{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "metformin",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "Increase the dose in increments of 500 mg weekly or 850 mg every 2 weeks on the basis of glycemic control and tolerability, up to a maximum dose of 2550 mg per day, given in divided doses.",
        "source": "US FDA label for metformin (Metformin Hydrochloride), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/metformin.json",
        "verbatim": true
      },
      {
        "text": "Doses above 2000 mg may be better tolerated given 3 times a day with meals.",
        "source": "US FDA label for metformin (Metformin Hydrochloride), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/metformin.json",
        "verbatim": true
      },
      {
        "text": "The recommended starting dose of metformin hydrochloride extended-release tablets is 500 mg orally once daily with the evening meal.",
        "source": "US FDA label for metformin (Metformin Hydrochloride), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/metformin.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "Metformin Hydrochloride Tablets The safety and effectiveness of metformin hydrochloride tablets for the treatment of type 2 diabetes mellitus have been established in pediatric patients 10 to 16 years old. Safety and effectiveness of metformin hydrochloride tablets have not been established in pediatric patients less than 10 years old.",
        "source": "US FDA label for metformin (Metformin Hydrochloride), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/metformin.json",
        "verbatim": true
      },
      {
        "text": "A maximum daily dose of 2000 mg of metformin hydrochloride tablets is recommended. [See Dosage and Administration ( 2.2 ) .] Metformin Hydrochloride Extended-Release Tablets Safety and effectiveness of metformin hydrochloride extended-release tablets in pediatric patients have not been established.",
        "source": "US FDA label for metformin (Metformin Hydrochloride), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/metformin.json",
        "verbatim": true
      },
      {
        "text": "Patients receiving metformin hydrochloride tablets may be switched to metformin hydrochloride extended-release tablets once daily at the same total daily dose, up to 2000 mg once daily. 2.2 Pediatric Dosage for metformin hydrochloride tablets The recommended starting dose of metformin hydrochloride tablets for pediatric patients 10 years of age and older is 500 mg orally twice a day, given with meals.",
        "source": "US FDA label for metformin (Metformin Hydrochloride), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/metformin.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "Increase dosage in increments of 500 mg weekly on the basis of glycemic control and tolerability, up to a maximum of 2000 mg per day, given in divided doses twice daily. 2.3 Recommendations for Use in Renal Impairment Assess renal function prior to initiation of metformin hydrochloride tablets and metformin hydrochloride extended-release tablets and periodically thereafter.",
        "source": "US FDA label for metformin (Metformin Hydrochloride), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/metformin.json",
        "verbatim": true
      },
      {
        "text": "Metformin hydrochloride tablets and metformin hydrochloride extended-release tablets is contraindicated in patients with an estimated glomerular filtration rate (eGFR) below 30 mL/minute/1.73 m 2 .",
        "source": "US FDA label for metformin (Metformin Hydrochloride), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/metformin.json",
        "verbatim": true
      },
      {
        "text": "Initiation of metformin hydrochloride tablets and metformin hydrochloride extended-release tablets in patients with an eGFR between 30 – 45 mL/minute/1.73 m 2 is not recommended.",
        "source": "US FDA label for metformin (Metformin Hydrochloride), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/metformin.json",
        "verbatim": true
      }
    ],
    "hepatic": [
      {
        "text": "(8.5) Hepatic Impairment: Avoid use in patients with hepatic impairment.",
        "source": "US FDA label for metformin (Metformin Hydrochloride), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/metformin.json",
        "verbatim": true
      },
      {
        "text": "Metformin hydrochloride tablets and metformin hydrochloride extended-release tablets is contraindicated in severe renal impairment, patients with an estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m 2 [see Dosage and Administration ( 2.3 ), Contraindications ( 4 ), Warnings and Precautions ( 5.1 ), and Clinical Pharmacology ( 12.3 ) ].",
        "source": "US FDA label for metformin (Metformin Hydrochloride), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/metformin.json",
        "verbatim": true
      },
      {
        "text": "Metformin hydrochloride tablets and metformin hydrochloride extended-release tablets is not recommended in patients with hepatic impairment. [see Warnings and Precautions ( 5.1 ) ].",
        "source": "US FDA label for metformin (Metformin Hydrochloride), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/metformin.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "Risk Summary Limited data with metformin hydrochloride tablets and metformin hydrochloride extended-release tablets in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage.",
        "source": "US FDA label for metformin (Metformin Hydrochloride), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/metformin.json",
        "verbatim": true
      },
      {
        "text": "Published studies with metformin use during pregnancy have not reported a clear association with metformin and major birth defect or miscarriage risk [see Data].",
        "source": "US FDA label for metformin (Metformin Hydrochloride), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/metformin.json",
        "verbatim": true
      },
      {
        "text": "There are risks to the mother and fetus associated with poorly controlled diabetes mellitus in pregnancy [see Clinical Considerations].",
        "source": "US FDA label for metformin (Metformin Hydrochloride), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/metformin.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Discuss the potential for unintended pregnancy with premenopausal women as therapy with metformin hydrochloride tablets and metformin hydrochloride extended-release tablets may result in ovulation in some an ovulatory women.",
        "source": "US FDA label for metformin (Metformin Hydrochloride), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/metformin.json",
        "verbatim": true
      },
      {
        "text": "Determination of fetal concentrations demonstrated a partial placental barrier to metformin. 8.2 Lactation Risk Summary Limited published studies report that metformin is present in human milk [see Data].",
        "source": "US FDA label for metformin (Metformin Hydrochloride), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/metformin.json",
        "verbatim": true
      },
      {
        "text": "However, there is insufficient information to determine the effects of metformin on the breastfed infant and no available information on the effects of metformin on milk production.",
        "source": "US FDA label for metformin (Metformin Hydrochloride), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/metformin.json",
        "verbatim": true
      }
    ]
  }
}