <1 3 2 Abnormal Dreams -- -- 3 2 Agitation 2 <1 3 <1 Hypertonia -- -- 2 1 Apathy 3 0 -- -- Paresthesia -- -- 3 2 Neurosis 2 <1 -- -- Twitching 2 0 -- -- RESPIRATORY SYSTEM Pharyngitis 6 <1 -- -- Yawn 2 0 5 <1 Laryngitis 3 0 -- -- Bronchitis -- -- 2 1 Epistaxis 2 0 -- -- SKIN Sweating 7 <1 6 2 Acne 2 0 -- -- SPECIAL SENSES Taste Perversion 2 <1 2 <1 Amblyopia 2 <1 -- -- UROGENITAL Abnormal Ejaculation 10 0 11 2 Anorgasmia 5 0 5 1 Male 4 0 4 2 Female 5 0 5 0 Menorrhagia 3 0 - - Sexual Function Abnormal 2 <1 3 <1 Male 4 3 2 1 Female 0 0 3 0 Urinary Tract Infection -- -- 2 <1 Polyuria 2 <1 -- -- 1 Events for which fluvoxamine maleate incidence was equal to or less than placebo include the following for OCD patients: abdominal pain, flu syndrome, infection, palpitation, flatulence, increased appetite, weight gain, abnormal dreams, amnesia, hypertonia, nervousness, paresthesia, increased cough, dyspnea, rhinitis, and ear pain. In the other studied population the following events were seen: abdominal pain, accidental injury, back pain, flu syndrome, infection, pain, flatulence, pharyngitis, rhinitis, rash, and dysmenorrhea. 2 Term includes body aches/pains, dental pain, pain from surgery, unspecified pain, and general pain secondary to injuries (sprains, fractures). 3 Includes, but is not limited to, loss of appetite and decreased appetite. 6.3 Other Adverse Reactions in OCD Pediatric Population In pediatric patients (N=57) treated with immediate-release fluvoxamine maleate tablets, the overall profile of adverse reactions was generally similar to that seen in adult studies, as shown in Table 2 . However, the following adverse reactions, not appearing in Table 2 , were reported in two or more of the pediatric patients and were more frequent with immediate-release fluvoxamine maleate tablets than with placebo: cough increase, dysmenorrhea, ecchymosis, emotional lability, epistaxis, hyperkinesia, manic reaction, rash, sinusitis, and weight decrease. 6.4 Male and Female Sexual Dysfunction with SSRIs Although changes in sexual desire, sexual performance, and sexual satisfaction often occur as manifestations of a psychiatric disorder and with aging, they may also be a consequence of pharmacologic treatment. In particular, some evidence suggests that selective serotonin reuptake inhibitors (SSRIs) can cause such untoward sexual experiences. Reliable estimates of the incidence and severity of untoward experiences involving sexual desire, performance, and satisfaction are difficult to obtain, however, in part because patients and health care providers may be reluctant to discuss them. Accordingly, estimates of the incidence of untoward sexual experience and performance cited in product labeling are likely to underestimate their actual incidence. Table 3 displays the incidence of sexual side effects reported by at least 2% of patients taking fluvoxamine maleate extended-release capsules in placebo-controlled trials. TABLE 3 PERCENTAGE OF PATIENTS REPORTING SEXUAL ADVERSE REACTIONS IN PLACEBO-CONTROLLED TRIALS Fluvoxamine Maleate Extended-Release Capsules N = 403 Placebo N = 400 Abnormal Ejaculation 11 2 Anorgasmia Male 4 1 Female 5 0 Impotence 2 2 Libido Decreased Male 8 5 Female 4 2 Sexual Function Abnormal Male 3 1 Female 2 0 Fluvoxamine treatment has been associated with several cases of priapism. In those cases with a known outcome, patients recovered without sequelae and upon discontinuation of fluvoxamine. While it is difficult to know the precise risk of sexual dysfunction associated with the use of SSRIs, health care providers should routinely inquire about such possible side effects. 6.5 Weight and Vital Sign Changes No statistically significant differences in weight gain or loss were found between patients treated with fluvoxamine maleate extended-release capsules or placebo. Comparisons of immediate-release fluvoxamine maleate tablets or fluvoxamine maleate extended-release capsules versus placebo groups in separate short-term trials on (1) median change from baseline on various vital signs variables and on (2) incidence of patients meeting criteria for potentially important changes from baseline on various measures of vital signs variables revealed no important differences between fluvoxamine maleate and placebo. 6.6 Laboratory Changes Comparisons of immediate-release fluvoxamine maleate tablets or fluvoxamine maleate extended-release capsules versus placebo groups in separate short-term trials on (1) median change from baseline on various serum chemistry, hematology, and urinalysis variables and on (2) incidence of patients meeting criteria for potentially important changes from baseline on various serum chemistry, hematology, and urinalysis variables revealed no important differences between fluvoxamine maleate and placebo. 6.7 ECG Changes Comparisons of immediate-release fluvoxamine maleate tablets or fluvoxamine maleate extended-release capsules and placebo groups in separate pools of short-term OCD and depression trials on (1) mean change from baseline on various ECG variables and on (2) incidence of patients meeting criteria for potentially important changes from baseline on various ECG variables revealed no important differences between fluvoxamine maleate and placebo. 6.8 Other Reactions Observed During the Premarketing Evaluation of Fluvoxamine During premarketing clinical trials conducted in North America and Europe, multiple doses of fluvoxamine maleate extended-release capsules or immediate-release fluvoxamine maleate tablets were administered for a combined total of 3219 patient exposures in patients suffering OCD or other studied disorders. These exposures include 482 patient exposures with fluvoxamine maleate extended-release capsules and 2737 patient exposures with immediate-release fluvoxamine maleate tablets. Untoward reactions associated with this exposure were recorded by clinical investigators using descriptive terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse reactions without first grouping similar types of untoward reactions into a limited (i.e., reduced) number of standard reaction categories. In the tabulations that follow, a COSTART-based Dictionary terminology has been used to classify reported adverse reactions. If the COSTART term for a reaction was so general as to be uninformative, it was replaced with a more informative term when possible. The frequencies presented, therefore, represent the proportion of the total patient exposures to multiple doses of fluvoxamine maleate who experienced a reaction of the type cited on at least one occasion while receiving fluvoxamine maleate. Reactions are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: frequent adverse reactions are defined as those occurring on one or more occasions in at least 1/100 patients; infrequent adverse reactions are those occurring between 1/100 and 1/1000 patients; and rare adverse reactions are those occurring in less than 1/1000 patients. It is important to emphasize that, although the events reported did occur during treatment with fluvoxamine maleate, a causal relationship to fluvoxamine maleate has not been established. For fluvoxamine maleate extended-release capsules, all reported events are included in the list below, with the following exclusions: 1) those events already listed in Table 2 or previous sections of this prescribing information; 2) those events for which there is no basis to suspect a causal relationship; and 3) events that were reported in only one patient and judged not to be potentially serious. Body as a Whole: Infrequent : chills, malaise, photosensitivity reaction, suicide attempt. Cardiovascular System: Infrequent: syncope. Digestive System: Infrequent: eructation, increased salivation. Metabolic and Nutritional Disorders: Frequent : weight gain. Nervous System: Infrequent: confusion, incoordination, sleep disorder, suicidal tendency. Skin and Appendages: Infrequent: eczema, urticaria. Special Senses: Infrequent: dry eyes, photophobia, taste loss. Urogenital System: Infrequent: vaginal hemorrhage 1 . 1 Based on the number of females. For immediate-release fluvoxamine tablets, all reported events are included in the list below, with the following exclusions: 1) those events already listed in Table 2 , in previous sections of this prescribing information, or in the fluvoxamine maleate extended-release capsules list of Other Reactions Observed During Premarketing Evaluation; 2) those events for which there is no basis to suspect a causal relationship; and 3) events that were reported in only one patient and judged not to be potentially serious. Body as a Whole: Infrequent: allergic reaction, neck pain, neck rigidity, overdose; Rare: sudden death. Cardiovascular System: Frequent: hypotension; Infrequent: angina pectoris, bradycardia, cardiomyopathy, cardiovascular disease, cold extremities, conduction delay, myocardial infarction, pallor, pulse irregular, ST segment changes; Rare: AV block, cerebrovascular accident, embolus, pericarditis, phlebitis, pulmonary infarction, supraventricular extrasystoles. Digestive System: Frequent: elevated liver transaminases; Infrequent: colitis, esophagitis, gastritis, gastroenteritis, gastrointestinal hemorrhage, gastrointestinal ulcer, glossitis, hemorrhoids, melena, rectal hemorrhage, stomatitis; Rare: biliary pain, cholecystitis, cholelithiasis, fecal incontinence, hematemesis, intestinal obstruction, jaundice. Endocrine System: Infrequent: hypothyroidism; Rare: goiter. Hemic and Lymphatic Systems: Infrequent: leukocytosis, lymphadenopathy, thrombocytopenia; Rare: leukopenia, purpura. Metabolic and Nutritional Systems: Frequent: edema; Infrequent: dehydration, hypercholesterolemia; Rare: diabetes mellitus, hyperglycemia, hyperlipidemia, hypoglycemia, hypokalemia, lactate dehydrogenase increased. Musculoskeletal System: Infrequent: arthralgia, arthritis, bursitis, generalized muscle spasm, myasthenia; Rare: myopathy. Nervous System: Frequent: amnesia, apathy, hyperkinesia, hypokinesia, manic reaction, myoclonus, psychotic reaction; Infrequent: agoraphobia, akathisia, ataxia, CNS depression, convulsion, delirium, delusion, depersonalization, dyskinesia, dystonia, emotional lability, euphoria, extrapyramidal syndrome, gait unsteady, hallucinations, hemiplegia, hostility, hypersomnia, hypochondriasis, hypotonia, hysteria, increased libido, paralysis, paranoid reaction, phobia, psychosis, stupor, twitching, vertigo; Rare: akinesia, coma, fibrillations, mutism, obsessions, reflexes decreased, slurred speech, tardive dyskinesia, torticollis, trismus, withdrawal syndrome. Respiratory System: Frequent: cough increased, sinusitis; Infrequent: asthma, bronchitis, hoarseness, hyperventilation; Rare: apnea, congestion of upper airway, hemoptysis, hiccups, laryngismus, obstructive pulmonary disease, pneumonia. Skin: Infrequent: alopecia, dry skin, exfoliative dermatitis, furunculosis, seborrhea, skin discoloration. Special Senses: Infrequent: accommodation abnormal, conjunctivitis, diplopia, eye pain, mydriasis, otitis media, parosmia, visual field defect; Rare: corneal ulcer. Urogenital System : Infrequent: anuria, cystitis, delayed menstruation 1 , dysuria, female lactation 1 , hematuria, menopause 1 , metrorrhagia 1 , nocturia, premenstrual syndrome 1 , urination impaired, vaginitis 1 ; Rare: kidney calculus, hematospermia 2 , oliguria. 1 Based on the number of females. 2 Based on the number of males. 6.9 Postmarketing Reports The following adverse reactions have been identified during post-approval use of immediate-release fluvoxamine maleate tablets or fluvoxamine maleate extended-release capsules. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. (Reactions that are discussed in other sections of this prescribing information are not repeated here.) These reactions include: activation syndrome, aggression, agranulocytosis, anaphylactic reaction, anger, blood glucose increased, bruxism, cardio-respiratory arrest, crying, dysarthria, dysphagia, electrocardiogram QT prolonged, fall, fatigue, feeling drunk, feeling jittery, gait disturbance, gastroesophageal reflux disease, glossodynia, hepatitis, homicidal ideation, impulsive behavior, ileus, inappropriate antidiuretic hormone secretion, interstitial lung disease, irritability, loss of consciousness, lethargy, muscular weakness, Parkinsonism, pancreatitis, pyrexia, renal impairment, rhabdomyolysis, self injurious behavior, shock, somnolence neonatal, Stevens-Johnson syndrome, tachycardia, urinary retention, ventricular arrhythmia, ventricular tachycardia (including torsades de pointes known to cause cardiac arrest, sometimes fatal), vision blurred, white blood cell count decreased, anosmia, and hyposmia.

FDA lists 5 drug label records with FLUVOXAMINE MALEATE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

2 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Fluvoxamine Maleate used for?
1 INDICATIONS AND USAGE Fluvoxamine 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 …

Who makes Fluvoxamine Maleate?
Par Health USA, LLC is the labeler of record for Fluvoxamine Maleate. 5 FDA label records share the active ingredient FLUVOXAMINE MALEATE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Fluvoxamine Maleate come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Fluvoxamine Maleate prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing FLUVOXAMINE MALEATE?
Yes. 5 FDA drug label records list FLUVOXAMINE MALEATE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Fluvoxamine Maleate been recalled?
2 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.