Zoledronic acid is a bisphosphonate indicated for treatment and prevention of postmenopausal osteoporosis, among other approved uses. It is available as injection for intravenous use. MedsAcross supplies Zoledronic acid for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
Reclast is a bisphosphonate indicated for: • Treatment and prevention of postmenopausal osteoporosis. • Treatment to increase bone mass in men with osteoporosis. • Treatment and prevention of glucocorticoid-induced osteoporosis. • Treatment of Paget’s disease of bone in men and women. Limitations of Use Optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use
Source: US FDA prescribing information
Reclast is a bisphosphonate and acts primarily on bone. It is an inhibitor of osteoclast-mediated bone resorption. The selective action of bisphosphonates on bone is based on their high affinity for mineralized bone. Intravenously administered zoledronic acid rapidly partitions to bone and localizes preferentially at sites of high bone turnover. The main molecular target of zoledronic acid in the osteoclast is the enzyme farnesyl pyrophosphate synthase. The relatively long duration of action of zoledronic acid is attributable to its high binding affinity to bone mineral.
Source: US FDA prescribing information
Infusion given intravenously over no less than 15 minutes: • Treatment of postmenopausal osteoporosis, treatment to increase bone mass in men with osteoporosis: treatment and prevention of glucocorticoid-induced osteoporosis: 5 mg once a year • Prevention of postmenopausal osteoporosis: 5 mg once every 2 years. • Treatment of Paget’s disease of bone: a single 5 mg infusion. Patients should receive 1500 mg elemental calcium and 800 international units vitamin D daily
Source: US FDA prescribing information
Reclast is contraindicated in patients with the following conditions: • Hypocalcemia • Creatinine clearance less than 35 mL/min and in those with evidence of acute renal impairment due to an increased risk of renal failure. • Known hypersensitivity to zoledronic acid or any components of Reclast. Hypersensitivity reactions, including urticaria, angioedema, and anaphylactic reaction/shock have been reported. • Hypocalcemia. • Patients with creatinine clearance less than 35 mL/min and in those with evidence of acute renal impairment. • Hypersensitivity to any component of Reclast
Source: US FDA prescribing information
• Products Containing Same Active Ingredient: Patients receiving Zometa should not receive Reclast. • Hypocalcemia may worsen during treatment. Patients must be adequately supplemented with calcium and vitamin D. • Renal Impairment: A single dose should not exceed 5 mg and the duration of infusion should be no less than 15 minutes. Renal toxicity may be greater in patients with underlying renal impairment or with other risk factors, including advanced age or dehydration. Monitor creatinine clearance before each dose. • Osteonecrosis of the Jaw (ONJ) has been reported. All patients should have a routine oral exam by the prescriber prior to treatment. • Atypical Fractures Including Femoral Fractures have been reported. Patients with thigh or groin pain should be evaluated to rule out a femoral fracture.
Source: US FDA prescribing information
The following clinically significant adverse drug reactions are described elsewhere in the labeling: • Drugs with Same Active Ingredient • Hypocalcemia and Mineral Metabolism • Renal Impairment • Osteonecrosis of the Jaw • Atypical Fractures Including Femoral Fractures • Musculoskeletal Pain • Patients with Asthma The most common adverse reactions (greater than 10%) were pyrexia, myalgia, headache, arthralgia, pain in extremity. Other important adverse reactions were flu-like illness, nausea, vomiting, diarrhea, and eye inflammation.
Source: US FDA prescribing information
No in vivo drug interaction studies have been performed for Reclast. In vitro and ex vivo studies showed low affinity of zoledronic acid for the cellular components of human blood. In vitro mean zoledronic acid protein binding in human plasma ranged from 28% at 200 ng/mL to 53% at 50 ng/mL. In vivo studies showed that zoledronic acid is not metabolized, and is excreted into the urine as the intact drug. • Aminoglycosides: May lower serum calcium for prolonged periods. • Loop Diuretics: May increase risk of hypocalcemia. • Nephrotoxic Drugs: Use with caution. • Drugs Primarily Excreted by the Kidney: Exposure may be increased with renal impairment. Monitor serum creatinine in patients at risk
Source: US FDA prescribing information
Storage Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F to 86°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
4 presentations of Zoledronic acid, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Zoledronic acid 4 mg/5 mL injectionIntravenousGeneric name | — | US FDA | Available on request |
| Zoledronic acid 5 mg/100 mL injectionIntravenousGeneric name | — | US FDA | Available on request |
| Zoledronic acid 4 mg/100 mL injectionIntravenousGeneric name | — | US FDA | Available on request |
| Reclast 5 mg/100 mL injectionIntravenous | Sandoz | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Conditions linked to Zoledronic acid in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 4 presentations of Zoledronic acid and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Zoledronic acid, including Reclast.
Yes. The US FDA first approved Zoledronic acid on 20 August 2001, according to Drugs@FDA.
Yes. Zoledronic acid has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Zoledronic acid is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Zoledronic acid is classified under ATC code M05BA08 (Zoledronic acid).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.