{
 "query": "duloxetine",
 "ingredient": "duloxetine",
 "slug": "duloxetine",
 "rxcui": "72625",
 "brands": [
  "Cymbalta",
  "Drizalma",
  "Irenka"
 ],
 "names": [
  "duloxetine",
  "duloxetine hydrochloride"
 ],
 "classes": [],
 "alternatives": [],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 127
  },
  "boxed_warning": "WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older [see Warnings and Precautions (5.1) ] . In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [see Warnings and Precautions (5.1) ]. Duloxetine Delayed-release 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. \u2022 Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants ( 5.1 ) \u2022 Monitor for worsening and emergence of suicidal thoughts and behaviors ( 5.1 ) \u2022 Duloxetine Delayed-release Capsules a...",
  "indications_and_usage": "1. INDICATIONS AND USAGE Duloxetine Delayed-release Capsules is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: \u2022 Major Depressive Disorder (MDD) ( 1.1 ) \u2022 Generalized Anxiety Disorder (GAD) ( 1.2 ) \u2022 Diabetic Peripheral Neuropathic Pain (DPNP) ( 1.3 ) \u2022 Chronic Musculoskeletal Pain ( 1.5 ) 1.1 Major Depressive Disorder Duloxetine Delayed-release Capsules are indicated for the treatment of major depressive disorder (MDD). The efficacy of Duloxetine Delayed-release Capsules was established in four short-term and one maintenance trial in adults [see Clinical Studies (14.1) ] . A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, or a suicide attempt or suicidal ideation. 1.2 Generalized Anxiety Disorder Duloxe...",
  "contraindications": "4. CONTRAINDICATIONS \u2022 Serotonin Syndrome and MAOIs: Do not use MAOIs intended to treat psychiatric disorders with Duloxetine Delayed-release Capsules or within 5 days of stopping treatment with Duloxetine Delayed-release Capsules. Do not use Duloxetine Delayed-release Capsules within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start Duloxetine Delayed-release Capsules in a patient who is treated with linezolid or intravenous methylene blue ( 4.1 ) \u2022 Use in patients with uncontrolled narrow-angle glaucoma ( 4.2 ) 4.1 Monoamine Oxidase Inhibitors (MAOIs) The use of MAOIs intended to treat psychiatric disorders with Duloxetine Delayed-release Capsules or within 5 days of stopping treatment with Duloxetine Delayed-release Capsules is contraindicated because of an increased risk of serotonin syndrome. The use of Duloxetine Delayed-release Capsules within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated [see Dosage and Administration (2.5) and Warnings and Precautions (5.4) ]. Starting Duloxetine Delayed-release Capsules in a patient who is being treated with MAOIs such as linezolid or intravenous me...",
  "warnings_and_cautions": "5. WARNINGS AND PRECAUTIONS \u2022 Suicidality: Monitor for clinical worsening and suicide risk ( 5.1 ) \u2022 Hepatotoxicity: Hepatic failure, sometimes fatal, has been reported in patients treated with Duloxetine Delayed-release Capsules. Duloxetine Delayed-release Capsules should be discontinued in patients who develop jaundice or other evidence of clinically significant liver dysfunction and should not be resumed unless another cause can be established. Duloxetine Delayed-release Capsules should not be prescribed to patients with substantial alcohol use or evidence of chronic liver disease ( 5.2 ) \u2022 Orthostatic Hypotension and Syncope: Cases have been reported with duloxetine therapy ( 5.3 ) \u2022 Serotonin Syndrome: Serotonin syndrome has been reported with SSRIs and SNRIs, including with Duloxetine Delayed-release Capsules, both when taken alone, but especially when co-administered with other serotonergic agents (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone and St. John's Wort). If such symptoms occur, discontinue Duloxetine Delayed-release Capsules and initiate supportive treatment. If concomitant use of Duloxetine Delayed-release Capsu...",
  "warnings": "",
  "adverse_reactions": "6. ADVERSE REACTIONS \u2022 Most common adverse reactions (\u22655% and at least twice the incidence of placebo patients): nausea, dry mouth, somnolence, constipation, decreased appetite, and hyperhidrosis ( 6.3 ). To report SUSPECTED ADVERSE REACTIONS, contact Breckenridge Pharmaceutical, Inc. at 1-800-367-3395 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Data Sources The data described below reflect exposure to duloxetine in placebo-controlled trials for MDD (N=2489), GAD (N=910), OA (N=239), CLBP (N=600), and DPNP (N=906). The population studied was 17 to 91 years of age; 65.5%, 62.5%, 61.5%, and 42.9% female; and 86.5%, 81.2%, 86.2%, and 74.0% Caucasian for MDD, GAD, OA and CLBP, DPNP, respectively. Most patients received doses of a total of 60 to 120 mg per day [see Clinical Studies (14) ] . The stated frequencies of adverse reactions represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse reaction of the type listed. A reaction was considered treatment-emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation. Reactions reported during the studies were not necessarily...",
  "drug_abuse_and_dependence": "9.2 Abuse In animal studies, duloxetine did not demonstrate barbiturate-like (depressant) abuse potential. While Duloxetine Delayed-release Capsules have not been systematically studied in humans for its potential for abuse, there was no indication of drug-seeking behavior in the clinical trials. However, it is not possible to predict on the basis of premarketing experience the extent to which a CNS active drug will be misused, diverted, and/or abused once marketed. Consequently, physicians should carefully evaluate patients for a history of drug abuse and follow such patients closely, observing them for signs of misuse or abuse of Duloxetine Delayed-release Capsules (e.g., development of tolerance, incrementation of dose, drug-seeking behavior). 9.3 Dependence In drug dependence studies, duloxetine did not demonstrate dependence-producing potential in rats.",
  "controlled_substance": "",
  "recent_major_changes": "Dosage and Administration: Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders ( 2.5 ) 10/2012 Use of Duloxetine Delayed-release Capsules with Other MAOIs such as Linezolid or Methylene Blue ( 2.6 ) 10/2012 Contraindications \u2013 Monoamine Oxidase Inhibitors ( 4.1 ) 10/2012 Warnings and Precautions: Serotonin Syndrome ( 5.4 ) 10/2012 Discontinuation of Treatment with Duloxetine Delayed-release Capsules ( 5.7 ) 08/2012",
  "information_for_patients": "See FDA-approved patient labeling ( Medication Guide ). 17.1 Information on Medication Guide Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with Duloxetine Delayed-release Capsules and should counsel them in its appropriate use. A patient Medication Guide is available for Duloxetine Delayed-release Capsules. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide before starting Duloxetine Delayed-release Capsules and each time their prescription is renewed, 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 Duloxetine Delayed-release Capsules. 17.2 Suicidal Thoughts and Behaviors Patients, their families, and their caregivers should be encouraged to be alert to...",
  "spl_medguide": "Medication Guide Duloxetine (doo-LOX-e-teen) Delayed-release Capsules, USP Rx Only Read the Medication Guide that comes with Duloxetine Delayed-release Capsules before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment. Talk with your healthcare provider if there is something you do not understand or want to learn more about. What is the most important information I should know about Duloxetine Delayed-release Capsules? Duloxetine Delayed-release Capsules and other antidepressant medicines may cause serious side effects, including: 1. Suicidal thoughts or actions: \u2022 Duloxetine Delayed-release Capsules and other antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment or when the dose is changed. \u2022 Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions. \u2022 Watch for these changes and call your healthcare provider right away if you notice: o New or sudden changes in mood, behavior, ac...",
  "clinical_studies": "14.1 Major Depressive Disorder The efficacy of Duloxetine Delayed-release Capsules as a treatment for depression was established in 4 randomized, double-blind, placebo-controlled, fixed-dose studies in adult outpatients (18 to 83 years) meeting DSM-IV criteria for major depression. In 2 studies, patients were randomized to Duloxetine Delayed-release Capsules 60 mg once daily (N=123 and N=128, respectively) or placebo (N=122 and N=139, respectively) for 9 weeks; in the third study, patients were randomized to Duloxetine Delayed-release Capsules 20 or 40 mg twice daily (N=86 and N=91, respectively) or placebo (N=89) for 8 weeks; in the fourth study, patients were randomized to Duloxetine Delayed-release Capsules 40 or 60 mg twice daily (N=95 and N=93, respectively) or placebo (N=93) for 8 weeks. There is no evidence that doses greater than 60 mg/day confer additional benefits. In all 4 studies, Duloxetine Delayed-release Capsules demonstrated superiority over placebo as measured by improvement in the 17-item Hamilton Depression Rating Scale (HAMD-17) total score. In all of these clinical studies, analyses of the relationship between treatment outcome and age, gender, and race did not...",
  "brand_name": "DULOXETINE DELAYED-RELEASE",
  "manufacturer": "Proficient Rx LP",
  "application_number": "ANDA203088",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20221001",
  "set_id": "22a8cc15-17fb-4c4e-8d2a-de5755ed6031",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 150037,
  "serious": 91611,
  "death": 9211,
  "hospitalization": 39213,
  "primary_suspect": 149305,
  "top_reactions": [
   [
    "Nausea",
    14622
   ],
   [
    "Fatigue",
    13924
   ],
   [
    "Drug Ineffective",
    12067
   ],
   [
    "Headache",
    11525
   ],
   [
    "Dizziness",
    11054
   ],
   [
    "Pain",
    10262
   ],
   [
    "Off Label Use",
    9165
   ],
   [
    "Diarrhoea",
    8748
   ],
   [
    "Anxiety",
    8072
   ],
   [
    "Insomnia",
    7906
   ],
   [
    "Vomiting",
    6985
   ],
   [
    "Drug Withdrawal Syndrome",
    6854
   ],
   [
    "Fall",
    6434
   ],
   [
    "Depression",
    6384
   ],
   [
    "Arthralgia",
    6243
   ]
  ],
  "by_year": {
   "2019": 13519,
   "2020": 12781,
   "2021": 10802,
   "2022": 10281,
   "2023": 9325,
   "2024": 9314,
   "2025": 9895,
   "2026": 4828
  },
  "by_year_primary": {
   "2019": 13506,
   "2020": 12762,
   "2021": 10750,
   "2022": 10103,
   "2023": 9229,
   "2024": 9196,
   "2025": 9756,
   "2026": 4730
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20260604",
   "reason": "CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit",
   "firm": "Breckenridge Pharmaceutical, Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20260604",
   "reason": "CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit",
   "firm": "Breckenridge Pharmaceutical, Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20260514",
   "reason": "CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.",
   "firm": "Asclemed USA Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20260429",
   "reason": "CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.",
   "firm": "Ajanta Pharma Ltd.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20260429",
   "reason": "CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.",
   "firm": "Ajanta Pharma Ltd.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20260429",
   "reason": "CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.",
   "firm": "Ajanta Pharma Ltd.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20260421",
   "reason": "CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit",
   "firm": "Breckenridge Pharmaceutical, Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20251124",
   "reason": "CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit",
   "firm": "Breckenridge Pharmaceutical, Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20251124",
   "reason": "CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit",
   "firm": "Breckenridge Pharmaceutical, Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20251009",
   "reason": "CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.",
   "firm": "Breckenridge Pharmaceutical, Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20250808",
   "reason": "CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.",
   "firm": "Breckenridge Pharmaceutical, Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20250725",
   "reason": "CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.",
   "firm": "Breckenridge Pharmaceutical, Inc.",
   "status": "Ongoing"
  }
 ],
 "recall_total": 29,
 "drugsfda": {
  "applications": 32,
  "nda": 6,
  "anda": 23,
  "first_approval": "20040803",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 32,
  "labeling_recent": 5,
  "sponsors": [
   "ACTAVIS ELIZABETH",
   "AJANTA PHARMA LTD",
   "ALEMBIC",
   "ALKEM LABS LTD",
   "ALMATICA",
   "APOTEX",
   "AUROBINDO PHARMA LTD",
   "BRECKENRIDGE"
  ],
  "unapproved": false,
  "first_approval_fmt": "08/03/2004"
 },
 "trials": {
  "total": 459,
  "completed": 299,
  "terminated": 45,
  "with_results": 147,
  "industry": 211,
  "phase3": 122,
  "results_share": 0.4916387959866221,
  "terminated_share": 0.09803921568627451
 },
 "pubmed": {
  "rct": 311,
  "meta": 109,
  "recent_rct": 62,
  "cochrane": [
   {
    "pmid": "24385423",
    "title": "Duloxetine for treating painful neuropathy, chronic pain or fibromyalgia",
    "year": "2014"
   },
   {
    "pmid": "23076926",
    "title": "Duloxetine versus other anti-depressive agents for depression",
    "year": "2012"
   },
   {
    "pmid": "19821395",
    "title": "Duloxetine for treating painful neuropathy or chronic pain",
    "year": "2009"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "duloxetine",
   "Cymbalta",
   "Drizalma",
   "Irenka"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 13124600,
  "beneficiaries": 2665006,
  "spend": 325905719.29,
  "by_brand": [
   {
    "brand": "Duloxetine HCl",
    "claims": 13094360,
    "per_claim": 23.584857455,
    "is_generic": true
   },
   {
    "brand": "Cymbalta",
    "claims": 23811,
    "per_claim": 667.27430221,
    "is_generic": false
   },
   {
    "brand": "Drizalma Sprinkle",
    "claims": 6429,
    "per_claim": 184.88673511,
    "is_generic": false
   }
  ],
  "per_claim": 24.831668720570534
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": {
  "section": "Haematology",
  "names": [
   "duloxetine",
   "milnacipran",
   "venlafaxine"
  ],
  "reason": "Duloxetine, milnacipran and venlafaxine are serotonin and noradrenaline (norepinephrine) reuptake inhibitors (SNRIs) that, as well as provoking the adverse effects of SSRI antidepressants, carry a risk of cardiac disorders due to their noradrenergic activity, including hypertension, tachycardia, arrhythmias, and QT prolongation. Compared with SSRIs, venlafaxine carries a higher risk of withdrawal symptoms following discontinuation, and a higher risk of cardiac arrest in cases of overdose (Prescrire Int n\u00b0 131, 170, 206, 250, 270; Rev Prescrire n\u00b0 338; Interactions M\u00e9dicamenteuses Prescrire). D...",
  "edition": "2026",
  "qualifier": null,
  "qualified": false,
  "matched": "duloxetine"
 },
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 23682,
  "fills": 13124600,
  "per_million": 1804.3978483153774,
  "ratio": 0.6516542403289625,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 60,
   "letter": "D",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "Listed by the independent review Prescrire as a drug to avoid (2026 edition) (-10)",
    "1,804 FDA reports naming it as the suspect drug per million Medicare fills, 0.7x the median drug on this site",
    "Death share in reports is near or below the FAERS average (0.7x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 65,
   "letter": "C",
   "why": [
    "311 randomized trials and 109 systematic reviews/meta-analyses indexed in PubMed",
    "Prescrire's independent reviewers find its harm-benefit balance unfavourable versus alternatives (-10)",
    "3 independent Cochrane review(s) exist",
    "Only 49% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 81,
   "letter": "B",
   "why": [
    "Recalls since 2016: 0 Class I, 27 Class II, 1 Class III across 23 generic makers (-6)",
    "5 label changes approved since 2021: the safety story is still moving (-8)",
    "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 (23 applications)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 71,
 "grade": "C",
 "questions": [
  "An independent reviewer (Prescrire) lists this as a drug to avoid because the harms outweigh the benefits versus alternatives. What is your view on that?",
  "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 nausea, fatigue, headache. How would we recognize and handle those?",
  "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.)"
 ]
}