{
 "query": "paroxetine",
 "ingredient": "paroxetine",
 "slug": "paroxetine",
 "rxcui": "32937",
 "brands": [
  "Paxil",
  "Brisdelle"
 ],
 "names": [
  "paroxetine",
  "paroxetine hydrochloride",
  "paroxetine hydrochloride anhydrous",
  "paroxetine hydrochloride, hemihydrate",
  "paroxetine mesylate"
 ],
 "classes": [
  {
   "id": "N06AB",
   "name": "Selective serotonin reuptake inhibitors"
  }
 ],
 "alternatives": [
  "citalopram",
  "escitalopram",
  "fluoxetine",
  "fluvoxamine",
  "sertraline"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 30
  },
  "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 paroxetine tablets 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. Paroxetine tablets are not approved for use in pediatric patients (see WARNINGS, Clinical Worsening and Suici...",
  "indications_and_usage": "INDICATIONS AND USAGE Major Depressive Disorder Paroxetine tablets are indicated for the treatment of major depressive disorder. The efficacy of paroxetine in the treatment of a major depressive episode was established in 6-week controlled trials of outpatients whose diagnoses corresponded most closely to the DSM-III category of major depressive disorder (see CLINICAL PHARMACOLOGY, Clinical Trials ). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: Change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The effects of paroxetine in hospitalized depressed patients have not been adequately studied. The efficacy of paroxetine in maintaining a response in major depressive disorder for up to 1 year was demonstrated in a placebo-controlled trial (see CLINICAL PHARMACOLOG...",
  "contraindications": "CONTRAINDICATIONS The use of MAOIs intended to treat psychiatric disorders with paroxetine tablets or within 14 days of stopping treatment with paroxetine tablets is contraindicated because of an increased risk of serotonin syndrome. The use of paroxetine within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated (see WARNINGS and DOSAGE AND ADMINISTRATION ). Starting paroxetine 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 WARNINGS and DOSAGE AND ADMINISTRATION ). Concomitant use with thioridazine is contraindicated (see WARNINGS and PRECAUTIONS ). Concomitant use in patients taking pimozide is contraindicated (see PRECAUTIONS ). Paroxetine tablets are contraindicated in patients with a hypersensitivity to paroxetine or any of the inactive ingredients in paroxetine tablets.",
  "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 Associated With Discontinuation of Treatment Twenty percent (1,199/6,145) of patients treated with paroxetine in worldwide clinical trials in major depressive disorder and 16.1% (84/522), 11.8% (64/542), 9.4% (44/469), and 10.7% (79/735) of patients treated with paroxetine in worldwide trials in social anxiety disorder, OCD, panic disorder, and GAD respectively, discontinued treatment due to an adverse event. The most common events (\u22651%) associated with discontinuation and considered to be drug related (i.e., those events associated with dropout at a rate approximately twice or greater for paroxetine compared to placebo) included the following: Major Depressive Disorder OCD Panic Disorder Social Anxiety Disorder Generalized Anziety Disorder Paroxetine Placebo Paroxetine Placebo Paroxetine Placebo Paroxetine Placebo Paroxetine Placebo CNS Somnolence 2.3% 0.7% \u2014 1.9% 0.3% 3.4% 0.3% 2.0% 0.2% Insomnia \u2014 \u2014 1.7% 0% 1.3% 0.3% 3.1% 0% Agitation 1.1% 0.5% \u2014 Tremor 1.1% 0.3% \u2014 1.7% 0% Anxiety \u2014 \u2014 \u2014 1.1% 0% Dizziness \u2014 \u2014 1.5% 0% 1.9% 0% 1.0% 0.2% Gastrointestinal Constipation \u2014 1.1% 0% Nausea 3.2% 1.1% 1.9% 0% 3.2% 1.2% 4.0% 0.3% 2.0% 0.2% Diarrhea 1.0% 0.3% \u2014 Dry mouth 1.0...",
  "drug_abuse_and_dependence": "DRUG ABUSE AND DEPENDENCE Controlled Substance Class Paroxetine is not a controlled substance. Physical and Psychologic Dependence Paroxetine has not been systematically studied in animals or humans for its potential for abuse, tolerance or physical dependence. While the clinical trials did not reveal any tendency for any drug-seeking behavior, 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, patients should be evaluated carefully for history of drug abuse, and such patients should be observed closely for signs of misuse or abuse of paroxetine (e.g., development of tolerance, incrementations of dose, drug-seeking behavior).",
  "controlled_substance": "Controlled Substance Class Paroxetine is not a controlled substance.",
  "recent_major_changes": "",
  "information_for_patients": "Information for Patients Paroxetine tablets should not be chewed or crushed, and should be swallowed whole. Patients should be cautioned about the risk of serotonin syndrome with the concomitant use of paroxetine and triptans, tramadol, or other serotonergic agents. Patients should be advised that taking paroxetine tablets can cause mild pupillary dilation, which in susceptible individuals, can lead to an episode of angle closure glaucoma. Pre-existing glaucoma is almost always open-angle glaucoma because angle closure glaucoma, when diagnosed, can be treated definitively with iridectomy. Open-angle glaucoma is not a risk factor for angle closure glaucoma. Patients may wish to be examined to determine whether they are susceptible to angle closure, and have a prophylactic procedure (e.g., iridectomy), if they are susceptible. Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with paroxetine and should counsel them in its appropriate use. A patient Medication Guide is available for paroxetine tablets. The prescriber or health professional should instruct patients, their familie...",
  "spl_medguide": "MEDICATION GUIDE Paroxetine Tablets, USP (pa rox\u2019 e teen) Read the Medication Guide that comes with paroxetine 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 paroxetine? Paroxetine and other antidepressant medicines may cause serious side effects, including: 1. Suicidal thoughts or actions: Paroxetine 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 . 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 paroxetine is started or when the ...",
  "clinical_studies": "",
  "brand_name": "PAROXETINE",
  "manufacturer": "Aphena Pharma Solutions - Tennessee, LLC",
  "application_number": "ANDA075356",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20181105",
  "set_id": "1801246b-02c3-430f-932a-b18cb0d13d1d",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 51906,
  "serious": 39523,
  "death": 5085,
  "hospitalization": 18873,
  "primary_suspect": 51283,
  "top_reactions": [
   [
    "Drug Ineffective",
    3353
   ],
   [
    "Fatigue",
    3249
   ],
   [
    "Nausea",
    2903
   ],
   [
    "Headache",
    2512
   ],
   [
    "Diarrhoea",
    2446
   ],
   [
    "Anxiety",
    2441
   ],
   [
    "Off Label Use",
    2285
   ],
   [
    "Dizziness",
    2206
   ],
   [
    "Drug Interaction",
    2164
   ],
   [
    "Depression",
    1979
   ],
   [
    "Fall",
    1955
   ],
   [
    "Foetal Exposure During Pregnancy",
    1943
   ],
   [
    "Vomiting",
    1861
   ],
   [
    "Pain",
    1838
   ],
   [
    "Dyspnoea",
    1827
   ]
  ],
  "by_year": {
   "2019": 6060,
   "2020": 4956,
   "2021": 4030,
   "2022": 3416,
   "2023": 3094,
   "2024": 2831,
   "2025": 3092,
   "2026": 1613
  },
  "by_year_primary": {
   "2019": 6050,
   "2020": 4940,
   "2021": 3996,
   "2022": 3284,
   "2023": 3011,
   "2024": 2681,
   "2025": 2978,
   "2026": 1545
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20260923",
   "reason": "Failed dissolution specifications.",
   "firm": "Apotex Corp.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20171120",
   "reason": "Presence of Foreign Tablets/Capsules: Risperidone Tablets were found in bottle of Paroxetine Tablets",
   "firm": "Zydus Pharmaceuticals USA Inc",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20171024",
   "reason": "Presence of Foreign Tablets/Capsules.",
   "firm": "Amerisource Health Services",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20170818",
   "reason": "Presence of Foreign tablets/capsules: risperidone Tablets were found in bottle of paroxetine Tablets",
   "firm": "Zydus Pharmaceuticals USA Inc",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20170622",
   "reason": "Failed Dissolution Specifications:  out of specification observed in dissolution testing at 3 month long term stability study.",
   "firm": "Lupin Pharmaceuticals Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20140324",
   "reason": "Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.",
   "firm": "Apotex Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20140324",
   "reason": "Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.",
   "firm": "Apotex Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20140324",
   "reason": "Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.",
   "firm": "Apotex Inc.",
   "status": "Terminated"
  }
 ],
 "recall_total": 8,
 "drugsfda": {
  "applications": 35,
  "nda": 6,
  "anda": 29,
  "first_approval": "19921229",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 118,
  "labeling_recent": 22,
  "sponsors": [
   "ACTAVIS LABS FL INC",
   "ALEMBIC",
   "ANNORA PHARMA",
   "APOTEX",
   "APOTEX INC",
   "AUROBINDO PHARMA",
   "AUROBINDO PHARMA USA",
   "CADILA PHARMS LTD"
  ],
  "unapproved": false,
  "first_approval_fmt": "12/29/1992"
 },
 "trials": {
  "total": 320,
  "completed": 226,
  "terminated": 29,
  "with_results": 71,
  "industry": 143,
  "phase3": 61,
  "results_share": 0.3141592920353982,
  "terminated_share": 0.090625
 },
 "pubmed": {
  "rct": 514,
  "meta": 29,
  "recent_rct": 20,
  "cochrane": [
   {
    "pmid": "24696195",
    "title": "Paroxetine versus other anti-depressive agents for depression",
    "year": "2014"
   },
   {
    "pmid": "25267892",
    "title": "Paroxetine versus other anti-depressive agents for depression",
    "year": "2007"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "paroxetine",
   "Paxil",
   "Brisdelle"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 3479484,
  "beneficiaries": 721662,
  "spend": 58260785.2,
  "by_brand": [
   {
    "brand": "Paroxetine HCl",
    "claims": 3371882,
    "per_claim": 13.53031636,
    "is_generic": true
   },
   {
    "brand": "Paroxetine ER",
    "claims": 60111,
    "per_claim": 82.551685382,
    "is_generic": false
   },
   {
    "brand": "Paroxetine Cr",
    "claims": 38204,
    "per_claim": 85.341341221,
    "is_generic": false
   },
   {
    "brand": "Paroxetine Mesylate",
    "claims": 3191,
    "per_claim": 196.18737073,
    "is_generic": true
   },
   {
    "brand": "Paxil Cr",
    "claims": 3152,
    "per_claim": 672.94228744,
    "is_generic": false
   },
   {
    "brand": "Paxil",
    "claims": 2944,
    "per_claim": 566.69906929,
    "is_generic": false
   }
  ],
  "per_claim": 16.74408768656502
 },
 "mdl": [],
 "dsc": [],
 "settlements": [
  {
   "year": 2012,
   "company": "GlaxoSmithKline",
   "amount_usd": 3000000000.0,
   "amount_text": "$3 billion ($1B criminal, $2B civil)",
   "violations": "Criminal: Off-label promotion, failure to disclose safety data. Civil: paying kickbacks to physicians, making false and misleading statements concerning the safety of Avandia, reporting false best prices and underpaying rebates owed under the Medicaid Drug Rebate Program",
   "products": "Avandia (not providing safety data), Wellbutrin, Paxil (promotion of paediatric use), Advair, Lamictal, Zofran, Imitrex, Lotronex, Flovent, Valtrex",
   "laws": "False Claims Act, FDCA",
   "urls": [
    "https://www.justice.gov/opa/pr/2012/July/12-civ-842.html",
    "https://web.archive.org/web/20240714112314/https://www.justice.gov/opa/pr/glaxosmithkline-plead-guilty-and-pay-3-billion-resolve-fraud-allegations-and-failure-report"
   ],
   "matched": "paxil"
  }
 ],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "paroxetine",
  "matched": "paroxetine",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 7204,
  "fills": 3479484,
  "per_million": 2070.421936126161,
  "ratio": 0.7477282436389254,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 70,
   "letter": "C",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "2,070 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 (1.1x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 59,
   "letter": "D",
   "why": [
    "514 randomized trials and 29 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "2 independent Cochrane review(s) exist",
    "Only 31% of completed registered trials posted results (-15)",
    "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 86,
   "letter": "B",
   "why": [
    "Recalls since 2016: 0 Class I, 4 Class II, 1 Class III across 29 generic makers (-6)",
    "22 label changes approved since 2021: the safety story is still moving (-8)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 65,
   "letter": "C",
   "why": [
    "Maker paid $3 billion ($1B criminal, $2B civil) in 2012 to settle federal allegations naming this drug (Criminal: Off-label promotion, failure to disclose safety data. Civil: paying kickbacks to) (-35)",
    "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 (29 applications)",
    "5 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 72,
 "grade": "C",
 "questions": [
  "The maker paid $3 billion in 2012 to settle federal allegations about how this drug was marketed. Is my use one of the uses that was promoted improperly?",
  "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, headache. How would we recognize and handle those?",
  "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.)"
 ]
}