{
 "query": "fluvoxamine",
 "ingredient": "fluvoxamine",
 "slug": "fluvoxamine",
 "rxcui": "42355",
 "brands": [],
 "names": [
  "fluvoxamine",
  "fluvoxamine maleate"
 ],
 "classes": [
  {
   "id": "N06AB",
   "name": "Selective serotonin reuptake inhibitors"
  }
 ],
 "alternatives": [
  "citalopram",
  "escitalopram",
  "fluoxetine",
  "paroxetine",
  "sertraline"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 24
  },
  "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 exce...",
  "indications_and_usage": "Fluvoxamine maleate tablets are indicated for the treatment of obsessions and compulsions in patients with obsessive-compulsive disorder (OCD) ( 1 ). 1.1 Obsessive-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) ] .",
  "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) , Warnin...",
  "warnings_and_cautions": "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 ...",
  "warnings": "",
  "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 \u2265 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. 6.1 Adverse 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 re...",
  "drug_abuse_and_dependence": "9.1 Controlled Substance Fluvoxamine maleate tablets are not a controlled substance. 9.3 Dependence The potential for abuse, tolerance and physical dependence with fluvoxamine maleate tablets have been studied in a nonhuman primate model. No evidence of dependency phenomena was found. The discontinuation effects of fluvoxamine maleate tablets were not systematically evaluated in controlled clinical trials. Fluvoxamine maleate tablets were not systematically studied in clinical trials for potential for abuse, but there was no indication of drug-seeking behavior in clinical trials. It should be noted, however, that patients at risk for drug dependency were systematically excluded from investigational studies of fluvoxamine maleate tablets. Generally, it is not possible to predict on the basis of preclinical or pre-marketing clinical experience the extent to which a CNS active drug will be misused, diverted, and/or abused once marketed. Consequently, physicians should carefully evaluate patients for a history of drug abuse and follow such patients closely, observing them for signs of fluvoxamine maleate tablets misuse or abuse (i.e., development of tolerance, incrementation of dose, d...",
  "controlled_substance": "9.1 Controlled Substance Fluvoxamine maleate tablets are not a controlled substance.",
  "recent_major_changes": "Warnings and Precautions ( 5.2 , 5.10 ) 8/2023",
  "information_for_patients": "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 an...",
  "spl_medguide": "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 s...",
  "clinical_studies": "14.1 Adult OCD Studies The effectiveness of fluvoxamine maleate tablets for the treatment of obsessive-compulsive disorder (OCD) was demonstrated in two 10-week multicenter, parallel group studies of adult outpatients. Patients in these trials were titrated to a total daily fluvoxamine maleate tablets dose of 150 mg/day over the first two weeks of the trial, following which the dose was adjusted within a range of 100 mg/day to 300 mg/day (on a b.i.d. schedule), on the basis of response and tolerance. Patients in these studies had moderate to severe OCD (DSM-III-R), with mean baseline ratings on the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS), total score of 23. Patients receiving fluvoxamine maleate tablets experienced mean reductions of approximately 4 units to 5 units on the Y-BOCS total score, compared to a 2-unit reduction for placebo patients. Table 6 provides the outcome classification by treatment group on the Global Improvement item of the Clinical Global Impressions (CGI) scale for both studies combined. Table 6: Outcome Classification (%) on CGI-Global Improvement Item for Completers in Pool of Two Adult OCD Studies Outcome Classification Fluvoxamine Maleate Tablets (N...",
  "brand_name": "Fluvoxamine maleate",
  "manufacturer": "Bionpharma Inc.",
  "application_number": "ANDA217917",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20250212",
  "set_id": "2df4f9cf-5803-d8ea-e063-6394a90ad855",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 6361,
  "serious": 4884,
  "death": 538,
  "hospitalization": 2421,
  "primary_suspect": 6213,
  "top_reactions": [
   [
    "Drug Interaction",
    599
   ],
   [
    "Drug Ineffective",
    591
   ],
   [
    "Off Label Use",
    453
   ],
   [
    "Suicidal Ideation",
    360
   ],
   [
    "Suicide Attempt",
    354
   ],
   [
    "Anxiety",
    327
   ],
   [
    "Condition Aggravated",
    316
   ],
   [
    "Nausea",
    306
   ],
   [
    "Somnolence",
    302
   ],
   [
    "Toxicity To Various Agents",
    293
   ],
   [
    "Depression",
    281
   ],
   [
    "Fatigue",
    273
   ],
   [
    "Intentional Overdose",
    256
   ],
   [
    "Weight Increased",
    239
   ],
   [
    "Headache",
    223
   ]
  ],
  "by_year": {
   "2019": 490,
   "2020": 542,
   "2021": 511,
   "2022": 595,
   "2023": 508,
   "2024": 510,
   "2025": 722,
   "2026": 264
  },
  "by_year_primary": {
   "2019": 489,
   "2020": 542,
   "2021": 489,
   "2022": 554,
   "2023": 485,
   "2024": 494,
   "2025": 690,
   "2026": 251
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 27,
  "nda": 4,
  "anda": 23,
  "first_approval": "19941205",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 25,
  "labeling_recent": 2,
  "sponsors": [
   "ACTAVIS ELIZABETH",
   "AIPING PHARM INC",
   "AJANTA PHARMA LTD",
   "ANI PHARMS",
   "ANNORA PHARMA",
   "APOTEX",
   "APPCO",
   "BIONPHARMA"
  ],
  "unapproved": false,
  "first_approval_fmt": "12/05/1994"
 },
 "trials": {
  "total": 104,
  "completed": 66,
  "terminated": 8,
  "with_results": 16,
  "industry": 32,
  "phase3": 15,
  "results_share": 0.24242424242424243,
  "terminated_share": 0.07692307692307693
 },
 "pubmed": {
  "rct": 248,
  "meta": 19,
  "recent_rct": 13,
  "cochrane": [
   {
    "pmid": "36103313",
    "title": "Fluvoxamine for the treatment of COVID-19",
    "year": "2022"
   },
   {
    "pmid": "20238342",
    "title": "Fluvoxamine versus other anti-depressive agents for depression",
    "year": "2010"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "fluvoxamine"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 427554,
  "beneficiaries": 57954,
  "spend": 23272141.259999998,
  "by_brand": [
   {
    "brand": "Fluvoxamine Maleate",
    "claims": 409767,
    "per_claim": 42.157298928,
    "is_generic": true
   },
   {
    "brand": "Fluvoxamine Maleate ER",
    "claims": 17787,
    "per_claim": 337.18284983,
    "is_generic": false
   }
  ],
  "per_claim": 54.430881853520255
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "fluvoxamine",
  "matched": "fluvoxamine",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 1435,
  "fills": 427554,
  "per_million": 3356.301192364005,
  "ratio": 1.212120656133082,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 63,
   "letter": "C",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "3,356 FDA reports naming it as the suspect drug per million Medicare fills, 1.2x the median drug on this site (-2)",
    "Death share in reports is near or below the FAERS average (0.9x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 56,
   "letter": "D",
   "why": [
    "248 randomized trials and 19 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "2 independent Cochrane review(s) exist",
    "Only 24% of completed registered trials posted results (-15)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 91,
   "letter": "A",
   "why": [
    "No recalls on record since 2016",
    "2 label changes approved since 2021 (-4)",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $0 tied to this drug last year: negligible",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 100,
   "letter": "A",
   "why": [
    "Generic versions approved (23 applications)",
    "5 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 75,
 "grade": "C",
 "questions": [
  "This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?",
  "The most-reported problems in FDA's adverse event data are drug interaction, suicidal ideation. How would we recognize and handle those?",
  "Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?",
  "Why this one over citalopram, escitalopram, fluoxetine? What would make you pick one of those instead?",
  "What result are we expecting, by when, and what is the plan if it does not happen?",
  "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)"
 ]
}