{
 "query": "fluoxetine",
 "ingredient": "fluoxetine",
 "slug": "fluoxetine",
 "rxcui": "4493",
 "brands": [
  "Prozac"
 ],
 "names": [
  "fluoxetine",
  "fluoxetine hydrochloride"
 ],
 "classes": [
  {
   "id": "N06AB",
   "name": "Selective serotonin reuptake inhibitors"
  }
 ],
 "alternatives": [
  "citalopram",
  "escitalopram",
  "fluvoxamine",
  "paroxetine",
  "sertraline"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 158
  },
  "boxed_warning": "WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older [see Warnings and Precautions (5.1) ] . In patients of all ages who are started on antidepressant therapy, monitor closely for worsening and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [see Warnings and Precautions (5.1) ] . Fluoxetine is not approved for use in children less than 7 years of age [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4) ] . When using fluoxetine and olanzapine in combination, also refer to Boxed Warning section of the package insert for Symbyax. WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taki...",
  "indications_and_usage": "Fluoxetine is indicated for the treatment of: Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1) ] . Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2) ] . Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3) ] . Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies (14.4) ] . Fluoxetine and Olanzapine in Combination is indicated for the treatment of: Acute treatment of depressive episodes associated with Bipolar I Disorder. Treatment resistant depression (Major Depressive Disorder in patients, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode). Fluoxetine monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression. When using fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax \u00ae . Fluoxetine c...",
  "contraindications": "When using fluoxetine capsules and olanzapine in combination, also refer to the Contraindications section of the package insert for Symbyax. Serotonin Syndrome and MAOIs: Do not use MAOIs intended to treat psychiatric disorders with fluoxetine or within 5 weeks of stopping treatment with fluoxetine. Do not use fluoxetine within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start fluoxetine in a patient who is being treated with linezolid or intravenous methylene blue ( 4.1 ) Pimozide: Do not use. Risk of QT prolongation and drug interaction ( 4.2 , 5.11 , 7.7 , 7.8 ) Thioridazine: Do not use. Risk of QT interval prolongation and elevated thioridazine plasma levels. Do not use thioridazine within 5 weeks of discontinuing fluoxetine. Do not use thioridazine within 5 weeks of discontinuing fluoxetine ( 4.2 , 5.11 , 7.7 , 7.8 ) When using fluoxetine and olanzapine in combination, also refer to the Contraindications section of the package insert for Symbyax ( 4 ) 4.1 Monoamine Oxidase Inhibitors (MAOIs) The use of MAOIs intended to treat psychiatric disorders with fluoxetine or within 5 weeks of stopping treatment with fluoxetine is contraindic...",
  "warnings_and_cautions": "When using fluoxetine and olanzapine in combination, also refer to the Warnings and Precautions section of the package insert for Symbyax. Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults: Monitor for clinical worsening and suicidal thinking and behavior ( 5.1 ) Serotonin Syndrome: Serotonin syndrome has been reported with SSRIs and SNRIs, including fluoxetine, both when taken alone, but especially when co-administered with other serotonergic agents (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John's Wort). If such symptoms occur, discontinue fluoxetine and initiate supportive treatment. If concomitant use of fluoxetine 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 ) Allergic Reactions and Rash: Discontinue upon appearance of rash or allergic phenomena ( 5.3 ) Activation of Mania/Hypomania: Screen for Bipolar Disorder and monitor for mania/hypomania ( 5.4 ) Seizures: Use cautiously in patients with a history of seizures or ...",
  "warnings": "",
  "adverse_reactions": "The following adverse reactions are discussed in more detail in other sections of the labeling: Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults [see Boxed Warning and Warnings and Precautions (5.1) ] Serotonin Syndrome [see Warnings and Precautions (5.2) ] Allergic Reactions and Rash [see Warnings and Precautions (5.3) ] Screening Patients for Bipolar Disorder and Monitoring for Mania/Hypomania [see Warnings and Precautions (5.4) ] Seizures [see Warnings and Precautions (5.5) ] Altered Appetite and Weight [see Warnings and Precautions (5.6) ] Abnormal Bleeding [see Warnings and Precautions (5.7) ] Angle-Closure Glaucoma [see Warnings and Precautions (5.8) ] Hyponatremia [see Warnings and Precautions (5.9) ] Anxiety and Insomnia [see Warnings and Precautions (5.10) ] QT Prolongation [see Warnings and Precautions (5.11) ] Potential for Cognitive and Motor Impairment [see Warnings and Precautions (5.13) ] Discontinuation Adverse Reactions [see Warnings and Precautions (5.15) ] Sexual Dysfunction [see Warnings and Precautions (5.17) ] When using fluoxetine and olanzapine in combination, also refer to the Adverse Reactions section of the package insert for Sym...",
  "drug_abuse_and_dependence": "9.3 Dependence Fluoxetine has not been systematically studied, in animals or humans, for its potential for abuse, tolerance, or physical dependence. While the premarketing clinical experience with fluoxetine did not reveal any tendency for a withdrawal syndrome or any drug seeking behavior, these observations were not systematic and it is not possible to predict on the basis of this limited experience the extent to which a CNS active drug will be misused, diverted, and/or abused once marketed. Consequently, healthcare providers should carefully evaluate patients for history of drug abuse and follow such patients closely, observing them for signs of misuse or abuse of fluoxetine (e.g., development of tolerance, incrementation of dose, drug-seeking behavior).",
  "controlled_substance": "",
  "recent_major_changes": "Warnings and Precautions, Sexual Dysfunction ( 5.17 ) 10/2021",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Medication Guide). Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking fluoxetine as monotherapy or in combination with olanzapine. When using fluoxetine and olanzapine in combination, also refer to the Patient Counseling Information section of the package insert for Symbyax. General Information Healthcare providers should instruct their patients to read the Medication Guide before starting therapy with fluoxetine and to reread it each time the prescription is renewed. Healthcare providers should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with fluoxetine and should counsel them in its appropriate use. Healthcare providers 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. Patients should be advised of the following issues and asked to alert their healthcare pro...",
  "spl_medguide": "Medication Guide Fluoxetine Capsules, USP (floo ox' e teen) Read the Medication Guide that comes with fluoxetine capsules 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 fluoxetine capsules? Fluoxetine capsules and other antidepressant medicines may cause serious side effects, including: 1. Suicidal thoughts or actions: Fluoxetine capsules and other 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 wh...",
  "clinical_studies": "Efficacy for fluoxetine was established for the: Acute and maintenance treatment of Major Depressive Disorder in adults, and children and adolescents (8 to 18 years) in 7 short-term and 2 long-term, placebo-controlled trials [see Clinical Studies 14.1 ] . Acute treatment of obsessions and compulsions in adults, and children and adolescents (7 to 17 years) with Obsessive Compulsive Disorder (OCD) in 3 short-term placebo-controlled trials [see Clinical Studies (14.2) ] . Acute and maintenance treatment of binge-eating and vomiting behaviors in adult patients with moderate to severe Bulimia Nervosa in 3 short-term and 1 long-term, placebo-controlled trials [see Clinical Studies (14.3) ] . Acute treatment of Panic Disorder, with or without agoraphobia, in adult patients in 2 short-term, placebo-controlled trials [see Clinical Studies (14.4) ] . Efficacy for fluoxetine and olanzapine in combination was established for the: Acute treatment of depressive episodes in Bipolar I Disorder in adults, and children and adolescents (10 to 17 years) in 3 short-term, placebo-controlled trials. Acute and maintenance treatment of treatment resistant depression in adults (18 to 85 years) in 3 short-te...",
  "brand_name": "Fluoxetine",
  "manufacturer": "Aphena Pharma Solutions - Tennessee, LLC",
  "application_number": "ANDA204597",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20230405",
  "set_id": "06582152-d7d3-4e87-8c13-a4416a6ec927",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 93174,
  "serious": 64872,
  "death": 8613,
  "hospitalization": 28432,
  "primary_suspect": 92136,
  "top_reactions": [
   [
    "Drug Ineffective",
    6221
   ],
   [
    "Fatigue",
    5796
   ],
   [
    "Nausea",
    5232
   ],
   [
    "Off Label Use",
    4836
   ],
   [
    "Headache",
    4711
   ],
   [
    "Anxiety",
    3983
   ],
   [
    "Diarrhoea",
    3931
   ],
   [
    "Toxicity To Various Agents",
    3882
   ],
   [
    "Drug Interaction",
    3854
   ],
   [
    "Dizziness",
    3721
   ],
   [
    "Depression",
    3705
   ],
   [
    "Pain",
    3415
   ],
   [
    "Vomiting",
    3365
   ],
   [
    "Fall",
    3175
   ],
   [
    "Dyspnoea",
    3150
   ]
  ],
  "by_year": {
   "2019": 9587,
   "2020": 8215,
   "2021": 7272,
   "2022": 6853,
   "2023": 6978,
   "2024": 7327,
   "2025": 7037,
   "2026": 3594
  },
  "by_year_primary": {
   "2019": 9578,
   "2020": 8205,
   "2021": 7202,
   "2022": 6704,
   "2023": 6760,
   "2024": 7092,
   "2025": 6851,
   "2026": 3450
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20150413",
   "reason": "Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of Toxicological Concern (TTC) calculation for the impurity.",
   "firm": "Teva Pharmaceuticals USA",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20150413",
   "reason": "Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of Toxicological Concern (TTC) calculation for the impurity.",
   "firm": "Teva Pharmaceuticals USA",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20140214",
   "reason": "Chemical Contamination: The recalling firm received notice that their supplier is recalling capsules due to complaints of capsules having an unusual odor.",
   "firm": "Legacy Pharmaceutical Packaging",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20140212",
   "reason": "Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.",
   "firm": "Teva Pharmaceuticals USA",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20140212",
   "reason": "Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.",
   "firm": "Teva Pharmaceuticals USA",
   "status": "Terminated"
  }
 ],
 "recall_total": 5,
 "drugsfda": {
  "applications": 75,
  "nda": 6,
  "anda": 69,
  "first_approval": "19871229",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 127,
  "labeling_recent": 6,
  "sponsors": [
   "ACCORD HLTHCARE",
   "ACTAVIS MID ATLANTIC",
   "ADAPTIS",
   "ALEMBIC",
   "ALEMBIC PHARMS LTD",
   "ANI PHARMS",
   "APIL",
   "AUROBINDO PHARMA"
  ],
  "unapproved": false,
  "first_approval_fmt": "12/29/1987"
 },
 "trials": {
  "total": 386,
  "completed": 245,
  "terminated": 42,
  "with_results": 110,
  "industry": 83,
  "phase3": 59,
  "results_share": 0.4489795918367347,
  "terminated_share": 0.10880829015544041
 },
 "pubmed": {
  "rct": 801,
  "meta": 70,
  "recent_rct": 44,
  "cochrane": [
   {
    "pmid": "31613390",
    "title": "Fluoxetine for adults who are overweight or obese",
    "year": "2019"
   },
   {
    "pmid": "24353997",
    "title": "Fluoxetine versus other types of pharmacotherapy for depression",
    "year": "2013"
   },
   {
    "pmid": "16235353",
    "title": "Fluoxetine versus other types of pharmacotherapy for depression",
    "year": "2005"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "fluoxetine",
   "Prozac"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 7499901,
  "beneficiaries": 1488060,
  "spend": 98619582.96,
  "by_brand": [
   {
    "brand": "Fluoxetine HCl",
    "claims": 7481805,
    "per_claim": 10.921387437,
    "is_generic": true
   },
   {
    "brand": "Prozac",
    "claims": 11749,
    "per_claim": 1331.9611201,
    "is_generic": false
   },
   {
    "brand": "Fluoxetine Dr",
    "claims": 6347,
    "per_claim": 198.31111234,
    "is_generic": false
   }
  ],
  "per_claim": 13.14945130075717
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "fluoxetine",
  "matched": "fluoxetine",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 17393,
  "fills": 7499901,
  "per_million": 2319.097278750746,
  "ratio": 0.8375367864931866,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 65,
   "letter": "C",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "2,319 FDA reports naming it as the suspect drug per million Medicare fills, 0.8x the median drug on this site",
    "Death share in reports is near or below the FAERS average (1.0x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 75,
   "letter": "B",
   "why": [
    "801 randomized trials and 70 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "3 independent Cochrane review(s) exist",
    "Only 45% of completed registered trials posted results (-8)",
    "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 87,
   "letter": "B",
   "why": [
    "No recalls on record since 2016",
    "6 label changes approved since 2021: the safety story is still moving (-8)",
    "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 (69 applications)",
    "5 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 80,
 "grade": "B",
 "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 fatigue, nausea. 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, fluvoxamine? 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.)"
 ]
}