{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "desloratadine",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "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",
        "cached_file": "labels/desloratadine.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "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",
        "cached_file": "labels/desloratadine.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/desloratadine.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "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",
        "cached_file": "labels/desloratadine.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/desloratadine.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/desloratadine.json",
        "verbatim": true
      }
    ],
    "hepatic": [
      {
        "text": "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",
        "cached_file": "labels/desloratadine.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/desloratadine.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "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",
        "cached_file": "labels/desloratadine.json",
        "verbatim": true
      },
      {
        "text": "There are no adequate and well-controlled studies in pregnant women.",
        "source": "US FDA label for desloratadine (DESLORATADINE), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/desloratadine.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/desloratadine.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "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",
        "cached_file": "labels/desloratadine.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/desloratadine.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/desloratadine.json",
        "verbatim": true
      }
    ]
  }
}