Labetalol

DRUG INFORMATION

  ADULT
    - The recommended initial dosage is 100 mg twice daily, alone or added to a diuretic
      regimen.
      Source: US FDA label for labetalol (Labetalol Hydrochloride), section 'dosage and
      administration', retrieved 2026-08-29
    - Titrate in increments of 100 mg twice daily every 2 or 3 days.
      Source: US FDA label for labetalol (Labetalol Hydrochloride), section 'dosage and
      administration', retrieved 2026-08-29
    - Maintenance dosage is between 200 and 400 mg twice daily.
      Source: US FDA label for labetalol (Labetalol Hydrochloride), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - Safety and effectiveness in pediatric patients have not been established.
      Source: US FDA label for labetalol (Labetalol Hydrochloride), 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 labetalol (Labetalol
      Hydrochloride), retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - No liver-impairment dose in this label. Not a statement that none is needed.
      Source: Read and found silent: the US FDA label for labetalol (Labetalol
      Hydrochloride), retrieved 2026-08-29

  PREGNANCY
    - Risk Summary The extensive experience with use of labetalol in pregnant women,
      based on published interventional and observational studies, has not identified a
      drug-associated risk for major birth defects, miscarriage, or adverse maternal or
      fetal outcomes (see Data).
      Source: US FDA label for labetalol (Labetalol Hydrochloride), section 'pregnancy',
      retrieved 2026-08-29
    - Untreated hypertension during pregnancy can lead to serious adverse outcomes for
      the mother and the fetus (see Clinical Considerations).
      Source: US FDA label for labetalol (Labetalol Hydrochloride), section 'pregnancy',
      retrieved 2026-08-29
    - In animal reproductive studies, oral administration of labetalol to pregnant rats
      and rabbits during organogenesis at doses up to approximately six and four times
      the maximum recommended human dose (MRHD), respectively, resulted in no fetal
      malformations; however, increased fetal resorptions were seen in both species at
      doses approximating the MRHD (see Data).
      Source: US FDA label for labetalol (Labetalol Hydrochloride), section 'pregnancy',
      retrieved 2026-08-29

  BREASTFEEDING
    - Oral administration of labetalol to rats during late gestation through weaning at
      doses of two to four times the MRHD caused a decrease in neonatal survival. 8.2
      Lactation Risk Summary Available published data report the presence of labetalol
      in human milk at low levels.
      Source: US FDA label for labetalol (Labetalol Hydrochloride), section 'use in
      specific populations', retrieved 2026-08-29
    - There are no data on the effects on the breastfed infant and on milk production.
      Source: US FDA label for labetalol (Labetalol Hydrochloride), section 'use in
      specific populations', retrieved 2026-08-29
    - The developmental and health benefits of breastfeeding should be considered along
      with the mother's clinical need for labetalol and any potential adverse effects on
      the breastfed infant from labetalol or from the underlying maternal condition. 8.4
      Pediatric Use Safety and effectiveness in pediatric patients have not been
      established. 8.5 Geriatric Use Pharmacokinetic studies indicate that the
      elimination of labetalol is reduced in elderly patients.
      Source: US FDA label for labetalol (Labetalol Hydrochloride), section 'use in
      specific populations', retrieved 2026-08-29