Droxidopa

DRUG INFORMATION

  ADULT
    - Titrate to symptomatic response, in increments of 100 mg three times daily every
      24 to 48 hours up to a maximum dose of 600 mg three times daily (i.e., a maximum
      total daily dose of 1,800 mg).
      Source: US FDA label for droxidopa (DROXIDOPA), section 'dosage and
      administration', retrieved 2026-08-29
    - Dosing Information The recommended starting dose of Droxidopa capsule is 100 mg,
      taken orally three times daily: upon arising in the morning, at midday, and in the
      late afternoon at least 3 hours prior to bedtime (to reduce the potential for
      supine hypertension during sleep).
      Source: US FDA label for droxidopa (DROXIDOPA), section 'dosage and
      administration', retrieved 2026-08-29
    - Dosing Information The recommended starting dose of Droxidopa capsule is 100 mg,
      taken orally three times daily: upon arising in the morning, at midday, and in the
      late afternoon at least 3 hours prior to bedtime (to reduce the potential for
      supine hypertension during sleep). Administer Droxidopa capsule consistently,
      either with food or without food. Take Droxidopa capsule whole.
      Source: US FDA label for droxidopa (DROXIDOPA), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - The safety and effectiveness of Droxidopa capsule in pediatric patients have not
      been established.
      Source: US FDA label for droxidopa (DROXIDOPA), section 'pediatric use', retrieved
      2026-08-29

  RENAL IMPAIRMENT
    - Lactation: Breastfeeding not recommended ( 8.2 ) Patients with Renal Impairment:
      Dosing recommendations cannot be provided for patients with GFR less than 30
      mL/min ( 8.6 ) 8.1 Pregnancy Risk Summary There are no available data on use of
      Droxidopa capsule in pregnant women and risk of major birth defects or
      miscarriage.
      Source: US FDA label for droxidopa (DROXIDOPA), section 'use in specific
      populations', retrieved 2026-08-29
    - No overall differences in safety or effectiveness were observed between these
      patients and younger patients, and other reported clinical experience has not
      identified differences in responses between the elderly and younger patients, but
      greater sensitivity of some older individuals cannot be ruled out. 8.6 Renal
      Impairment Droxidopa capsule and its metabolites are primarily cleared renally.
      Source: US FDA label for droxidopa (DROXIDOPA), section 'use in specific
      populations', retrieved 2026-08-29
    - Patients with mild or moderate renal impairment (GFR greater than 30 mL/min) were
      included in clinical trials and did not have a higher frequency of adverse
      reactions.
      Source: US FDA label for droxidopa (DROXIDOPA), section 'use in specific
      populations', 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 droxidopa (DROXIDOPA),
      retrieved 2026-08-29

  PREGNANCY
    - Risk Summary There are no available data on use of Droxidopa capsule in pregnant
      women and risk of major birth defects or miscarriage.
      Source: US FDA label for droxidopa (DROXIDOPA), section 'pregnancy', retrieved
      2026-08-29
    - Droxidopa capsule did not produce significant reproductive toxicity in pregnant
      female rats or rabbits or in their fetuses.
      Source: US FDA label for droxidopa (DROXIDOPA), section 'pregnancy', retrieved
      2026-08-29
    - The estimated background risk of major birth defects and miscarriage in the
      indicated population is unknown.
      Source: US FDA label for droxidopa (DROXIDOPA), section 'pregnancy', retrieved
      2026-08-29

  BREASTFEEDING
    - Lactation: Breastfeeding not recommended ( 8.2 ) Patients with Renal Impairment:
      Dosing recommendations cannot be provided for patients with GFR less than 30
      mL/min ( 8.6 ) 8.1 Pregnancy Risk Summary There are no available data on use of
      Droxidopa capsule in pregnant women and risk of major birth defects or
      miscarriage.
      Source: US FDA label for droxidopa (DROXIDOPA), section 'use in specific
      populations', retrieved 2026-08-29
    - When their male and female offspring (who were exposed to Droxidopa capsule only
      during fetal life) were subsequently bred, the female offspring exhibited a dose-
      dependent reduction in the number of live fetuses across all three doses and an
      increased number of embryonic/fetal deaths at the two higher doses.
      Source: US FDA label for droxidopa (DROXIDOPA), section 'use in specific
      populations', retrieved 2026-08-29
    - However, due to species-specific differences in lactation physiology, animal
      lactation data typically do not reliably predict levels in humans.
      Source: US FDA label for droxidopa (DROXIDOPA), section 'use in specific
      populations', retrieved 2026-08-29