{
 "query": "guanfacine",
 "ingredient": "guanfacine",
 "slug": "guanfacine",
 "rxcui": "40114",
 "brands": [],
 "names": [
  "guanfacine",
  "guanfacine hydrochloride"
 ],
 "classes": [
  {
   "id": "C02AC",
   "name": "Imidazoline receptor agonists"
  }
 ],
 "alternatives": [
  "clonidine",
  "moxonidine",
  "rilmenidine"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 57
  },
  "boxed_warning": "",
  "indications_and_usage": "\u00ae is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications [see Clinical Studies (14) ]. INTUNIV is a central alpha 2A -adrenergic receptor agonist indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications ( 1 , 14 ).",
  "contraindications": "is contraindicated in patients with a history of a hypersensitivity reaction to INTUNIV or its inactive ingredients, or other products containing guanfacine. Rash and pruritus have been reported. History of hypersensitivity to INTUNIV , its inactive ingredients, or other products containing guanfacine ( 4 ).",
  "warnings_and_cautions": "Hypotension, bradycardia, syncope: Titrate slowly and monitor vital signs frequently in patients at risk for hypotension, heart block, bradycardia, syncope, cardiovascular disease, vascular disease, cerebrovascular disease or chronic renal failure. Measure heart rate and blood pressure prior to initiation of therapy, following dose increases, and periodically while on therapy. Avoid concomitant use of drugs with additive effects unless clinically indicated. Advise patients to avoid becoming dehydrated or overheated ( 5.1 ). Sedation and somnolence: Occur commonly with INTUNIV . Consider the potential for additive sedative effects with CNS depressant drugs. Caution patients against operating heavy equipment or driving until they know how they respond to INTUNIV ( 5.2 ). Cardiac Conduction Abnormalities: May worsen sinus node dysfunction and atrioventricular (AV) block, especially in patients taking other sympatholytic drugs. Titrate slowly and monitor vital signs frequently ( 5.3 ). Rebound Hypertension: Abrupt discontinuation of INTUNIV can lead to clinically significant and persistent rebound hypertension. Subsequent hypertensive encephalopathy was also reported. To minimize the r...",
  "warnings": "",
  "adverse_reactions": "The following serious adverse reactions are described elsewhere in the labeling: Hypotension, bradycardia, and syncope [see Warnings and Precautions (5.1) ] Sedation and somnolence [see Warnings and Precautions (5.2) ] Cardiac conduction abnormalities [see Warnings and Precautions (5.3) ] Rebound Hypertension [see Warnings and Precautions (5.4) ] Most common adverse reactions (\u22655% and at least twice placebo rate) in fixed-dose monotherapy ADHD trials in children and adolescents (6 to 17 years): hypotension, somnolence, fatigue, nausea, and lethargy ( 6.1 ) Flexible dose-optimization ADHD trials in children (6 to 12 years) and adolescents (13 to 17 years): somnolence, hypotension, abdominal pain, insomnia, fatigue, dizziness, dry mouth, irritability, nausea, vomiting, and bradycardia ( 6.1 ). Adjunctive treatment to psychostimulant ADHD trial in children and adolescents (6 to 17 years): somnolence, fatigue, insomnia, dizziness, and abdominal pain ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals at 1-877-TAKEDA-7 (1-877-825-3327) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under w...",
  "drug_abuse_and_dependence": "9.1 Controlled Substance INTUNIV is not a controlled substance and has no known potential for abuse or dependence.",
  "controlled_substance": "9.1 Controlled Substance INTUNIV is not a controlled substance and has no known potential for abuse or dependence.",
  "recent_major_changes": "",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling ( Patient Information ). Dosing and Administration Instruct patients to swallow INTUNIV whole with water, milk, or other liquid. Tablets should not be crushed, chewed or broken prior to administration because this may increase the rate of release of the active drug . Patients should not take INTUNIV together with a high-fat meal, since this can raise blood levels of INTUNIV. Instruct the parent or caregiver to supervise the child or adolescent taking INTUNIV and to keep the bottle of tablets out of reach of children. Advise patients not to abruptly discontinue INTUNIV as abrupt discontinuation can result in clinically significant rebound hypertension. Concomitant stimulant use and abrupt discontinuation of INTUNIV may increase this hypertensive response. Instruct patients on how to properly taper the dose to minimize the risk of rebound hypertension [see Dosage and Administration (2.5) and Warnings and Precautions (5.4) ]. Adverse Reactions Advise patients that sedation can occur, particularly early in treatment or with dose increases. Caution against operating heavy equipment or driving until they know how they respond t...",
  "spl_medguide": "",
  "clinical_studies": "Efficacy of INTUNIV in the treatment of ADHD was established in children and adolescents (6 to 17 years) in: Five short-term, placebo-controlled monotherapy trials (Studies 1, 2, 4, 5, and 6). One short-term, placebo-controlled adjunctive trial with psychostimulants (Study 3). One long-term, placebo-controlled monotherapy maintenance trial (Study 7). Studies 1 and 2: Fixed-dose INTUNIV Monotherapy Study 1 (301 study) was a double-blind, placebo-controlled, parallel-group, fixed-dose study, in which efficacy of once daily dosing with INTUNIV (2 mg, 3 mg, and 4 mg) was evaluated for 5 weeks (n=345) in children and adolescents aged 6 to 17 years. Study 2 (304 study) was a double-blind, placebo-controlled, parallel-group, fixed-dose study, in which efficacy of once daily dosing with INTUNIV (1 mg, 2 mg, 3 mg, and 4 mg) was evaluated for 6 weeks (n=324) in children and adolescents aged 6 to 17 years. In both studies, randomized patients in 2 mg, 3 mg, and 4 mg dose groups were titrated to their target fixed dose, and continued on the same dose until a dose tapering phase started. The lowest dose of 1 mg used in Study 2 was not randomized to patients weighing more than 50 kg. Patients wh...",
  "brand_name": "Intuniv",
  "manufacturer": "Takeda Pharmaceuticals America, Inc.",
  "application_number": "NDA022037",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20250623",
  "set_id": "b972af81-3a37-40be-9fe1-3ddf59852528",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 7962,
  "serious": 4510,
  "death": 252,
  "hospitalization": 1900,
  "primary_suspect": 7900,
  "top_reactions": [
   [
    "Drug Ineffective",
    909
   ],
   [
    "Off Label Use",
    638
   ],
   [
    "Somnolence",
    507
   ],
   [
    "Aggression",
    451
   ],
   [
    "Fatigue",
    371
   ],
   [
    "Insomnia",
    316
   ],
   [
    "Product Substitution Issue",
    312
   ],
   [
    "Headache",
    300
   ],
   [
    "Hypotension",
    291
   ],
   [
    "Anxiety",
    288
   ],
   [
    "Dizziness",
    287
   ],
   [
    "Nausea",
    282
   ],
   [
    "Intentional Overdose",
    265
   ],
   [
    "Suicidal Ideation",
    264
   ],
   [
    "Abnormal Behaviour",
    256
   ]
  ],
  "by_year": {
   "2019": 589,
   "2020": 620,
   "2021": 668,
   "2022": 657,
   "2023": 722,
   "2024": 761,
   "2025": 655,
   "2026": 427
  },
  "by_year_primary": {
   "2019": 588,
   "2020": 619,
   "2021": 667,
   "2022": 654,
   "2023": 701,
   "2024": 753,
   "2025": 646,
   "2026": 411
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20210331",
   "reason": "Cross Contamination with Other Product: Product is being recalled due to Trace Amounts of Quetiapine Fumarate",
   "firm": "Apotex Corp.",
   "status": "Ongoing"
  }
 ],
 "recall_total": 1,
 "drugsfda": {
  "applications": 27,
  "nda": 2,
  "anda": 25,
  "first_approval": "19861027",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 12,
  "labeling_recent": 0,
  "sponsors": [
   "ACTAVIS ELIZABETH",
   "AIPING PHARM INC",
   "AJANTA PHARMA LTD",
   "ALEMBIC",
   "AMNEAL PHARM",
   "APOTEX",
   "ASCENT PHARMS INC",
   "AUROBINDO PHARMA USA"
  ],
  "unapproved": false,
  "first_approval_fmt": "10/27/1986"
 },
 "trials": {
  "total": 97,
  "completed": 67,
  "terminated": 11,
  "with_results": 50,
  "industry": 35,
  "phase3": 15,
  "results_share": 0.746268656716418,
  "terminated_share": 0.1134020618556701
 },
 "pubmed": {
  "rct": 103,
  "meta": 3,
  "recent_rct": 5,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "guanfacine"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 252301,
  "beneficiaries": 47001,
  "spend": 9106281.63,
  "by_brand": [
   {
    "brand": "Guanfacine HCl ER",
    "claims": 134577,
    "per_claim": 34.440420874,
    "is_generic": false
   },
   {
    "brand": "Guanfacine HCl",
    "claims": 117298,
    "per_claim": 36.339941516,
    "is_generic": true
   },
   {
    "brand": "Intuniv",
    "claims": 426,
    "per_claim": 490.11889671,
    "is_generic": false
   }
  ],
  "per_claim": 36.092927217886576
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 1810,
  "fills": 252301,
  "per_million": 7173.97077300526,
  "ratio": 2.5908634720383588,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 87,
   "letter": "B",
   "why": [
    "7,174 FDA reports naming it as the suspect drug per million Medicare fills, 2.6x the median drug on this site (-8)",
    "Death share in reports is near or below the FAERS average (0.3x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 45,
   "letter": "F",
   "why": [
    "103 randomized trials and 3 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)",
    "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 99,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 1 Class II, 0 Class III across 25 generic makers (-1)"
   ],
   "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 (25 applications)",
    "3 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 82,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are somnolence, aggression. 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 clonidine, moxonidine, rilmenidine? 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.)"
 ]
}