Prescription medication · Bisphosphonate (IV)
zoledronic acid
Also sold as Reclast, Zometa. This medicine can treat high calcium levels in your blood caused by cancer.
Data updated 2026-05-15
- 38,197
- FDA reportsModerately reported
- 1
- InteractionFew interactions
- $0.59
- Generic price (NADAC)
What the data shows
zoledronic acid (Reclast) is a prescription Bisphosphonate (IV), reported at a middle-of-the-pack volume (38,197 FDA reports), with 1 documented drug interaction.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
zoledronic acid (Reclast) is a prescription Bisphosphonate (IV). This medicine can treat high calcium levels in your blood caused by cancer.
Zoledronic acid injection is a medicine that helps treat high calcium levels in the blood and bone problems caused by cancer. It belongs to a class of drugs called bisphosphonates and is given through a vein.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Generic Price
$0.59/unit
Generic Available
Yes (20 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
This medicine can treat high calcium levels in your blood caused by cancer.
Common side effects
Nausea, Tiredness, Anemia (low red blood cells)
Key warnings
Do not take zoledronic acid if you are also taking Reclast or other bisphosphonates.
The sections below are summarized in plain English from zoledronic acid's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Zoledronic acid works by slowing down the breakdown of bone. It does this by targeting cells called osteoclasts, which are responsible for breaking down bone tissue. By slowing down bone breakdown, it can lower calcium levels in the blood and reduce bone pain and fractures.
Side Effects (from patient reports)
Based on 38,197 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for zoledronic acid, by number of reports
- Arthralgia
Arthralgia
3,083 reports
- Pain
Pain
3,046 reports
- Pyrexia
Pyrexia
2,701 reports
- Nausea
Nausea
2,690 reports
- Fatigue
Fatigue
2,657 reports
- Osteonecrosis Of Jaw
Osteonecrosis Of Jaw
2,613 reports
- Death
Death
2,438 reports
- Headache
Headache
2,278 reports
- Diarrhoea
Diarrhoea
2,189 reports
- Vomiting
Vomiting
1,983 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for zoledronic acid each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where zoledronic acid sits
zoledronic acid has more FDA adverse-event reports than 69% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is zoledronic acid; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 38,197 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2003–2025.
Total Reports
38,197
Reports Mentioning Death
4,999
13.1% of reports — not proof of cause
Hospitalization Reports
11,023
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | ARTHRALGIA | 3,083 |
| 2 | PAIN | 3,046 |
| 3 | PYREXIA | 2,701 |
| 4 | NAUSEA | 2,690 |
| 5 | FATIGUE | 2,657 |
| 6 | OSTEONECROSIS OF JAW | 2,613 |
| 7 | DEATH | 2,438 |
| 8 | HEADACHE | 2,278 |
| 9 | DIARRHOEA | 2,189 |
| 10 | VOMITING | 1,983 |
| 11 | ASTHENIA | 1,893 |
| 12 | MYALGIA | 1,806 |
| 14 | PAIN IN EXTREMITY | 1,624 |
| 15 | DYSPNOEA | 1,594 |
| 16 | BONE PAIN | 1,519 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Do not take zoledronic acid if you are also taking Reclast or other bisphosphonates. This medicine can cause kidney problems, especially if you already have kidney issues. It can also cause a rare but serious condition called osteonecrosis of the jaw (ONJ). Tell your doctor right away if you have severe bone, joint, or muscle pain. This medicine may also increase your risk of unusual thigh bone fractures.
Known Drug Interactions
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.
Mechanism: Both of these medicines lower the amount of calcium in your blood. Taking them together can cause your calcium levels to drop too low for a long time.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
Common Questions
What should I do before each treatment?
Can I take this with other medications?
What if I have dental problems?
How long will I be on this medication?
What are the signs of kidney problems?
What are the symptoms of osteonecrosis of the jaw (ONJ)?
Can this medicine affect my fertility?
What if I have pain in my thigh or groin?
Do I need to drink more water while taking this?
What are the common side effects of zoledronic acid?
Does zoledronic acid interact with other medications?
What drug class is zoledronic acid?
What pregnancy or breastfeeding source fields are listed for zoledronic acid?
Related Medications in Bisphosphonate (IV)
Other drugs grouped near zoledronic acid - same-class peers and common alternatives.
abaloparatide
Tymlos
Tymlos is a medicine to treat osteoporosis.
Compare with zoledronic acid →
alendronate
Fosamax
Binosto is a medicine that helps make your bones stronger.
Compare with zoledronic acid →
calcitonin
Miacalcin, Fortical
Calcitonin is a medicine that helps manage calcium levels in your body.
Compare with zoledronic acid →
denosumab
Prolia, Xgeva
Stoboclo is a medicine that helps to treat osteoporosis and increase bone mass.
Compare with zoledronic acid →
ibandronate
Boniva
Ibandronate (Boniva) is a medicine that helps treat and prevent bone loss in women after menopause.
Compare with zoledronic acid →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for zoledronic acid: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 38,197.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 13.09%.
- paroxetine Δ 0.00 pts · 32,666 reports · Selective Serotonin Reuptake Inhibitor (SSRI) 13.09%death share
- febuxostat Δ 0.03 pts · 16,005 reports · Xanthine Oxidase Inhibitor 13.11%death share
- cyclosporine Δ 0.03 pts · 106,440 reports · Calcineurin Inhibitor (Immunosuppressant) 13.12%death share
- docusate Δ 0.05 pts · 55,963 reports · Stool Softener 13.04%death share
Medication Guides
Understanding Drug Interactions
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Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for zoledronic acid
The FDA label for zoledronic acid (sold under brand names such as Reclast, Zometa) classifies it as a prescription-only medication in the Bisphosphonate (IV) class. This medicine can treat high calcium levels in your blood caused by cancer. Official labeling lists 8 commonly reported side effects, including Nausea, Tiredness, Anemia (low red blood cells).
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 38,197 voluntary reports. The database also lists 1 documented drug interaction derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS shows a generic unit cost of $0.59.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.
Last updated: September 18, 2023
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages