Desloratadine

DRUG INFORMATION

  ADULT
    - Dosage (by age): Adults and Adolescents 12 Years of Age and Over: Desloratadine
      Tablets - one 5 mg tablet once daily Desloratadine tablets may be taken without
      regard to meals. 2.1 Adults and Adolescents 12 Years of Age and Over The
      recommended dose of desloratadine tablets is one 5 mg tablet once daily.
      Source: US FDA label for desloratadine (DESLORATADINE), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - The recommended dose of desloratadine oral solution in the pediatric population is
      based on cross-study comparison of the plasma concentration of desloratadine in
      adults and pediatric subjects. The safety of desloratadine oral solution has been
      established in 246 pediatric subjects aged 6 months to 11 years in three placebo-
      controlled clinical studies.
      Source: US FDA label for desloratadine (DESLORATADINE), section 'pediatric use',
      retrieved 2026-08-29
    - Dosage (by age): Adults and Adolescents 12 Years of Age and Over: Desloratadine
      Tablets - one 5 mg tablet once daily Desloratadine tablets may be taken without
      regard to meals. 2.1 Adults and Adolescents 12 Years of Age and Over The
      recommended dose of desloratadine tablets is one 5 mg tablet once daily.
      Source: US FDA label for desloratadine (DESLORATADINE), section 'dosage and
      administration', retrieved 2026-08-29

  RENAL IMPAIRMENT
    - Dosage (by age): Adults and Adolescents 12 Years of Age and Over: Desloratadine
      Tablets - one 5 mg tablet once daily Desloratadine tablets may be taken without
      regard to meals. 2.1 Adults and Adolescents 12 Years of Age and Over The
      recommended dose of desloratadine tablets is one 5 mg tablet once daily.
      Source: US FDA label for desloratadine (DESLORATADINE), section 'dosage and
      administration', retrieved 2026-08-29
    - Dosing recommendation for children with liver or renal impairment cannot be made
      due to lack of data [see CLINICAL PHARMACOLOGY ( 12.3 )] .
      Source: US FDA label for desloratadine (DESLORATADINE), section 'dosage and
      administration', retrieved 2026-08-29
    - Renal impairment: dosage adjustment is recommended ( 2.5 , 8.6 , 12.3 ) Hepatic
      impairment: dosage adjustment is recommended ( 2.5 , 8.7 , 12.3 ) 8.1 Pregnancy
      Risk Summary The limited available data with desloratadine in pregnant women are
      not sufficient to inform a drug-associated risk for major birth defects and
      miscarriage.
      Source: US FDA label for desloratadine (DESLORATADINE), section 'use in specific
      populations', retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - Renal impairment: dosage adjustment is recommended ( 2.5 , 8.6 , 12.3 ) Hepatic
      impairment: dosage adjustment is recommended ( 2.5 , 8.7 , 12.3 ) 8.1 Pregnancy
      Risk Summary The limited available data with desloratadine in pregnant women are
      not sufficient to inform a drug-associated risk for major birth defects and
      miscarriage.
      Source: US FDA label for desloratadine (DESLORATADINE), section 'use in specific
      populations', retrieved 2026-08-29
    - In general, dose selection for an elderly patient should be cautious, reflecting
      the greater frequency of decreased hepatic, renal, or cardiac function, and of
      concomitant disease or other drug therapy. [See CLINICAL PHARMACOLOGY ( 12.3 )].
      8.6 Renal Impairment Dosage adjustment for patients with renal impairment is
      recommended [see DOSAGE AND ADMINISTRATION ( 2.5 ) and CLINICAL PHARMACOLOGY (
      12.3 )].
      Source: US FDA label for desloratadine (DESLORATADINE), section 'use in specific
      populations', retrieved 2026-08-29

  PREGNANCY
    - Risk Summary The limited available data with desloratadine in pregnant women are
      not sufficient to inform a drug-associated risk for major birth defects and
      miscarriage.
      Source: US FDA label for desloratadine (DESLORATADINE), section 'pregnancy',
      retrieved 2026-08-29
    - There are no adequate and well-controlled studies in pregnant women.
      Source: US FDA label for desloratadine (DESLORATADINE), section 'pregnancy',
      retrieved 2026-08-29
    - Desloratadine given during organogenesis to pregnant rats was not teratogenic at
      the summed area under the concentration-time curve (AUC)-based exposures of
      desloratadine and its metabolite approximately 320 times that at the recommended
      human daily oral dose (RHD) of 5 mg/day.
      Source: US FDA label for desloratadine (DESLORATADINE), section 'pregnancy',
      retrieved 2026-08-29

  BREASTFEEDING
    - Infertility There are no data available on human infertility associated with
      desloratadine.
      Source: US FDA label for desloratadine (DESLORATADINE), section 'nursing mothers',
      retrieved 2026-08-29
    - There were no clinically relevant effects of desloratadine on female fertility in
      rats.
      Source: US FDA label for desloratadine (DESLORATADINE), section 'nursing mothers',
      retrieved 2026-08-29
    - A male specific decrease in fertility occurred at an oral desloratadine dose of 12
      mg/kg or greater in rats (approximately 65 times the summed AUC-based exposure of
      desloratadine and its metabolite at the RHD).
      Source: US FDA label for desloratadine (DESLORATADINE), section 'nursing mothers',
      retrieved 2026-08-29