85/100 · Critical
Manufactured by Sandoz Inc
Zoledronic Acid Adverse Events: High Seriousness and Diverse Reactions
89,511 FDA adverse event reports analyzed
Last updated: 2026-05-12
ZOLEDRONIC ACID is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Sandoz Inc. Based on analysis of 89,511 FDA adverse event reports, ZOLEDRONIC ACID has a safety score of 85 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for ZOLEDRONIC ACID include ARTHRALGIA, PAIN, PYREXIA, NAUSEA, FATIGUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ZOLEDRONIC ACID.
Zoledronic Acid has a safety concern score of 85 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 89,511 adverse event reports for this medication, which is primarily manufactured by Sandoz Inc.
The most commonly reported adverse events include Arthralgia, Pain, Pyrexia. Of classified reports, 86.7% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The most common reactions are pain, fatigue, and osteonecrosis of the jaw, indicating a significant risk profile.
Serious adverse events, such as death and osteonecrosis, account for 86.7% of reports, highlighting the severity. A wide range of reactions, including renal impairment and thrombocytopenia, suggests a complex safety profile.
Patients taking Zoledronic Acid should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Zoledronic acid can cause severe side effects such as osteonecrosis of the jaw and renal impairment, and should be used with caution in patients with pre-existing kidney conditions or dental issues. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Zoledronic Acid received a safety concern score of 85/100 (high concern). This is based on a 86.7% serious event ratio across 38,189 classified reports. The score accounts for 89,511 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Female: 26,321, Male: 8,914, Unknown: 72. The most frequently reported age groups are age 65 (832 reports), age 75 (804 reports), age 68 (797 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 38,189 classified reports for ZOLEDRONIC ACID:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Zoledronic acid can cause severe side effects such as osteonecrosis of the jaw and renal impairment, and should be used with caution in patients with pre-existing kidney conditions or dental issues.
If you are taking Zoledronic Acid, here are important things to know. The most commonly reported side effects include arthralgia, pain, pyrexia, nausea, fatigue. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should inform their healthcare provider of any pre-existing conditions, especially kidney disease or dental issues, before starting zoledronic acid treatment. Regular monitoring of kidney function and dental health is recommended during treatment. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA closely monitors adverse events for zoledronic acid, and the drug is subject to ongoing safety reviews and potential restrictions based on emerging data.
The FDA has received approximately 89,511 adverse event reports associated with Zoledronic Acid. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Zoledronic Acid include Arthralgia, Pain, Pyrexia, Nausea, Fatigue. By volume, the top reported reactions are: Arthralgia (3,083 reports), Pain (3,044 reports), Pyrexia (2,705 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Zoledronic Acid.
Out of 38,189 classified reports, 33,127 (86.7%) were classified as serious and 5,062 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Zoledronic Acid break down by patient sex as follows: Female: 26,321, Male: 8,914, Unknown: 72. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Zoledronic Acid adverse events are: age 65: 832 reports, age 75: 804 reports, age 68: 797 reports, age 72: 795 reports, age 67: 782 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Zoledronic Acid adverse event reports is Sandoz Inc. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Zoledronic Acid include: Osteonecrosis Of Jaw, Death, Headache, Diarrhoea, Vomiting. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Zoledronic Acid to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Zoledronic Acid has a safety concern score of 85 out of 100 (high concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. The most common reactions are pain, fatigue, and osteonecrosis of the jaw, indicating a significant risk profile.
Key safety signals identified in Zoledronic Acid's adverse event data include: Osteonecrosis of the jaw (2614 reports). Death (2435 reports). Renal impairment (429 reports). These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Zoledronic acid can cause severe side effects such as osteonecrosis of the jaw and renal impairment, and should be used with caution in patients with pre-existing kidney conditions or dental issues. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Zoledronic Acid.
Patients should inform their healthcare provider of any pre-existing conditions, especially kidney disease or dental issues, before starting zoledronic acid treatment. Regular monitoring of kidney function and dental health is recommended during treatment.
Zoledronic Acid has 89,511 adverse event reports on file with the FDA. Serious adverse events, such as death and osteonecrosis, account for 86.7% of reports, highlighting the severity. The volume of reports for Zoledronic Acid reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors adverse events for zoledronic acid, and the drug is subject to ongoing safety reviews and potential restrictions based on emerging data. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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