{
 "query": "prazosin",
 "ingredient": "prazosin",
 "slug": "prazosin",
 "rxcui": "8629",
 "brands": [
  "Minipress"
 ],
 "names": [
  "prazosin",
  "prazosin hydrochloride"
 ],
 "classes": [
  {
   "id": "C02CA",
   "name": "Alpha-adrenoreceptor antagonists"
  }
 ],
 "alternatives": [
  "doxazosin",
  "indoramin",
  "urapidil"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 66
  },
  "boxed_warning": "",
  "indications_and_usage": "INDICATIONS AND USAGE Prazosin hydrochloride capsules are 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 this drug. 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 specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concl...",
  "contraindications": "CONTRAINDICATIONS Prazosin hydrochloride capsules are contraindicated in patients with known sensitivity to quinazolines, prazosin, or any of the inert ingredients.",
  "warnings_and_cautions": "",
  "warnings": "WARNINGS As with all alpha-blockers, prazosin hydrochloride capsules may cause syncope with sudden loss of consciousness. In most cases, this is believed to be due to an excessive postural hypotensive effect, although occasionally the syncopal episode has been preceded by a bout of severe tachycardia with heart rates of 120\u2013160 beats per minute. Syncopal episodes have usually occurred within 30 to 90 minutes of the initial dose of the drug; occasionally, they have been reported in association with rapid dosage increases or the introduction of another antihypertensive drug into the regimen of a patient taking high doses of prazosin hydrochloride capsules. The incidence of syncopal episodes is approximately 1% in patients given an initial dose of 2 mg or greater. Clinical trials conducted during the investigational phase of this drug suggest that syncopal episodes can be minimized by limiting the initial dose of the drug to 1 mg, by subsequently increasing the dosage slowly, and by introducing any additional antihypertensive drugs into the patient's regimen with caution (see DOSAGE AND ADMINISTRATION ). Hypotension may develop in patients given prazosin hydrochloride capsules who are...",
  "adverse_reactions": "ADVERSE REACTIONS Clinical trials were conducted on more than 900 patients. During these trials and subsequent marketing experience, the most frequent reactions associated with prazosin hydrochloride therapy are: dizziness 10.3%, headache 7.8%, drowsiness 7.6%, lack of energy 6.9%, weakness 6.5%, palpitations 5.3%, and nausea 4.9%. In most instances, side effects have disappeared with continued therapy or have been tolerated with no decrease in dose of drug. Less frequent adverse reactions which are reported to occur in 1\u20134% of patients are: Gastrointestinal: vomiting, diarrhea, constipation. Cardiovascular: edema, orthostatic hypotension, dyspnea, syncope. Central Nervous System: vertigo, depression, nervousness. Dermatologic: rash. Genitourinary: urinary frequency. EENT: blurred vision, reddened sclera, epistaxis, dry mouth, nasal congestion. In addition, fewer than 1% of patients have reported the following (in some instances, exact causal relationships have not been established): Gastrointestinal: abdominal discomfort and/or pain, liver function abnormalities, pancreatitis. Cardiovascular: tachycardia. Central Nervous System: paresthesia, hallucinations. Dermatologic: pruritus,...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Information for Patients Dizziness or drowsiness may occur after the first dose of this medicine. Avoid driving or performing hazardous tasks for the first 24 hours after taking this medicine or when the dose is increased. Dizziness, lightheadedness, or fainting may occur, especially when rising from a lying or sitting position. Getting up slowly may help lessen the problem. These effects may also occur if you drink alcohol, stand for long periods of time, exercise, or if the weather is hot. While taking prazosin hydrochloride capsules, be careful in the amount of alcohol you drink. Also, use extra care during exercise or hot weather, or if standing for long periods. Check with your physician if you have any questions.",
  "spl_medguide": "",
  "clinical_studies": "",
  "brand_name": "Prazosin Hydrochloride",
  "manufacturer": "Prasco Laboratories",
  "application_number": "NDA017442",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20260306",
  "set_id": "cbe89216-7dea-43d7-b12e-44ccfb69af3d",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 8127,
  "serious": 5735,
  "death": 788,
  "hospitalization": 2861,
  "primary_suspect": 8076,
  "top_reactions": [
   [
    "Off Label Use",
    530
   ],
   [
    "Nausea",
    512
   ],
   [
    "Drug Ineffective",
    504
   ],
   [
    "Fatigue",
    434
   ],
   [
    "Diarrhoea",
    367
   ],
   [
    "Anxiety",
    364
   ],
   [
    "Pain",
    363
   ],
   [
    "Dizziness",
    360
   ],
   [
    "Headache",
    359
   ],
   [
    "Vomiting",
    336
   ],
   [
    "Depression",
    321
   ],
   [
    "Dyspnoea",
    317
   ],
   [
    "Fall",
    293
   ],
   [
    "Hypotension",
    286
   ],
   [
    "Suicidal Ideation",
    272
   ]
  ],
  "by_year": {
   "2019": 805,
   "2020": 747,
   "2021": 627,
   "2022": 721,
   "2023": 685,
   "2024": 706,
   "2025": 810,
   "2026": 365
  },
  "by_year_primary": {
   "2019": 804,
   "2020": 746,
   "2021": 625,
   "2022": 705,
   "2023": 673,
   "2024": 689,
   "2025": 810,
   "2026": 364
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20260327",
   "reason": "cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.",
   "firm": "Appco Pharma LLC",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20260327",
   "reason": "cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.",
   "firm": "Appco Pharma LLC",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20260327",
   "reason": "cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.",
   "firm": "Appco Pharma LLC",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20251016",
   "reason": "Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit",
   "firm": "Amerisource Health Services LLC",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20251016",
   "reason": "Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit",
   "firm": "Amerisource Health Services LLC",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20251016",
   "reason": "Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit",
   "firm": "Amerisource Health Services LLC",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20220413",
   "reason": "cGMP deviations: Temperature abuse",
   "firm": "Mckesson Medical-Surgical Inc. Corporate Office",
   "status": "Terminated"
  }
 ],
 "recall_total": 7,
 "drugsfda": {
  "applications": 29,
  "nda": 2,
  "anda": 21,
  "first_approval": "19760623",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 14,
  "labeling_recent": 0,
  "sponsors": [
   "ALEMBIC",
   "AM THERAP",
   "ANI PHARMS",
   "APPCO",
   "AUROBINDO PHARMA LTD",
   "DAVA PHARMS INC",
   "GRANULES",
   "IVAX SUB TEVA PHARMS"
  ],
  "unapproved": false,
  "first_approval_fmt": "06/23/1976"
 },
 "trials": {
  "total": 126,
  "completed": 88,
  "terminated": 23,
  "with_results": 46,
  "industry": 15,
  "phase3": 9,
  "results_share": 0.5227272727272727,
  "terminated_share": 0.18253968253968253
 },
 "pubmed": {
  "rct": 177,
  "meta": 14,
  "recent_rct": 7,
  "cochrane": [
   {
    "pmid": "10796398",
    "title": "Prazosin for Raynaud's phenomenon in progressive systemic sclerosis",
    "year": "2000"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "prazosin",
   "Minipress"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 1287778,
  "beneficiaries": 220558,
  "spend": 25097911.88,
  "by_brand": [
   {
    "brand": "Prazosin HCl",
    "claims": 1287778,
    "per_claim": 19.489315612,
    "is_generic": true
   }
  ],
  "per_claim": 19.48931561185235
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 1863,
  "fills": 1287778,
  "per_million": 1446.6779211944915,
  "ratio": 0.5224644900883885,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 95,
   "letter": "A",
   "why": [
    "1,447 FDA reports naming it as the suspect drug per million Medicare fills, 0.5x the median drug on this site",
    "Death share in reports is near or below the FAERS average (1.1x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 67,
   "letter": "C",
   "why": [
    "177 randomized trials and 14 systematic reviews/meta-analyses indexed in PubMed",
    "1 independent Cochrane review(s) exist"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 94,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 7 Class II, 0 Class III across 21 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 (21 applications)",
    "3 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 89,
 "grade": "A",
 "questions": [
  "The most-reported problems in FDA's adverse event data are nausea, fatigue. 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 doxazosin, indoramin, urapidil? 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.)"
 ]
}