Zoledronic Acid: uses, dosing, side effects & brands
Zoledronic Acid is a bisphosphonate sold in the U.S. under 3 brand and generic names, for bone neoplasms, hypercalcemia and multiple myeloma. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Bisphosphonate
- Treats (across its forms)
- Bone Neoplasms, Hypercalcemia and Multiple Myeloma
- Available as
- Injectable · Solution
- Sold as
- 3 products — Zometa, Reclast and Zoledronic Acid
- Prescription?
- Prescription only
- Generic available?
- Yes
- What the pharmacy pays
- about $0.47 per ml — not your price
How zoledronic acid is dosed
From the FDA label for Zoledronic Acid (application ANDA201783). Other zoledronic acid products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
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. Multiple myeloma and bone metastasis from solid tumors. ( 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. Reduce the dose for patients with renal impairment. Coadminister oral calcium supplements of 500 mg and a multiple vitamin containing 400 international units of vitamin D daily. Administer through a separate vented infusion line and do not allow to come in contact with any calcium or divalent cation-containing solutions. ( 2.3 ) Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. 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. The 4 mg dose must be given as a single-dose intravenous infusion over no less than 15 minutes . Patients who receive zoledronic acid injection should have serum creatinine assessed prior to each treatment. Dose adjustments of zoledronic acid injection are not necessary in treating patients for hypercalcemia of…
Zoledronic Acid side effects
The most common adverse events (greater than 25%) were nausea, fatigue, anemia, bone pain, constipation, fever, vomiting, and dyspnea ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Avet Pharmaceuticals Inc. at 1-866-901-DRUG (3784) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Hypercalcemia of Malignancy The safety of zoledronic acid injection was studied in 185 patients with hypercalcemia of malignancy (HCM) who received either zoledronic acid injection 4 mg given as a 5-minute intravenous infusion (n=86) or pamidronate 90 mg given as a 2-hour intravenous infusion (n=103). The population was aged 33 to 84 years, 60% male and 81% Caucasian, with breast, lung, head and neck, and renal cancer as the most common forms of malignancy. NOTE: pamidronate 90 mg was given as a 2-hour intravenous infusion. The relative safety of pamidronate 90 mg given as a 2-hour intravenous infusion compared to the same dose given as a 24-hour intravenous infusion has not been adequately studied in controlled clinical trials. Renal Toxicity Administration of zoledronic acid injection 4 mg given as a…
Who shouldn’t take zoledronic acid
Hypersensitivity to any component of zoledronic acid injection (4) Hypersensitivity to Zoledronic Acid or Any Components of Zoledronic Acid Injection Hypersensitivity reactions including rare cases of urticaria and angioedema, and very rare cases of anaphylactic reaction/shock have been reported [ see Adverse Reactions (6.2) ].
Zoledronic Acid drug interactions
Aminoglycosides: May have an additive effect to lower serum calcium for prolonged periods. ( 7.1 ) Loop Diuretics: Concomitant use with zoledronic acid injection may increase risk of hypocalcemia. ( 7.2 ) Nephrotoxic Drugs: Use with caution. ( 7.3 ) In vitro studies indicate that the plasma protein binding of zoledronic acid is low, with the unbound fraction ranging from 60% to 77%. In vitro studies also indicate that zoledronic acid does not inhibit microsomal CYP450 enzymes. In vivo studies showed that zoledronic acid is not metabolized, and is excreted into the urine as the intact drug. 7.1 Aminoglycosides and Calcitonin Caution is advised when bisphosphonates are administered with aminoglycosides or calcitonin, since these agents may have an additive effect to lower serum calcium level for prolonged periods. This effect has not been reported in zoledronic acid injection clinical trials. 7.2 Loop Diuretics Caution should also be exercised when zoledronic acid injection is used in combination with loop diuretics due to an increased risk of hypocalcemia. 7.3 Nephrotoxic Drugs Caution is indicated when zoledronic acid injection is used with other potentially nephrotoxic drugs. 7.4 Thalidomide No dose adjustment for zoledronic acid injection 4 mg is needed when coadministered with thalidomide. In a pharmacokinetic study of 24 patients with multiple myeloma, zoledronic acid injection 4 mg given as a 15 - minute infusion was administered either alone or with thalidomide (100 mg once daily on days 1 to 14 and 200 mg once daily on Days 15 to 28). Coadministration of thalidomide with zoledronic acid injection did not significantly change the pharmacokinetics of zoledronic acid or creatinine clearance.
Every zoledronic acid product we track (3)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | 70/100 | Prescription | Injectable | Generic | $0 | View → | |
| 2 | 68/100 | Prescription | Injectable | Generic | $0 | View → | |
| 3 | Not yet rated | Prescription | Injectable | Generic | $0 | View → |
Zoledronic Acid recalls
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
How long zoledronic acid keeps
The date on a sealed pack is not the only one: some zoledronic acid labels start a second clock once the product is opened or mixed, as short as 24 hours.
Does zoledronic acid expire? The in-use limits and storage rules from its labelsWhat people report to the FDA about zoledronic acid
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 28,316 reports naming zoledronic acid, and the FDA flagged 92% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- osteonecrosis of jaw2,597 reports
- fatigue1,967 reports
- diarrhoea1,845 reports
- nausea1,803 reports
- pyrexia1,711 reports
- arthralgia1,457 reports
- vomiting1,438 reports
- neutropenia1,405 reports
Read these as a signal, not a rate. A report does not mean zoledronic acid caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 26, 2026.
Related guides
Related calculators
Frequently asked questions
What is zoledronic acid?
Zoledronic Acid is a bisphosphonate used to treat Bone Neoplasms, Hypercalcemia, Multiple Myeloma, Extramammary Paget Disease.
What kind of drug is zoledronic acid?
The FDA classifies zoledronic acid as a bisphosphonate. Bisphosphonates stick to the mineral surface of bone, especially where it is being broken down. When the bone-dissolving cells (osteoclasts) take the drug up, it disables or kills them, slowing bone loss and helping keep bones denser and stronger. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take zoledronic acid with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run zoledronic acid against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is zoledronic acid sold under?
We track 3 zoledronic acid-containing products in the U.S.: Zometa, Reclast and Zoledronic Acid. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does zoledronic acid come in?
Across the brands we track, zoledronic acid is currently marketed as injectable and solution, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic zoledronic acid?
Yes. Our catalog lists 1 generic zoledronic acid product alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.
Has zoledronic acid been recalled?
The FDA's Enforcement database lists 1 recall record whose product description mentions zoledronic acid. The most recent: Zoledronic Acid Injection 5mg/100mL Sterile Solution (May 23, 2024). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.
Cite this page
- APA
- pharmaranks. (2026, July 24). Zoledronic Acid: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/zoledronic-acid
- MLA
- “Zoledronic Acid: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/zoledronic-acid.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for zoledronic acid on DailyMed (NIH) ↗.