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Quick facts
- How it is given
- oral
- Type
- human prescription drug
- RxNorm ID
- 903873
We do not publish dosing. How much of this medicine to take, how often, and for how long depends on your age, weight, kidney and liver function, other conditions and other medicines. That is a decision for the person who prescribes or dispenses it. Follow the directions on your own pack and ask your pharmacist if anything is unclear.
What it is used to treat
Fluvoxamine maleate extended-release capsules is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of obsessive compulsive disorder (OCD) ( 1 ). Efficacy was demonstrated in: One 12-week study fluvoxamine maleate extended-release capsules in adults ( 14.1 ). 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 years 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 ]).
About this medicine
Fluvoxamine maleate extended-release capsules, for oral administration, contain fluvoxamine maleate, USP a selective serotonin (5-HT) reuptake inhibitor (SSRI) belonging to the chemical series, the 2-aminoethyl oxime ethers of aralkylketones. Fluvoxamine maleate, USP is chemically designated as 5-methoxy-4'-(trifluoromethyl) valerophenone-(E)-O-(2-aminoethyl)oxime maleate (1:1) and has the empirical formula C 15 H 21 O 2 N 2 F 3 •C 4 H 4 O 4 . Its molecular weight is 434.41. The structural formula is: Fluvoxamine maleate, USP is a white to off-white, odorless, crystalline powder that is sparingly soluble in water, freely soluble in ethanol and chloroform, and practically insoluble in diethyl ether. Fluvoxamine maleate extended-release capsules are available in 100 mg and 150 mg strengths for oral administration. In addition to the active ingredient, fluvoxamine maleate, USP each capsule contains the following inactive ingredients: ethyl cellulose, hydroxypropyl cellulose, hypromellose, sugar spheres (which contain sucrose and corn starch), triethyl citrate, and talc. The capsule shell contains gelatin, titanium dioxide, black iron oxide, iron oxide yellow, FD&C Blue No. 1 and sodium lauryl sulfate. The capsule shell is printed with black ink. The black ink contains shellac, propylene glycol, potassium hydroxide, and black iron oxide. Fluvoxamine maleate extended-release capsules are gluten-free. structure
How it works
12.1 Mechanism of Action The mechanism of action of fluvoxamine maleate in obsessive compulsive disorder is presumed to be linked to its specific serotonin reuptake inhibition in brain neurons. Fluvoxamine has been shown to be a potent inhibitor of the serotonin reuptake transporter in preclinical studies, both in vitro and in vivo .
Who should not take it
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 is contraindicated because of an increased risk of serotonin syndrome. The use of fluvoxamine maleate extended-release 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 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 ] ).
Warnings and cautions
Clinical Worsening/Suicide Risk: Monitor for clinical worsening of suicidal thoughts/behaviors especially during the initial months of therapy and at times of dose changes ( 5.1 ). Bipolar Disorder: Screen for bipolar disorder ( 5.1 ). Serotonin Syndrome: Serotonin syndrome has been reported with SSRIs and SNRIs, including fluvoxamine maleate extended-release capsules, both when taken alone, but especially when co-administered with other serotonergic agents. If such symptoms occur, discontinue fluvoxamine maleate extended-release capsules and serotonergic agents and initiate supportive treatment. If concomitant use of fluvoxamine maleate extended-release capsules with other serotonergic drugs is clinically warranted, patients should be made aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases ( 5.2 ). Angle Closure Glaucoma: Angle closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants ( 5.3 ). Other Potentially Important Drug Interactions: Benzodiazepines : Use with caution. Coadministration with diazepam is generally not advisable ( 5.9 ). Clozapine: Clozapine levels may be increased and produce orthostatic hypotension or seizures ( 5.9 ). Methadone: Coadministration may produce opioid intoxication. Discontinuation of fluvoxamine may produce opioid withdrawal ( 5.9 ). Mexiletine: Monitor serum mexiletine levels ( 5.9 ). Theophylline: Clearance decreased; reduce theophylline dose by one-third ( 5.9 ). Warfarin: Plasma concentrations increased and prothrombin times prolonged; monitor prothrombin time and adjust warfarin dose accordingly ( 5.9 ). Discontinuation: Symptoms associated with discontinuation have been reported ( 5.10 ). In the absence of an emergency, abrupt discontinuation not recommended ( 2.7 , 5.2 ). Abnormal Bleeding: May increase bleeding risk, especially when used with NSAIDs, aspirin, warfarin, or other drugs that affect coagulation ( 5.11 ). Activation of Mania/Hypomania has occurred ( 5.12 ). […]
Reported side effects
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Most common reactions in controlled trials with OCD patients and patients from another studied population (incidence ≥5% and at least twice that for placebo) were abnormal ejaculation, anorexia, anorgasmia, asthenia, diarrhea, nausea, somnolence, sweating and tremor ( 6.2 ) . The following additional reactions occurred: anxiety, decreased libido, myalgia, pharyngitis, and vomiting in the OCD population; and dyspepsia, dizziness, insomnia, and yawning in another studied population. To report SUSPECTED ADVERSE REACTIONS, contact Ajanta Pharma USA Inc., at 855-664-7744 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Data Sources Fluvoxamine maleate extended-release capsules were studied in one 12-week controlled trial in patients with OCD (N = 124; mean exposure 66.6 days) and in two 12-week controlled trials for another condition (N = 279; mean exposure 59.2 days). Patients in these trials were initiated on 100 mg/day and were titrated in 50 mg increments over the first 6 weeks to within a range of 100 mg/day to 300 mg/day. The reactions listed in Table 2 show reactions from the two populations separately. Table 3 shows reactions from the three controlled studies combined. 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. […]
Interactions with other medicines
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) ( 7.1 ) . Carbamazepine: Elevated carbamazepine levels and symptoms of toxicity with coadministration ( 7.2 ) . Sumatriptan: Rare postmarketing reports of weakness, hyperreflexia, and incoordination following use of an SSRI and sumatriptan. Monitor appropriately if concomitant treatment is clinically warranted ( 7.2 ) . Tacrine: Coadministration increased tacrine C max and AUC five-and eight-fold and caused nausea, vomiting, sweating, and diarrhea ( 7.2 ) . Tricyclic Antidepressants (TCAs): Coadministration significantly increased plasma TCA levels. Use caution; monitor plasma TCA levels; reduce TCA dose if indicated ( 7.2 ) . Tryptophan: Severe vomiting with coadministration ( 7.2 ) . Diltiazem: Bradycardia with coadministration ( 7.3 ) . Propranolol or Metoprolol: Reduce dose if coadministered with fluvoxamine and titrate more cautiously ( 7.3 ) . 7.1 Potential 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 ] for details) 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). […]
Use in specific groups
Specific populations not discussed in Dosage and Administration or Warnings and Precautions include: Pregnancy: Consider both potential risks and benefits when treating a pregnant woman. Infants exposed to SSRIs in pregnancy have developed various complications and may be at risk for persistent pulmonary hypertension of the newborn (PPHN) ( 2.7 , 8.1 ). Nursing mothers: Fluvoxamine is secreted in human breast milk ( 8.3 ). Geriatric: Use of a lower starting dose may be warranted. Titrate slowly during initiation of therapy ( 2.3 , 8.5 ). Smokers: Smokers had a 25% increase in fluvoxamine metabolism ( 7.4 ). 8.1 Pregnancy Teratogenic Effects: When pregnant rats were given daily doses of fluvoxamine (60 mg/kg, 120 mg/kg, or 240 mg/kg) orally throughout the period of organogenesis, developmental toxicity in the form of increased embryofetal death and increased incidences of fetal eye abnormalities (folded retinas) was observed at doses of 120 mg/kg or greater. Decreased fetal body weight was seen at the high dose. The no effect dose for developmental toxicity in this study was 60 mg/kg (approximately 2 time the maximum recommended human dose [MRHD] on a mg/m 2 basis). In a study in which pregnant rabbits were administered doses of up to 40 mg/kg (approximately 2 times the MRHD on a mg/m 2 basis) orally during organogenesis, no adverse effects on embryofetal development were observed. In other reproduction studies in which female rats were dosed orally during pregnancy and lactation (5 mg/kg, 20 mg/kg, 80 mg/kg, or 160 mg/kg), increased pup mortality at birth was seen at doses of 80 mg/kg or greater and decreases in pup body weight and survival were observed at all doses (low effect dose approximately 0.1 times the MRHD on a mg/m 2 basis). Nonteratogenic Effects: 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 haemorrhage [see Warnings and Precautions ( 5.11 ) and Clinical Considerations]. […]
If too much is taken
10.1 Human Experience Exposure to immediate-release fluvoxamine maleate tablets includes over 45,000 patients treated in clinical trials and an estimated exposure of 50,000,000 patients treated during worldwide marketing experience (end of 2005). Of the 539 cases of deliberate or accidental overdose involving fluvoxamine reported from this population, there were 55 deaths. Of these, 9 were in patients thought to be taking immediate-release fluvoxamine tablets alone and the remaining 46 were in patients taking fluvoxamine along with other drugs. Among non-fatal overdose cases, 404 patients recovered completely. Five patients experienced adverse sequelae of overdosage, to include persistent mydriasis, unsteady gait, hypoxic encephalopathy, kidney complications (from trauma associated with overdose), bowel infarction requiring a hemicolectomy, and vegetative state. In 13 patients, the outcome was provided as abating at the time of reporting. In the remaining 62 patients, the outcome was unknown. The largest known ingestion of fluvoxamine immediate-release tablets involved 12,000 mg (equivalent to 2 months to 3 months' dosage). The patient fully recovered. However, ingestions as low as 1,400 mg have been associated with lethal outcome, indicating considerable prognostic variability. In the controlled clinical trials with 403 patients treated with fluvoxamine maleate extended-release capsules, there was one nonfatal intentional overdose. Commonly (≥5%) observed adverse reactions associated with fluvoxamine maleate overdose include gastrointestinal complaints (nausea, vomiting, and diarrhea), coma, hypokalemia, hypotension, respiratory difficulties, somnolence, and tachycardia. Other notable signs and symptoms seen with immediate-release fluvoxamine maleate overdose (single or multiple drugs) include bradycardia, ECG abnormalities (such as heart arrest, QT interval prolongation, first degree atrioventricular block, bundle branch block, and junctional rhythm), convulsions, dizziness, liver function disturbances, tremor, and increased reflexes. […]
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This page is built from the openFDA record of the U.S. Food and Drug Administration's approved labelling for this product, effective 4 November 2025. Label text has been shortened and reformatted for readability; safety wording has not been altered in meaning. FDA labelling describes products approved in the United States — brand names, strengths, formulations and approved uses may differ in your country. Always read the leaflet that comes with your own pack. PocketsInfo is not affiliated with, and is not endorsed by, the FDA. Retrieved 2026-07-30.