{
 "query": "chlorthalidone",
 "ingredient": "chlorthalidone",
 "slug": "chlorthalidone",
 "rxcui": "2409",
 "brands": [
  "Thalitone",
  "Hemiclor"
 ],
 "names": [
  "chlorthalidone"
 ],
 "classes": [
  {
   "id": "C03BA",
   "name": "Sulfonamides, plain"
  }
 ],
 "alternatives": [
  "clopamide",
  "indapamide",
  "mefruside",
  "metolazone",
  "quinethazone",
  "xipamide"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 86
  },
  "boxed_warning": "",
  "indications_and_usage": "is a thiazide-like diuretic indicated: \u2022 For the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.1). \u2022 as adjunctive therapy in edema associated with heart failure, cirrhosis of the liver, and renal disease, including nephrotic syndrome (1.2). 1.1 Hypertension THALITONE \u00ae is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with THALITONE. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For speci...",
  "contraindications": "is contraindicated in patients with anuria or hypersensitivity to chlorthalidone or other sulfonamide-derived drugs. \u2022 Anuria (4). \u2022 Hypersensitivity (4).",
  "warnings_and_cautions": "\u2022 Hypotension: Higher risk for patients with impaired sympathetic response, volume-depletion or salt restriction (5.1). \u2022 Renal Impairment: Patients with pre-existing kidney disease may be at higher risk. (5.2). \u2022 Monitor serum electrolytes periodically (5.3). 5.1 Hypotension THALITONE may cause symptomatic hypotension. Patients with impaired sympathetic response, volume-depletion or who are salt restricted may be at increased risk for developing hypotension. If hypotension occurs, place the patient in the supine position and, if necessary, give intravenous normal saline. A transient hypotensive response is not a contraindication to further treatment, which usually can be continued without difficulty once the blood pressure has stabilized. 5.2 Impaired Renal Function Changes in renal function including acute renal failure can be caused by diuretics. Patients with chronic kidney disease, heart failure, or volume depletion may be at particular risk of developing acute renal failure on THALITONE. Monitor renal function periodically. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function on THALITONE [see Drug Interacti...",
  "warnings": "",
  "adverse_reactions": "The following adverse reactions are described in more detail elsewhere in the label; \u2022 Hypotension [see Warnings and Precautions (5.1)] \u2022 Impaired Renal Function [see Warnings and Precautions (5.2)] \u2022 Electrolyte Abnormalities [see Warnings and Precautions (5.3)] \u2022 Metabolic Disturbances [see Warnings and Precautions (5.4)] The following adverse reactions have been observed, but there is not enough systematic collection of data to support an estimate of their frequency. Gastrointestinal System Reactions: anorexia, gastric irritation, nausea, vomiting, cramping, diarrhea, constipation, jaundice (intrahepatic cholestatic jaundice), pancreatitis. Central Nervous System Reactions : dizziness, paresthesias, headache. Hematologic Reactions: leukopenia, agranulocytosis, thrombocytopenia, aplastic anemia. Dermatologic-Hypersensitivity Reactions: purpura, photosensitivity, rash, urticaria, necrotizing angiitis (vasculitis) (cutaneous vasculitis), Lyell\u2019s syndrome (toxic epidermal necrolysis). Cardiovascular Reaction: Orthostatic hypotension. Other Adverse Reactions: muscle spasm, weakness, restlessness, impotence, xanthopsia. The most frequently expected adverse drug reactions among patient...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "\u2022 Patients should inform their doctor if they have had an allergic reaction to chlorthalidone or other diuretics; kidney disease; gout; been taking lithium carbonate. \u2022 Patients should be cautioned to contact their physician if they experience any of the following symptoms of potassium loss: excess thirst, tiredness, drowsiness, restlessness, muscle pains or cramps, nausea, vomiting or increased heart rate or pulse. \u2022 Patients should inform their doctor if they have symptoms of light-headedness or dizziness. \u2022 Pregnancy Advise a pregnant woman of the potential risk to a fetus. Advise females of reproductive potential to inform their prescriber of a known or suspected pregnancy [see Use in Specific Populations (8.1)] . \u2022 Lactation Advise females not to breastfeed during treatment with chlorthalidone [see Use in Specific Populations (8.2)] . Rx Only PIB00101-05 Manufactured for: Casper Pharma LLC East Brunswick, NJ 08816 Made in India. Revised: 12/2019",
  "spl_medguide": "",
  "clinical_studies": "Two similarly designed, 12-week, double-blind, parallel group, placebo-controlled multicenter studies were conducted to compare THALITONE 15 mg to the standard chlorthalidone 25 mg in terms of reduction in blood pressure and metabolic disturbances. Collectively, a total of 222 patients with long-standing diastolic blood pressure between 90 and 104 mm Hg were randomized to receive THALITONE 15 mg (N=71), standard chlorthalidone 25 mg (N=75), or placebo (N=76). THALITONE 15 mg has the advantage of demonstrating potentially fewer metabolic disturbances (Table 1) in particular, lowered glucose levels when compared to Hygroton\u00ae 25 mg in clinical setting (Table 2). THALITONE 15 mg helps meet the goal of lowering blood pressure in patients that respond to Chlorthalidone therapy. In general, electrolyte abnormalities are a class effect associated with Chlorthalidone therapy. Table 1. Reduction in blood pressure at 12 weeks (THALITONE 15 mg vs. Standard chlorthalidone 25 mg) Pairwise comparison 2 through 12 weeks 4 through 12 weeks Mean change (95% CI) Significance level Mean change (95% CI) Significance level Standing SBP, mm Hg THALITONE 15 mg vs. placebo \u221211.77 vs. \u22121.89 (\u221213.02, \u22126.74) ...",
  "brand_name": "Thalitone",
  "manufacturer": "Casper Pharma LLC",
  "application_number": "NDA019574",
  "pharm_class_epc": [
   "Thiazide-like Diuretic [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20260625",
  "set_id": "bc5a0299-115b-4e60-bb3f-c75a95c51c15",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 12351,
  "serious": 8065,
  "death": 725,
  "hospitalization": 4165,
  "primary_suspect": 12268,
  "top_reactions": [
   [
    "Fatigue",
    931
   ],
   [
    "Nausea",
    792
   ],
   [
    "Drug Ineffective",
    769
   ],
   [
    "Diarrhoea",
    751
   ],
   [
    "Dizziness",
    629
   ],
   [
    "Off Label Use",
    588
   ],
   [
    "Headache",
    581
   ],
   [
    "Pain",
    570
   ],
   [
    "Dyspnoea",
    563
   ],
   [
    "Acute Kidney Injury",
    552
   ],
   [
    "Chronic Kidney Disease",
    548
   ],
   [
    "Arthralgia",
    470
   ],
   [
    "Asthenia",
    467
   ],
   [
    "Hypertension",
    446
   ],
   [
    "Vomiting",
    435
   ]
  ],
  "by_year": {
   "2019": 1263,
   "2020": 1205,
   "2021": 1206,
   "2022": 1128,
   "2023": 1060,
   "2024": 1099,
   "2025": 1169,
   "2026": 502
  },
  "by_year_primary": {
   "2019": 1263,
   "2020": 1197,
   "2021": 1200,
   "2022": 1118,
   "2023": 1043,
   "2024": 1090,
   "2025": 1142,
   "2026": 497
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20260903",
   "reason": "Failed Dissolution Specifications",
   "firm": "Inventia Healthcare Limited",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20260605",
   "reason": "Failed Dissolution Specifications",
   "firm": "Inventia Healthcare Limited",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20250509",
   "reason": "Failed Dissolution Specifications",
   "firm": "AvKARE",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20220207",
   "reason": "Foreign Matter identified as stainless steel microscopic wear particles mixed with punch lubricant oil and silicone particles from the dust cup",
   "firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20220126",
   "reason": "CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.",
   "firm": "CARDINAL HEALTHCARE",
   "status": "Terminated"
  }
 ],
 "recall_total": 5,
 "drugsfda": {
  "applications": 64,
  "nda": 3,
  "anda": 47,
  "first_approval": "19600407",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 6,
  "labeling_recent": 0,
  "sponsors": [
   "ABBOTT",
   "ADAPTIS",
   "AIPING PHARM INC",
   "AJANTA PHARMA LTD",
   "ALEMBIC",
   "ALKEM LABS LTD",
   "AMNEAL PHARMS CO",
   "ANI PHARMS"
  ],
  "unapproved": false,
  "first_approval_fmt": "04/07/1960"
 },
 "trials": {
  "total": 109,
  "completed": 74,
  "terminated": 16,
  "with_results": 31,
  "industry": 44,
  "phase3": 39,
  "results_share": 0.4189189189189189,
  "terminated_share": 0.14678899082568808
 },
 "pubmed": {
  "rct": 128,
  "meta": 13,
  "recent_rct": 21,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "chlorthalidone",
   "Thalitone",
   "Hemiclor"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 2944741,
  "beneficiaries": 815578,
  "spend": 48920349.0,
  "by_brand": [
   {
    "brand": "Chlorthalidone",
    "claims": 2941224,
    "per_claim": 16.436107512,
    "is_generic": true
   },
   {
    "brand": "Thalitone",
    "claims": 3517,
    "per_claim": 164.365971,
    "is_generic": false
   }
  ],
  "per_claim": 16.61278496139389
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 2729,
  "fills": 2944741,
  "per_million": 926.736850541355,
  "ratio": 0.3346889373029382,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 100,
   "letter": "A",
   "why": [
    "927 FDA reports naming it as the suspect drug per million Medicare fills, 0.3x the median drug on this site",
    "Death share in reports is near or below the FAERS average (0.6x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 51,
   "letter": "D",
   "why": [
    "128 randomized trials and 13 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)",
    "Only 42% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 94,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 5 Class II, 0 Class III across 47 generic makers (-6)"
   ],
   "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 (47 applications)",
    "6 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 87,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are fatigue, nausea, diarrhoea. 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 clopamide, indapamide, mefruside? 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.)"
 ]
}