Drug profile
Doxazosin
Adult, child, renal, hepatic, pregnancy and breastfeeding information, with the source named on every line.
DRUG INFORMATION
ADULT
- 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
- 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
- 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
CHILD
- 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
RENAL IMPAIRMENT
- 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
HEPATIC IMPAIRMENT
- ( 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
- 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
- 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
PREGNANCY
- 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
- 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
- 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
BREASTFEEDING
- 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
- 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