{
 "query": "losartan",
 "ingredient": "losartan",
 "slug": "losartan",
 "rxcui": "52175",
 "brands": [
  "Cozaar",
  "Arbli"
 ],
 "names": [
  "losartan",
  "losartan potassium"
 ],
 "classes": [
  {
   "id": "C09CA",
   "name": "Angiotensin II receptor blockers (ARBs), plain"
  }
 ],
 "alternatives": [
  "azilsartan medoxomil",
  "candesartan",
  "eprosartan",
  "irbesartan",
  "olmesartan medoxomil",
  "telmisartan",
  "valsartan"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 208
  },
  "boxed_warning": "WARNING: FETAL TOXICITY When pregnancy is detected, discontinue COZAAR as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions (5.1) ] . WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue COZAAR as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. ( 5.1 )",
  "indications_and_usage": "is an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1 ) Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. ( 1.2 ) Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. ( 1.3 ) 1.1 Hypertension COZAAR \u00ae is indicated for the treatment of hypertension in adults and pediatric patients 6 years of age and older, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarction. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including losartan. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, ...",
  "contraindications": "is contraindicated: In patients who are hypersensitive to any component of this product. For coadministration with aliskiren in patients with diabetes. Hypersensitivity to any component. ( 4 ) Coadministration with aliskiren in patients with diabetes. ( 4 )",
  "warnings_and_cautions": "Hypotension: Correct volume or salt depletion prior to administration of COZAAR. ( 5.2 ) Monitor renal function and potassium in susceptible patients. ( 5.3 , 5.4 ) 5.1 Fetal Toxicity COZAAR can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue COZAAR as soon as possible [see Use in Specific Populations (8.1) ] . 5.2 Hypotension in Volume- or Salt-Depleted Patients In patients with an activated renin-angiotensin system, such as volume- or salt-depleted patients (e.g., those being treated with high doses of diuretics), symptomatic hypotension may occur after initiation of treatment with COZAAR. Correct volume or salt depletion prior to administration of COZAAR [see Dosage and Administration (2.1) ] . 5.3 Renal Function Deterioration Changes in renal ...",
  "warnings": "",
  "adverse_reactions": "Most common adverse reactions (incidence \u22652% and greater than placebo) are: dizziness, upper respiratory infection, nasal congestion, and back pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Organon LLC, a subsidiary of Organon & Co., at 1-844-674-3200 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials 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 rates observed in practice. Hypertension COZAAR has been evaluated for safety in more than 3300 adult patients treated for essential hypertension and 4058 patients/subjects overall. Over 1200 patients were treated for over 6 months and more than 800 for over one year. Treatment with COZAAR was well-tolerated with an overall incidence of adverse events similar to that of placebo. In controlled clinical trials, discontinuation of therapy for adverse events occurred in 2.3% of patients treated with COZAAR and 3.7% of patients given placebo. In 4 clinical trials involving over 1000 patients on various doses (10-15...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Patient Information). Pregnancy Advise female patients of childbearing age about the consequences of exposure to COZAAR during pregnancy. Discuss treatment options with women planning to become pregnant. Tell patients to report pregnancies to their physicians as soon as possible [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ] . Potassium Supplements Advise patients receiving COZAAR not to use potassium supplements or salt substitutes containing potassium without consulting their healthcare provider [see Drug Interactions (7.1) ] .",
  "spl_medguide": "",
  "clinical_studies": "14.1 Hypertension Adult Hypertension The antihypertensive effects of COZAAR were demonstrated principally in 4 placebo-controlled, 6- to 12-week trials of dosages from 10 to 150 mg per day in patients with baseline diastolic blood pressures of 95-115. The studies allowed comparisons of two doses (50-100 mg/day) as once-daily or twice-daily regimens, comparisons of peak and trough effects, and comparisons of response by gender, age, and race. Three additional studies examined the antihypertensive effects of losartan and hydrochlorothiazide in combination. The 4 studies of losartan monotherapy included a total of 1075 patients randomized to several doses of losartan and 334 to placebo. The 10- and 25-mg doses produced some effect at peak (6 hours after dosing) but small and inconsistent trough (24 hour) responses. Doses of 50, 100 and 150 mg once daily gave statistically significant systolic/diastolic mean decreases in blood pressure, compared to placebo in the range of 5.5-10.5/3.5-7.5 mmHg, with the 150-mg dose giving no greater effect than 50-100 mg. Twice-daily dosing at 50-100 mg/day gave consistently larger trough responses than once-daily dosing at the same total dose. Peak (6...",
  "brand_name": "COZAAR",
  "manufacturer": "Organon LLC",
  "application_number": "NDA020386",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20260120",
  "set_id": "9949448f-c3b9-44ee-94ed-c1aca8c90f39",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 177558,
  "serious": 111045,
  "death": 12805,
  "hospitalization": 52191,
  "primary_suspect": 177092,
  "top_reactions": [
   [
    "Fatigue",
    12773
   ],
   [
    "Diarrhoea",
    10798
   ],
   [
    "Drug Ineffective",
    9805
   ],
   [
    "Nausea",
    9772
   ],
   [
    "Dyspnoea",
    8866
   ],
   [
    "Dizziness",
    8499
   ],
   [
    "Headache",
    8482
   ],
   [
    "Off Label Use",
    7938
   ],
   [
    "Pain",
    7802
   ],
   [
    "Arthralgia",
    6690
   ],
   [
    "Malaise",
    6187
   ],
   [
    "Asthenia",
    6168
   ],
   [
    "Cough",
    5773
   ],
   [
    "Fall",
    5518
   ],
   [
    "Vomiting",
    5429
   ]
  ],
  "by_year": {
   "2019": 19151,
   "2020": 16151,
   "2021": 14174,
   "2022": 13268,
   "2023": 13698,
   "2024": 12242,
   "2025": 14359,
   "2026": 7927
  },
  "by_year_primary": {
   "2019": 19139,
   "2020": 16138,
   "2021": 14139,
   "2022": 13198,
   "2023": 13580,
   "2024": 12160,
   "2025": 14292,
   "2026": 7864
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20230626",
   "reason": "Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet.",
   "firm": "Strides Pharma Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20220606",
   "reason": "CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits",
   "firm": "PD-Rx Pharmaceuticals, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20220606",
   "reason": "CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits",
   "firm": "PD-Rx Pharmaceuticals, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20220606",
   "reason": "CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits",
   "firm": "PD-Rx Pharmaceuticals, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20220518",
   "reason": "CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits",
   "firm": "Strides Pharma Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20220518",
   "reason": "CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits",
   "firm": "Strides Pharma Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20220518",
   "reason": "CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits",
   "firm": "Strides Pharma Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20220415",
   "reason": "CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits",
   "firm": "Macleods Pharma Usa Inc",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20220415",
   "reason": "CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits",
   "firm": "Macleods Pharma Usa Inc",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20220415",
   "reason": "CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits",
   "firm": "Macleods Pharma Usa Inc",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20220331",
   "reason": "CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits",
   "firm": "Lupin Pharmaceuticals Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20220331",
   "reason": "CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits",
   "firm": "Lupin Pharmaceuticals Inc.",
   "status": "Terminated"
  }
 ],
 "recall_total": 19,
 "drugsfda": {
  "applications": 27,
  "nda": 2,
  "anda": 25,
  "first_approval": "19950414",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 34,
  "labeling_recent": 3,
  "sponsors": [
   "AIPING PHARM INC",
   "ALEMBIC PHARMS LTD",
   "APOTEX",
   "APOTEX CORP",
   "AUROBINDO PHARMA",
   "CHARTWELL RX",
   "GRANULES",
   "GRAVITI PHARMS"
  ],
  "unapproved": false,
  "first_approval_fmt": "04/14/1995"
 },
 "trials": {
  "total": 456,
  "completed": 273,
  "terminated": 57,
  "with_results": 97,
  "industry": 171,
  "phase3": 93,
  "results_share": 0.3553113553113553,
  "terminated_share": 0.125
 },
 "pubmed": {
  "rct": 654,
  "meta": 22,
  "recent_rct": 42,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "losartan",
   "Cozaar",
   "Arbli"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 36252456,
  "beneficiaries": 8913904,
  "spend": 359526344.61,
  "by_brand": [
   {
    "brand": "Losartan Potassium",
    "claims": 36240406,
    "per_claim": 9.8003644137,
    "is_generic": true
   },
   {
    "brand": "Cozaar",
    "claims": 12050,
    "per_claim": 361.58998423,
    "is_generic": false
   }
  ],
  "per_claim": 9.91729621325518
 },
 "mdl": [
  {
   "number": "2875",
   "title": "Valsartan, Losartan, and Irbesartan Products Liability Litigation",
   "judge": "Bumb, Renee M.",
   "court": "NJ",
   "docket": "1:19-md-2875",
   "actions": "",
   "matched": "losartan"
  }
 ],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "losartan",
  "matched": "losartan",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 34316,
  "fills": 36252456,
  "per_million": 946.5841431543287,
  "ratio": 0.34185674256405013,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 70,
   "letter": "C",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "947 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 (0.8x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 67,
   "letter": "C",
   "why": [
    "654 randomized trials and 22 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 36% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 90,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 19 Class II, 0 Class III across 25 generic makers (-6)",
    "3 label changes approved since 2021 (-4)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 60,
   "letter": "D",
   "why": [
    "Pharma paid doctors $0 tied to this drug last year: negligible",
    "Named in 1 active federal multidistrict litigation(s) (-40)"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 100,
   "letter": "A",
   "why": [
    "Generic versions approved (25 applications)",
    "7 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 74,
 "grade": "C",
 "questions": [
  "This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?",
  "The most-reported problems in FDA's adverse event data are fatigue, diarrhoea, nausea. How would we recognize and handle those?",
  "Why this one over azilsartan medoxomil, candesartan, eprosartan? What would make you pick one of those instead?",
  "This drug is in active federal litigation. What is the claim, and does it affect my risk?",
  "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.)"
 ]
}