Prescription medicine
Zoledronic acid Brand names: Reclast; first approved as Zometa
Zoledronic acid (Reclast) is a prescription medicine with an FDA approval on record since 2001. FDA's NDC Directory lists it from 21 generic labelers, and pharmacies paid $0.475 per mL (Zoledronic acid 5 mg/100 mL) in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the zoledronic acid FDA label on DailyMed (effective November 15, 2023, Gland Pharma Limited); the NDA 21223 record on Drugs@FDA; every zoledronic acid label on DailyMed.
Highlights of the record
FDA label of November 15, 2023; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageZoledronic Acid Injection is a bisphosphonate indicated for the treatment of:
Hypercalcemia of malignancy.
Forms and strengths
- 0.04 mg/ml
- 0.05 mg/ml
- 4 mg/5ml
- 4 mg/100ml
- 5 mg/100ml
Injection (solution) (concentrate); injection (solution); injection.
On the market
- Earliest approval on file
- August 20, 2001 Zometa, Novartis; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 37 first March 4, 2013; 24 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 22 of which 21 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- August 5, 2028 Reclast injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.475 per mL Zoledronic acid 5 mg/100 mL
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 6 since 2014 0 Class I among all firms' recalls; latest May 23, 2024
- FAERS reports
- 39,910 through July 30, 2026
What is zoledronic acid used for?
From the label: indications and usageZoledronic Acid Injection is a bisphosphonate indicated for the treatment of:
Hypercalcemia of malignancy. ( 1.1 )
Patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy. […]
Conditions named in the indications of zoledronic acid's FDA labels, with every medicine labeled for each:
From other zoledronic acid labelsOsteoporosis: Osteoporosis in Postmenopausal Women Zoledronic acid injection is indicated for treatment of osteoporosis in postmenopausal women.
FDA pharmacologic class: Bisphosphonate.
Source: FDA drug label (Zoledronic Acid), Gland Pharma Limited, effective November 15, 2023 (SPL set 7a5e8962-7c4b-40bb-ad69-0c3edb0338af), via openFDA; the full label on DailyMed
What does the patient leaflet for zoledronic acid say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about Reclast?You should not receive Reclast if you are already receiving Zometa. Both Reclast and Zometa contain zoledronic acid. Reclast can cause serious side effects, including: 1. Low calcium levels in your blood (hypocalcemia) 2. Severe kidney problems 3. Severe jaw bone problems (osteonecrosis) 4. Unusual breaks in thigh and other bones 5. Bone, joint or muscle pain 1. Low calcium levels in your blood (hypocalcemia). Reclast may lower the calcium levels in your blood. If you have low blood calcium before you start taking Reclast, it may get worse during treatment. Your low blood calcium must be treated before you take Reclast. Most people with low blood calcium levels do not have symptoms, but some people may have symptoms. Call your doctor right away if you have symptoms of low blood calcium, such as: • Spasms, twitches, or cramps in your muscles • Numbness or tingling in your fingers, toes, or around your mouth Your doctor may prescribe calcium and vitamin D to help prevent low calcium levels in your blood, while you take Reclast. Take calcium and vitamin D as your doctor tells you to. 2 . Severe kidney problems. Severe kidney problems may happen when you take Reclast. Severe kidney problems may lead to hospitalization or kidney dialysis and can be life-threatening. Your risk of kidney problems is higher if you: • already have kidney problems • take a diuretic or “water pill” • do not have enough water in your body (dehydrated) before or after you receive Reclast • are of advanced age since the risk increases as you get older • take any medicines known to harm your kidneys You should drink at least 2 glasses of fluid within a few hours before receiving Reclast to reduce the risk of kidney problems. 3 . Severe jaw bone problems (osteonecrosis). […]
Source: FDA drug label (Reclast), Sandoz Inc, effective February 3, 2026 (SPL set 5a9b3737-9ce6-4a89-b76e-6aab79eba9cf), via openFDA; the full label on DailyMed
Is there a generic for zoledronic acid (Reclast)?
The FDA approved the first generic zoledronic acid on March 4, 2013. 37 generic applications are approved; 24 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 12 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists zoledronic acid from 21 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 1 patent for Reclast injection, the last expiring on August 5, 2028. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2001 earliest approval on file
- 2013 first generic approved
- 2028 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for zoledronic acid (Reclast)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.475 per mL (Zoledronic acid 5 mg/100 mL), down 29% from $0.669 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Zoledronic acid 5 mg/100 mL (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Zoledronic acid 5 mg/100 mL | Generic | $0.475 per mL | n/a | -29% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has zoledronic acid been recalled?
The FDA's Enforcement Report lists 6 recalls naming zoledronic acid since 2014: 0 Class I (the most serious), 3 Class II, 3 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| May 23, 2024 | Class II | Dr. Reddy's Laboratories, Inc. | Lack of Assurance of Sterility: Leaking vials |
| February 24, 2020 | Class III | Breckenridge Pharmaceutical, Inc | Failed Impurities/Degradation Specifications: Out-of-specification results obtained for impurities during stability testing. |
| September 12, 2018 | Class III | Dr. Reddy's Laboratories, Inc. | Failed Impurities/Degradation Specifications: OOS for unknown impurities. |
| March 3, 2016 | Class II | Dr. Reddy's Laboratories, Inc. | Lack of Assurance of Sterility; defective seals where the metal silver ring was not attached tightly to the vial |
| March 4, 2014 | Class II | Sagent Pharmaceuticals Inc | Lack of Assurance of Sterility; leaking of premix bags |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the zoledronic acid label say about other medicines?
The zoledronic acid label names 4 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Dexamethasone | warnings and precautions | A number of case reports noted that patients were also receiving treatment with glucocorticoids (such as prednisone or dexamethasone) at the time of fracture. |
| Digoxin | drug interactions | In patients with renal impairment, the exposure to concomitant medications that are primarily renally excreted (e.g., digoxin) may increase. |
| Prednisone | warnings and precautions | A number of case reports noted that patients were also receiving treatment with glucocorticoids (such as prednisone or dexamethasone) at the time of fracture. |
| Thalidomide | drug interactions | No dose adjustment for Zoledronic Acid Injection 4 mg is needed when coadministered with thalidomide. |
Source: FDA drug label (Zoledronic Acid), Gland Pharma Limited, effective November 15, 2023 (SPL set 7a5e8962-7c4b-40bb-ad69-0c3edb0338af), via openFDA; the full label on DailyMed
What do FAERS reports show for zoledronic acid?
The FDA Adverse Event Reporting System holds 39,910 reports that list zoledronic acid among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 5,134 are coded as a death and 11,505 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as zoledronic acid?
1 other medicine is given the same way (intravenous) and in the same FDA class as zoledronic acid or labeled mainly for the same use (osteoporosis), the same class first. Osteoporosis lists all 16 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Ibandronate | Osteoporosis | 3 labelers | $52.65 per mL 3 mg/3 mL syringe | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Other bisphosphonates
- the pharmacologic class, with prices and generics
- Zoledronic acid side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other