{
 "query": "clonidine",
 "ingredient": "clonidine",
 "slug": "clonidine",
 "rxcui": "2599",
 "brands": [
  "Catapres",
  "Duraclon",
  "Javadin",
  "Kapvay",
  "Nexiclon",
  "Onyda",
  "Qlonilik"
 ],
 "names": [
  "clonidine",
  "clonidine hydrochloride"
 ],
 "classes": [
  {
   "id": "C02AC",
   "name": "Imidazoline receptor agonists"
  },
  {
   "id": "S01EA",
   "name": "Sympathomimetics in glaucoma therapy"
  }
 ],
 "alternatives": [
  "apraclonidine",
  "brimonidine",
  "dipivefrin",
  "epinephrine",
  "guanfacine",
  "moxonidine",
  "rilmenidine"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 110,
   "TRANSDERMAL": 5,
   "EPIDURAL": 2,
   "INTRAVENOUS": 2
  },
  "boxed_warning": "",
  "indications_and_usage": "is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to central nervous system (CNS) stimulant medications in pediatric patients 6 years of age and older [see Clinical Studies ( 14 )]. ONYDA XR is a centrally acting alpha 2 -adrenergic agonist indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy or as adjunctive therapy to central nervous system (CNS) stimulant medications in pediatric patients 6 years of age and older. ( 1 )",
  "contraindications": "is contraindicated in patients with a history of a hypersensitivity reaction to clonidine. Reactions have included generalized rash, urticaria, and angioedema [see Warnings and Precautions ( 5.4 ) and Adverse Reactions ( 6 )]. History of a hypersensitivity reaction to clonidine. Reactions have included generalized rash, urticaria, angioedema. ( 4 )",
  "warnings_and_cautions": "Hypotension/bradycardia: 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 ) Somnolence/Sedation: Has been observed with clonidine. 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 ONYDA XR ( 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. ( 5.5 ) 5.1 Hypotension/Bradycardia Treatment with ONYDA XR can cause dose-related decreases in blood pressure and heart rate [see Adverse Reactions ( 6.1 )]. Measure heart rate and blood pressure prior to initiation of ...",
  "warnings": "",
  "adverse_reactions": "The following serious adverse reactions are described in greater detail elsewhere in labeling: Hypotension/bradycardia [see Warnings and Precautions ( 5.1 )] Sedation and somnolence [see Warnings and Precautions ( 5.2 )] Rebound hypertension [see Warnings and Precautions ( 5.3 )] Allergic reactions [see Warnings and Precautions ( 5.4 )] Cardiac Conduction Abnormalities [see Warnings and Precautions ( 5.5 )] Most common adverse reactions (incidence at least 5% and twice the rate of placebo) as monotherapy in ADHD: somnolence, fatigue, irritability, nightmare, insomnia, constipation, dry mouth. ( 6.1 ) Most common adverse reactions (incidence at least 5% and twice the rate of placebo) as adjunct therapy to psychostimulant in ADHD: somnolence, fatigue, decreased appetite, dizziness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Tris Pharma, Inc. at (732) 940-0358 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the r...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "RECENT MAJOR CHANGES Warnings and Precautions ( 5.3 ) 04/2025",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling ( Patient Information and Instructions for Use ). Dosage and Administration Advise patients that ONYDA XR may be taken with or without food. When initiating treatment, provide titration instructions [see Dosage and Administration ( 2.1 )]. Administration Instructions Instruct patients to read the \u201cInstructions for Use\u201d for complete administration instructions [see Dosage and Administration ( 2.2 )] . Advise patients to: firmly insert the bottle adapter into the bottle and do not remove the bottle adapter once inserted. Use the oral dispenser provided with ONYDA XR. gently shake ONYDA XR with a smooth up and down motion (to avoid foaming) for at least 10 seconds before each administration. For the bottles of 30 mL and 60 mL, discard any unused ONYDA XR 30 days after first opening the bottle. For the 120 mL bottle, discard any unused ONYDA XR 60 days after first opening the bottle. Missed Dose If patients miss a dose of ONYDA XR, advise them to skip the dose and take the next dose as scheduled and not to take more than the prescribed total daily amount of ONYDA XR in any 24\u2011hour period [see Dosage and Administration ( 2.5 )...",
  "spl_medguide": "",
  "clinical_studies": "The efficacy of ONYDA XR for the treatment of ADHD in pediatric patients 6 years of age and older is based upon adequate and well-controlled studies of clonidine hydrochloride extended-release tablets (referred to as \u201cclonidine hydrochloride extended-release\u201d in this section). The efficacy results of these adequate and well-controlled studies of clonidine hydrochloride extended-release tablets are presented below. Efficacy of clonidine hydrochloride extended-release in the treatment of ADHD was established in pediatric patients 6 to 17 years in: One short-term, placebo-controlled monotherapy trial (Study 1) One short-term adjunctive therapy to psychostimulants trial (Study 2) One randomized withdrawal trial as monotherapy (Study 3) Short-term Monotherapy and Adjunctive Therapy to Psychostimulant Studies for ADHD The efficacy of clonidine hydrochloride extended-release in the treatment of ADHD was established in 2 (one monotherapy and one adjunctive therapy) placebo-controlled trials in pediatric patients aged 6 to 17 years, who met DSM-IV criteria of ADHD hyperactive or combined hyperactive/inattentive subtypes. Signs and symptoms of ADHD were evaluated using the investigator admin...",
  "brand_name": "ONYDA XR",
  "manufacturer": "NextWave Pharmaceuticals, Inc",
  "application_number": "NDA217645",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20250411",
  "set_id": "4a15c850-9da5-4bdc-a34d-7f740a6149b7",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 50160,
  "serious": 33913,
  "death": 5653,
  "hospitalization": 17294,
  "primary_suspect": 49986,
  "top_reactions": [
   [
    "Drug Ineffective",
    3948
   ],
   [
    "Off Label Use",
    3509
   ],
   [
    "Fatigue",
    3347
   ],
   [
    "Headache",
    3046
   ],
   [
    "Pain",
    2952
   ],
   [
    "Nausea",
    2904
   ],
   [
    "Hypertension",
    2788
   ],
   [
    "Diarrhoea",
    2454
   ],
   [
    "Chronic Kidney Disease",
    2443
   ],
   [
    "Acute Kidney Injury",
    2207
   ],
   [
    "Dyspnoea",
    2195
   ],
   [
    "Vomiting",
    2063
   ],
   [
    "Renal Failure",
    1855
   ],
   [
    "Dizziness",
    1854
   ],
   [
    "Death",
    1566
   ]
  ],
  "by_year": {
   "2019": 5190,
   "2020": 4319,
   "2021": 3737,
   "2022": 3246,
   "2023": 3496,
   "2024": 3802,
   "2025": 3870,
   "2026": 1862
  },
  "by_year_primary": {
   "2019": 5190,
   "2020": 4310,
   "2021": 3711,
   "2022": 3215,
   "2023": 3464,
   "2024": 3785,
   "2025": 3826,
   "2026": 1849
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20260319",
   "reason": "CGMP Deviations: use of an unapproved raw material",
   "firm": "Teva Pharmaceuticals USA, Inc",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20260319",
   "reason": "CGMP Deviations: use of an unapproved raw material",
   "firm": "Teva Pharmaceuticals USA, Inc",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20260319",
   "reason": "CGMP Deviations: use of an unapproved raw material",
   "firm": "Teva Pharmaceuticals USA, Inc",
   "status": "Ongoing"
  },
  {
   "class": "Class III",
   "date": "20220919",
   "reason": "Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg strength Clonidine Hydrochloride Tablets,",
   "firm": "UNICHEM PHARMACEUTICALS USA INC",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20220609",
   "reason": "Defective Delivery System:  Out of specification for release liner removal force results at the 3-month CRT stability timepoint.",
   "firm": "Mayne Pharma Inc",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20220413",
   "reason": "cGMP deviations: Temperature abuse",
   "firm": "Mckesson Medical-Surgical Inc. Corporate Office",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20211028",
   "reason": "Failed Impurities/Degradation Specifications",
   "firm": "Teva Pharmaceuticals USA",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20200526",
   "reason": "Failed Impurities/Degradation Specifications: potential migration of benzophenone at very low level into the product from container.",
   "firm": "UNICHEM PHARMACEUTICALS USA INC",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20200129",
   "reason": "Failed Impurities/Degredation Specifications: This recall is initiated as a precautionary measure due to potential migration of Benzophenone at very low level into product from container label.",
   "firm": "UNICHEM PHARMACEUTICALS USA INC",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20190329",
   "reason": "Labeling: Label Error on Declared Strength: Side carton panel incorrectly lists the concentration as \"500 mcg Clonidine Hydrochloride\" rather than the correct concentration of \"100 mcg Clonidine Hydrochloride\" per mL.",
   "firm": "X-Gen Pharmaceuticals Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20140717",
   "reason": "Labeling: Label Error On Declared Strength: The side label description incorrectly states \"Each mL contains 500 mcg Clonidine Hydrochloride\" instead of stating \"Each mL contains 100 mcg Clonidine Hydrochloride\".",
   "firm": "X-Gen Pharmaceuticals Inc.",
   "status": "Terminated"
  }
 ],
 "recall_total": 11,
 "drugsfda": {
  "applications": 67,
  "nda": 9,
  "anda": 37,
  "first_approval": "19740903",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 36,
  "labeling_recent": 3,
  "sponsors": [
   "ACTAVIS ELIZABETH",
   "ACTAVIS LABS UT INC",
   "ADAPTIS",
   "AJANTA PHARMA LTD",
   "ALEMBIC PHARMS LTD",
   "AM REGENT",
   "AM THERAP",
   "AMNEAL PHARMS NY"
  ],
  "unapproved": false,
  "first_approval_fmt": "09/03/1974"
 },
 "trials": {
  "total": 333,
  "completed": 192,
  "terminated": 55,
  "with_results": 83,
  "industry": 32,
  "phase3": 57,
  "results_share": 0.4322916666666667,
  "terminated_share": 0.16516516516516516
 },
 "pubmed": {
  "rct": 1099,
  "meta": 47,
  "recent_rct": 50,
  "cochrane": [
   {
    "pmid": "35587172",
    "title": "Topical clonidine for neuropathic pain in adults",
    "year": "2022"
   },
   {
    "pmid": "32270873",
    "title": "Clonidine for pain in non-ventilated infants",
    "year": "2020"
   },
   {
    "pmid": "28488361",
    "title": "Clonidine for sedation and analgesia for neonates receiving mechanical ventilation",
    "year": "2017"
   },
   {
    "pmid": "26329307",
    "title": "Topical clonidine for neuropathic pain",
    "year": "2015"
   },
   {
    "pmid": "24470114",
    "title": "Clonidine premedication for postoperative analgesia in children",
    "year": "2014"
   },
   {
    "pmid": "15266422",
    "title": "Clonidine for smoking cessation",
    "year": "2004"
   },
   {
    "pmid": "10796479",
    "title": "Clonidine for smoking cessation",
    "year": "2000"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "clonidine",
   "Catapres",
   "Duraclon",
   "Javadin",
   "Kapvay",
   "Nexiclon",
   "Onyda",
   "Qlonilik"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 3973347,
  "beneficiaries": 1022209,
  "spend": 84417253.55,
  "by_brand": [
   {
    "brand": "Clonidine HCl",
    "claims": 3484806,
    "per_claim": 6.4639708552,
    "is_generic": true
   },
   {
    "brand": "Clonidine",
    "claims": 473634,
    "per_claim": 127.82140858,
    "is_generic": true
   },
   {
    "brand": "Clonidine HCl ER",
    "claims": 14907,
    "per_claim": 90.628838801,
    "is_generic": false
   }
  ],
  "per_claim": 21.245879997392624
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 9460,
  "fills": 3973347,
  "per_million": 2380.8642940070426,
  "ratio": 0.8598438056695885,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 95,
   "letter": "A",
   "why": [
    "2,381 FDA reports naming it as the suspect drug per million Medicare fills, 0.9x the median drug on this site",
    "Death share in reports is near or below the FAERS average (1.2x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 75,
   "letter": "B",
   "why": [
    "1099 randomized trials and 47 systematic reviews/meta-analyses indexed in PubMed",
    "7 independent Cochrane review(s) exist",
    "Only 43% of completed registered trials posted results (-8)",
    "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 84,
   "letter": "B",
   "why": [
    "Recalls since 2016: 0 Class I, 5 Class II, 5 Class III across 37 generic makers (-7)",
    "3 label changes approved since 2021 (-4)",
    "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": 100,
   "letter": "A",
   "why": [
    "Generic versions approved (37 applications)",
    "7 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 90,
 "grade": "A",
 "questions": [
  "The most-reported problems in FDA's adverse event data are 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 apraclonidine, brimonidine, dipivefrin? 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.)"
 ]
}