Reclastzoledronic acid
According to the FDA label: Zoledronic 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.
39,017 adverse event reports submitted to the FDA (2003–2026)
Top Reported Adverse Events
The most frequently reported events in association with Reclast in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Arthralgia 3,144 reports
Pain 3,090 reports
A general report of physical discomfort, used when no more specific location is given.
Full definition in the glossary →Pyrexia 2,754 reports
The medical term for fever, meaning a raised body temperature.
Full definition in the glossary → See all drugs reporting this event →Nausea 2,736 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Fatigue 2,707 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →- Osteonecrosis Of Jaw 2,654 reports
Death 2,468 reports
A report that the person died. A death appearing in reports for a drug does not mean the drug caused it. Reports record that a death occurred while the medication was being used, which can happen for many unrelated reasons.
Full definition in the glossary →Headache 2,324 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Diarrhoea 2,222 reports
Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.
Full definition in the glossary → See all drugs reporting this event →Vomiting 2,018 reports
Throwing up the contents of the stomach.
Full definition in the glossary → See all drugs reporting this event →Asthenia 1,933 reports
Physical weakness or lack of strength.
Full definition in the glossary →Myalgia 1,832 reports
Off Label Use 1,707 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Pain in Extremity 1,647 reports
Pain in an arm or leg.
Full definition in the glossary →Dyspnoea 1,615 reports
Shortness of breath or difficulty breathing. Also spelled dyspnea in American English.
Full definition in the glossary → See all drugs reporting this event →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 26,914 |
| Male | 9,077 |
| Unknown | 72 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 690 |
| 18-34 | 489 |
| 35-49 | 2,383 |
| 50-64 | 8,024 |
| 65-74 | 7,773 |
| 75+ | 6,599 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Reclast. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Other Serious | 23,465 |
| Hospitalization | 11,257 |
| Non-Serious | 5,181 |
| Death | 5,060 |
| Disability | 1,981 |
| Life-Threatening | 1,677 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Reclast. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2003 | 1 |
| 2004 | 40 |
| 2005 | 92 |
| 2006 | 108 |
| 2007 | 281 |
| 2008 | 853 |
| 2009 | 1,339 |
| 2010 | 1,535 |
| 2011 | 2,240 |
| 2012 | 2,416 |
| 2013 | 996 |
| 2014 | 809 |
| 2015 | 1,331 |
| 2016 | 1,465 |
| 2017 | 1,672 |
| 2018 | 2,316 |
| 2019 | 2,672 |
| 2020 | 2,706 |
| 2021 | 2,705 |
| 2022 | 2,795 |
| 2023 | 3,043 |
| 2024 | 3,312 |
| 2025 | 3,530 |
| 2026 (partial) | 760 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Reclast
In FDA adverse event reports that mention Reclast, these medications appeared most often in the same report.
- Dexamethasone (4,059 reports)
- Ergocalciferol (3,987 reports)
- Lenalidomide (2,829 reports)
- Letrozole (2,795 reports)
- Aspirin (2,763 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026