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Zoledronic Acid

Zoledronic acid is an intravenous bisphosphonate (a bone-strengthening medicine) used for osteoporosis and Paget’s disease of bone, and for high blood calcium from cancer and cancer that affects the bones.

Brand name Reclast
Drug class Bisphosphonate
Rx Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 35 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 7, 2026
Other forms & routes:
Zoledronic Acid at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Zoledronic acid is a long-acting IV bisphosphonate (bone-strengthening medicine) that slows osteoclasts, the cells that break bone down, and treats osteoporosis and Paget’s disease of bone and, in cancer-care products, high calcium from cancer, multiple myeloma and cancer that has spread to bone; around since about 1995 and available generically, it is often chosen for osteoporosis when bisphosphonate tablets are hard to take. It is usually well tolerated, though many people get a flu-like reaction (fever, headache, aching muscles and joints) for a few days after the first infusion. The main thing to watch is your kidneys, so drink plenty beforehand and expect a kidney blood test first.

Clinical pearls

  • Low calcium must be corrected before the infusion, and keep taking calcium and vitamin D as directed afterward.
  • Get a dental exam before starting, and put off invasive dental work during treatment when possible, to lower jaw bone risk.
  • Report new thigh, groin or hip pain promptly, since it can signal an unusual thigh bone fracture.
  • Loop diuretics (water pills), aminoglycoside antibiotics and NSAID pain relievers like ibuprofen can deepen low calcium or strain kidneys.
How you get itPrescription only
Comes asInjection
Earliest FDA record1995
Companies listing it with the FDA20
FDA label last updatedFeb 3, 2026
FDA’s strongest warning (boxed)None on the label

Patient information guide A plain-language walkthrough of Zoledronic Acid, written from its FDA label.

What Zoledronic Acid is used for

▾

Zoledronic acid is an IV bisphosphonate with different approved uses depending on the product.

  • Reclast and zoledronic acid injection (osteoporosis labels): treatment and prevention of postmenopausal osteoporosis.
  • Treatment to increase bone mass in men with osteoporosis.
  • Treatment and prevention of glucocorticoid-induced osteoporosis in men and women.
  • Treatment of Paget’s disease of bone in men and women.
  • Zoledronic acid injection (concentrate label): hypercalcemia of malignancy.
  • Zoledronic acid injection (concentrate label): multiple myeloma and bone metastases from solid tumors, alongside standard cancer therapy. Prostate cancer must have progressed after at least one hormonal therapy.

How Zoledronic Acid works

▾

Zoledronic acid targets bone. It sticks to mineralized bone and collects where bone turnover is high. There it blocks an enzyme (farnesyl pyrophosphate synthase) in osteoclasts, the cells that break bone down. Less bone breakdown means stronger bone and less calcium released into the blood. It binds tightly to bone, so its effects last a long time.

Zoledronic Acid dosage

▾

Zoledronic acid is given by a healthcare professional as an IV infusion lasting at least 15 minutes. It is not taken by mouth, so food does not matter.

  • Osteoporosis products: about once a year or every 2 years, depending on the use.
  • Paget’s disease: a single infusion, with re-treatment considered if it returns.
  • Cancer-care products: a single infusion for high calcium, or about every 3 to 4 weeks for multiple myeloma and bone metastases.

Because it is given in a clinic, missed doses are handled by your care team. Follow your prescriber’s plan.

Dosing details from the FDA-approved label

From the Zoledronic Acid prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Treatment of Osteoporosis in Postmenopausal Women
    • 5 mg infusion once a year given intravenously over no less than 15 minutes
    • Contraindicated if creatinine clearance less than 35 mL/min; no adjustment if greater than or equal to 35 mL/min
  • Prevention of Osteoporosis in Postmenopausal Women
    • 5 mg infusion given once every 2 years intravenously over no less than 15 minutes
    • Contraindicated if creatinine clearance less than 35 mL/min
  • Osteoporosis in Men
    • 5 mg infusion once a year given intravenously over no less than 15 minutes
    • Contraindicated if creatinine clearance less than 35 mL/min
  • Treatment and Prevention of Glucocorticoid-Induced Osteoporosis
    • 5 mg infusion once a year given intravenously over no less than 15 minutes
    • Contraindicated if creatinine clearance less than 35 mL/min
  • Treatment of Paget's Disease of Bone
    • A single 5 mg infusion
    • Infusion time must not be less than 15 minutes at a constant infusion rate
    • Re-treatment may be considered in patients who have relapsed
    • Patients should take 1500 mg elemental calcium and 800 international units vitamin D daily; contraindicated if creatinine clearance less than 35 mL/min
  • Hypercalcemia of malignancy (albumin-corrected serum calcium greater than or equal to 12 mg/dL [3.0 mmol/L])
    • 4 mg as a single-dose intravenous infusion over no less than 15 minutes
    • Retreatment with 4 mg may be considered after a minimum of 7 days
    • Maximum: 4 mg
    • No dose adjustment for mild-to-moderate renal impairment (serum creatinine less than 400 µmol/L or less than 4.5 mg/dL) prior to therapy
  • Multiple myeloma and bone metastases of solid tumors, CrCl greater than 60 mL/min
    • 4 mg infused over no less than 15 minutes every 3 to 4 weeks
    • Also give oral calcium 500 mg and a multiple vitamin containing 400 international units vitamin D daily
  • Multiple myeloma and bone metastases of solid tumors, baseline CrCl 50 to 60 mL/min
    • 3.5 mg every 3 to 4 weeks
    • Reduced dose for renal impairment
  • Multiple myeloma and bone metastases of solid tumors, baseline CrCl 40 to 49 mL/min
    • 3.3 mg every 3 to 4 weeks
    • Reduced dose for renal impairment
  • Multiple myeloma and bone metastases of solid tumors, baseline CrCl 30 to 39 mL/min
    • 3 mg every 3 to 4 weeks
    • Reduced dose for renal impairment
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Hypercalcemia of malignancy ( 2.1 ) • 4 mg as a single-dose 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-dose 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 ) 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 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 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). Patients should be adequately rehydrated prior to administration of zoledronic acid injection [see Warnings and Precautions (5.2) ] . Consideration should be given to the severity of, as well as the symptoms of, tumor-induced hypercalcemia when considering use of zoledronic acid injection. Vigorous saline hydration, an integral part of hypercalcemia therapy, should be initiated promptly and an attempt should be made to restore the urine output to about 2 L/day throughout treatment. Mild or asymptomatic hypercalcemia may be treated with conservative measures (i.e., saline hydration, with or without loop diuretics). Patients should be hydrated adequately throughout the treatment, but overhydration, especially in those patients who have cardiac failure, must be avoided.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Zoledronic Acid side effects

▾

Common effects tend to be flu-like and bone- or muscle-related.

Common side effects

  • Fever
  • Muscle pain
  • Headache
  • Joint pain
  • Pain in arms or legs
  • Flu-like illness
  • Nausea
  • Vomiting or diarrhea

When to get medical help

  • Call your doctor right away for new thigh, groin or hip pain. It could signal an unusual thigh bone fracture.
  • Get help for jaw pain, swelling, loose teeth or sores that won’t heal. These can be signs of osteonecrosis of the jaw.
  • Tell your doctor about severe bone, joint or muscle pain. The medicine may need to be stopped.
  • Seek help for muscle spasms, numbness, seizures or an irregular heartbeat. These can come from very low calcium.
  • Get urgent help for hives, swelling of the face or throat, or trouble breathing. These can be signs of a serious allergic reaction.
  • Report less urination or other signs of kidney problems.

Zoledronic Acid warnings and precautions

▾
  • Kidney problems: the drug leaves the body through the kidneys. Risk is higher with existing kidney disease, dehydration or other kidney-harming drugs.
  • Low calcium: it can cause irregular heartbeat, seizures, tetany (muscle spasms) and numbness. It must be corrected before treatment.
  • Osteonecrosis of the jaw: a dental exam before treatment is advised, and avoid invasive dental work if possible.
  • Severe bone, joint or muscle pain: stop the drug if severe symptoms develop.
  • Unusual thigh bone fractures: report thigh or groin pain.
  • Pregnancy: it can cause fetal harm.

Zoledronic Acid interactions

▾

Tell your care team about all your medicines. Key ones include:

  • Aminoglycoside antibiotics: can lower calcium for a long time.
  • Loop diuretics: raise the risk of low calcium.
  • NSAIDs and other kidney-harming drugs: call for caution.
  • Digoxin and other drugs cleared by the kidneys: levels may rise if kidney function is poor.
  • Reclast or other bisphosphonates: should not be used along with zoledronic acid injection.

Interactions listed in the FDA-approved label

From the Zoledronic Acid prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Aminoglycosides: May have an additive effect to lower serum calcium level for prolonged periods. Caution is advised.
  • Loop diuretics: Increased risk of hypocalcemia. Caution should be exercised when used in combination.
  • Nephrotoxic drugs (e.g., NSAIDs): Potentially nephrotoxic drugs used with zoledronic acid. Caution is indicated.
  • Drugs primarily excreted by the kidney (e.g., digoxin): In patients with renal impairment, exposure to concomitant renally excreted medications may increase. Consider monitoring serum creatinine in patients at risk for renal impairment.
Read the label’s full interactions text

7 DRUG INTERACTIONS No in vivo drug interaction studies have been performed for zoledronic acid injection. 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 ( 7.1 ) • Loop Diuretics: May increase risk of hypocalcemia ( 7.2 ) • Nephrotoxic Drugs: Use with caution ( 7.3 ) • Drugs Primarily Excreted by the kidney: Exposure may be increased with renal impairment. Monitor serum creatinine in patients at risk ( 7.4 ) 7.1 Aminoglycosides Caution is advised when bisphosphonates, including zoledronic acid, are administered with aminoglycosides, 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 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 such as nonsteroidal anti-inflammatory drugs (NSAIDs). 7.4 Drugs Primarily Excreted by the Kidney Renal impairment has been observed following the administration of zoledronic acid in patients with pre-existing renal compromise or other risk factors [ see Warnings and Precautions ( 5.3 )]. In patients with renal impairment, the exposure to concomitant medications that are primarily renally excreted (e.g., digoxin) may increase. Consider monitoring serum creatinine in patients at risk for renal impairment who are taking concomitant medications that are primarily excreted by the kidney.

Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Before taking Zoledronic Acid

▾
  • Not for people with low calcium, a known allergy to it, or reduced kidney function below the label limit or sudden kidney problems.
  • Tell your doctor if you are pregnant, planning pregnancy or breastfeeding.
  • Not indicated for children.
  • Older adults need kidney function monitored.
  • Little clinical data exist in people with liver problems.
  • Get a dental check first, and tell your doctor if you are sensitive to aspirin.

Zoledronic Acid overdose

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Too much zoledronic acid can cause low calcium, phosphate and magnesium. Other reported effects include fever, tingling, abnormal liver tests and kidney harm. Low mineral levels are corrected with IV replacement.

What Zoledronic Acid does in the body

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In people with high calcium from cancer, single infusions lower blood calcium and phosphorus and increase calcium and phosphorus lost in the urine. Excess bone breakdown drives this condition, and the drug reduces it.

How your body processes Zoledronic Acid

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Blood levels fall quickly after an infusion, while the drug moves into bone. It is not metabolized and leaves the body mostly unchanged through the kidneys. About 39% of a dose appeared in the urine within 24 hours. The rest binds to bone and is released slowly. Kidney impairment raises drug exposure.

How to store Zoledronic Acid

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Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F).

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

Zoledronic Acid: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Zoledronic Acid — the kind of thing our pharmacy team would talk through with you at the counter.

What is zoledronic acid for?

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It depends on the product. Reclast and similar zoledronic acid injections treat and prevent osteoporosis and treat Paget’s disease of bone. A different zoledronic acid injection treats high calcium from cancer, and bone problems from multiple myeloma and bone metastases.

How is it given, and what should I do beforehand?

▾
It is an IV infusion given by a healthcare professional over at least 15 minutes. You should be well hydrated beforehand. Your team will tell you about calcium and vitamin D.

What side effects should I expect?

▾
Fever, muscle or joint aches, headache and flu-like symptoms are common. They often come soon after an infusion. Acetaminophen afterward may ease them, if your prescriber agrees.

When should I call my doctor?

▾
Call for jaw pain or swelling, new thigh or groin pain, severe bone or muscle pain, muscle spasms or numbness, or less urination. Get urgent help for facial swelling or trouble breathing.

Can I take it if I’m pregnant or breastfeeding?

▾
Tell your doctor if you are pregnant or could become pregnant. It can harm an unborn baby and stays in bone for a long time. There are no data on breastfeeding.

Do I need dental care before treatment?

▾
A dental exam before starting is advised, since the drug can cause jaw bone damage. Try to avoid invasive dental work during treatment, and keep good oral hygiene.

Is Zoledronic Acid available over the counter?

▾
No. Zoledronic Acid is a prescription medicine: every Zoledronic Acid product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Zoledronic Acid first available?

▾
The earliest FDA record we hold for Zoledronic Acid is from 1995: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Zoledronic Acid was first used.

Who makes Zoledronic Acid?

▾
20 companies currently list Zoledronic Acid products in the FDA's NDC Directory, including Gland Pharma Limited, Dr. Reddy's Laboratories Inc., BluePoint Laboratories. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Zoledronic Acid on HelloPharmacist

Detailed data & references for Zoledronic Acid Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Zoledronic Acid forms and strengths (how it comes)

Zoledronic Acid is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Zoledronic Acid inactive ingredients by manufacturer.

Injection

Into a vein
Brands Reclast
How this form is used
What it may be used for
  • Reclast is used for postmenopausal osteoporosis, osteoporosis in men, glucocorticoid-induced osteoporosis and Paget’s disease of bone.
  • Zoledronic acid injection (osteoporosis labels) is used for the same osteoporosis and Paget’s disease uses.
  • Zoledronic acid injection (concentrate label) is used for hypercalcemia of malignancy, multiple myeloma and bone metastases from solid tumors.
Important instructions
  • Reclast is given as an IV infusion over at least 15 minutes, followed by a saline flush.
  • Reclast: you should be well hydrated first, and acetaminophen afterward may ease flu-like reactions.
  • Zoledronic acid injection (cancer-care label) is given as an IV infusion over at least 15 minutes, with kidney function checked before each dose.
  • Zoledronic acid injection (cancer-care label) should run through a separate line, away from solutions containing calcium.
Available strengths 5 strengths
68 FDA-listed product records ⓘ

Zoledronic Acid on the U.S. market: products, makers and brands

How Zoledronic Acid appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

20 companies list 35 Zoledronic Acid product records with the FDA, mostly as injection; the earliest marketing or approval year on record is 1995. Brand names on the directory include Reclast; the rest are generics.

1
Dose forms ⓘ
20
Labelers (makers, repackagers, distributors)
2
Brand names
35
FDA-listed product records ⓘ
1995
Earliest FDA record ⓘ

Also listed with the FDA, not a patient dose form: Powder (14) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Gland Pharma Limited17%
Dr. Reddy's Laboratories Inc.11%
BluePoint Laboratories9%
Mylan Institutional LLC9%
BPI Labs LLC6%
Fresenius Kabi USA, LLC6%
Other makers43%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Zoledronic Acid is used (Medicaid data)

A general measure of how commonly Zoledronic Acid is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Zoledronic Acid is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

26,317
Medicaid prescriptions filled (Q1–Q4 2025)
$2.7M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Zoledronic Acid prescribed? Of the 1,601 medications we measure, Zoledronic Acid ranks #760 by Medicaid prescriptions — more than 53% of them.

Where Zoledronic Acid ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Zoledronic Acid product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 5 mL / 0.8 mg/mL injection is the most-dispensed Zoledronic Acid product — about 43% of these Medicaid prescriptions.

5 ML zoledronic acid 0.8 MG/ML Injection Most dispensed

11,340 Medicaid prescriptions (Q1–Q4 2025) 43% of Zoledronic Acid prescriptions shown $992,043 gross reimbursement (before rebates) ≈ $87 per prescription (gross)

Summed across the 10 of 26 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 351114

100 ML zoledronic acid 0.04 MG/ML Injection

9,806 Medicaid prescriptions (Q1–Q4 2025) 37% of Zoledronic Acid prescriptions shown $1.3M gross reimbursement (before rebates) ≈ $135 per prescription (gross)

Summed across the 3 of 7 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1114085

100 ML zoledronic acid 0.05 MG/ML Injection

5,171 Medicaid prescriptions (Q1–Q4 2025) 20% of Zoledronic Acid prescriptions shown $347,265 gross reimbursement (before rebates) ≈ $67 per prescription (gross)

Summed across the 8 of 19 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 705824

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Zoledronic Acid, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 21 of 52 listed Zoledronic Acid NDCs with Medicaid activity.

Compare Zoledronic Acid products

A representative set of FDA-listed product records for Zoledronic Acid — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 35 of 35 products — FDA National Drug Code Directory. See every product, package size and price: browse all 35 Zoledronic Acid NDCs →

Zoledronic Acid side effects reported to the FDA (FAERS)

After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Zoledronic Acid — a signal of what to watch for, not proof the drug caused it.

The effects most often named in FDA reports that mention Zoledronic Acid are arthralgia, pain, nausea; about 87% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.

39,910
Reports mentioning it
87%
Reported as serious
12
Distinct effects shown
Most reported effects
Arthralgia
3,219
Pain
3,151
Nausea
2,819
Pyrexia
2,811
Fatigue
2,797
Osteonecrosis Of Jaw
2,708
Death
2,498
Headache
2,366
Diarrhoea
2,278
Vomiting
2,061
Age groups
Elderly · 3,384Adult · 2,531Child · 103Adolescent · 47Neonate · 14Infant · 8

Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Zoledronic Acid in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.

Zoledronic Acid FDA approval history

How Zoledronic Acid went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.

Zoledronic Acid was first approved by the FDA in 1995; the first generic version was approved in 2013. It remains available in U.S. pharmacies today.

1995
First FDA approval
2013
First generic approved
Lower-cost ANDA competition begins
2026
Available today
Active in U.S. pharmacies

Source: Drugs@FDA.

Zoledronic Acid recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Zoledronic Acid recalls since July 2021.

✅No Zoledronic Acid recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Zoledronic Acid RxCUI 77655 1 dose form · 4 strengths

Look up RxCUI 77655 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

Zoledronic Acid brand names

Zoledronic Acid is sold under one brand name in the FDA directory — Reclast. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Reclast

Who makes Zoledronic Acid: manufacturers and labelers

20 companies list Zoledronic Acid products with the FDA. By number of product records, the largest are Gland Pharma Limited, Dr. Reddy's Laboratories Inc., BluePoint Laboratories. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Gland Pharma Limited 6 Dr. Reddy's Laboratories Inc. 4 BluePoint Laboratories 3 Mylan Institutional LLC 3 BPI Labs LLC 2 Fresenius Kabi USA, LLC 2 Sagent Pharmaceuticals 2 Accord Healthcare Inc. 1 AuroMedics Pharma LLC 1 Avenacy Inc. 1 Dr. Reddy's Laboratories Limited 1 Dr.Reddy's Laboratories Ltd 1 Eugia US LLC 1 Fosun Pharma Usa Inc 1 Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 1 Hikma Pharmaceuticals USA Inc. 1 Meitheal Pharmaceuticals Inc. 1 Northstar Rx Llc 1 Sandoz Inc 1 Westminster Pharmaceuticals, LLC 1

Zoledronic Acid drug class (RxNorm)

Zoledronic Acid belongs to the Bisphosphonate class.

Pharmacologic class Bisphosphonate
Drug family (ATC) Bisphosphonates

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Zoledronic Acid page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Feb 3, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Zoledronic Acid.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Zoledronic Acid after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
35
Finished products in the current FDA directory
35
Companies listing them (makers, repackagers, distributors)
20
FDA labeler codes behind them ⓘ
18
Linked representative label ⓘ
Sandoz Inc
Linked label effective
Feb 3, 2026
Composite sections available
24
Linked SPL Set ID
5a9b3737-9ce6-4a89-b76e-6aab79eba9cf
Linked SPL Document ID
12a00376-75c0-41e4-b0a5-d8adb81a3cc4
Open the linked representative label on DailyMed ↗
NDC package records associated with this linked SPL 1

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Sandoz Inc is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →