{
 "query": "escitalopram",
 "ingredient": "escitalopram",
 "slug": "escitalopram",
 "rxcui": "321988",
 "brands": [
  "Lexapro"
 ],
 "names": [
  "escitalopram",
  "escitalopram oxalate"
 ],
 "classes": [
  {
   "id": "N06AB",
   "name": "Selective serotonin reuptake inhibitors"
  }
 ],
 "alternatives": [
  "citalopram",
  "fluoxetine",
  "fluvoxamine",
  "paroxetine",
  "sertraline"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 109
  },
  "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) ] . Escitalopram oxalate is not approved for use in pediatric patients less than 7 years of age [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 behavior in pediatric and young adult patients taking antidepressants. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors (5.1). Escitalopram oxalate is not approved for use in pediatric patients less than 7 years of age ( 8.4 ).",
  "indications_and_usage": "Escitalopram tablets are indicated for the treatment of: major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older. generalized anxiety disorder (GAD) inadults. Additional pediatric use information is approved for AbbVie Inc.\u2019s LEXAPRO (escitalopram) tablets. However, due to AbbVie Inc.\u2019s marketing exclusivity rights, this drug product is not labeled with that information. Escitalopram oxalate is a selective serotonin reuptake inhibitor (SSRI) indicated for the: treatment of major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older ( 1 ) treatment of generalized anxiety disorder (GAD) in adults ( 1 )",
  "contraindications": "Escitalopram tablets is contraindicated in patients: taking MAOIs with escitalopram tablets or within 14 days of stopping treatment with escitalopram tablets because of an increased risk of serotonin syndrome. The use of escitalopram tablets within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated [see Dosage and Administration (2.7) , and Warnings and Precautions (5.2) ] . Starting escitalopram tablets 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 Dosage and Administration (2.6) , and Warnings and Precautions (5.2) ]. taking pimozide [see Drug Interactions (7) ]. with a hypersensitivity to escitalopram or citalopram or any of the inactive ingredients in escitalopram tablets. Do not use MAOIs intended to treat psychiatric disorders with escitalopram tablets or within 14 days of stopping treatment with escitalopram tablets. Do not use escitalopram tablets within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start escitalopram tablets in a patient who is being treated with li...",
  "warnings_and_cautions": "Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents but also when taken alone. If it occurs, discontinue escitalopram oxalate and serotonergic agents and initiate supportive treatment ( 4 , 5.2 ) Discontinuation syndrome: When discontinuing escitalopram oxalate, reduce dosage gradually whenever possible, and monitor for discontinuation symptoms ( 5.3 ) Seizures: Use with caution in patients with a history of seizure ( 5.4 ) Activation of Mania/Hypomania: Screen patients for bipolar disorder ( 5.5 ) Hyponatremia: Can occur in association with syndrome of inappropriate antidiuretic hormone secretion ( 5.6 ) Increased Risk of Bleeding: Concomitant use of nonsteroidal anti-inflammatory drugs, aspirin, other antiplatelet drugs, warfarin and other drugs that affect coagulation may increase risk ( 5.7 ) Interference with Cognitive and Motor Performance: Use caution when operating machinery ( 5.8 ) Angle Closure Glaucoma: Angle closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants ( 5.9 ) Use in Patients with Concomitant Illness: Use caution in patients with diseases or conditions that produce alt...",
  "warnings": "",
  "adverse_reactions": "The following adverse reactions are discussed in greater detail in other sections of 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) ] Discontinuation syndrome [see Warnings and Precautions (5.3) ] Seizures [see Warnings and Precautions (5.4) ] Activation of mania or hypomania [see Warnings and Precautions (5.5) ] Hyponatremia [see Warnings and Precautions (5.6) ] Increased Risk of Bleeding [see Warnings and Precautions (5.7) ] Interference with Cognitive and Motor Performance [see Warnings and Precautions (5.8) ] Angle-closure glaucoma [see Warnings and Precautions (5.9) ] Use in Patients with Concomitant Illness [see Warnings and Precautions (5.10) ] Sexual Dysfunction [see Warnings and Precautions (5.11) ] Most commonly observed adverse reactions (incidence \u2265 5% and at least twice the incidence of placebo patients) are: insomnia, ejaculation disorder (primarily ejaculatory delay), nausea, sweating increased, fatigue and somnolence, decreased libido, and anorgasmia (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-28...",
  "drug_abuse_and_dependence": "9.2 Abuse and Dependence Physical and Psychological Dependence Animal studies suggest that the abuse liability of racemic citalopram is low. Escitalopram oxalate has not been systematically studied in humans for its potential for abuse, tolerance, or physical dependence. The premarketing clinical experience with escitalopram oxalate did not reveal any drug-seeking behavior. However, these observations were not systematic and it is not possible to predict on the basis of this limited experience the extent to which a CNS-active drug will be misused, diverted, and/or abused once marketed. Consequently, physicians should carefully evaluate escitalopram oxalate patients for history of drug abuse and follow such patients closely, observing them for signs of misuse or abuse (e.g., development of tolerance, incrementations of dose, drug-seeking behavior).",
  "controlled_substance": "",
  "recent_major_changes": "Indications ( 1 ) 5/2023 Dosage and Administration ( 2.2 , 2.3 , 2.5 ) 5/2023 Dosage and Administration, Use of Escitalopram with Other MAOIs such as Linezolid or Methylene Blue ( 2.7 ) - Removed 5/2023 Warnings and Precautions ( 5.2 , 5.7 ) 8/2023",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Medication Guide). Suicidal Thoughts and Behaviors Advise patients, their families and caregivers to look for the emergence of suicidal ideation and behavior, especially during treatment and when the dose is adjusted up or down, and instruct them to report such symptoms to their healthcare provider [see Boxed Warning and Warnings and Precautions (5.1)]. Serotonin Syndrome Caution patients about the risk of serotonin syndrome, particularly with the with the concomitant use of escitalopram oxalate with other serotonergic drugs including triptans, tricyclic antidepressants, opioids, lithium, tryptophan, buspirone, amphetamines, 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). Instruct patients to contact their health care provider or report to the emergency room if they experience signs or symptoms of serotonin syndrome [see Warnings and Precautions (5.2) , Drug Interactions (7) ] . Discontinuation Syndrome Advise patients not to abruptly discontinue escitalopram oxalate and to discuss any ta...",
  "spl_medguide": "Dispense with Medication Guide available at: www.aurobindousa.com/medication-guides MEDICATION GUIDE Escitalopram Tablets USP (es'' sye tal' oh pram) What is the most important information I should know about escitalopram tablets? Escitalopram tablets may cause serious side effects, including: Increased risk of suicidal thoughts or actions. Escitalopram tablets and other antidepressant medicines 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. Depression or other mental illnesses are the most important causes of suicidal thoughts or actions. How can I watch for and try to prevent suicidal thoughts and actions? Pay close attention to any changes, especially sudden changes in mood, behavior, thoughts, or feelings, or if you or your child develop suicidal thoughts or actions. This is very important when an antidepressant medicine is started or when the dose is changed. Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings or if you or your child develop suicidal thoughts or actions. Keep all follow-up visi...",
  "clinical_studies": "14.1 Major Depressive Disorder Adults The efficacy of escitalopram oxalate as a treatment for major depressive disorder was established in three, 8-week, placebo-controlled studies conducted in outpatients between 18 and 65 years of age who met DSM-IV criteria for major depressive disorder. The primary outcome in all three studies was change from baseline to endpoint in the Montgomery Asberg Depression Rating Scale (MADRS). A fixed-dose study compared 10 mg daily escitalopram oxalate and 20 mg daily escitalopram oxalate to placebo and 40 mg daily citalopram. The 10 mg daily and 20 mg daily escitalopram oxalate treatment groups showed statistically significant greater mean improvement compared to placebo on the MADRS. The 10 mg and 20 mg escitalopram oxalate groups were similar on this outcome measure. In a second fixed-dose study of 10 mg daily escitalopram oxalate and placebo, the 10 mg daily escitalopram oxalate treatment group showed statistically significant greater mean improvement compared to placebo on the MADRS. In a flexible-dose study, comparing escitalopram oxalate, titrated between 10 mg and 20 mg daily, to placebo and citalopram, titrated between 20 mg and 40 mg daily,...",
  "brand_name": "Escitalopram",
  "manufacturer": "Advanced Rx Pharmacy of Tennessee, LLC",
  "application_number": "ANDA090432",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20240319",
  "set_id": "138f8703-2f13-6d07-e063-6394a90a4413",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 115316,
  "serious": 78861,
  "death": 9090,
  "hospitalization": 37441,
  "primary_suspect": 114542,
  "top_reactions": [
   [
    "Fatigue",
    8214
   ],
   [
    "Drug Ineffective",
    7938
   ],
   [
    "Nausea",
    7608
   ],
   [
    "Off Label Use",
    6520
   ],
   [
    "Headache",
    6244
   ],
   [
    "Diarrhoea",
    6063
   ],
   [
    "Dizziness",
    5078
   ],
   [
    "Anxiety",
    5045
   ],
   [
    "Fall",
    4745
   ],
   [
    "Pain",
    4544
   ],
   [
    "Dyspnoea",
    4542
   ],
   [
    "Depression",
    4413
   ],
   [
    "Vomiting",
    4227
   ],
   [
    "Condition Aggravated",
    3737
   ],
   [
    "Malaise",
    3682
   ]
  ],
  "by_year": {
   "2019": 11269,
   "2020": 10924,
   "2021": 9057,
   "2022": 9343,
   "2023": 9335,
   "2024": 9637,
   "2025": 9485,
   "2026": 4752
  },
  "by_year_primary": {
   "2019": 11260,
   "2020": 10917,
   "2021": 9018,
   "2022": 9196,
   "2023": 9153,
   "2024": 9477,
   "2025": 9348,
   "2026": 4673
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 35,
  "nda": 4,
  "anda": 25,
  "first_approval": "20020814",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 36,
  "labeling_recent": 6,
  "sponsors": [
   "ABBVIE",
   "ACCORD HLTHCARE",
   "AIPING PHARM INC",
   "ALMATICA",
   "ALPHAPHARM",
   "AMNEAL PHARMS",
   "ANTRIM PHARMS LLC",
   "ASCENT PHARMS INC"
  ],
  "unapproved": false,
  "first_approval_fmt": "08/14/2002"
 },
 "trials": {
  "total": 726,
  "completed": 475,
  "terminated": 84,
  "with_results": 197,
  "industry": 219,
  "phase3": 125,
  "results_share": 0.4147368421052632,
  "terminated_share": 0.11570247933884298
 },
 "pubmed": {
  "rct": 372,
  "meta": 31,
  "recent_rct": 78,
  "cochrane": [
   {
    "pmid": "19370639",
    "title": "Escitalopram versus other antidepressive agents for depression",
    "year": "2009"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 27168.88,
  "records": 12,
  "by_name": [
   [
    "escitalopram",
    27168.88
   ]
  ],
  "names_checked": [
   "escitalopram",
   "Lexapro"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 12705284,
  "beneficiaries": 2729789,
  "spend": 158593098.4,
  "by_brand": [
   {
    "brand": "Escitalopram Oxalate",
    "claims": 12685003,
    "per_claim": 11.114745577,
    "is_generic": true
   },
   {
    "brand": "Lexapro",
    "claims": 20281,
    "per_claim": 867.93143385,
    "is_generic": false
   }
  ],
  "per_claim": 12.482452056955202
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": {
  "section": "Haematology",
  "names": [
   "citalopram",
   "escitalopram"
  ],
  "reason": "Citalopram and escitalopram are \u201cselective\u201d serotonin reuptake inhibitor (SSRI) antidepressants that expose patients to a higher incidence of QT prolongation, torsade de pointes and sudden death than other SSRIs, as well as worse outcomes in the event of overdose ( Prescrire Int n\u00b0 170, 174, 221; Rev Prescrire n\u00b0 369).",
  "edition": "2026",
  "qualifier": null,
  "qualified": false,
  "matched": "escitalopram"
 },
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "escitalopram",
  "matched": "escitalopram",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 23498,
  "fills": 12705284,
  "per_million": 1849.466725812662,
  "ratio": 0.6679307644643642,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 55,
   "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)",
    "1,849 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 (0.9x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 59,
   "letter": "D",
   "why": [
    "372 randomized trials and 31 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "Prescrire's independent reviewers find its harm-benefit balance unfavourable versus alternatives (-10)",
    "1 independent Cochrane review(s) exist",
    "Only 41% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 87,
   "letter": "B",
   "why": [
    "No recalls on record since 2016",
    "6 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 $27,169 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 (25 applications)",
    "5 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 72,
 "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 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 citalopram, fluoxetine, fluvoxamine? 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.)"
 ]
}