Risedronate sodium: adverse event reports filed with FDA

3,512

reports as suspect product

0% of all reports · about 156 a year

552

reports, 12 months to June 2026

518 in the 12 months before

92.5%

marked serious by the reporter

90.3% across the class

4.2%

record death among outcomes, as reported

147 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 Risedronate sodium reports recording the termmedian drug in bisphosphonate

1. Asthmaasthma34%1,193
2. Drug hypersensitivityan allergic-type reaction to a medicine33.4%1,173
3. Vomitingbeing sick29.8%1,047
4. Dyspnoeashortness of breath28.6%1,006
5. Pneumonialung infection27.4%963
6. Wheezingwheezing26.3%925
7. Oedemaswelling from fluid26.2%919
8. Painpain, site not specified21.6%758
9. Malaisegeneral feeling of being unwell18.2%640
10. Drug ineffectivethe medicine did not work as expected18.1%636
11. Coughcough14.2%499
12. Gastrooesophageal reflux diseaseacid reflux11.2%394
13. Chest painchest pain11.1%390
14. Off label useused for a purpose or in a way not on the label11.1%390
15. Nauseafeeling sick10.9%384
16. Respiratory tract infectiona respiratory infection10.3%363
17. Fatiguetiredness9.6%336
18. Condition aggravatedthe condition being treated got worse9.2%322
19. Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease9.1%318
20. Mobility decreasedreduced ability to move about8.5%297
21. Arthralgiajoint pain8.2%289
22. Pyrexiafever7.6%266
23. Diarrhoealoose or frequent stools7.1%249
24. Pulmonary fibrosis7.1%248
25. Hypertensionhigh blood pressure7%247
26. Headachehead pain7%245
27. Drug intolerancethe medicine was not tolerated6.8%240
28. Infectionan infection, type not specified6.8%240
29. Contraindicated product administered6.5%230
30. Oedema peripheralswelling of the legs, ankles or hands6.3%220

Top 30 of 866 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. 12% 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 3,512 reports.

Drugs most often listed in the same reports

Other products listed in reports where Risedronate sodium 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 Risedronate sodium as a suspect or interacting product; reports listing it only as a concomitant medication (9,097) 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.