{
 "query": "doxepin",
 "ingredient": "doxepin",
 "slug": "doxepin",
 "rxcui": "3638",
 "brands": [
  "Silenor",
  "Zonalon",
  "Prudoxin"
 ],
 "names": [
  "doxepin",
  "doxepin hydrochloride"
 ],
 "classes": [
  {
   "id": "N06AA",
   "name": "Non-selective monoamine reuptake inhibitors"
  }
 ],
 "alternatives": [
  "amineptin",
  "amitriptyline",
  "amoxapine",
  "butriptyline",
  "clomipramine",
  "desipramine",
  "dibenzepin",
  "dothiepin",
  "imipramine",
  "iprindole",
  "lofepramine",
  "maprotiline",
  "melitracen",
  "nortriptyline",
  "opipramol",
  "protriptyline",
  "quinupramine",
  "trimipramine"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 95,
   "TOPICAL": 5
  },
  "boxed_warning": "WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increase 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 emergence of suicidal thoughts and behaviors [see Warnings and Precautions ( 5.1 )]. Doxepin hydrochloride capsules 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. Increased risk of suicidal thoughts and behaviors in pediatric and young adults taking antidepressants. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors ( 5.1 ) Doxepin hydrochloride capsules are not approved for use in pediatric patients ( 8.4 )",
  "indications_and_usage": "Doxepin hydrochloride capsules are indicated for the treatment of major depressive disorder (MDD) in adults. Doxepin hydrochloride capsule is a tricyclic antidepressant (TCA) indicated for the treatment of major depressive disorder (MDD) in adults ( 1 ).",
  "contraindications": "Doxepin hydrochloride capsules are contraindicated in patients: With hypersensitivity to doxepin (hypersensitivity reactions have included tongue edema and urticaria). The possibility of cross sensitivity with other dibenzoxepines should be kept in mind. With glaucoma [see Warnings and Precautions ( 5.3 )]. With current or past urinary retention [see Adverse Reactions ( 6.1 )]. Taking MAOIs, or within 14 days of stopping MAOIs (including the MAOIs linezolid or intravenous methylene blue) because of an increased risk of serotonin syndrome [see Warnings and Precautions ( 5.2 ) and Drug Interactions ( 7 )]. Hypersensitivity to doxepin ( 4 ) Glaucoma ( 4 ) Current or past urinary retention ( 4 ) Taking MAOIs, or within 14 days of stopping MAOIs ( 4 )",
  "warnings_and_cautions": "Suicidal Thoughts and Behaviors : Monitor for clinical worsening and suicide thoughts and behaviors. Consider changing the therapeutic regimen, including possibly discontinuing doxepin hydrochloride, in patients who are experiencing emergent suicidal thoughts or behaviors. ( 5.1 ) Serotonin Syndrome : Risk increases with concomitant use of other serotonergic drugs. Monitor all patients taking doxepin hydrochloride for the emergence of serotonin syndrome. Discontinue doxepin hydrochloride and any concomitant serotonergic agents immediately and initiate supportive treatment if serotonin syndrome occurs. ( 5.2 , 7 ) Angle-Closure Glaucoma : Avoid use of doxepin hydrochloride in patients with untreated anatomically narrow angles. ( 5.3 ) Sedation and Driving Risks : Because doxepin hydrochloride can cause sedation, warn patients against driving a car or operating dangerous machinery while taking doxepin hydrochloride. ( 5.4 ) Activation of Mania or Hypomania : Prior to initiating antidepressant therapy, screen for bipolar disorder. Doxepin hydrochloride is not approved for use in treating bipolar depression. ( 5.5 ) 5.1 Suicidal Thoughts and Behaviors in Adolescents and Young Adults In...",
  "warnings": "",
  "adverse_reactions": "The following clinically significant adverse reactions are described elsewhere in the labeling: Suicidal Thoughts and Behaviors in Adolescents and Young Adults [see Warnings and Precautions ( 5.1 )] Serotonin Syndrome [see Warnings and Precautions ( 5.2 )] Angle-Closure Glaucoma [see Warnings and Precautions ( 5.3 )] Sedation and Driving Risks [see Warnings and Precautions ( 5.4 )] Activation of Mania or Hypomania [see Warnings and Precautions ( 5.5 )] Risk of Seizures [see Warnings and Precautions ( 5.6 )] Psychosis [see Warnings and Precautions ( 5.7 )] Most common adverse reactions (incidence greater than or equal to 5%) are somnolence, dry mouth, dizziness, constipation and fatigue. ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Ajanta Pharma USP Inc. at 1-855-664-7744 and or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials 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 practice. Adverse reactions (greater than or equal to 2% of doxepin ...",
  "drug_abuse_and_dependence": "9.1 Controlled Substance Doxepin hydrochloride capsules contain doxepin, which is not a controlled substance. 9.2 Abuse Doxepin hydrochloride capsules are not associated with abuse. 9.3 Dependence Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. Abrupt cessation of doxepin hydrochloride capsules after prolonged administration can result in withdrawal symptoms, which is indicative of physical dependence.",
  "controlled_substance": "9.1 Controlled Substance Doxepin hydrochloride capsules contain doxepin, which is not a controlled substance.",
  "recent_major_changes": "Dosage and Administration ( 2.4 , 2.5 , 2.6 , 2.7 ) 7/2025 Warnings and Precautions ( 5.2 , 5.5 ) 7/2025",
  "information_for_patients": "Advise patients to read FDA-approved patient labeling (Medication Guide). Suicidal Thoughts and Behaviors Advise patients and caregivers to look for the emergence of suicidal thoughts and behaviors, especially early during doxepin hydrochloride capsules treatment and when the dosage is increased or decreased, and instruct them to report suicidal thinking and behavior to their health care provider [see Warnings and Precautions ( 5.1 )]. Serotonin Syndrome Caution patients about the risk of serotonin syndrome particularly with the concomitant use of doxepin hydrochloride capsules and other serotonergic drugs (e.g., other TCAs, SSRIs, SNRIs, triptans, opioids), lithium, tryptophan, buspirone, and 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) [see Warnings and Precautions ( 5.2 ), Drug Interactions ( 7 )]. Instruct patients to contact their health care provider or report to the emergency room if they experience signs or symptoms of serotonin syndrome. Angle-Closure Glaucoma Advise patients that taking doxepin hydrochloride capsules can cause pupillary dilat...",
  "spl_medguide": "MEDICATION GUIDE Doxepin Hydrochloride (dox' e pin hye'' droe klor' ide) Capsules, USP for oral use What is the most important information I should know about doxepin hydrochloride capsules? D oxepin hydrochloride capsules can cause serious side effects, including: Increased risk of suicidal thoughts and actions. Doxepin hydrochloride capsules and other antidepressant medicines may 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. Doxepin hydrochloride capsules are not for use in children. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member? 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 when the dose is changed. Call your health care 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 visits with your health care provider as scheduled. Call...",
  "clinical_studies": "",
  "brand_name": "Doxepin hydrochloride",
  "manufacturer": "Ajanta Pharma USA Inc.",
  "application_number": "ANDA212624",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20251117",
  "set_id": "1513c98c-e7ef-4009-b932-6757048bb86a",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 13065,
  "serious": 8597,
  "death": 2105,
  "hospitalization": 3543,
  "primary_suspect": 12945,
  "top_reactions": [
   [
    "Drug Ineffective",
    1115
   ],
   [
    "Toxicity To Various Agents",
    969
   ],
   [
    "Fatigue",
    848
   ],
   [
    "Completed Suicide",
    836
   ],
   [
    "Pain",
    733
   ],
   [
    "Off Label Use",
    699
   ],
   [
    "Nausea",
    671
   ],
   [
    "Pruritus",
    669
   ],
   [
    "Headache",
    663
   ],
   [
    "Insomnia",
    627
   ],
   [
    "Dizziness",
    609
   ],
   [
    "Diarrhoea",
    583
   ],
   [
    "Fall",
    577
   ],
   [
    "Dyspnoea",
    560
   ],
   [
    "Anxiety",
    540
   ]
  ],
  "by_year": {
   "2019": 1506,
   "2020": 1218,
   "2021": 1067,
   "2022": 958,
   "2023": 937,
   "2024": 932,
   "2025": 936,
   "2026": 419
  },
  "by_year_primary": {
   "2019": 1503,
   "2020": 1218,
   "2021": 1048,
   "2022": 932,
   "2023": 891,
   "2024": 925,
   "2025": 919,
   "2026": 418
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20250725",
   "reason": "CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.",
   "firm": "Alembic Pharmaceuticals Limited",
   "status": "Ongoing"
  }
 ],
 "recall_total": 1,
 "drugsfda": {
  "applications": 87,
  "nda": 5,
  "anda": 60,
  "first_approval": "19690923",
  "rems": false,
  "rems_last": "20111030",
  "labeling_supplements": 30,
  "labeling_recent": 2,
  "sponsors": [
   "ACTAVIS ELIZABETH",
   "ADAPTIS",
   "AIPING PHARM INC",
   "AJANTA PHARMA LTD",
   "ALEMBIC",
   "AMNEAL",
   "AMNEAL PHARMS CO",
   "APPCO"
  ],
  "unapproved": false,
  "first_approval_fmt": "09/23/1969"
 },
 "trials": {
  "total": 23,
  "completed": 13,
  "terminated": 4,
  "with_results": 5,
  "industry": 4,
  "phase3": 4,
  "results_share": 0.38461538461538464,
  "terminated_share": 0.17391304347826086
 },
 "pubmed": {
  "rct": 79,
  "meta": 1,
  "recent_rct": 4,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "doxepin",
   "Silenor",
   "Zonalon",
   "Prudoxin"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 1271244,
  "beneficiaries": 292471,
  "spend": 66175426.120000005,
  "by_brand": [
   {
    "brand": "Doxepin HCl",
    "claims": 1270415,
    "per_claim": 51.683756765,
    "is_generic": true
   },
   {
    "brand": "Silenor",
    "claims": 816,
    "per_claim": 617.16761029,
    "is_generic": false
   },
   {
    "brand": "Zonalon",
    "claims": 13,
    "per_claim": 922.88461538,
    "is_generic": false
   }
  ],
  "per_claim": 52.05564480147006
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 2262,
  "fills": 1271244,
  "per_million": 1779.3594306049822,
  "ratio": 0.6426116718691629,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 67,
   "letter": "C",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "1,779 FDA reports naming it as the suspect drug per million Medicare fills, 0.6x the median drug on this site",
    "Death appears in 1.8x the share of reports seen across all of FAERS (-3)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 30,
   "letter": "F",
   "why": [
    "79 randomized trials and 1 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)",
    "Only 38% 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": 90,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 1 Class II, 0 Class III across 60 generic makers (-1)",
    "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": 100,
   "letter": "A",
   "why": [
    "Generic versions approved (60 applications)",
    "18 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 69,
 "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 toxicity to various agents, fatigue, completed suicide. 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.)"
 ]
}