Drug profile
Zoledronic Acid
Adult, child, renal, hepatic, pregnancy and breastfeeding information, with the source named on every line.
DRUG INFORMATION
ADULT
- 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
- 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
- ( 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
CHILD
- 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
- 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
RENAL IMPAIRMENT
- ( 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
- 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
- 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
HEPATIC IMPAIRMENT
- 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
PREGNANCY
- 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
- 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
- Discontinue use if severe symptoms develop.
Source: US FDA label for zoledronic acid (Zoledronic Acid), section 'pregnancy',
retrieved 2026-08-29
BREASTFEEDING
- 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
- 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
- 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