{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "losartan",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "Hypertension Usual adult dose: 50 mg once daily.",
        "source": "US FDA label for losartan (Losartan Potassium), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/losartan.json",
        "verbatim": true
      },
      {
        "text": "( 2.1 ) Hypertensive Patients with Left Ventricular Hypertrophy Usual starting dose: 50 mg once daily.",
        "source": "US FDA label for losartan (Losartan Potassium), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/losartan.json",
        "verbatim": true
      },
      {
        "text": "( 2.2 , 14.2 ) Nephropathy in Type 2 Diabetic Patients Usual dose: 50 mg once daily.",
        "source": "US FDA label for losartan (Losartan Potassium), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/losartan.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "Antihypertensive effects of losartan potassium tablets have been established in hypertensive pediatric patients aged 6 to 16 years. Safety and effectiveness have not been established in pediatric patients under the age of 6 or in pediatric patients with glomerular filtration rate <30 mL/min/1.73 m 2 [see DOSAGE AND ADMINISTRATION ( 2.1 ), CLINICAL PHARMACOLOGY ( 12.3 ), and CLINICAL STUDIES ( 14.1 )].",
        "source": "US FDA label for losartan (Losartan Potassium), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/losartan.json",
        "verbatim": true
      },
      {
        "text": "Hypertension Usual adult dose: 50 mg once daily. ( 2.1 ) Usual pediatric starting dose: 0.7 mg per kg once daily (up to 50 mg). ( 2.1 ) Hypertensive Patients with Left Ventricular Hypertrophy Usual starting dose: 50 mg once daily. ( 2.2 ) Add hydrochlorothiazide 12.5 mg and/or increase losartan potassium tablets to 100 mg followed by an increase to hydrochlorothiazide 25 mg if further blood pressure response is needed.",
        "source": "US FDA label for losartan (Losartan Potassium), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/losartan.json",
        "verbatim": true
      },
      {
        "text": "( 2.1 ) Usual pediatric starting dose: 0.7 mg per kg once daily (up to 50 mg).",
        "source": "US FDA label for losartan (Losartan Potassium), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/losartan.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "Exchange transfusions or dialysis may be required as a means of reversing hypotension and replacing renal function.",
        "source": "US FDA label for losartan (Losartan Potassium), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/losartan.json",
        "verbatim": true
      },
      {
        "text": "However, the LIFE study provides no evidence that the benefits of losartan potassium tablets on reducing the risk of cardiovascular events in hypertensive patients with left ventricular hypertrophy apply to Black patients [see CLINICAL STUDIES ( 14.2 )]. 8.7 Renal Impairment Patients with renal insufficiency have elevated plasma concentrations of losartan and its active metabolite compared to subjects with normal renal function.",
        "source": "US FDA label for losartan (Losartan Potassium), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/losartan.json",
        "verbatim": true
      },
      {
        "text": "No dose adjustment is necessary in patients with renal impairment unless a patient with renal impairment is also volume depleted [see DOSAGE AND ADMINISTRATION ( 2.3 ), WARNINGS AND PRECAUTIONS ( 5.3 ) and CLINICAL PHARMACOLOGY ( 12.3 )]. 8.8 Hepatic Impairment The recommended starting dose of losartan potassium tablets is 25 mg in patients with mild-to-moderate hepatic impairment.",
        "source": "US FDA label for losartan (Losartan Potassium), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/losartan.json",
        "verbatim": true
      }
    ],
    "hepatic": [
      {
        "text": "The dose should be increased to 100 mg once daily based on blood pressure response [see CLINICAL STUDIES ( 14.3 )]. 2.4 Dosage Modifications in Patients with Hepatic Impairment In patients with mild-to-moderate hepatic impairment the recommended starting dose of losartan potassium tablet USP is 25 mg once daily.",
        "source": "US FDA label for losartan (Losartan Potassium), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/losartan.json",
        "verbatim": true
      },
      {
        "text": "Losartan potassium tablet USP has not been studied in patients with severe hepatic impairment [see USE IN SPECIFIC POPULATIONS ( 8.8 ) and CLINICAL PHARMACOLOGY ( 12.3 )]. 2.5 Preparation of Suspension (for 200 mL of a 2.5 mg/mL suspension) Add 10 mL of Purified Water USP to an 8 ounce (240 mL) amber polyethylene terephthalate (PET) bottle containing ten 50 mg losartan potassium tablets.",
        "source": "US FDA label for losartan (Losartan Potassium), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/losartan.json",
        "verbatim": true
      },
      {
        "text": "( 2.1 , 8.4 ) Hepatic Impairment: Recommended starting dose 25 mg once daily.",
        "source": "US FDA label for losartan (Losartan Potassium), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/losartan.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "Pregnancy Risk Summary Losartan potassium tablets can cause fetal harm when administered to a pregnant woman.",
        "source": "US FDA label for losartan (Losartan Potassium), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/losartan.json",
        "verbatim": true
      },
      {
        "text": "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.",
        "source": "US FDA label for losartan (Losartan Potassium), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/losartan.json",
        "verbatim": true
      },
      {
        "text": "Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents.",
        "source": "US FDA label for losartan (Losartan Potassium), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/losartan.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Risk Summary It is not known whether losartan is excreted in human milk, but significant levels of losartan and its active metabolite were shown to be present in rat milk.",
        "source": "US FDA label for losartan (Losartan Potassium), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/losartan.json",
        "verbatim": true
      },
      {
        "text": "Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.",
        "source": "US FDA label for losartan (Losartan Potassium), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/losartan.json",
        "verbatim": true
      },
      {
        "text": "Data Animal Data Losartan potassium was administered orally to rats during the period of late gestation through lactation (Gestation Day 15 through Lactation Day 20) at doses of 10, 25, and 100 mg/kg/day.",
        "source": "US FDA label for losartan (Losartan Potassium), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/losartan.json",
        "verbatim": true
      }
    ]
  }
}