{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "amlodipine",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "Adult recommended starting dose: 5 mg once daily with maximum dose10 mg once daily.",
        "source": "US FDA label for amlodipine (Amlodipine besylate), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/amlodipine.json",
        "verbatim": true
      },
      {
        "text": "( 2.1 ) Small, fragile, or elderly patients, or patients with hepatic insufficiency may be started on 2.5 mg once daily.",
        "source": "US FDA label for amlodipine (Amlodipine besylate), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/amlodipine.json",
        "verbatim": true
      },
      {
        "text": "( 2.2 ) 2.1 Adults The usual initial antihypertensive oral dose of amlodipine besylate tablets is 5 mg once daily with a maximum dose of 10 mg once daily.",
        "source": "US FDA label for amlodipine (Amlodipine besylate), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/amlodipine.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "Effect of amlodipine on blood pressure in patients less than 6 years of age is not known.",
        "source": "US FDA label for amlodipine (Amlodipine besylate), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/amlodipine.json",
        "verbatim": true
      },
      {
        "text": "Adult recommended starting dose: 5 mg once daily with maximum dose10 mg once daily. ( 2.1 ) Small, fragile, or elderly patients, or patients with hepatic insufficiency may be started on 2.5 mg once daily. ( 2.1 ) Pediatric starting dose: 2.5 mg to 5 mg once daily. ( 2.2 ) Important Limitation: Doses in excess of 5 mg daily have not been studied in pediatric patients.",
        "source": "US FDA label for amlodipine (Amlodipine besylate), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/amlodipine.json",
        "verbatim": true
      },
      {
        "text": "( 2.1 ) Pediatric starting dose: 2.5 mg to 5 mg once daily.",
        "source": "US FDA label for amlodipine (Amlodipine besylate), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/amlodipine.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "No kidney-impairment dose in this label. Not a statement that none is needed.",
        "source": "Read and found silent: the US FDA label for amlodipine (Amlodipine besylate), retrieved 2026-08-29",
        "cached_file": "labels/amlodipine.json",
        "verbatim": false
      }
    ],
    "hepatic": [
      {
        "text": "( 2.1 ) Small, fragile, or elderly patients, or patients with hepatic insufficiency may be started on 2.5 mg once daily.",
        "source": "US FDA label for amlodipine (Amlodipine besylate), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/amlodipine.json",
        "verbatim": true
      },
      {
        "text": "Small, fragile, or elderly patients, or patients with hepatic insufficiency may be started on 2.5 mg once daily and this dose may be used when adding amlodipine besylate tablets to other antihypertensive therapy.",
        "source": "US FDA label for amlodipine (Amlodipine besylate), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/amlodipine.json",
        "verbatim": true
      },
      {
        "text": "The recommended dose for chronic stable or vasospastic angina is 5–10 mg, with the lower dose suggested in the elderly and in patients with hepatic insufficiency.",
        "source": "US FDA label for amlodipine (Amlodipine besylate), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/amlodipine.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "Pregnancy Category C There are no adequate and well-controlled studies in pregnant women.",
        "source": "US FDA label for amlodipine (Amlodipine besylate), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/amlodipine.json",
        "verbatim": true
      },
      {
        "text": "Amlodipine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.",
        "source": "US FDA label for amlodipine (Amlodipine besylate), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/amlodipine.json",
        "verbatim": true
      },
      {
        "text": "No evidence of teratogenicity or other embryo/fetal toxicity was found when pregnant rats and rabbits were treated orally with amlodipine maleate at doses up to 10 mg amlodipine/kg/day (respectively, 8 times 2 and 23 times 2 the maximum recommended human dose of 10 mg on a mg/m 2 basis) during their respective periods of major organogenesis.",
        "source": "US FDA label for amlodipine (Amlodipine besylate), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/amlodipine.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "It is not known whether amlodipine is excreted in human milk.",
        "source": "US FDA label for amlodipine (Amlodipine besylate), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/amlodipine.json",
        "verbatim": true
      },
      {
        "text": "In the absence of this information, it is recommended that nursing be discontinued while amlodipine is administered.",
        "source": "US FDA label for amlodipine (Amlodipine besylate), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/amlodipine.json",
        "verbatim": true
      },
      {
        "text": "( 8.1 ) Nursing: Discontinue when administering amlodipine besylate tablets.",
        "source": "US FDA label for amlodipine (Amlodipine besylate), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/amlodipine.json",
        "verbatim": true
      }
    ]
  },
  "verdicts": {
    "pregnancy": {
      "level": "caution",
      "line": "The label allows it only when the benefit is judged to outweigh the risk. Read the quote below.",
      "set_by": "Set from the label's own words, not from a reading of them: 'should be used during pregnancy only if'."
    }
  }
}