{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "sitagliptin",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "The recommended dose of sitagliptin tablets is 100 mg once daily.",
        "source": "US FDA label for sitagliptin (Sitagliptin), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/sitagliptin.json",
        "verbatim": true
      },
      {
        "text": "The recommended dose of sitagliptin tablets is 100 mg once daily. Sitagliptin tablets can be taken with or without food. ( 2.1 ) Dosage adjustment is recommended for patients with eGFR less than 45 mL/min/1.73 m 2 .",
        "source": "US FDA label for sitagliptin (Sitagliptin), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/sitagliptin.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "The safety and effectiveness of sitagliptin have not been established in pediatric patients. Three 20-week double-blind, placebo-controlled studies each with 34-week extensions were conducted to evaluate the efficacy and safety of sitagliptin in 410 pediatric patients aged 10 to 17 years with inadequately controlled type 2 diabetes, with or without insulin therapy (HbA1c 6.5 to 10% for patients not on insulin, HbA1c 7 to 10% for patients on insulin).",
        "source": "US FDA label for sitagliptin (Sitagliptin), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/sitagliptin.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "( 2.1 ) Dosage adjustment is recommended for patients with eGFR less than 45 mL/min/1.73 m 2 .",
        "source": "US FDA label for sitagliptin (Sitagliptin), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/sitagliptin.json",
        "verbatim": true
      },
      {
        "text": "( 2.2 ) Dosage Adjustment in Patients With Renal Impairment ( 2.2 ) eGFR greater than or equal to 30 mL/min/1.73 m 2 to less than 45 mL/min/1.73 m 2 eGFR less than 30 mL/min/1.73 m 2 (including patients with end stage renal disease [ESRD] on dialysis) 50 mg once daily 25 mg once daily 2.1 Recommended Dosing The recommended dose of sitagliptin tablets is 100 mg once daily.",
        "source": "US FDA label for sitagliptin (Sitagliptin), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/sitagliptin.json",
        "verbatim": true
      },
      {
        "text": "Sitagliptin tablets can be taken with or without food. 2.2 Recommendations for Use in Renal Impairment Assess renal function prior to initiation of sitagliptin tablets and periodically thereafter.",
        "source": "US FDA label for sitagliptin (Sitagliptin), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/sitagliptin.json",
        "verbatim": true
      }
    ],
    "hepatic": [
      {
        "text": "No liver-impairment dose in this label. Not a statement that none is needed.",
        "source": "Read and found silent: the US FDA label for sitagliptin (Sitagliptin), retrieved 2026-08-29",
        "cached_file": "labels/sitagliptin.json",
        "verbatim": false
      }
    ],
    "pregnancy": [
      {
        "text": "Risk Summary The limited available data with sitagliptin tablets in pregnant women are not sufficient to inform a drug- associated risk for major birth defects and miscarriage.",
        "source": "US FDA label for sitagliptin (Sitagliptin), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/sitagliptin.json",
        "verbatim": true
      },
      {
        "text": "There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see Clinical Considerations] .",
        "source": "US FDA label for sitagliptin (Sitagliptin), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/sitagliptin.json",
        "verbatim": true
      },
      {
        "text": "No adverse developmental effects were observed when sitagliptin was administered to pregnant rats and rabbits during organogenesis at oral doses up to 30-times and 20-times, respectively, the 100 mg clinical dose, based on AUC [see Data] .",
        "source": "US FDA label for sitagliptin (Sitagliptin), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/sitagliptin.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Risk Summary There is no information regarding the presence of sitagliptin in human milk, the effects on the breastfed infant, or the effects on milk production.",
        "source": "US FDA label for sitagliptin (Sitagliptin), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/sitagliptin.json",
        "verbatim": true
      },
      {
        "text": "Sitagliptin is present in rat milk and therefore possibly present in human milk [see Data] .",
        "source": "US FDA label for sitagliptin (Sitagliptin), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/sitagliptin.json",
        "verbatim": true
      },
      {
        "text": "The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for sitagliptin tablets and any potential adverse effects on the breastfed infant from sitagliptin tablets or from the underlying maternal condition.",
        "source": "US FDA label for sitagliptin (Sitagliptin), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/sitagliptin.json",
        "verbatim": true
      }
    ]
  }
}