Mirtazapine

DRUG INFORMATION

  ADULT
    - • Starting dose: 15 mg once daily; may increase up to maximum recommended dose of
      45 mg once daily.
      Source: US FDA label for mirtazapine (Mirtazapine), section 'dosage and
      administration', retrieved 2026-08-29
    - ( 2.6 , 5.13 ) 2.1 Recommended Dosage The recommended starting dose of mirtazapine
      tablets is 15 mg once daily, administered orally, preferably in the evening prior
      to sleep.
      Source: US FDA label for mirtazapine (Mirtazapine), section 'dosage and
      administration', retrieved 2026-08-29
    - If patients do not have an adequate response to the initial 15 mg dose, increase
      the dose up to a maximum of 45 mg per day.
      Source: US FDA label for mirtazapine (Mirtazapine), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - The safety and effectiveness of mirtazapine have not been established in pediatric
      patients with MDD. Two placebo-controlled trials in 258 pediatric patients with
      MDD have been conducted with mirtazapine, and the data were insufficient to
      establish the safety and effectiveness of mirtazapine in pediatric patients with
      MDD.
      Source: US FDA label for mirtazapine (Mirtazapine), section 'pediatric use',
      retrieved 2026-08-29
    - In an 8-week-long clinical trial in pediatric patients receiving doses between 15
      to 45 mg per day, 49% of mirtazapine-treated patients had a weight gain of at
      least 7%, compared to 5.7% of placebo-treated patients.
      Source: US FDA label for mirtazapine (Mirtazapine), section 'pediatric use',
      retrieved 2026-08-29

  RENAL IMPAIRMENT
    - ( 5.11 , 5.14 , 8.5 ) • Renal impairment: Dosage decrease may be needed in
      patients with moderate to severe renal impairment.
      Source: US FDA label for mirtazapine (Mirtazapine), section 'use in specific
      populations', retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - ( 8.6 ) • Hepatic impairment : Dosage decrease may be needed in patients with
      hepatic impairment.
      Source: US FDA label for mirtazapine (Mirtazapine), section 'use in specific
      populations', retrieved 2026-08-29
    - In general, dose selection for an elderly patient should be conservative, usually
      starting at the low end of the dosing range, reflecting the greater frequency of
      decreased hepatic, renal, or cardiac function, and of concomitant disease or other
      drug therapy. 8.6 Renal or Hepatic Impairment The clearance of mirtazapine is
      reduced in patients with moderate to severe renal or hepatic impairment.
      Source: US FDA label for mirtazapine (Mirtazapine), section 'use in specific
      populations', retrieved 2026-08-29
    - Consequently, plasma mirtazapine levels may be increased in these patient groups,
      compared to levels observed in patients without renal or hepatic impairment.
      Source: US FDA label for mirtazapine (Mirtazapine), section 'use in specific
      populations', retrieved 2026-08-29

  PREGNANCY
    - Reproduction studies in pregnant rats and rabbits at doses up to 100 mg/kg and 40
      mg/kg, respectively [20 and 17 times the maximum recommended human dose (MRHD) on
      an mg/m 2 basis, respectively], have revealed no evidence of teratogenic effects.
      Source: US FDA label for mirtazapine (Mirtazapine), section 'pregnancy', retrieved
      2026-08-29
    - However, in rats, there was an increase in post-implantation losses in dams
      treated with mirtazapine.
      Source: US FDA label for mirtazapine (Mirtazapine), section 'pregnancy', retrieved
      2026-08-29
    - There was an increase in pup deaths during the first 3 days of lactation and a
      decrease in pup birth weights.
      Source: US FDA label for mirtazapine (Mirtazapine), section 'pregnancy', retrieved
      2026-08-29

  BREASTFEEDING   [ CAUTION ]
    The label allows it only when the benefit is judged to outweigh the risk. Read the
      quote below.
    - Mirtazapine may be excreted in breast milk.
      Source: US FDA label for mirtazapine (Mirtazapine), section 'nursing mothers',
      retrieved 2026-08-29
    - Exercise caution when administering mirtazapine to nursing women.
      Source: US FDA label for mirtazapine (Mirtazapine), section 'nursing mothers',
      retrieved 2026-08-29
    - ( 8.1 ) • Nursing Mothers: Caution should be exercised when administered to a
      nursing woman.
      Source: US FDA label for mirtazapine (Mirtazapine), section 'use in specific
      populations', retrieved 2026-08-29