Zoledronic acid: adverse event reports filed with FDA

16,682

reports as suspect product

0.1% of all reports · about 744 a year

1,868

reports, 12 months to June 2026

1,914 in the 12 months before

97.1%

marked serious by the reporter

90.3% across the class

9%

record death among outcomes, as reported

1,509 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Zoledronic acid reports recording the termmedian drug in bisphosphonate

1. Osteonecrosis of jawdeath of jaw bone tissue14.9%2,479
2. Pyrexiafever7.1%1,192
3. Arthralgiajoint pain6.5%1,082
4. Painpain, site not specified6.1%1,025
5. Fatiguetiredness6%1,009
6. Nauseafeeling sick5.9%986
7. Osteonecrosis5.6%930
8. Off label useused for a purpose or in a way not on the label5.4%894
9. Vomitingbeing sick5.2%872
10. Neutropenialow neutrophils, a type of white blood cell5.2%861
11. Headachehead pain5.1%850
12. Diarrhoealoose or frequent stools4.8%807
13. Astheniaweakness or lack of energy4.8%803
14. Malignant neoplasm progression4.6%771
15. Malaisegeneral feeling of being unwell4.4%736
16. Myalgiamuscle pain4.3%709
17. Dyspnoeashortness of breath4.1%679
18. Metastases to bone4%671
19. Decreased appetitereduced appetite3.7%618
20. Drug ineffectivethe medicine did not work as expected3.7%609
21. Dizzinesslight-headedness or unsteadiness3.6%604
22. Chillschills or shivering3.3%553
23. Anaemialow red blood cells3.2%535
24. Falla fall3.2%535
25. Bone painbone pain3.2%527
26. Acute kidney injurysudden loss of kidney function3%506
27. Deaththe patient died; cause not stated by this term3%495
28. Back painback pain2.8%459
29. Product use in unapproved indicationused for a purpose not on the label2.7%453
30. Hypocalcaemialow blood calcium2.6%430

Top 30 of 2,016 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 9 drugs in the bisphosphonate class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 97,060 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 15.2% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 16,682 reports.

Drugs most often listed in the same reports

Other products listed in reports where Zoledronic acid is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the bisphosphonate class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Zoledronic acid as a suspect or interacting product; reports listing it only as a concomitant medication (10,606) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.