{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "doxazosin",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "Recommended starting dose (initial therapy or switching from immediate-release): 4 mg once daily with breakfast ( 2.1 , 2.2 ) Dose range: 4 to 8 mg once daily ( 2.1 ) 2.1 General Dosing Information The initial dose of CARDURA XL, 4 mg given once daily, should be administered with breakfast.",
        "source": "US FDA label for doxazosin (Cardura XL), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/doxazosin.json",
        "verbatim": true
      },
      {
        "text": "Depending on the patient’s symptomatic response and tolerability, the dose may be increased to 8 mg, the maximum recommended dose.",
        "source": "US FDA label for doxazosin (Cardura XL), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/doxazosin.json",
        "verbatim": true
      },
      {
        "text": "If CARDURA XL administration is discontinued for several days, therapy should be restarted using the 4 mg once daily dose.",
        "source": "US FDA label for doxazosin (Cardura XL), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/doxazosin.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "The safety and effectiveness of CARDURA XL in pediatric patients have not been established.",
        "source": "US FDA label for doxazosin (Cardura XL), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/doxazosin.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "No kidney-impairment dose in this label. Not a statement that none is needed.",
        "source": "Read and found silent: the US FDA label for doxazosin (Cardura XL), retrieved 2026-08-29",
        "cached_file": "labels/doxazosin.json",
        "verbatim": false
      }
    ],
    "hepatic": [
      {
        "text": "( 8.5 ) Hepatic Impairment: CARDURA XL is not recommended for patients with severe hepatic impairment and should be administered with caution to patients with mild or moderate hepatic impairment.",
        "source": "US FDA label for doxazosin (Cardura XL), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/doxazosin.json",
        "verbatim": true
      },
      {
        "text": "The incidence of hypotension reported as an adverse reaction was higher in patients 70 years of age and older (4/136; 2.9%) as compared to patients < 70 years of age (7/530; 1.3%). 8.6 Hepatic Impairment Since there is no clinical experience in patients with severe hepatic impairment, use in these patients is not recommended.",
        "source": "US FDA label for doxazosin (Cardura XL), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/doxazosin.json",
        "verbatim": true
      },
      {
        "text": "CARDURA XL should be administered with caution to patients with mild or moderate hepatic impairment [see Warnings and Precautions (5.6) , Clinical Pharmacology (12.3) ] .",
        "source": "US FDA label for doxazosin (Cardura XL), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/doxazosin.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "Risk Summary CARDURA XL is not indicated for use in females and is not indicated for the treatment of hypertension.",
        "source": "US FDA label for doxazosin (Cardura XL), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/doxazosin.json",
        "verbatim": true
      },
      {
        "text": "The limited available data with CARDURA XL in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage.",
        "source": "US FDA label for doxazosin (Cardura XL), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/doxazosin.json",
        "verbatim": true
      },
      {
        "text": "No adverse developmental outcomes were observed in animal reproduction studies with oral administration of doxazosin to pregnant rats and rabbits at doses of up to 10 and 4 times, respectively, the 12 mg/day recommended dose.",
        "source": "US FDA label for doxazosin (Cardura XL), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/doxazosin.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "In peri- and postnatal studies in rats, postnatal development at maternal doses of 40 or 50 mg/kg/day of doxazosin (about 8 times human AUC exposure with a 12 mg/day therapeutic dose) was delayed, as evidenced by slower body weight gain and slightly later appearance of anatomical features and reflexes. 8.2 Lactation Risk Summary CARDURA XL is not indicated for use in females and is not indicated for the treatment of hypertension.",
        "source": "US FDA label for doxazosin (Cardura XL), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/doxazosin.json",
        "verbatim": true
      },
      {
        "text": "There is no information on the effects of CARDURA XL on the breastfeed infant or the effects on milk production. 8.4 Pediatric Use The safety and effectiveness of CARDURA XL in pediatric patients have not been established. 8.5 Geriatric Use The incidence of hypotension with CARDURA XL use appears to be age related and more prevalent in patients 70 years or older.",
        "source": "US FDA label for doxazosin (Cardura XL), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/doxazosin.json",
        "verbatim": true
      }
    ]
  }
}