{
 "query": "trazodone",
 "ingredient": "trazodone",
 "slug": "trazodone",
 "rxcui": "10737",
 "brands": [
  "Raldesy"
 ],
 "names": [
  "trazodone",
  "trazodone hydrochloride"
 ],
 "classes": [],
 "alternatives": [],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 101
  },
  "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) ]. Trazodone Hydrochloride Tablets are 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. Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients ( 5.1 ) Closely monitor for clinical worsening and emergence of suicidal thoughts and behaviors ( 5.1 ) Trazodone Hydrochloride Tablets are not approved for use in pediatric patients ( 8.4 )",
  "indications_and_usage": "Trazodone Hydrochloride Tablets are indicated for the treatment of major depressive disorder (MDD) in adults. Trazodone Hydrochloride Tablets are a selective serotonin reuptake inhibitor indicated for the treatment of major depressive disorder (MDD) ( 1 ).",
  "contraindications": "Trazodone Hydrochloride Tablets are contraindicated in: Patients taking, or within 14 days of stopping, monoamine oxidase inhibitors (MAOIs), including MAOIs such as linezolid or intravenous methylene blue, because of an increased risk of serotonin syndrome [see Warnings and Precautions (5.2) , Drug Interactions (7.1) ]. Concomitant use of monoamine oxidase inhibitors (MAOIs), or use within 14 days of stopping MAOIs ( 4 ).",
  "warnings_and_cautions": "Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents (e.g., SSRI, SNRI, triptans), but also when taken alone. If it occurs, discontinue Trazodone Hydrochloride Tablets and initiate supportive treatment ( 5.2 ). Cardiac Arrhythmias: Increases the QT interval. Avoid use with drugs that also increase the QT interval and in patients with risk factors for prolonged QT interval ( 5.3 ) Orthostatic Hypotension and Syncope: Warn patients of risk and symptoms of hypotension ( 5.4 ). Increased Risk of Bleeding: Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), other antiplatelet drugs, warfarin, and other anticoagulants may increase this risk ( 5.5 ). Priapism: Cases of painful and prolonged penile erections and priapism have been reported. Immediate medical attention should be sought if signs and symptoms of prolonged penile erections or priapism are observed ( 5.6 ). Activation of Mania or Hypomania: Screen for bipolar disorder and monitor for mania or hypomania ( 5.7 ). Potential for Cognitive and Motor Impairment: Has potential to impair judgment, thinking, and motor skills. Advise patients to use caution when operating machinery...",
  "warnings": "",
  "adverse_reactions": "The following serious adverse reactions are described elsewhere in the labeling: Suicidal Thoughts and Behavior in Children, Adolescents and Young Adults [see Boxed Warning and Warnings and Precautions (5.1) ] Serotonin Syndrome [see Warnings and Precautions (5.2) ] Cardiac Arrythmias [see Warnings and Precautions (5.3) ] Orthostatic Hypotension and Syncope [see Warnings and Precautions (5.4) ] Increased Risk of Bleeding [see Warnings and Precautions (5.5) ] Priapism [see Warnings and Precautions (5.6) ] Activation of Mania or Hypomania [see Warnings and Precautions (5.7) ] Discontinuation Syndrome [see Warnings and Precautions (5.8) ] Potential for Cognitive and Motor Impairment [see Warnings and Precautions (5.9) ] Angle-Closure Glaucoma [see Warnings and Precautions (5.10) ] Hyponatremia [see Warnings and Precautions (5.11) ] Most common adverse reactions (incidence \u2265 5% and twice that of placebo) are: edema, blurred vision, syncope, drowsiness, fatigue, diarrhea, nasal congestion, weight loss ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because ...",
  "drug_abuse_and_dependence": "9.1 Controlled Substance Trazodone Hydrochloride Tablets are not a controlled substance. 9.2 Abuse Although trazodone hydrochloride has not been systematically studied in preclinical or clinical studies for its potential for abuse, no indication of drug-seeking behavior was seen in the clinical studies with trazodone hydrochloride.",
  "controlled_substance": "9.1 Controlled Substance Trazodone Hydrochloride Tablets are not a 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 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 Box Warning and Warnings and Precautions (5.1) ]. Dosage and Administration Advise patients that Trazodone Hydrochloride Tablets should be taken shortly after a meal or light snack. Advise patients regarding the importance of following dosage titration instructions [see Dosage and Administration (2) ]. Serotonin Syndrome Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of Trazodone Hydrochloride Tablets with other serotonergic drugs including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John\u2019s 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). Patients should contact their health care provider or report to the emergency room if they experience ...",
  "spl_medguide": "MEDICATION GUIDE Trazodone Hydrochloride Tablets, USP (traz\u2019 oh done hye\u2019\u2019 droeklor\u2019 ide) What is the most important information I should know about Trazodone Hydrochloride Tablets? Antidepressant medicines, depression or other serious mental illnesses, and suicidal thoughts or actions: Talk to your healthcare provider about: All risks and benefits of treatment with antidepressant medicines All treatment choices for depression or other serious mental illnesses 1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment. 2. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a higher risk of having suicidal thoughts or actions. These include people who have or have a family history of bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions. 3. How can I watch for and try to prevent suicidal thoughts and actions? Pay close attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started...",
  "clinical_studies": "The efficacy and safety of trazodone hydrochloride were established from inpatient and outpatient trials of the trazodone immediate release formulation in the treatment of major depressive disorder.",
  "brand_name": "TRAZODONE HYDROCHLORIDE",
  "manufacturer": "Bryant Ranch Prepack",
  "application_number": "ANDA204852",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20250919",
  "set_id": "1514b3b0-7742-4247-b9fd-ea14849d3fdd",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 102640,
  "serious": 68393,
  "death": 12076,
  "hospitalization": 33182,
  "primary_suspect": 101949,
  "top_reactions": [
   [
    "Drug Ineffective",
    7957
   ],
   [
    "Fatigue",
    7375
   ],
   [
    "Nausea",
    6884
   ],
   [
    "Off Label Use",
    6137
   ],
   [
    "Headache",
    5727
   ],
   [
    "Diarrhoea",
    5578
   ],
   [
    "Pain",
    5371
   ],
   [
    "Dyspnoea",
    4550
   ],
   [
    "Dizziness",
    4297
   ],
   [
    "Vomiting",
    4253
   ],
   [
    "Fall",
    4247
   ],
   [
    "Insomnia",
    3883
   ],
   [
    "Anxiety",
    3707
   ],
   [
    "Arthralgia",
    3625
   ],
   [
    "Depression",
    3545
   ]
  ],
  "by_year": {
   "2019": 9781,
   "2020": 10008,
   "2021": 8690,
   "2022": 7942,
   "2023": 7819,
   "2024": 7861,
   "2025": 8816,
   "2026": 4313
  },
  "by_year_primary": {
   "2019": 9772,
   "2020": 9983,
   "2021": 8648,
   "2022": 7837,
   "2023": 7641,
   "2024": 7724,
   "2025": 8700,
   "2026": 4247
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20260824",
   "reason": "Presence of Foreign Tablets/Capsules",
   "firm": "Teva Pharmaceuticals USA, Inc",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20260126",
   "reason": "Presence of Foreign Tablets/Capsules",
   "firm": "Granules Pharmaceuticals Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class III",
   "date": "20251219",
   "reason": "Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.",
   "firm": "Zydus Pharmaceuticals (USA) Inc",
   "status": "Ongoing"
  }
 ],
 "recall_total": 3,
 "drugsfda": {
  "applications": 36,
  "nda": 3,
  "anda": 25,
  "first_approval": "19811224",
  "rems": false,
  "rems_last": "20110511",
  "labeling_supplements": 17,
  "labeling_recent": 3,
  "sponsors": [
   "ACCORD HLTHCARE",
   "AIPING PHARM INC",
   "ALVOGEN",
   "AM THERAP",
   "ANGELINI PHARMA",
   "APOTEX",
   "APOTEX INC",
   "AUROBINDO PHARMA"
  ],
  "unapproved": false,
  "first_approval_fmt": "12/24/1981"
 },
 "trials": {
  "total": 84,
  "completed": 44,
  "terminated": 11,
  "with_results": 19,
  "industry": 22,
  "phase3": 12,
  "results_share": 0.4318181818181818,
  "terminated_share": 0.13095238095238096
 },
 "pubmed": {
  "rct": 128,
  "meta": 15,
  "recent_rct": 13,
  "cochrane": [
   {
    "pmid": "15495135",
    "title": "Trazodone for agitation in dementia",
    "year": "2004"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "trazodone",
   "Raldesy"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 18424765,
  "beneficiaries": 3945008,
  "spend": 165400397.52,
  "by_brand": [
   {
    "brand": "Trazodone HCl",
    "claims": 18424765,
    "per_claim": 8.9770695865,
    "is_generic": true
   }
  ],
  "per_claim": 8.977069586504903
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 20671,
  "fills": 18424765,
  "per_million": 1121.9139022940049,
  "ratio": 0.4051766922668808,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 65,
   "letter": "C",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "1,122 FDA reports naming it as the suspect drug per million Medicare fills, 0.4x the median drug on this site",
    "Death share in reports is near or below the FAERS average (1.3x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 52,
   "letter": "D",
   "why": [
    "128 randomized trials and 15 systematic reviews/meta-analyses indexed in PubMed",
    "1 independent Cochrane review(s) exist",
    "Only 43% 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": 93,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 2 Class II, 1 Class III across 25 generic makers (-3)",
    "3 label changes approved since 2021 (-4)"
   ],
   "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 (25 applications)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 72,
 "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 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.)"
 ]
}