Formulary
Zoledronic acid: Indications, Dosing, Side Effects and Interactions
Bisphosphonates are adsorbed onto hydroxyapatite crystals in bone, slowing both their rate of growth and dissolution, and therefore reducing the rate of bone...
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Zoledronic acid: Indications, Dosing, Side Effects and Interactions
Bisphosphonates are adsorbed onto hydroxyapatite crystals in bone, slowing both their rate of growth and dissolution, and therefore reducing the rate of bone...
Drug action
Bisphosphonates are adsorbed onto hydroxyapatite crystals in bone, slowing both their rate of growth and dissolution, and therefore reducing the rate of bone turnover.
Indications and dose
**Prevention of skeletal related events in advanced malignancies involving bone (specialist use only)**
- **Adult** (By Intravenous Infusion): 4 mg every 3-4 weeks, calcium 500 mg daily and vitamin D 400 units daily should also be taken.
**Tumour-induced hypercalcaemia (specialist use only)**
- **Adult** (By Intravenous Infusion): 4 mg for 1 dose.
**Paget's disease of bone (specialist use only)**
- **Adult** (By Intravenous Infusion): 5 mg for 1 dose, at least 500 mg elemental calcium twice daily (with vitamin D) for at least 10 days is recommended following infusion.
**Osteoporosis (including corticosteroid-induced osteoporosis) in men and postmenopausal women**
- **Adult** (By Intravenous Infusion): 5 mg once yearly as a single dose, in patients with a recent low-trauma hip fracture, the dose should be given at least 2 weeks after hip fracture repair; before first infusion give 50 000-125 000 units of vitamin D.
**Fracture prevention in osteopenia [hip or femoral neck]**
- **Elderly** (By Intravenous Infusion): (female) 5 mg once every 18 months as a single dose.
Cautions
Cautions, further information Elderly With oral use: Screening Tool of Older Persons' potentially inappropriate Prescriptions (STOPP) criteria to aid medication reviews (see Prescribing in the elderly for information): potentially inappropriate in patients with a current or recent history of upper gastro-intestinal disease or bleeding (risk of relapse/exacerbation of oesophagitis, oesophageal ulcer, or oesophageal stricture). Cautions For zoledronic acid Atypical femoral fractures; cardiac disease (avoid fluid overload); concomitant medicines that affect renal function
Contraindications
When used for Fracture prevention in osteopenia [hip or femoral neck] Hypocalcaemia When used for Osteoporosis (including corticosteroid-induced osteoporosis) in men and postmenopausal women Hypocalcaemia When used for Paget's disease of bone Hypocalcaemia
Side effects
Common or very common Alopecia; anaemia; appetite decreased; arthralgia; asthenia; chills; constipation; diarrhoea; dizziness; dysphagia; electrolyte imbalance; eye inflammation; fever; gastritis; gastrointestinal discomfort; headache; influenza like illness; malaise; myalgia; nausea; oesophageal ulcer (discontinue); oesophagitis (discontinue); pain; peripheral oedema; renal impairment; skin reactions; taste altered; vomiting Uncommon Anaphylactic reaction; angioedema; bronchospasm; oesophageal stenosis (discontinue); osteonecrosis Rare or very rare Atypical femur fracture; Stevens-Johnson syndrome Side-effects For zoledronic acid Common or very common Flushing Uncommon Anaphylactic shock; anxiety; arrhythmias; bronchoconstriction; chest pain; circulatory collapse; cough; drowsiness; dry mouth; dyspnoea; haematuria; hyperhidrosis; hypertension; hypotension; leucopenia; muscle spasms; proteinuria; sensation abnormal; sleep disorder; stomatitis; syncope; thrombocytopenia; tremor; vision blurred; weight increased Rare or very rare Confusion; Fanconi syndrome acquired; interstitial lung disease; pancytopenia Frequency not known Acute phase reaction Side-effects, further information Renal impairment and renal failure have been reported; ensure patient is hydrated before each dose and assess renal function.
Interactions
**Other interactions (2):**
- In clinical studies, Zoledronic Acid Concentrate has been administered concomitantly with commonly used anticancer agents, diuretics, antibiotics and analgesics without clinically apparent...
- Caution is advised when bisphosphonates are administered with aminoglycosides, calcitonin or loop diuretics, since these agents may have an additive effect, resulting in a lower serum calcium level...
Pregnancy
Avoid-toxicity in animal studies.
Breast feeding
Avoid-no information available.
Hepatic impairment
Manufacturer advises caution in severe hepatic impairment (limited information available).
Renal impairment
Avoid in tumour-induced hypercalcaemia if serum creatinine above 400 micromol/litre. M Avoid in advanced malignancies involving bone if creatinine clearance less than 30 mL/minute (or if serum creatinine greater than 265 micromol/litre). M Avoid in Paget's disease, treatment of postmenopausal osteoporosis and osteoporosis in men if creatinine clearance less than 35 mL/minute. M Dose adjustments In advanced malignancies involving bone, if creatinine clearance 50-60 mL/minute reduce dose to 3.5 mg every 3-4 weeks; if creatinine clearance 40-50 mL/minute reduce dose to 3.3 mg every 3-4 weeks; if creatinine clearance 30-40 mL/minute reduce dose to 3 mg every 3-4 weeks; if renal function deteriorates in patients with bone metastases, withhold dose until serum creatinine returns to within 10% of baseline value. M See Prescribing in renal impairment .
Medicinal forms
Solution
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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