{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "zoledronic acid",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "Hypercalcemia of malignancy ( 2.1 ) 4 mg as a single-use intravenous infusion over no less than 15 minutes. 4 mg as retreatment after a minimum of 7 days.",
        "source": "US FDA label for zoledronic acid (Zoledronic Acid), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/zoledronic-acid.json",
        "verbatim": true
      },
      {
        "text": "Coadminister oral calcium supplements of 500 mg and a multiple vitamin containing 400 international units of vitamin D daily.",
        "source": "US FDA label for zoledronic acid (Zoledronic Acid), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/zoledronic-acid.json",
        "verbatim": true
      },
      {
        "text": "( 2.3 ) 2.1 Hypercalcemia of Malignancy The maximum recommended dose of zoledronic acid injection in hypercalcemia of malignancy (albumin-corrected serum calcium greater than or equal to 12 mg/dL [3.0 mmol/L]) is 4 mg.",
        "source": "US FDA label for zoledronic acid (Zoledronic Acid), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/zoledronic-acid.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "Zoledronic acid injection is not indicated for use in children. The safety and effectiveness of zoledronic acid was studied in a one-year, active-controlled trial of 152 pediatric subjects (74 receiving zoledronic acid).",
        "source": "US FDA label for zoledronic acid (Zoledronic Acid), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/zoledronic-acid.json",
        "verbatim": true
      },
      {
        "text": "Plasma zoledronic acid concentration data was obtained from 10 patients with severe osteogenesis imperfecta (4 in the age group of 3 to 8 years and 6 in the age group of 9 to 17 years) infused with 0.05 mg/kg dose over 30 min.",
        "source": "US FDA label for zoledronic acid (Zoledronic Acid), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/zoledronic-acid.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "( 2.2 ) 4 mg as a single-use intravenous infusion over no less than 15 minutes every 3 to 4 weeks for patients with creatinine clearance of greater than 60 mL/min.",
        "source": "US FDA label for zoledronic acid (Zoledronic Acid), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/zoledronic-acid.json",
        "verbatim": true
      },
      {
        "text": "Reduce the dose for patients with renal impairment.",
        "source": "US FDA label for zoledronic acid (Zoledronic Acid), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/zoledronic-acid.json",
        "verbatim": true
      },
      {
        "text": "Dose adjustments of zoledronic acid injection are not necessary in treating patients for hypercalcemia of malignancy presenting with mild-to-moderate renal impairment prior to initiation of therapy (serum creatinine less than 400 µmol/L or less than 4.5 mg/dL).",
        "source": "US FDA label for zoledronic acid (Zoledronic Acid), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/zoledronic-acid.json",
        "verbatim": true
      }
    ],
    "hepatic": [
      {
        "text": "It is unknown whether the risk of atypical femur fracture continues after stopping therapy. 5.7 Patients With Asthma While not observed in clinical trials with zoledronic acid injection, there have been reports of bronchoconstriction in aspirin-sensitive patients receiving bisphosphonates.",
        "source": "US FDA label for zoledronic acid (Zoledronic Acid), section 'warnings and cautions', retrieved 2026-08-29",
        "cached_file": "labels/zoledronic-acid.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "Musculoskeletal Pain In postmarketing experience, severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported in patients taking bisphosphonates, including zoledronic acid injection.",
        "source": "US FDA label for zoledronic acid (Zoledronic Acid), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/zoledronic-acid.json",
        "verbatim": true
      },
      {
        "text": "The time to onset of symptoms varied from one day to several months after starting the drug.",
        "source": "US FDA label for zoledronic acid (Zoledronic Acid), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/zoledronic-acid.json",
        "verbatim": true
      },
      {
        "text": "Discontinue use if severe symptoms develop.",
        "source": "US FDA label for zoledronic acid (Zoledronic Acid), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/zoledronic-acid.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Risk Summary After administration of zoledronic acid, it is not known whether zoledronic acid is present in human milk, or whether it affects milk production or the breastfed child.",
        "source": "US FDA label for zoledronic acid (Zoledronic Acid), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/zoledronic-acid.json",
        "verbatim": true
      },
      {
        "text": "Zoledronic acid binds to bone long term and may be released over periods of weeks to years.",
        "source": "US FDA label for zoledronic acid (Zoledronic Acid), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/zoledronic-acid.json",
        "verbatim": true
      },
      {
        "text": "Because of the potential for serious adverse reactions in a breastfed child, advise a lactating woman not to breastfeed during and after zoledronic acid treatment.",
        "source": "US FDA label for zoledronic acid (Zoledronic Acid), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/zoledronic-acid.json",
        "verbatim": true
      }
    ]
  }
}