Sertraline

DRUG INFORMATION

  ADULT
    - A dosage of 25 mg or 50 mg per day is the initial therapeutic dosage.
      Source: US FDA label for sertraline (Sertraline Hydrochloride), section 'dosage
      and administration', retrieved 2026-08-29
    - For adults and pediatric patients, subsequent dosages may be increased in case of
      an inadequate response in 25 to 50 mg per day increments once a week, depending on
      tolerability, up to a maximum of 200 mg per day.
      Source: US FDA label for sertraline (Sertraline Hydrochloride), section 'dosage
      and administration', retrieved 2026-08-29
    - When dosing continuously , patients not responding to a 50 mg dosage may benefit
      from dosage increases at 50 mg increments per menstrual cycle up to 150 mg per
      day.
      Source: US FDA label for sertraline (Sertraline Hydrochloride), section 'dosage
      and administration', retrieved 2026-08-29

  CHILD
    - The safety and efficacy of sertraline hydrochloride have been established in the
      treatment of OCD in pediatric patients aged 6 to 17 [See Adverse Reactions (6.1) ,
      Clinical Pharmacology (12.3) , Clinical Studies (14.2) ] . Safety and
      effectiveness in pediatric patients in patients with OCD below the age of 6 have
      not been established. Safety and effectiveness have not been established in
      pediatric patients for indications other than OCD.
      Source: US FDA label for sertraline (Sertraline Hydrochloride), section 'pediatric
      use', retrieved 2026-08-29
    - In this study in which juvenile rats were treated with oral doses of sertraline at
      0, 10, 40 or 80 mg/kg/day from postnatal day 21 to 56, a delay in sexual
      maturation was observed in males treated with 80 mg/kg/day and females treated
      with doses ≥10 mg/kg/day.
      Source: US FDA label for sertraline (Sertraline Hydrochloride), section 'pediatric
      use', retrieved 2026-08-29
    - There was no effect on male and female reproductive endpoints or neurobehavioral
      development up to the highest dose tested (80 mg/kg/day), except a decrease in
      auditory startle response in females at 40 and 80 mg/kg/day at the end of
      treatment but not at the end of the drug–free period.
      Source: US FDA label for sertraline (Sertraline Hydrochloride), section 'pediatric
      use', retrieved 2026-08-29

  RENAL IMPAIRMENT
    - The use of sertraline hydrochloride in patients with moderate (Child-Pugh score 7
      to 10) or severe hepatic impairment (Child-Pugh score 10 to 15) is not
      recommended, because sertraline hydrochloride is extensively metabolized, and the
      effects of sertraline hydrochloride in patients with moderate and severe hepatic
      impairment have not been studied [See Dosage and Administration (2.4) , Clinical
      Pharmacology (12.3) ] .
      Source: US FDA label for sertraline (Sertraline Hydrochloride), section 'use in
      specific populations', retrieved 2026-08-29
    - Sertraline exposure does not appear to be affected by renal impairment [See
      Clinical Pharmacology (12.3) ] .
      Source: US FDA label for sertraline (Sertraline Hydrochloride), section 'use in
      specific populations', retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - When dosing intermittently , patients not responding to a 50 mg dosage may benefit
      from increasing the dosage up to a maximum of 100 mg per day during the next
      menstrual cycle (and subsequent cycles) as follows: 50 mg per day during the first
      3 days of dosing followed by 100 mg per day during the remaining days in the
      dosing cycle.
      Source: US FDA label for sertraline (Sertraline Hydrochloride), section 'dosage
      and administration', retrieved 2026-08-29
    - The use of sertraline hydrochloride oral solution in patients with moderate (Child
      Pugh scores 7 to 9) or severe hepatic impairment (Child Pugh scores 10 to 15) is
      not recommended [See Use in Specific Populations (8.6) , Clinical Pharmacology
      (12.3) ].
      Source: US FDA label for sertraline (Sertraline Hydrochloride), section 'dosage
      and administration', retrieved 2026-08-29
    - SNRIs and SSRIs, including sertraline hydrochloride, have been associated with
      cases of clinically significant hyponatremia in elderly patients, who may be at
      greater risk for this adverse reaction [See Warnings and Precautions (5.8) ] . 8.6
      Hepatic Impairment The recommended dosage in patients with mild hepatic impairment
      (Child-Pugh score 5 or 6) is half the recommended dosage due to increased exposure
      in this patient population.
      Source: US FDA label for sertraline (Sertraline Hydrochloride), section 'use in
      specific populations', retrieved 2026-08-29

  PREGNANCY
    - Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors
      pregnancy outcomes in women exposed to antidepressants during pregnancy.
      Source: US FDA label for sertraline (Sertraline Hydrochloride), section
      'pregnancy', retrieved 2026-08-29
    - Healthcare providers should encourage patients to enroll by calling the National
      Pregnancy Registry for Antidepressants at 1-866-961-2388 or visiting online at
      https://womensmentalhealth.org/research/pregnancyregistry/antidepressants .
      Source: US FDA label for sertraline (Sertraline Hydrochloride), section
      'pregnancy', retrieved 2026-08-29
    - Risk Summary Based on data from published observational studies, exposure to
      SSRIs, particularly in the month before delivery, has been associated with a less
      than 2-fold increase in the risk of postpartum hemorrhage [see Warnings and
      Precautions (5.3) and Clinical Considerations] .
      Source: US FDA label for sertraline (Sertraline Hydrochloride), section
      'pregnancy', retrieved 2026-08-29

  BREASTFEEDING
    - When female rats received sertraline during the last third of gestation and
      throughout lactation, there was an increase in stillborn pups and pup deaths
      during the first 4 days after birth.
      Source: US FDA label for sertraline (Sertraline Hydrochloride), section 'use in
      specific populations', retrieved 2026-08-29
    - The clinical significance of these effects is unknown. 8.2 Lactation Risk Summary
      Available data from published literature demonstrate low levels of sertraline and
      its metabolites in human milk [See Data] .
      Source: US FDA label for sertraline (Sertraline 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 sertraline hydrochloride and any potential
      adverse effects on the breastfed infant from the drug or from the underlying
      maternal condition.
      Source: US FDA label for sertraline (Sertraline Hydrochloride), section 'use in
      specific populations', retrieved 2026-08-29