FDA-filed SPL labeling · retrieved through openFDA

Zoledronic Acid

Zoledronic acid is an intravenous bisphosphonate used to treat and prevent osteoporosis, treat Paget's disease of bone, and — in certain formulations — to treat high blood calcium caused by cancer and bone complications from multiple myeloma or solid tumor metastases.

Brand name Reclast
Drug class ⓘ Bisphosphonate
Rx Form 1 Route Intravenous
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 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 36 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 →

At a glance
Linked label effectiveFeb 3, 2026
Clinical labels in scope ⓘ36
AvailabilityRx
Earliest approval/marketing year ⓘ1995
FDA-listed product records ⓘ91
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 21, 2026 🚨Recall on record
Other forms & routes:
Injection
⭐ Zoledronic Acid at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Zoledronic acid is a powerful once-yearly (or less frequent) IV bone medication that can significantly reduce fracture risk in osteoporosis, treat Paget's disease of bone, and manage serious bone complications from cancer. It requires careful monitoring of kidney function and blood calcium levels before and during treatment. Talk to your care team about dental health, pregnancy planning, and any kidney or medication concerns before your infusion.
How we write & review this content — our editorial policy →

📖 Zoledronic Acid: Patient Information Guide

A plain-language walkthrough of Zoledronic Acid — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for▾

Zoledronic acid is an IV bisphosphonate approved across several products for a range of bone conditions. Not all formulations cover every use — specific products are noted below.

  • Reclast and zoledronic acid injection: Treatment of osteoporosis in postmenopausal women, including reducing hip, spine, and other fracture risk
  • Reclast and zoledronic acid injection: Prevention of osteoporosis in postmenopausal women
  • Reclast and zoledronic acid injection: Treatment to increase bone mass in men with osteoporosis
  • Reclast and zoledronic acid injection: Treatment and prevention of glucocorticoid-induced osteoporosis (bone loss caused by long-term steroid use) in men and women expected to remain on steroids for at least 12 months
  • Reclast and zoledronic acid injection: Treatment of Paget's disease of bone in men and women
  • Zoledronic Acid injection (oncology formulations): Treatment of hypercalcemia of malignancy — dangerously elevated blood calcium caused by cancer
  • Zoledronic Acid injection (oncology formulations): Treatment of bone complications in patients with multiple myeloma or bone metastases from solid tumors (prostate cancer must have progressed after at least one hormonal therapy), used with standard cancer treatment
⚙️How it works▾

Zoledronic acid works by targeting osteoclasts — the cells that break down and resorb (dissolve) bone. It binds tightly to mineralized bone and blocks a key enzyme inside osteoclasts called farnesyl pyrophosphate synthase. This causes osteoclasts to become inactive and die off, slowing the rate at which bone is broken down. In cancer-related bone disease, it also blunts the excessive calcium release from bone that tumors can trigger. Because zoledronic acid binds so firmly to bone mineral, it stays in bone tissue for a very long time, which is why a single yearly infusion can be effective.

💊How it's taken▾

Zoledronic acid is always given as an intravenous (IV) infusion in a clinical setting — never taken by mouth. The infusion must run over at least 15 minutes. Reclast is typically given once a year for osteoporosis treatment in postmenopausal women and men, and once every two years for osteoporosis prevention; a single infusion is used for Paget's disease. Oncology formulations of zoledronic acid are given on a schedule your oncology team will determine based on your condition.

  • Patients must be well-hydrated before each infusion
  • Calcium and vitamin D supplements are typically required alongside treatment — follow your prescriber's guidance on timing and amount
  • Do not receive both Reclast and a zoledronic acid oncology product at the same time — they contain the same active ingredient
🤒Side effects — in detail▾

The most common side effects tend to occur in the first few days after an infusion and often resemble a flu-like illness:

  • Fever (very common, especially after the first dose)
  • Muscle aches and joint pain
  • Headache
  • Chills and fatigue
  • Nausea, vomiting, or diarrhea
  • Pain in the arms or legs
  • Eye inflammation (redness or irritation)

More serious reactions — including low blood calcium, kidney problems, jaw bone damage, unusual thigh fractures, and severe bone or muscle pain — require prompt medical attention. Contact your doctor right away if you experience any of these.

⚠️Warnings & precautions▾
  • Kidney damage: Zoledronic acid is cleared by the kidneys and can worsen kidney function. Kidney tests are required before each dose. People with severe kidney impairment should not receive this drug.
  • Low blood calcium (hypocalcemia): Can cause muscle cramps, numbness, tingling, seizures, or heart rhythm problems. Blood calcium must be normal before starting, and calcium plus vitamin D supplements are usually required during treatment.
  • Osteonecrosis of the jaw (ONJ): Bone damage in the jaw has been reported, especially in cancer patients. A dental exam before starting treatment and avoiding invasive dental procedures during treatment are strongly recommended.
  • Unusual thigh bone fractures: Atypical fractures of the femur (thigh bone) have been reported, sometimes with little or no trauma. Report thigh or groin pain to your doctor promptly.
  • Severe bone, joint, or muscle pain: Can occur at any time after starting treatment. The drug may need to be stopped if symptoms are severe.
  • Fetal harm: Zoledronic acid can harm a developing baby. Women of childbearing age should use effective contraception during and after treatment. Stop the drug if pregnancy is recognized.
  • Do not combine products: Patients receiving zoledronic acid injection for cancer indications should not also receive Reclast — both contain the same active ingredient.
🔀What it interacts with▾

Zoledronic acid has several important drug interactions, mainly related to calcium levels and kidney function:

  • Aminoglycoside antibiotics (e.g., gentamicin): Can compound the calcium-lowering effect of zoledronic acid, potentially causing prolonged low blood calcium
  • Loop diuretics (e.g., furosemide/Lasix): Increase the risk of low blood calcium; should not be used until the patient is properly hydrated
  • NSAIDs (e.g., ibuprofen, naproxen): May amplify the risk of kidney damage when taken alongside zoledronic acid
  • Drugs cleared by the kidneys (e.g., digoxin): If zoledronic acid reduces kidney function, these drugs can accumulate to higher-than-normal levels; monitoring may be needed

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it▾
  • Do not use if you have low blood calcium (hypocalcemia) — it must be corrected first
  • Do not use if your kidney clearance (creatinine clearance) is below 35 mL/min or if you have signs of acute kidney injury
  • Do not use if you have a known allergy to zoledronic acid or any ingredient in the injection — serious allergic reactions including anaphylaxis have been reported
  • Tell your doctor if you are pregnant or may become pregnant — this drug can cause fetal harm, and should be stopped as soon as pregnancy is recognized
  • Breastfeeding mothers should discuss risks with their doctor; no data are available on whether zoledronic acid passes into breast milk
  • Not approved for use in children
  • Older adults should have kidney function monitored carefully — kidney function naturally declines with age and can affect how safely this drug is used
  • Tell your dentist about this medication before any dental procedures; preventive dental care is recommended before starting
  • People with aspirin-sensitive asthma should inform their doctor — some bisphosphonates have been linked to airway tightening in this group
  • Tell your doctor if you have liver disease — limited data are available for this group
🚑If you take too much▾

An overdose of zoledronic acid may cause low levels of calcium, phosphorus, and magnesium in the blood, which can lead to muscle cramps, numbness, abnormal heart rhythms, or other serious symptoms. In reported cases from clinical trials, these mineral imbalances were treated with IV replacement of calcium, phosphorus, and magnesium as needed. Getting the infusion too quickly also raises the risk of kidney toxicity — which is why the 15-minute minimum infusion time is strictly required.

📡Pharmacodynamics — effects in the body▾

Zoledronic acid directly reduces the activity of osteoclasts — the cells that break down bone — leading to less bone resorption (breakdown) and more stable bone mineral density. In patients with cancer-related high blood calcium, a single infusion lowers serum calcium and phosphorus levels while increasing their excretion in the urine. In metastatic bone disease, it blunts the tumor-driven signals that cause osteoclasts to release excess calcium from bone, helping to interrupt the cycle of worsening hypercalcemia (high blood calcium).

🔬Pharmacokinetics — how your body processes it▾

After an IV infusion, zoledronic acid levels in the blood drop rapidly — to less than 1% of peak levels within 24 hours — as the drug is quickly taken up by bone tissue. The drug is not broken down (metabolized) by the body; it is excreted unchanged through the kidneys, with roughly 39% of a dose recovered in the urine within the first 24 hours. The portion that binds to bone is released back into the bloodstream very slowly over weeks to years, giving the drug a prolonged terminal half-life of around 146 hours. Kidney function directly affects how quickly zoledronic acid is cleared — people with reduced kidney function have higher drug exposure and are at greater risk of side effects.

📦How to store it▾

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

📄 Written from Zoledronic Acid’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

🩺 Pharmacist Counseling Corner

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.

Why do I only need this infusion once a year? How can that be enough? ▾
Great question — it surprised a lot of patients at first. Zoledronic acid binds extremely tightly to bone mineral, so after your infusion, it stays embedded in your bone tissue and keeps working for many months. That long-lasting grip on bone is what allows a single yearly infusion to meaningfully reduce bone loss and fracture risk. For prevention of osteoporosis in postmenopausal women, it's actually given only once every two years.
What side effects should I expect after my infusion? ▾
The most common ones — especially after your first infusion — feel a lot like the flu: fever, muscle aches, joint pain, headache, and chills. These usually show up within the first day or two and tend to get better on their own. Taking acetaminophen (like Tylenol) after your infusion can help ease these symptoms. With repeat doses, most people find these reactions are much milder or don't happen at all.
I've heard this drug can cause jaw problems. Should I be worried? ▾
It's a real concern worth knowing about, but it's most commonly seen in cancer patients receiving this medication frequently and at higher intensity. The risk in osteoporosis patients is much lower. The best thing you can do is see your dentist before you start treatment, keep up good oral hygiene, and let both your doctor and dentist know you're on this medication. Try to avoid major dental procedures — like tooth extractions — while on therapy if at all possible.
Can I take this if I have kidney problems? ▾
That depends on how well your kidneys are working. Zoledronic acid is cleared entirely through the kidneys, and it can be hard on kidney function. If your kidney clearance is below a certain level — specifically below 35 mL/min — this drug is not safe for you. Your doctor will check your kidney function before each infusion. If you already have some kidney disease, it doesn't necessarily mean you can't use it, but your team will watch you closely.
Do I need to take calcium and vitamin D with this? ▾
Yes — this is really important. Zoledronic acid works by slowing bone breakdown, and if your calcium levels drop too low, it can cause serious problems including muscle cramps, numbness, and even heart rhythm issues. Your doctor will likely recommend calcium and vitamin D supplements to keep your levels stable. Make sure you're taking them as directed and don't skip them.
Is this safe if I'm thinking about getting pregnant? ▾
This is a medication that requires serious conversation with your doctor if pregnancy is on your mind. Zoledronic acid can harm a developing baby, and because it stays stored in bone for years after treatment, there's a potential risk even after you stop taking it. If you're of childbearing age, you should use effective contraception during treatment and discuss your family planning timeline with your doctor before and after therapy. If you find out you're pregnant while on this medication, stop it and contact your doctor right away.
Is Zoledronic Acid available over the counter? ▾
Zoledronic Acid is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Zoledronic Acid first available? ▾
Zoledronic Acid has been available in the United States since at least 1995, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Zoledronic Acid? ▾
Zoledronic Acid is supplied by 43 manufacturers listed in the FDA NDC Directory, including Mylan Institutional LLC, Gland Pharma Limited, Sagent Pharmaceuticals.

💬 Answers drafted from Zoledronic Acid’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

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💊 How Zoledronic Acid 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.

Injection

Into a vein
Brands Reclast
How this form is used
What it may be used for
  • Reclast is used to treat and prevent osteoporosis in postmenopausal women, treat osteoporosis in men, treat and prevent steroid-induced osteoporosis, and treat Paget's disease of bone
  • Zoledronic Acid injection (concentrate/solution formulations) is used to treat hypercalcemia of malignancy (dangerously high blood calcium due to cancer)
  • Zoledronic Acid injection is used to reduce bone complications in patients with multiple myeloma or bone metastases from solid tumors, alongside cancer treatment
Important instructions
  • Reclast is given as an IV infusion over no less than 15 minutes, once yearly for most osteoporosis indications, once every two years for prevention in postmenopausal women, or as a single infusion for Paget's disease
  • Reclast patients should be well-hydrated before their infusion; taking acetaminophen afterward may help reduce flu-like symptoms
  • Zoledronic Acid injection for cancer-related uses is administered intravenously over no less than 15 minutes; it must not come into contact with calcium-containing IV solutions and should be given through a separate infusion line
  • Patients receiving Zoledronic Acid injection for cancer indications should also take daily oral calcium and vitamin D supplements as directed by their care team
Available strengths 6 strengths
0.04 mg/mL 0.05 mg/mL 0.8 mg/mL 4 mg/5 mL 4 mg/100 mL 5 mg/100 mL
77 FDA-listed product records ⓘ

📊 Zoledronic Acid across the U.S. market

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.

1
Dose forms ⓘ
43
Manufacturers
2
Brand names
91
FDA-listed product records ⓘ
1995
First marketed ⓘ

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.

Mylan Institutional LLC11%
Gland Pharma Limited11%
Sagent Pharmaceuticals7%
BluePoint Laboratories6%
Fresenius Kabi USA, LLC5%
Dr. Reddy's Laboratories Inc.5%
Other makers56%

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

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 1,596 medications we measure, Zoledronic Acid ranks #760 by Medicaid prescriptions — more than 52% of them.

Where Zoledronic Acid ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #760 of 1,596
#755 Emicizumab 27,047 Rx #756 Zolmitriptan 27,026 Rx #757 Abemaciclib 27,007 Rx #758 Ampicillin and Sulbact... 26,484 Rx #759 Ampicillin / Sulbactam 26,484 Rx #760 Zoledronic Acid Inject... 26,317 Rx #761 Zoledronic Acid 26,317 Rx #762 Dolutegravir / Rilpivi... 26,206 Rx #763 Succinylcholine 25,454 Rx #764 Irinotecan Injection 25,359 Rx #765 Irinotecan 25,359 Rx

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 91 of 91 products — FDA National Drug Code Directory. See every product, package size and price: browse all 91 Zoledronic Acid NDCs →

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.

🏷️ Sold under these brand names

Reclast

🏭 Manufacturers & labelers

Mylan Institutional LLC 10 Gland Pharma Limited 10 Sagent Pharmaceuticals 6 BluePoint Laboratories 5 Fresenius Kabi USA, LLC 4 Dr. Reddy's Laboratories Inc. 4 Fosun Pharma Usa Inc 3 Dr.Reddy's Laboratories Ltd 3 Westminster Pharmaceuticals, LLC 2 Meitheal Pharmaceuticals Inc. 2 Hospira, Inc. 2 Accord Healthcare Inc. 2 Eugia US LLC 2 Emcure Pharmaceuticals Limited 2 Dr. Reddy's Laboratories Limited 2 BPI Labs, LLC 2 BPI Labs LLC 2 AuroMedics Pharma LLC 2 Athenex Pharmaceutical Division, LLC. 2 Novartis Pharmaceuticals Corporation 1 Sandoz Inc 1 ScinoPharm Taiwan Ltd. 1 Northstar RxLLC 1 Northstar Rx Llc 1

…and 16 more on the FDA NDC directory.

RxNorm drug class

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.

🔬 Where this comes from

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
36
NDC products indexed
91
Distinct labelers/manufacturers represented
43
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 we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 36 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Sandoz Inc is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.