{
 "query": "hydrochlorothiazide",
 "ingredient": "hydrochlorothiazide",
 "slug": "hydrochlorothiazide",
 "rxcui": "5487",
 "brands": [
  "Inzirqo"
 ],
 "names": [
  "hydrochlorothiazide"
 ],
 "classes": [
  {
   "id": "C03AA",
   "name": "Thiazides, plain"
  }
 ],
 "alternatives": [
  "bendroflumethiazide",
  "chlorothiazide",
  "cyclopenthiazide",
  "cyclothiazide",
  "hydroflumethiazide",
  "methyclothiazide",
  "polythiazide",
  "trichlormethiazide"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 524
  },
  "boxed_warning": "",
  "indications_and_usage": "INDICATIONS AND USAGE Hydrochlorothiazide tablets, USP are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide tablets, USP have also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide tablets, USP are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension. Use in Pregnancy Routine use of diuretics during normal pregnancy is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy and there is no satisfactory evidence that they are useful in the treatment of toxemia. Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Thiazides are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy (see PRECAUTIONS, Pregnancy ). Dependent edema in pre...",
  "contraindications": "CONTRAINDICATIONS Anuria. Hypersensitivity to this product or to other sulfonamide-derived drugs.",
  "warnings_and_cautions": "",
  "warnings": "WARNINGS Use with caution in severe renal disease. In patients with renal disease, thiazides may precipitate azotemia. Cumulative effects of the drug may develop in patients with impaired renal function. Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma. Thiazides may add to or potentiate the action of other antihypertensive drugs. Sensitivity reactions may occur in patients with or without a history of allergy or bronchial asthma. The possibility of exacerbation or activation of systemic lupus erythematosus has been reported. Lithium generally should not be given with diuretics (see PRECAUTIONS, Drug Interactions ). Acute Myopia and Secondary Angle-Closure Glaucoma Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction, resulting in acute transient myopia and acute angle-closure glaucoma. Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation. Untreated acute angle-closure glaucoma can lead to permanent vision loss. The primary treatment is to ...",
  "adverse_reactions": "ADVERSE REACTIONS The following adverse reactions have been reported and, within each category, are listed in the order of decreasing severity. Body as a Whole Weakness. Cardiovascular Hypotension including orthostatic hypotension (may be aggravated by alcohol, barbiturates, narcotics or antihypertensive drugs). Digestive Pancreatitis, jaundice (intrahepatic cholestatic jaundice), diarrhea, vomiting, sialadenitis, cramping, constipation, gastric irritation, nausea, anorexia. Hematologic Aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia. Hypersensitivity Anaphylactic reactions, necrotizing angiitis (vasculitis and cutaneous vasculitis), respiratory distress including pneumonitis and pulmonary edema, photosensitivity, fever, urticaria, rash, purpura. Metabolic Electrolyte imbalance (see PRECAUTIONS ), hyperglycemia, glycosuria, hyperuricemia. Musculoskeletal Muscle spasm. Nervous System/Psychiatric Vertigo, paresthesias, dizziness, headache, restlessness. Renal Renal failure, renal dysfunction, interstitial nephritis (see WARNINGS ). Skin Erythema multiforme including Stevens-Johnson syndrome, exfoliative dermatitis including toxic epidermal necrolysis,...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Non-melanoma Skin Cancer: Instruct patients taking hydrochlorothiazide to protect skin from the sun and undergo regular skin cancer screening.",
  "spl_medguide": "",
  "clinical_studies": "",
  "brand_name": "Hydrochlorothiazide",
  "manufacturer": "Aurobindo Pharma Limited",
  "application_number": "ANDA040780",
  "pharm_class_epc": [
   "Thiazide Diuretic [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20240626",
  "set_id": "01f1f478-5493-439f-9b99-f4f82023781c",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 127896,
  "serious": 86602,
  "death": 8959,
  "hospitalization": 44607,
  "primary_suspect": 127259,
  "top_reactions": [
   [
    "Fatigue",
    9764
   ],
   [
    "Drug Ineffective",
    8533
   ],
   [
    "Nausea",
    8478
   ],
   [
    "Diarrhoea",
    7989
   ],
   [
    "Headache",
    7003
   ],
   [
    "Pain",
    6762
   ],
   [
    "Dyspnoea",
    6553
   ],
   [
    "Off Label Use",
    6401
   ],
   [
    "Dizziness",
    6153
   ],
   [
    "Acute Kidney Injury",
    6099
   ],
   [
    "Arthralgia",
    5693
   ],
   [
    "Fall",
    5306
   ],
   [
    "Malaise",
    4909
   ],
   [
    "Vomiting",
    4806
   ],
   [
    "Asthenia",
    4804
   ]
  ],
  "by_year": {
   "2019": 13882,
   "2020": 12569,
   "2021": 10774,
   "2022": 9072,
   "2023": 8237,
   "2024": 7797,
   "2025": 7908,
   "2026": 3717
  },
  "by_year_primary": {
   "2019": 13869,
   "2020": 12552,
   "2021": 10718,
   "2022": 8936,
   "2023": 8137,
   "2024": 7692,
   "2025": 7754,
   "2026": 3670
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class I",
   "date": "20180821",
   "reason": "Product Mix-Up: customer complaint that a sealed bottle labeled as Hydrochlorothiazide Tablets USP 12.5 mg contained only Spironolactone Tablets USP 25 mg.",
   "firm": "Accord Healthcare, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20150730",
   "reason": "Presence of Foreign Tablet: A pharmacist found a clopidogrel tablet in  the 1000-count bottle of hydrochlorothiazide 25 mg tablets.",
   "firm": "Unichem Pharmaceuticals Usa Inc",
   "status": "Terminated"
  }
 ],
 "recall_total": 2,
 "drugsfda": {
  "applications": 41,
  "nda": 3,
  "anda": 32,
  "first_approval": "19590224",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 7,
  "labeling_recent": 0,
  "sponsors": [
   "ABC HOLDING",
   "ACTAVIS ELIZABETH",
   "ALRA",
   "APOTEX",
   "AUROLIFE PHARMA LLC",
   "BARR",
   "CHARTWELL MOLECULAR",
   "CHARTWELL RX"
  ],
  "unapproved": false,
  "first_approval_fmt": "02/24/1959"
 },
 "trials": {
  "total": 507,
  "completed": 399,
  "terminated": 46,
  "with_results": 138,
  "industry": 328,
  "phase3": 138,
  "results_share": 0.3458646616541353,
  "terminated_share": 0.09072978303747535
 },
 "pubmed": {
  "rct": 822,
  "meta": 31,
  "recent_rct": 20,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "hydrochlorothiazide",
   "Inzirqo"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 18462765,
  "beneficiaries": 4944477,
  "spend": 81181506.45,
  "by_brand": [
   {
    "brand": "Hydrochlorothiazide",
    "claims": 18462765,
    "per_claim": 4.3970394711,
    "is_generic": true
   }
  ],
  "per_claim": 4.397039471065141
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "hydrochlorothiazide",
  "matched": "hydrochlorothiazide",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 19116,
  "fills": 18462765,
  "per_million": 1035.381211860737,
  "ratio": 0.3739256049855705,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 90,
   "letter": "A",
   "why": [
    "1,035 FDA reports naming it as the suspect drug per million Medicare fills, 0.4x the median drug on this site",
    "Death share in reports is near or below the FAERS average (0.8x)",
    "1 Class I recall(s): reasonable probability of serious harm (-10)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 64,
   "letter": "C",
   "why": [
    "822 randomized trials and 31 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "No Cochrane review found (-5)",
    "Only 35% of completed registered trials posted results (-15)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 85,
   "letter": "B",
   "why": [
    "Recalls since 2016: 1 Class I, 0 Class II, 0 Class III across 32 generic makers (-15)"
   ],
   "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 (32 applications)",
    "8 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 85,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are fatigue, nausea, diarrhoea. How would we recognize and handle those?",
  "Why this one over bendroflumethiazide, chlorothiazide, cyclopenthiazide? 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.)"
 ]
}