{
 "query": "mirtazapine",
 "ingredient": "mirtazapine",
 "slug": "mirtazapine",
 "rxcui": "15996",
 "brands": [
  "Remeron"
 ],
 "names": [
  "mirtazapine",
  "mirtazapine hemihydrate"
 ],
 "classes": [],
 "alternatives": [],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 86
  },
  "boxed_warning": "WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behaviors 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) ] . REMERON/REMERONSolTab 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 thoughts and behavior in pediatric and young adult patients taking antidepressants. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors. REMERON/REMERONSolTab is not approved for use in pediatric patients. ( 5.1 , 8.4 )",
  "indications_and_usage": "REMERON/REMERONSolTab are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14) ] . REMERON/REMERONSolTab is indicated for the treatment of major depressive disorder (MDD) in adults. ( 1 )",
  "contraindications": "REMERON/REMERONSolTab is contraindicated in patients: Taking, or within 14 days of stopping, MAOIs (including the MAOIs linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome [see Warnings and Precautions (5.3) , Drug Interactions (7) ] . With a known hypersensitivity to mirtazapine or to any of the excipients in REMERON/REMERONSolTab . Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome, bullous dermatitis, erythema multiforme and toxic epidermal necrolysis have been reported following the use of REMERON/REMERONSolTab [see Warnings and Precautions (5.6) , Adverse Reactions (6.2) ]. Concomitant use of monoamine oxidase inhibitors (MAOIs) or use within 14 days of stopping MAOIs. ( 2.4 , 4 , 7 ) Known hypersensitivity to mirtazapine or any of the excipients in REMERON/REMERONSolTab. ( 4 )",
  "warnings_and_cautions": "Agranulocytosis : If sore throat, fever, stomatitis or signs of infection occur, along with a low white blood cell count, treatment with REMERON/REMERONSolTab should be discontinued and the patient should be closely monitored. ( 5.2 ) Serotonin Syndrome : Increased risk when co-administered with other serotonergic drugs (e.g., SSRI, SNRI, triptans), but also when taken alone. If it occurs, discontinue REMERON/REMERONSolTab and initiate supportive treatment. ( 2.4 , 4 , 5.3 , 7 ) Angle-Closure Glaucoma : Angle closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants. ( 5.4 ) QT Prolongation : Use REMERON/REMERONSolTab with caution in patients with risk factors for QT prolongation. ( 5.5 , 7 ) Drug Reaction with Eosinophilia and System Symptoms (DRESS) : Discontinue REMERON/REMERONSolTab if DRESS is suspected. ( 5.6 ) Increased Appetite/Weight Gain : REMERON/REMERONSolTab has been associated with increased appetite and weight gain. ( 5.7 ) Somnolence : May impair judgment, thinking and/or motor skills. Use with caution when engaging in activities requiring alertness, such as driving or operating machinery. ( 5.8 , 7 ) Activation...",
  "warnings": "",
  "adverse_reactions": "The following adverse reactions are described in more detail in other sections of the prescribing information: Hypersensitivity [see Contraindications (4) ] Suicidal Thoughts and Behaviors [see Warnings and Precautions (5.1) ] Agranulocytosis [see Warnings and Precautions (5.2) ] Serotonin Syndrome [see Contraindications (4) , Warnings and Precautions (5.3) , Drug Interactions (7) ] Angle-Closure Glaucoma [see Warnings and Precautions (5.4) ] QT Prolongation and Torsades de Pointes [see Warnings and Precautions (5.5) ] Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) [see Warnings and Precautions (5.6) ] Increased Appetite and Weight Gain [see Warnings and Precautions (5.7) ] Somnolence [see Warnings and Precautions (5.8) ] Activation of Mania or Hypomania [see Warnings and Precautions (5.9) ] Seizures [see Warnings and Precautions (5.10) ] Elevated Cholesterol and Triglycerides [see Warnings and Precautions (5.11) ] Hyponatremia [see Warnings and Precautions (5.12) ] Transaminase Elevations [see Warnings and Precautions (5.13) ] Discontinuation Syndrome [see Warnings and Precautions (5.14) ] Use in Patients with Concomitant Illness [see Warnings and Precautions (5.15)...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Contraindications ( 4 ) 11/2021 Warnings and Precautions ( 5.6 ) 11/2021",
  "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 suicidality, especially early during treatment and when the dosage is adjusted up or down, and instruct them to report such symptoms to the healthcare provider [see Boxed Warning and Warnings and Precautions (5.1) ]. Agranulocytosis Advise patients to contact their physician if they experience fever, chills, sore throat, mucous membrane ulceration, flu-like complaints, or other symptoms that might suggest infection [see Warnings and Precautions (5.2) ]. Serotonin Syndrome Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of REMERON/REMERONSolTab with other serotonergic drugs including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, St. John's Wort, and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid). Advise patients to contact their healthcare provider or report to the emergency room if they experience signs ...",
  "spl_medguide": "MEDICATION GUIDE REMERON \u00ae (r\u0115m' - \u0115 \u2013 r\u014fn) (mirtazapine) tablets, for oral use REMERONSolTab \u00ae (r\u0115m' - \u0115 - r\u014fn - s\u014fl' \u2013 t\u0103b) (mirtazapine) orally disintegrating tablets, for oral use This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: 11/2021 What is the most important information I should know about REMERON and REMERONSolTab? REMERON and REMERONSolTab may cause serious side effects, including: Increased risk of suicidal thoughts or actions in some children and young adults. REMERON, REMERONSolTab, and other antidepressant medicines may increase suicidal thoughts or actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. REMERON and REMERONSolTab are not for use in children. Depression or other serious 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, or if you develop suicidal thoughts or actions. This is very important when an antidepressant medicine is started or w...",
  "clinical_studies": "The efficacy of REMERON as a treatment for major depressive disorder was established in 4 placebo-controlled, 6-week trials in adult outpatients meeting DSM-III criteria for major depressive disorder. Patients were titrated with REMERON from a dose range of 5 mg to 35 mg/day. The mean mirtazapine dose for patients who completed these 4 studies ranged from 21 to 32 mg/day. Overall, these studies demonstrated REMERON to be superior to placebo on at least 3 of the following 4 measures: 21-Item Hamilton Depression Rating Scale (HDRS) total score; HDRS Depressed Mood Item; CGI Severity score; and Montgomery and Asberg Depression Rating Scale (MADRS). Superiority of REMERON over placebo was also found for certain factors of the HDRS, including anxiety/somatization factor and sleep disturbance factor. Examination of age and gender subsets of the population did not reveal any differential responsiveness on the basis of these subgroupings. In a longer-term study, patients meeting (DSM-IV) criteria for major depressive disorder who had responded during an initial 8 to 12 weeks of acute treatment on REMERON were randomized to continuation of REMERON or placebo for up to 40 weeks of observatio...",
  "brand_name": "REMERON",
  "manufacturer": "Organon LLC",
  "application_number": "NDA020415",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20250806",
  "set_id": "98ad1917-a094-44f5-a28f-a64a8cfcd887",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 79699,
  "serious": 67215,
  "death": 11827,
  "hospitalization": 33425,
  "primary_suspect": 78928,
  "top_reactions": [
   [
    "Fatigue",
    4497
   ],
   [
    "Nausea",
    4357
   ],
   [
    "Drug Ineffective",
    4279
   ],
   [
    "Off Label Use",
    3999
   ],
   [
    "Fall",
    3798
   ],
   [
    "Diarrhoea",
    3757
   ],
   [
    "Toxicity To Various Agents",
    3708
   ],
   [
    "Dizziness",
    3205
   ],
   [
    "Death",
    3153
   ],
   [
    "Dyspnoea",
    3138
   ],
   [
    "Anxiety",
    2894
   ],
   [
    "Vomiting",
    2840
   ],
   [
    "Somnolence",
    2786
   ],
   [
    "Drug Interaction",
    2785
   ],
   [
    "Headache",
    2708
   ]
  ],
  "by_year": {
   "2019": 8456,
   "2020": 8289,
   "2021": 6750,
   "2022": 6359,
   "2023": 6420,
   "2024": 6299,
   "2025": 6763,
   "2026": 3120
  },
  "by_year_primary": {
   "2019": 8442,
   "2020": 8254,
   "2021": 6708,
   "2022": 6179,
   "2023": 6251,
   "2024": 6190,
   "2025": 6634,
   "2026": 3045
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20200318",
   "reason": "CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed",
   "firm": "Aurobindo Pharma USA Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class I",
   "date": "20191120",
   "reason": "Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg tablets labelled as Mirtazapine 7.5 mg tablets.",
   "firm": "AuroMedics Pharma LLC",
   "status": "Terminated"
  },
  {
   "class": "Class I",
   "date": "20191120",
   "reason": "Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg tablets labelled as Mirtazapine 7.5 mg tablets.",
   "firm": "AuroMedics Pharma LLC",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20170127",
   "reason": "Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablets commingled",
   "firm": "Mylan Institutional, Inc. (d.b.a. UDL Laboratories)",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20170119",
   "reason": "Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablet in bottle",
   "firm": "Mylan Pharmaceuticals Inc.",
   "status": "Terminated"
  }
 ],
 "recall_total": 5,
 "drugsfda": {
  "applications": 26,
  "nda": 2,
  "anda": 24,
  "first_approval": "19960614",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 35,
  "labeling_recent": 2,
  "sponsors": [
   "ACTAVIS ELIZABETH",
   "ACTAVIS LABS FL INC",
   "ANNORA PHARMA",
   "APOTEX",
   "AUROBINDO",
   "AUROBINDO PHARMA",
   "CHARTWELL RX",
   "IMPAX LABS INC"
  ],
  "unapproved": false,
  "first_approval_fmt": "06/14/1996"
 },
 "trials": {
  "total": 143,
  "completed": 87,
  "terminated": 17,
  "with_results": 40,
  "industry": 23,
  "phase3": 25,
  "results_share": 0.45977011494252873,
  "terminated_share": 0.11888111888111888
 },
 "pubmed": {
  "rct": 191,
  "meta": 27,
  "recent_rct": 30,
  "cochrane": [
   {
    "pmid": "30080242",
    "title": "Mirtazapine for fibromyalgia in adults",
    "year": "2018"
   },
   {
    "pmid": "29802811",
    "title": "Mirtazapine adjunct for people with schizophrenia",
    "year": "2018"
   },
   {
    "pmid": "22161405",
    "title": "Mirtazapine versus other antidepressive agents for depression",
    "year": "2011"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "mirtazapine",
   "Remeron"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 8340645,
  "beneficiaries": 1648545,
  "spend": 158579878.54,
  "by_brand": [
   {
    "brand": "Mirtazapine",
    "claims": 8338476,
    "per_claim": 18.930116108,
    "is_generic": true
   },
   {
    "brand": "Remeron",
    "claims": 2169,
    "per_claim": 337.27971415,
    "is_generic": false
   }
  ],
  "per_claim": 19.012903503266234
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 15869,
  "fills": 8340645,
  "per_million": 1902.610649416202,
  "ratio": 0.6871235734096297,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 43,
   "letter": "F",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "1,903 FDA reports naming it as the suspect drug per million Medicare fills, 0.7x the median drug on this site",
    "Death appears in 1.6x the share of reports seen across all of FAERS (-2)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)",
    "2 Class I recall(s): reasonable probability of serious harm (-20)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 63,
   "letter": "C",
   "why": [
    "191 randomized trials and 27 systematic reviews/meta-analyses indexed in PubMed",
    "3 independent Cochrane review(s) exist",
    "Only 46% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 61,
   "letter": "D",
   "why": [
    "Recalls since 2016: 2 Class I, 3 Class II, 0 Class III across 24 generic makers (-30)",
    "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": 70,
   "letter": "C",
   "why": [
    "Generic versions approved (24 applications)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 62,
 "grade": "D",
 "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?",
  "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.)"
 ]
}