{
 "query": "nortriptyline",
 "ingredient": "nortriptyline",
 "slug": "nortriptyline",
 "rxcui": "7531",
 "brands": [
  "Pamelor"
 ],
 "names": [
  "nortriptyline",
  "nortriptyline hydrochloride"
 ],
 "classes": [
  {
   "id": "N06AA",
   "name": "Non-selective monoamine reuptake inhibitors"
  }
 ],
 "alternatives": [
  "amineptin",
  "amitriptyline",
  "amoxapine",
  "butriptyline",
  "clomipramine",
  "desipramine",
  "dibenzepin",
  "dothiepin",
  "doxepin",
  "imipramine",
  "iprindole",
  "lofepramine",
  "maprotiline",
  "melitracen",
  "opipramol",
  "protriptyline",
  "quinupramine",
  "trimipramine"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 55
  },
  "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 nortriptyline 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. Nortriptyline hydrochloride is not approved for use in pediatric patients ( see WARNINGS, Clinical W...",
  "indications_and_usage": "INDICATIONS AND USAGE Nortriptyline hydrochloride is indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states.",
  "contraindications": "CONTRAINDICATIONS Monoamine Oxidase Inhibitors (MAOIs) The use of MAOIs intended to treat psychiatric disorders with nortriptyline hydrochloride or within 14 days of stopping treatment with nortriptyline hydrochloride is contraindicated because of an increased risk of serotonin syndrome. The use of nortriptyline hydrochloride within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated ( see WARNINGS and DOSAGE AND ADMINISTRATION ). Starting nortriptyline hydrochloride 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 DOSAGE AND ADMINISTRATION ). Hypersensitivity to Tricyclic Antidepressants Cross-sensitivity between nortriptyline hydrochloride and other dibenzazepines is a possibility. Myocardial Infarction Nortriptyline hydrochloride is contraindicated during the acute recovery period after 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 Note - Included in the following list are a few adverse reactions that have not been reported with this specific drug. However, the pharmacologic similarities among the tricyclic antidepressant drugs require that each of the reactions be considered when nortriptyline is administered. Cardiovascular - Hypotension, hypertension, tachycardia, palpitation, myocardial infarction, arrhythmias, heart block, stroke. Psychiatric - Confusional states (especially in the elderly), with hallucinations, disorientation, delusions; anxiety, restlessness, agitation; insomnia, panic, nightmares; hypomania; exacerbation of psychosis. Neurologic - Numbness, tingling, paresthesias of extremities; incoordination, ataxia, tremors; peripheral neuropathy; extrapyramidal symptoms; seizures, alteration in EEG patterns; tinnitus. Anticholinergic - Dry mouth and, rarely, associated sublingual adenitis, blurred vision, disturbance of accommodation, mydriasis; constipation, paralytic ileus; urinary retention, delayed micturition, dilation of the urinary tract. Allergic - Skin rash, petechiae, urticaria, itching, photosensitization (avoid excessive exposure to sunlight); edema (general or of fac...",
  "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 nortriptyline hydrochloride and should counsel them in its appropriate use. A patient Medication Guide about \"Antidepressant Medicines, Depression and other Serious Mental Illness, and Suicidal Thoughts or Actions\" is available for nortriptyline 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 nortriptyline hydrochloride.",
  "spl_medguide": "Medication Guide Nortriptyline Hydrochloride (nor trip' ti leen hye'' droe klor' ide) Capsules, USP 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. 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 illness (also called manic-depressive illness) or suicidal thoughts or actions. How can I watch for and try to pr...",
  "clinical_studies": "",
  "brand_name": "Nortriptyline Hydrochloride",
  "manufacturer": "Northwind Health Company, LLC",
  "application_number": "ANDA075520",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20251226",
  "set_id": "09a54dbd-6bde-3083-e063-6394a90a5297",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 20193,
  "serious": 14244,
  "death": 2529,
  "hospitalization": 5197,
  "primary_suspect": 20107,
  "top_reactions": [
   [
    "Drug Ineffective",
    2538
   ],
   [
    "Off Label Use",
    2115
   ],
   [
    "Fatigue",
    1889
   ],
   [
    "Nausea",
    1826
   ],
   [
    "Headache",
    1740
   ],
   [
    "Pain",
    1654
   ],
   [
    "Hyperhidrosis",
    1196
   ],
   [
    "Toxicity To Various Agents",
    1139
   ],
   [
    "Dizziness",
    1000
   ],
   [
    "Drug Hypersensitivity",
    999
   ],
   [
    "Constipation",
    968
   ],
   [
    "Diarrhoea",
    941
   ],
   [
    "Back Pain",
    889
   ],
   [
    "Hypersensitivity",
    888
   ],
   [
    "Rash",
    829
   ]
  ],
  "by_year": {
   "2019": 2285,
   "2020": 2178,
   "2021": 1839,
   "2022": 1468,
   "2023": 1351,
   "2024": 1667,
   "2025": 1449,
   "2026": 707
  },
  "by_year_primary": {
   "2019": 2285,
   "2020": 2176,
   "2021": 1835,
   "2022": 1448,
   "2023": 1326,
   "2024": 1654,
   "2025": 1435,
   "2026": 699
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20210108",
   "reason": "CGMP deviations.",
   "firm": "Taro Pharmaceuticals U.S.A., Inc.",
   "status": "Terminated"
  }
 ],
 "recall_total": 1,
 "drugsfda": {
  "applications": 15,
  "nda": 4,
  "anda": 11,
  "first_approval": "19641106",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 50,
  "labeling_recent": 0,
  "sponsors": [
   "ANI PHARMS",
   "AUROBINDO PHARMA LTD",
   "DR REDDYS LABS SA",
   "LILLY",
   "PHARM ASSOC",
   "RANBAXY",
   "RISING",
   "RUBICON RESEARCH"
  ],
  "unapproved": false,
  "first_approval_fmt": "11/06/1964"
 },
 "trials": {
  "total": 68,
  "completed": 42,
  "terminated": 10,
  "with_results": 20,
  "industry": 9,
  "phase3": 8,
  "results_share": 0.47619047619047616,
  "terminated_share": 0.14705882352941177
 },
 "pubmed": {
  "rct": 157,
  "meta": 4,
  "recent_rct": 11,
  "cochrane": [
   {
    "pmid": "25569864",
    "title": "Nortriptyline for neuropathic pain in adults",
    "year": "2015"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "nortriptyline",
   "Pamelor"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 1280031,
  "beneficiaries": 310158,
  "spend": 20981223.38,
  "by_brand": [
   {
    "brand": "Nortriptyline HCl",
    "claims": 1279736,
    "per_claim": 15.600531758,
    "is_generic": true
   },
   {
    "brand": "Pamelor",
    "claims": 295,
    "per_claim": 3446.3093898,
    "is_generic": false
   }
  ],
  "per_claim": 16.391183791642547
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 3788,
  "fills": 1280031,
  "per_million": 2959.303329372492,
  "ratio": 1.0687457673514928,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 65,
   "letter": "C",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "2,959 FDA reports naming it as the suspect drug per million Medicare fills, 1.1x the median drug on this site",
    "Death share in reports is near or below the FAERS average (1.4x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 46,
   "letter": "F",
   "why": [
    "157 randomized trials and 4 systematic reviews/meta-analyses indexed in PubMed",
    "1 independent Cochrane review(s) exist",
    "Only 48% 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": 99,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 1 Class II, 0 Class III across 11 generic makers (-1)"
   ],
   "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 (11 applications)",
    "18 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 74,
 "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?",
  "Why this one over amineptin, amitriptyline, amoxapine? 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.)"
 ]
}