{
 "query": "sertraline",
 "ingredient": "sertraline",
 "slug": "sertraline",
 "rxcui": "36437",
 "brands": [
  "Zoloft"
 ],
 "names": [
  "sertraline",
  "sertraline hydrochloride"
 ],
 "classes": [
  {
   "id": "N06AB",
   "name": "Selective serotonin reuptake inhibitors"
  }
 ],
 "alternatives": [
  "citalopram",
  "escitalopram",
  "fluoxetine",
  "fluvoxamine",
  "paroxetine"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 153
  },
  "boxed_warning": "WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased 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 for emergence of suicidal thoughts and behaviors [See Warnings and Precautions (5.1) ]. WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients ( 5.1 ) Closely monitor for clinical worsening and emergence of suicidal thoughts and behaviors ( 5.1 )",
  "indications_and_usage": "Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14) ]: Major depressive disorder (MDD) Obsessive-compulsive disorder (OCD) Panic disorder (PD) Posttraumatic stress disorder (PTSD) Social anxiety disorder (SAD) Premenstrual dysphoric disorder (PMDD) Sertraline hydrochloride tablets are a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of ( 1 ): Major depressive disorder (MDD) Obsessive-compulsive disorder (OCD) Panic disorder (PD) Posttraumatic stress disorder (PTSD) Social anxiety disorder (SAD) Premenstrual dysphoric disorder (PMDD)",
  "contraindications": "Sertraline hydrochloride tablets are contraindicated in patients: Taking, or within 14 days of stopping, MAOIs, (including the MAOIs linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome [See Warnings and Precautions (5.2) , Drug Interactions (7.1) ] . Taking pimozide [See Drug Interactions (7.1) ] . With known hypersensitivity to sertraline (e.g., anaphylaxis, angioedema) [See Adverse Reactions (6.1 , 6.2) ]. Concomitant use of monoamine oxidase inhibitors (MAOIs), or use within 14 days of stopping MAOIs ( 4 , 7.1 ) Concomitant use of pimozide ( 4 , 7.1 ) Known hypersensitivity to sertraline or excipients ( 4 , 5.4 )",
  "warnings_and_cautions": "Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents, but also when taken alone. If it occurs, discontinue sertraline and initiate supportive treatment. ( 5.2 ) Increased Risk of Bleeding: Concomitant use of aspirin, nonsteroidal anti- inflammatory drugs (NSAIDs), other antiplatelet drugs, warfarin, and other anticoagulants may increase this risk. ( 5.3 ) Activation of Mania/Hypomania: Screen patients for bipolar disorder. ( 5.4 ) Seizures: Use with caution in patients with seizure disorders. ( 5.6 ) Angle Closure Glaucoma: Avoid use of antidepressants, including sertraline hydrochloride, in patients with untreated anatomically narrow angles. ( 5.7 ) QTc Prolongation: Sertraline hydrochloride should be used with caution in patients with risk factors for QTc prolongation. ( 5.10 ) Sexual Dysfunction: Sertraline hydrochloride may cause symptoms of sexual dysfunction. ( 5.11 ) 5.1 Suicidal Thoughts and Behaviors in Pediatric and Young Adult Patients In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included approximately 77,000 adult patients and over 4,400 pediatric patients, the inc...",
  "warnings": "",
  "adverse_reactions": "The following adverse reactions are described in more detail in other sections of the prescribing information: Hypersensitivity reactions to sertraline [See Contraindications (4) ] QTc prolongation and ventricular arrhythmias when taken with pimozide [See Contraindications (4) , Clinical Pharmacology (12.2) ] Suicidal thoughts and behaviors [See Warnings and Precautions (5.1) ] Serotonin syndrome [See Contraindications (4) , Warnings and Precautions (5.2) , Drug Interactions (7.1) ] Increased risk of bleeding [See Warnings and Precautions (5.3) ] Activation of mania/hypomania [See Warnings and Precautions (5.4) ] Discontinuation syndrome [See Warnings and Precautions (5.5) ] Seizures [See Warnings and Precautions (5.6) ] Angle-closure glaucoma [See Warnings and Precautions (5.7) ] Hyponatremia [See Warnings and Precautions (5.8) ] Sexual Dysfunction [See Warnings and Precautions (5.11) ] Most common adverse reactions (\u22655% and twice placebo) in pooled placebo- controlled MDD, OCD, PD, PTSD, SAD and PMDD clinical trials were nausea, diarrhea/loose stool, tremor, dyspepsia, decreased appetite, hyperhidrosis, ejaculation failure, and decreased libido. ( 6.1 ) To report SUSPECTED ADVERS...",
  "drug_abuse_and_dependence": "9.1 Controlled Substance Sertraline hydrochloride tablets contain sertraline, which is not a controlled substance. 9.2 Abuse In a placebo-controlled, double-blind, randomized study of the comparative abuse liability of sertraline hydrochloride, alprazolam, and d-amphetamine in humans, sertraline hydrochloride did not produce the positive subjective effects indicative of abuse potential, such as euphoria or drug liking, that were observed with the other two drugs.",
  "controlled_substance": "9.1 Controlled Substance Sertraline hydrochloride tablets contain sertraline, which is not a controlled substance.",
  "recent_major_changes": "Warnings and Precautions ( 5.2 , 5.3 ) 8/2023",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling ( Medication Guide ). Suicidal Thoughts and Behaviors Advise patients and caregivers to look for the emergence of suicidality, especially early during treatment and when the dosage is adjusted up or down, and instruct them to report such symptoms to the healthcare provider [See Boxed Warning and Warnings and Precautions (5.1) ]. Serotonin Syndrome Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of sertraline hydrochloride with other serotonergic drugs including triptans, tricyclic antidepressants, opioids, lithium, tramadol, tryptophan, buspirone, amphetamines, 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). Patients should 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 (7.1) ] . Increased Risk of Bleeding Inform patients about the concomitant use of sertraline hydrochloride with aspirin, NSAIDs, other antiplatelet d...",
  "spl_medguide": "Medication Guide Sertraline Hydrochloride Tablets USP (ser' tra leen hye'' droe klor' ide) What is the most important information I should know about sertraline hydrochloride tablets? Sertraline hydrochloride tablets and other antidepressant medicines may cause serious side effects. Call your healthcare provider right away if you have any of the following symptoms, or call 911 if there is an emergency. 1. Suicidal thoughts or actions: Sertraline hydrochloride tablets and other antidepressant medicines may increase suicidal thoughts or actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions. Watch for these changes and call your healthcare provider right away if you notice new or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe. Pay particular attention to such changes when sertraline hydrochloride tablets are started or when the dose is changed. Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms. Call ...",
  "clinical_studies": "Efficacy of sertraline hydrochloride was established in the following trials: MDD: two short-term trials and one maintenance trials in adults [See Clinical Studies (14.1) ]. OCD: three short-term trials in adults and one short-term trial in pediatric patients [See Clinical Studies (14.2) ]. PD: three short-term trials and one maintenance trial in adults [See Clinical Studies (14.3) ]. PTSD: two short-term trials and one maintenance trial in adults [See Clinical Studies (14.4) ]. SAD: two short-term trials and one maintenance trial in adults [See Clinical Studies (14.5) ]. PMDD: two short-term trials in adult female patients [See Clinical Studies (14.6) ]. 14.1 Major Depressive Disorder The efficacy of sertraline hydrochloride as a treatment for MDD was established in two randomized, double-blind, placebo-controlled studies and one double-blind, randomized-withdrawal study following an open label study in adult (ages 18 to 65) outpatients who met the Diagnostic and Statistical Manual of Mental Disorders (DSM-III) criteria for MDD (studies MDD-1 and MDD-2). Study MDD-1 was an 8-week, 3-arm study with flexible dosing of sertraline hydrochloride, amitriptyline, and placebo. Adult patie...",
  "brand_name": "SERTRALINE HYDROCHLORIDE",
  "manufacturer": "ScieGen Pharmaceuticals Inc",
  "application_number": "ANDA076442",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20231108",
  "set_id": "10b9cae4-b452-4abb-866a-9f9d2568f212",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 168875,
  "serious": 120939,
  "death": 14174,
  "hospitalization": 52844,
  "primary_suspect": 167577,
  "top_reactions": [
   [
    "Nausea",
    10629
   ],
   [
    "Drug Ineffective",
    10495
   ],
   [
    "Fatigue",
    10201
   ],
   [
    "Headache",
    8633
   ],
   [
    "Diarrhoea",
    8452
   ],
   [
    "Off Label Use",
    7949
   ],
   [
    "Anxiety",
    7378
   ],
   [
    "Dizziness",
    7342
   ],
   [
    "Depression",
    6417
   ],
   [
    "Vomiting",
    6279
   ],
   [
    "Dyspnoea",
    6062
   ],
   [
    "Pain",
    5837
   ],
   [
    "Fall",
    5773
   ],
   [
    "Drug Interaction",
    5361
   ],
   [
    "Insomnia",
    5102
   ]
  ],
  "by_year": {
   "2019": 17489,
   "2020": 16132,
   "2021": 13362,
   "2022": 12986,
   "2023": 11912,
   "2024": 12813,
   "2025": 14104,
   "2026": 6839
  },
  "by_year_primary": {
   "2019": 17455,
   "2020": 16100,
   "2021": 13246,
   "2022": 12719,
   "2023": 11656,
   "2024": 12612,
   "2025": 13888,
   "2026": 6704
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20251105",
   "reason": "Defective container - seal not adhering to bottles",
   "firm": "Lupin Pharmaceuticals Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20231211",
   "reason": "CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product.",
   "firm": "Legacy Pharmaceutical Packaging LLC",
   "status": "Ongoing"
  }
 ],
 "recall_total": 2,
 "drugsfda": {
  "applications": 39,
  "nda": 3,
  "anda": 34,
  "first_approval": "19911230",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 74,
  "labeling_recent": 8,
  "sponsors": [
   "ACCORD HLTHCARE",
   "ALMATICA",
   "AMNEAL",
   "APPCO",
   "ASCENT PHARMS INC",
   "AUROBINDO PHARMA",
   "CHARTWELL MOLECULAR",
   "GRANULES"
  ],
  "unapproved": false,
  "first_approval_fmt": "12/30/1991"
 },
 "trials": {
  "total": 438,
  "completed": 281,
  "terminated": 52,
  "with_results": 132,
  "industry": 108,
  "phase3": 79,
  "results_share": 0.4697508896797153,
  "terminated_share": 0.1187214611872146
 },
 "pubmed": {
  "rct": 529,
  "meta": 19,
  "recent_rct": 49,
  "cochrane": [
   {
    "pmid": "20393946",
    "title": "Sertraline versus other antidepressive agents for depression",
    "year": "2010"
   },
   {
    "pmid": "20091586",
    "title": "Sertraline versus other antidepressive agents for depression",
    "year": "2010"
   },
   {
    "pmid": "19370626",
    "title": "Sertraline versus other antidepressive agents for depression",
    "year": "2009"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 31113.72,
  "records": 11,
  "by_name": [
   [
    "Zoloft",
    31113.72
   ]
  ],
  "names_checked": [
   "sertraline",
   "Zoloft"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 16161912,
  "beneficiaries": 3202060,
  "spend": 161680366.71,
  "by_brand": [
   {
    "brand": "Sertraline HCl",
    "claims": 16148462,
    "per_claim": 9.1365731418,
    "is_generic": true
   },
   {
    "brand": "Zoloft",
    "claims": 13450,
    "per_claim": 1051.2091093,
    "is_generic": false
   }
  ],
  "per_claim": 10.003789570813156
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "sertraline",
  "matched": "sertraline",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 33204,
  "fills": 16161912,
  "per_million": 2054.4598931116566,
  "ratio": 0.7419635875657503,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 70,
   "letter": "C",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "2,054 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)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 69,
   "letter": "C",
   "why": [
    "529 randomized trials and 19 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "3 independent Cochrane review(s) exist",
    "Only 47% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 84,
   "letter": "B",
   "why": [
    "Recalls since 2016: 0 Class I, 2 Class II, 0 Class III across 34 generic makers (-3)",
    "8 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 $31,114 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 (34 applications)",
    "5 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 79,
 "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 nausea, fatigue, headache. 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, escitalopram, fluoxetine? 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.)"
 ]
}