{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "rasagiline",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "Monotherapy: AZILECT 1 mg once daily ( 2.1 ) As adjunct without levodopa: AZILECT 1 mg once daily ( 2.1 ) As adjunct to levodopa: AZILECT 0.5 mg once daily.",
        "source": "US FDA label for rasagiline (Azilect), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/rasagiline.json",
        "verbatim": true
      },
      {
        "text": "In patients taking levodopa, with or without other PD drugs (e.g., dopamine agonist, amantadine, anticholinergics), the recommended initial dose of AZILECT is 0.5 mg once daily.",
        "source": "US FDA label for rasagiline (Azilect), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/rasagiline.json",
        "verbatim": true
      },
      {
        "text": "If the patient tolerates the daily 0.5 mg dose, but a sufficient clinical response is not achieved, the dose may be increased to 1 mg once daily.",
        "source": "US FDA label for rasagiline (Azilect), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/rasagiline.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "The safety and effectiveness in pediatric patients have not been established.",
        "source": "US FDA label for rasagiline (Azilect), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/rasagiline.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "AZILECT should not be used in patients with moderate or severe hepatic impairment [see Dosage and Administration ( 2.3 ), Warnings and Precautions ( 5.5 ) and Clinical Pharmacology ( 12.3 )] . 8.7 Renal Impairment Dose adjustment of AZILECT is not required for patients with mild or moderate renal impairment because AZILECT plasma concentrations are not increased in patients with moderate renal impairment.",
        "source": "US FDA label for rasagiline (Azilect), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/rasagiline.json",
        "verbatim": true
      },
      {
        "text": "Rasagiline has not been studied in patients with severe renal impairment [see Clinical Pharmacology ( 12.3 )] .",
        "source": "US FDA label for rasagiline (Azilect), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/rasagiline.json",
        "verbatim": true
      }
    ],
    "hepatic": [
      {
        "text": "Increase dose to 1 mg daily as needed for sufficient clinical response ( 2.1 ) Patients taking ciprofloxacin or other CYP1A2 inhibitors: AZILECT 0.5 mg once daily ( 2.2 , 5.4 ) Patients with mild hepatic impairment: AZILECT 0.5 mg once daily.",
        "source": "US FDA label for rasagiline (Azilect), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/rasagiline.json",
        "verbatim": true
      },
      {
        "text": "AZILECT should not be used in patients with moderate or severe hepatic impairment ( 2.3 , 5.5 ) 2.1 General Dosing Recommendations When AZILECT is prescribed as monotherapy or as adjunct therapy in patients not taking levodopa, patients may start AZILECT at the recommended dose of 1 mg administered orally once daily.",
        "source": "US FDA label for rasagiline (Azilect), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/rasagiline.json",
        "verbatim": true
      },
      {
        "text": "The recommended doses of AZILECT should not be exceeded because of risk of hypertension [see Warnings and Precautions ( 5.1 )]. 2.2 Patients Taking Ciprofloxacin or Other CYP1A2 Inhibitors Patients taking concomitant ciprofloxacin or other CYP1A2 inhibitors should not exceed a dose of AZILECT 0.5 mg once daily [see Warnings and Precautions ( 5.4 ), Drug Interactions ( 7.6 ), and Clinical Pharmacology ( 12.3 )].",
        "source": "US FDA label for rasagiline (Azilect), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/rasagiline.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "Risk Summary There are no adequate data on the developmental risks associated with the use of AZILECT in pregnant women.",
        "source": "US FDA label for rasagiline (Azilect), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/rasagiline.json",
        "verbatim": true
      },
      {
        "text": "In animal studies, oral administration of rasagiline to rats during gestation and lactation resulted in decreased survival and reduced body weight in the offspring at doses similar to those used clinically.",
        "source": "US FDA label for rasagiline (Azilect), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/rasagiline.json",
        "verbatim": true
      },
      {
        "text": "When administered to pregnant animals in combination with levodopa/carbidopa, there were increased incidences of fetal skeletal variations in rats and increases in embryofetal death and cardiovascular abnormalities in rabbits [see Data] .",
        "source": "US FDA label for rasagiline (Azilect), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/rasagiline.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Risk Summary There are no data on the presence of rasagiline in human milk or the effects on the breastfed infant.",
        "source": "US FDA label for rasagiline (Azilect), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/rasagiline.json",
        "verbatim": true
      },
      {
        "text": "In rats, rasagiline was shown to inhibit prolactin secretion.",
        "source": "US FDA label for rasagiline (Azilect), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/rasagiline.json",
        "verbatim": true
      },
      {
        "text": "The clinical relevance in humans is unknown, and there are no data on the effects of rasagiline on prolactin secretion or milk production in humans.",
        "source": "US FDA label for rasagiline (Azilect), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/rasagiline.json",
        "verbatim": true
      }
    ]
  }
}