Venlafaxine

DRUG INFORMATION

  ADULT
    - Indication Starting Dose Target Dose Maximum Dose MDD (2.1) 37.5 to 75 mg/day 75
      mg/day 225 mg/day GAD (2.2) 37.5 to 75 mg/day 75 mg/day 225 mg/day SAD (2.3) 75
      mg/day 75 mg/day 75 mg/day PD (2.4) 37.5 mg/day 75 mg/day 225 mg/day • Take once
      daily with food (2).
      Source: US FDA label for venlafaxine (Venlafaxine Hydrochloride), section 'dosage
      and administration', retrieved 2026-08-29
    - For some patients, it may be desirable to start at 37.5 mg per day for 4 to 7 days
      to allow new patients to adjust to the medication before increasing to 75 mg per
      day.
      Source: US FDA label for venlafaxine (Venlafaxine Hydrochloride), section 'dosage
      and administration', retrieved 2026-08-29
    - Patients not responding to the initial 75 mg per day dose may benefit from dose
      increases to a maximum of 225 mg per day.
      Source: US FDA label for venlafaxine (Venlafaxine Hydrochloride), section 'dosage
      and administration', retrieved 2026-08-29

  CHILD
    - Two placebo-controlled trials in 766 pediatric patients with MDD and two placebo-
      controlled trials in 793 pediatric patients with GAD have been conducted with
      venlafaxine hydrochloride extended-release capsules, and the data were not
      sufficient to support a claim for use in pediatric patients.
      Source: US FDA label for venlafaxine (Venlafaxine Hydrochloride), section
      'pediatric use', retrieved 2026-08-29
    - Venlafaxine hydrochloride extended-release capsules should be administered in a
      single dose with food, either in the morning or in the evening at approximately
      the same time each day [see Clinical Pharmacology (12.3) ] . Each capsule should
      be swallowed whole with fluid and not divided, crushed, chewed, or placed in water
      or it may be administered by carefully opening the capsule and sprinkling the
      entire contents on a spoonful of applesauce.
      Source: US FDA label for venlafaxine (Venlafaxine Hydrochloride), section 'dosage
      and administration', retrieved 2026-08-29
    - The risk of administering methylene blue by non-intravenous routes (such as oral
      tablets or by local injection) or in intravenous doses much lower than 1 mg/kg
      concomitantly with venlafaxine hydrochloride extended-release capsules are
      unclear.
      Source: US FDA label for venlafaxine (Venlafaxine Hydrochloride), section 'dosage
      and administration', retrieved 2026-08-29

  RENAL IMPAIRMENT
    - Capsules should be taken whole; do not divide, crush, chew, or dissolve ( 2 ). •
      When discontinuing treatment, reduce the dose gradually ( 2.8 , 5.7 ). • Renal
      impairment: reduce the total daily dose by 25% to 50% in patients with renal
      impairment.
      Source: US FDA label for venlafaxine (Venlafaxine Hydrochloride), section 'dosage
      and administration', retrieved 2026-08-29
    - Reduce the total daily dose by 50% or more in patients undergoing dialysis or with
      severe renal impairment ( 2.6 ). • Hepatic impairment: reduce the daily dose by
      50% in patients with mild to moderate hepatic impairment.
      Source: US FDA label for venlafaxine (Venlafaxine Hydrochloride), section 'dosage
      and administration', retrieved 2026-08-29
    - Patients with Renal Impairment The total daily dose should be reduced by 25% to
      50% in patients with mild (CLcr= 60 to 89 mL/min) or moderate (CLcr= 30 to 59
      mL/min) renal impairment.
      Source: US FDA label for venlafaxine (Venlafaxine Hydrochloride), section 'dosage
      and administration', retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - Reduce the total daily dose by 50% or more in patients undergoing dialysis or with
      severe renal impairment ( 2.6 ). • Hepatic impairment: reduce the daily dose by
      50% in patients with mild to moderate hepatic impairment.
      Source: US FDA label for venlafaxine (Venlafaxine Hydrochloride), section 'dosage
      and administration', retrieved 2026-08-29
    - In patients with severe hepatic impairment or hepatic cirrhosis, it may be
      necessary to reduce the dose by more than 50% ( 2.6 ). 2.1 Major Depressive
      Disorder For most patients, the recommended starting dose for venlafaxine
      hydrochloride extended-release capsules are 75 mg per day, administered in a
      single dose.
      Source: US FDA label for venlafaxine (Venlafaxine Hydrochloride), section 'dosage
      and administration', retrieved 2026-08-29
    - However, individual dosage adjustments may be necessary. 2.6 Specific Populations
      Patients with Hepatic Impairment The total daily dose should be reduced by 50% in
      patients with mild (Child-Pugh=5 to 6) to moderate (Child-Pugh=7 to 9) hepatic
      impairment.
      Source: US FDA label for venlafaxine (Venlafaxine Hydrochloride), section 'dosage
      and administration', retrieved 2026-08-29

  PREGNANCY
    - Teratogenic Effects – Pregnancy Category C Venlafaxine did not cause malformations
      in offspring of rats or rabbits given doses up to 2.5 times (rat) or 4 times
      (rabbit) the maximum recommended human daily dose on a mg/m 2 basis.
      Source: US FDA label for venlafaxine (Venlafaxine Hydrochloride), section
      'pregnancy', retrieved 2026-08-29
    - However, in rats, there was a decrease in pup weight, an increase in stillborn
      pups, and an increase in pup deaths during the first 5 days of lactation, when
      dosing began during pregnancy and continued until weaning.
      Source: US FDA label for venlafaxine (Venlafaxine Hydrochloride), section
      'pregnancy', retrieved 2026-08-29
    - These effects occurred at 2.5 times (mg/m 2 ) the maximum human daily dose.
      Source: US FDA label for venlafaxine (Venlafaxine Hydrochloride), section
      'pregnancy', retrieved 2026-08-29

  BREASTFEEDING
    - Venlafaxine and ODV have been reported to be excreted in human milk.
      Source: US FDA label for venlafaxine (Venlafaxine Hydrochloride), section 'nursing
      mothers', retrieved 2026-08-29
    - Because of the potential for serious adverse reactions in nursing infants from
      venlafaxine hydrochloride extended-release capsules, a decision should be made
      whether to discontinue nursing or to discontinue the drug, taking into account the
      importance of the drug to the mother.
      Source: US FDA label for venlafaxine (Venlafaxine Hydrochloride), section 'nursing
      mothers', retrieved 2026-08-29
    - • Pregnancy: Based on animal data, may cause fetal harm ( 8.1 ). • Nursing
      Mothers: Discontinue drug or nursing, taking into consideration importance of drug
      to mother ( 8.3 ) 8.1 Pregnancy Teratogenic Effects – Pregnancy Category C
      Venlafaxine did not cause malformations in offspring of rats or rabbits given
      doses up to 2.5 times (rat) or 4 times (rabbit) the maximum recommended human
      daily dose on a mg/m 2 basis.
      Source: US FDA label for venlafaxine (Venlafaxine Hydrochloride), section 'use in
      specific populations', retrieved 2026-08-29