{
 "query": "amitriptyline",
 "ingredient": "amitriptyline",
 "slug": "amitriptyline",
 "rxcui": "704",
 "brands": [
  "Elavil"
 ],
 "names": [
  "amitriptyline",
  "amitriptyline hydrochloride",
  "amitriptyline oxide",
  "amitriptyline pamoate"
 ],
 "classes": [
  {
   "id": "N06AA",
   "name": "Non-selective monoamine reuptake inhibitors"
  }
 ],
 "alternatives": [
  "amineptin",
  "amoxapine",
  "butriptyline",
  "clomipramine",
  "desipramine",
  "dibenzepin",
  "dothiepin",
  "doxepin",
  "imipramine",
  "iprindole",
  "lofepramine",
  "maprotiline",
  "melitracen",
  "nortriptyline",
  "opipramol",
  "protriptyline",
  "quinupramine",
  "trimipramine"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 121
  },
  "boxed_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 amitriptyline hydrochloride 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; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 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. Amitriptyline hydrochloride is not approved for use in pediatric patients. (See WARNINGS: Clinical ...",
  "indications_and_usage": "INDICATIONS AND USAGE For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.",
  "contraindications": "CONTRAINDICATIONS Amitriptyline hydrochloride is contraindicated in patients who have shown prior hypersensitivity to it. It should not be given concomitantly with monoamine oxidase inhibitors. Hyperpyretic crises, severe convulsions, and deaths have occurred in patients receiving tricyclic antidepressant and monoamine oxidase inhibiting drugs simultaneously. When it is desired to replace a monoamine oxidase inhibitor with amitriptyline hydrochloride, a minimum of 14 days should be allowed to elapse after the former is discontinued. Amitriptyline hydrochloride should then be initiated cautiously with gradual increase in dosage until optimum response is achieved. Amitriptyline hydrochloride should not be given with cisapride due to the potential for increased QT interval and increased risk for arrhythmia. This drug is not recommended for use during the acute recovery phase following myocardial infarction.",
  "warnings_and_cautions": "",
  "warnings": "WARNINGS Clinical Worsening and Suicide Risk Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. There has been a long-standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18 to 24) with major depressive disorder (MDD) and other psychiatric disorders. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age ...",
  "adverse_reactions": "ADVERSE REACTIONS Within each category the following adverse reactions are listed in order of decreasing severity. Included in the listing are a few adverse reactions which have not been reported with this specific drug. However, pharmacological similarities among the tricyclic antidepressant drugs require that each of the reactions be considered when amitriptyline is administered. Cardiovascular: Myocardial infarction; stroke; nonspecific ECG changes and changes in AV conduction; heart block; arrhythmias; hypotension, particularly orthostatic hypotension; syncope; hypertension; tachycardia; palpitation. CNS and Neuromuscular: Coma; seizures; hallucinations; delusions; confusional states; disorientation; incoordination; ataxia; tremors; peripheral neuropathy; numbness, tingling, and paresthesias of the extremities; extrapyramidal symptoms including abnormal involuntary movements and tardive dyskinesia; dysarthria; disturbed concentration; excitement; anxiety; insomnia; restlessness; nightmares; drowsiness; dizziness; weakness; fatigue; headache; syndrome of inappropriate ADH (antidiuretic hormone) secretion; tinnitus; alteration in EEG patterns. Anticholinergic: Paralytic ileus; hy...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Information for Patients Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with amitriptyline hydrochloride and should counsel them in its appropriate use. A patient Medication Guide about \"Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions\" is available for amitriptyline hydrochloride. 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 amitriptyline hydrochloride. Patients should be advised that taking amitriptyline hydrochloride can cause mild pupillary dilation, which in susceptible individuals, can lead to an episode of angle-closure glaucoma. Pre-exis...",
  "spl_medguide": "MEDICATION GUIDE Amitriptyline Hydrochloride Tablets, USP (am'' i trip' ti leen hye'' droe klor' ide) Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions Read the Medication Guide that comes with you or your family member's antidepressant medicine. This Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant medicines. Talk to your, or your family member's, healthcare provider about: all risks and benefits of treatment with antidepressant medicines all treatment choices for depression or other serious mental illness What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions? Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar il...",
  "clinical_studies": "",
  "brand_name": "Amitriptyline Hydrochloride",
  "manufacturer": "Aphena Pharma Solutions - Tennessee, LLC",
  "application_number": "ANDA089399",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20231114",
  "set_id": "25832051-837b-4682-8548-5ab9a1b7cdac",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 84051,
  "serious": 66145,
  "death": 8656,
  "hospitalization": 28925,
  "primary_suspect": 83526,
  "top_reactions": [
   [
    "Drug Ineffective",
    6929
   ],
   [
    "Fatigue",
    6271
   ],
   [
    "Nausea",
    6089
   ],
   [
    "Off Label Use",
    5851
   ],
   [
    "Pain",
    5700
   ],
   [
    "Headache",
    5585
   ],
   [
    "Diarrhoea",
    4568
   ],
   [
    "Dizziness",
    4486
   ],
   [
    "Dyspnoea",
    4406
   ],
   [
    "Arthralgia",
    3838
   ],
   [
    "Fall",
    3764
   ],
   [
    "Malaise",
    3699
   ],
   [
    "Toxicity To Various Agents",
    3689
   ],
   [
    "Vomiting",
    3645
   ],
   [
    "Anxiety",
    2973
   ]
  ],
  "by_year": {
   "2019": 9074,
   "2020": 7862,
   "2021": 7302,
   "2022": 6387,
   "2023": 6255,
   "2024": 6605,
   "2025": 6064,
   "2026": 2941
  },
  "by_year_primary": {
   "2019": 9069,
   "2020": 7842,
   "2021": 7275,
   "2022": 6301,
   "2023": 6116,
   "2024": 6518,
   "2025": 5981,
   "2026": 2882
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class III",
   "date": "20170616",
   "reason": "Cross Contamination With Other Product: Imipramine",
   "firm": "Sandoz Incorporated",
   "status": "Terminated"
  }
 ],
 "recall_total": 1,
 "drugsfda": {
  "applications": 141,
  "nda": 2,
  "anda": 77,
  "first_approval": "19610407",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 40,
  "labeling_recent": 0,
  "sponsors": [
   "ACCORD HLTHCARE",
   "AIPING PHARM INC",
   "AM THERAP",
   "ANI PHARMS",
   "ANI PHARMS INC",
   "ASTRAZENECA",
   "AUROBINDO PHARMA USA",
   "BRECKENRIDGE"
  ],
  "unapproved": false,
  "first_approval_fmt": "04/07/1961"
 },
 "trials": {
  "total": 153,
  "completed": 78,
  "terminated": 18,
  "with_results": 21,
  "industry": 20,
  "phase3": 37,
  "results_share": 0.2692307692307692,
  "terminated_share": 0.11764705882352941
 },
 "pubmed": {
  "rct": 475,
  "meta": 25,
  "recent_rct": 22,
  "cochrane": [
   {
    "pmid": "35658166",
    "title": "Amitriptyline for fibromyalgia in adults",
    "year": "2019"
   },
   {
    "pmid": "26146793",
    "title": "Amitriptyline for neuropathic pain in adults",
    "year": "2015"
   },
   {
    "pmid": "23235671",
    "title": "Amitriptyline versus placebo for major depressive disorder",
    "year": "2012"
   },
   {
    "pmid": "23235657",
    "title": "Amitriptyline for neuropathic pain and fibromyalgia in adults",
    "year": "2012"
   },
   {
    "pmid": "17636748",
    "title": "Amitriptyline for depression",
    "year": "2007"
   },
   {
    "pmid": "12804503",
    "title": "Amitriptyline versus other types of pharmacotherapy for depression",
    "year": "2003"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "amitriptyline",
   "Elavil"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 3704512,
  "beneficiaries": 848297,
  "spend": 54717091.64,
  "by_brand": [
   {
    "brand": "Amitriptyline HCl",
    "claims": 3704512,
    "per_claim": 14.770391253,
    "is_generic": true
   }
  ],
  "per_claim": 14.77039125261303
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "amitriptyline",
  "matched": "amitriptyline",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 15381,
  "fills": 3704512,
  "per_million": 4151.9638754038315,
  "ratio": 1.4994724515026572,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 61,
   "letter": "D",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "4,152 FDA reports naming it as the suspect drug per million Medicare fills, 1.5x the median drug on this site (-4)",
    "Death share in reports is near or below the FAERS average (1.1x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 58,
   "letter": "D",
   "why": [
    "475 randomized trials and 25 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "6 independent Cochrane review(s) exist",
    "Only 27% of completed registered trials posted results (-15)",
    "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 100,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 0 Class II, 1 Class III across 77 generic makers (-0)"
   ],
   "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 (77 applications)",
    "18 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 76,
 "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 amineptin, amoxapine, butriptyline? 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.)"
 ]
}