{
 "query": "vortioxetine",
 "ingredient": "vortioxetine",
 "slug": "vortioxetine",
 "rxcui": "1455099",
 "brands": [
  "Trintellix"
 ],
 "names": [
  "vortioxetine",
  "vortioxetine hydrobromide"
 ],
 "classes": [],
 "alternatives": [],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 4
  },
  "boxed_warning": "WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions (5.1) ] . TRINTELLIX is not approved for use in pediatric patients [see Use in Specific Populations (8.4) ] . WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. Increased risk of suicidal thinking and behavior in pediatric and young adult patients taking antidepressants. Closely monitor for worsening and emergence of suicidal thoughts and behaviors ( 5.1 ). TRINTELLIX is not approved for use in pediatric patients ( 8.4 ).",
  "indications_and_usage": "is indicated for the treatment of major depressive disorder (MDD) in adults. TRINTELLIX is indicated for the treatment of major depressive disorder (MDD) in adults ( 1 , 14 ).",
  "contraindications": "Hypersensitivity to vortioxetine or any component of the formulation. Hypersensitivity reactions including anaphylaxis, angioedema, and urticaria have been reported in patients treated with TRINTELLIX [see Adverse Reactions (6.2) ] . The use of MAOIs intended to treat psychiatric disorders with TRINTELLIX or within 21 days of stopping treatment with TRINTELLIX is contraindicated because of an increased risk of serotonin syndrome. The use of TRINTELLIX 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 TRINTELLIX 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 Warnings and Precautions (5.2) ] . Hypersensitivity to vortioxetine or any components of the TRINTELLIX formulation ( 4 ). Monoamine Oxidase Inhibitors (MAOIs): Do not use MAOIs intended to treat psychiatric disorders with TRINTELLIX or within 21 days of stopping treatment with TRINTELLIX. Do not use TRINTELLIX within 14 days of stopping an MAOI intended to treat psychiatric ...",
  "warnings_and_cautions": "Serotonin Syndrome : Increased risk when coadministered with other serotonergic agents, but also when taken alone. If it occurs, discontinue TRINTELLIX and serotonergic agents and initiate supportive measures ( 5.2 ). Increased Risk of Bleeding : Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs, other antiplatelet drugs, warfarin, or other drugs that affect coagulation may increase risk ( 5.3 ). Activation of Mania/Hypomania : Screen patients for bipolar disorder ( 5.4 ). Angle Closure Glaucoma: Angle closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants ( 5.6 ). Hyponatremia : Can occur in association with the syndrome of inappropriate antidiuretic hormone secretion (SIADH) ( 5.7 ). Sexual Dysfunction: TRINTELLIX may cause symptoms of sexual dysfunction ( 5.8 ). 5.1 Suicidal Thoughts and Behaviors in Adolescents and Young Adults In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included approximately 77,000 adult patients and 4,500 pediatric patients, the incidence of suicidal thoughts and behaviors in antidepressant-treated patients age 24...",
  "warnings": "",
  "adverse_reactions": "The following adverse reactions are discussed in greater detail in other sections of the label. Hypersensitivity [see Contraindications (4) ] Clinical Worsening and Suicide Risk [see Warnings and Precautions (5.1) ] Serotonin Syndrome [see Warnings and Precautions (5.2) ] Increased Risk of Bleeding [see Warnings and Precautions (5.3) ] Activation of Mania/Hypomania [see Warnings and Precautions (5.4) ] Discontinuation Syndrome [see Warnings and Precautions (5.5) ] Angle Closure Glaucoma [see Warnings and Precautions (5.6) ] Hyponatremia [see Warnings and Precautions (5.7) ] Most common adverse reactions (incidence \u22655% and at least twice the rate of placebo) were: nausea, constipation and vomiting ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals America, Inc. at 1-877-TAKEDA-7 (1-877-825-3327) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience 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. Patient Expos...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Medication Guide) . Suicidal Thoughts and Behaviors Advise patients and caregivers to look for the emergence of suicidal ideation and behavior, especially early during treatment and when the dose is adjusted up or down, and instruct them to report such symptoms to the healthcare provider [see Boxed Warning , Warnings and Precautions (5.1) ] . Concomitant Medication Advise patients to inform their healthcare provider if they are taking, or plan to take, any prescription or over-the-counter medications because of a potential for interactions. Instruct patients not to take TRINTELLIX with an MAOI or within 14 days of stopping an MAOI and to allow 21 days after stopping TRINTELLIX before starting an MAOI [see Dosage and Administration (2.4) , Contraindications (4) , Warnings and Precautions (5.2) , Drug Interactions (7.1) ] . Serotonin Syndrome Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of TRINTELLIX and triptans, tricyclic antidepressants, opioids, lithium, tryptophan supplements, busipirone, and St. John's Wort and with drugs that impair metabolism of serotonin (in particul...",
  "spl_medguide": "This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 2/2025 MEDICATION GUIDE TRINTELLIX \u00ae (trin'-TELL-ix) (vortioxetine) Tablets What is the most important information I should know about TRINTELLIX? TRINTELLIX can cause serious side effects, including: Increased risk of suicidal thoughts and actions. TRINTELLIX and other antidepressant medicines increase the risk of suicidal thoughts and actions in people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. TRINTELLIX is not for use in children. Depression or other mental illnesses are the most important causes of suicidal thoughts or actions. How can I watch for and try to prevent suicidal thoughts and actions? Pay close attention to any changes, especially sudden changes in mood, behavior, thoughts, or feelings, of if you develop suicidal thoughts or actions. This is very important when an antidepressant medicine is started or when the dose is changed. Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings or if you develop suicidal thoughts or actions. Keep all follow-up visit...",
  "clinical_studies": "The efficacy of TRINTELLIX in treatment for MDD was established in six, 6 to 8 week randomized, double-blind, placebo-controlled, fixed-dose studies (including one study in the elderly) and one maintenance study in adult inpatients and outpatients who met the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria for MDD. Adults (aged 18 years to 75 years) The efficacy of TRINTELLIX in patients aged 18 years to 75 years was demonstrated in five, 6 to 8 week, placebo-controlled studies (Studies 1 to 5 in Table 5 ). In these studies, patients were randomized to TRINTELLIX 5 mg, 10 mg, 15 mg, or 20 mg or placebo once daily. For patients who were randomized to TRINTELLIX 15 mg/day or 20 mg/day, the final doses were titrated up from 10 mg/day after the first week. The primary efficacy measures were the Hamilton Depression Scale (HAMD-24) total score in Study 2 and the Montgomery-Asberg Depression Rating Scale (MADRS) total score in all other studies. In each of these studies, at least one dose group of TRINTELLIX was superior to placebo in improvement of depressive symptoms as measured by mean change from baseline to endpoint visit on the primary efficacy measurement...",
  "brand_name": "Trintellix",
  "manufacturer": "Takeda Pharmaceuticals America, Inc.",
  "application_number": "NDA204447",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20250305",
  "set_id": "1a5b68e2-14d0-419d-9ec6-1ca97145e838",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 23715,
  "serious": 12572,
  "death": 1304,
  "hospitalization": 4616,
  "primary_suspect": 23569,
  "top_reactions": [
   [
    "Nausea",
    3056
   ],
   [
    "Drug Ineffective",
    1479
   ],
   [
    "Fatigue",
    1458
   ],
   [
    "Headache",
    1401
   ],
   [
    "Anxiety",
    1375
   ],
   [
    "Vomiting",
    1367
   ],
   [
    "Suicidal Ideation",
    1335
   ],
   [
    "Dizziness",
    1187
   ],
   [
    "Insomnia",
    1145
   ],
   [
    "Off Label Use",
    1120
   ],
   [
    "Pruritus",
    1060
   ],
   [
    "Diarrhoea",
    1052
   ],
   [
    "Depression",
    963
   ],
   [
    "Asthenia",
    908
   ],
   [
    "Feeling Abnormal",
    859
   ]
  ],
  "by_year": {
   "2019": 2489,
   "2020": 2082,
   "2021": 1880,
   "2022": 1735,
   "2023": 1660,
   "2024": 1862,
   "2025": 1717,
   "2026": 798
  },
  "by_year_primary": {
   "2019": 2488,
   "2020": 2081,
   "2021": 1867,
   "2022": 1714,
   "2023": 1636,
   "2024": 1844,
   "2025": 1674,
   "2026": 774
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 8,
  "nda": 1,
  "anda": 0,
  "first_approval": "20130930",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 10,
  "labeling_recent": 3,
  "sponsors": [
   "ALKEM LABS LTD",
   "APOTEX INC",
   "CIPLA LTD",
   "MACLEODS PHARMACEUTICALS LTD",
   "MSN LABORATORIES PRIVATE LTD",
   "PRINSTON PHARMA INC",
   "TAKEDA PHARMS USA",
   "ZYDUS PHARMS"
  ],
  "unapproved": false,
  "first_approval_fmt": "09/30/2013"
 },
 "trials": {
  "total": 120,
  "completed": 83,
  "terminated": 9,
  "with_results": 51,
  "industry": 86,
  "phase3": 47,
  "results_share": 0.6144578313253012,
  "terminated_share": 0.075
 },
 "pubmed": {
  "rct": 92,
  "meta": 40,
  "recent_rct": 31,
  "cochrane": [
   {
    "pmid": "28677828",
    "title": "Vortioxetine for depression in adults",
    "year": "2017"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 700887.49,
  "records": 37933,
  "by_name": [
   [
    "Trintellix",
    700887.49
   ]
  ],
  "names_checked": [
   "vortioxetine",
   "Trintellix"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 610008,
  "beneficiaries": 100706,
  "spend": 392486138.2,
  "by_brand": [
   {
    "brand": "Trintellix",
    "claims": 610008,
    "per_claim": 643.41146051,
    "is_generic": false
   }
  ],
  "per_claim": 643.411460505436
 },
 "mdl": [],
 "dsc": [
  {
   "date": "20160502",
   "title": "FDA approves brand name change for antidepressant drug Brintellix (vortioxetine) to avoid confusion with antiplatelet drug Brilinta (ticagrelor)",
   "url": "https://www.fda.gov/Drugs/DrugSafety/ucm497942.htm",
   "kind": "drug",
   "matched": "vortioxetine"
  },
  {
   "date": "20150730",
   "title": "FDA warns about prescribing and dispensing errors resulting from brand name confusion with antidepressant Brintellix (vortioxetine) and antiplatelet Brilinta (ticagrelor)",
   "url": "https://www.fda.gov/Drugs/DrugSafety/ucm456341.htm",
   "kind": "drug",
   "matched": "vortioxetine"
  }
 ],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 4292,
  "fills": 610008,
  "per_million": 7035.973298710836,
  "ratio": 2.5410259933677843,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 46,
   "letter": "F",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "FDA issued 2 Drug Safety Communication(s) naming this drug since 2010, most recently 2016 (-16)",
    "7,036 FDA reports naming it as the suspect drug per million Medicare fills, 2.5x the median drug on this site (-8)",
    "Death share in reports is near or below the FAERS average (0.6x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 68,
   "letter": "C",
   "why": [
    "92 randomized trials and 40 systematic reviews/meta-analyses indexed in PubMed",
    "1 independent Cochrane review(s) exist"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 96,
   "letter": "A",
   "why": [
    "No recalls on record since 2016",
    "3 label changes approved since 2021 (-4)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 85,
   "letter": "B",
   "why": [
    "Pharma paid doctors $700,887 tied to this drug last year (-15)",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 40,
   "letter": "F",
   "why": [
    "No generic version approved: brand-only pricing (-30)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 64,
 "grade": "C",
 "questions": [
  "In 2016 the FDA issued a safety communication about this drug (FDA approves brand name change for antidepressant drug Brintellix (vortioxetine) to avoid confusion with antip). Does that risk apply to me?",
  "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 nausea, fatigue, headache. How would we recognize and handle those?",
  "There is no generic. Is there an older generic in the same class that works as well for my situation?",
  "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.)"
 ]
}