Alendronate: adverse event reports filed with FDA

4,045

reports as suspect product

0% of all reports · about 189 a year

213

reports, 12 months to June 2026

239 in the 12 months before

79.6%

marked serious by the reporter

90.3% across the class

7.7%

record death among outcomes, as reported

311 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 Alendronate reports recording the termmedian drug in bisphosphonate

1. Arthralgiajoint pain13.1%529
2. Painpain, site not specified11.3%459
3. Drug ineffectivethe medicine did not work as expected10.3%417
4. Fatiguetiredness9.2%372
5. Osteonecrosis of jawdeath of jaw bone tissue8.4%339
6. Dyspnoeashortness of breath8.3%337
7. Pain in extremitypain in an arm or leg8.2%333
8. Abdominal discomfortstomach discomfort7.9%319
9. Rashskin rash7.5%303
10. Diarrhoealoose or frequent stools7.4%298
11. Nauseafeeling sick7.2%292
12. Off label useused for a purpose or in a way not on the label7.2%291
13. Femur fracture7.1%287
14. Condition aggravatedthe condition being treated got worse7%283
15. Joint swellinga swollen joint6.9%280
16. Alopeciahair loss6.9%278
17. Headachehead pain6.9%278
18. Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease6.8%275
19. Hypersensitivityan allergic-type reaction6.7%269
20. Infusion related reactiona reaction during or soon after an infusion6.6%267
21. Atypical femur fracture6.5%261
22. Malaisegeneral feeling of being unwell6.4%259
23. Peripheral swellingswelling of the arms or legs6.4%259
24. Drug hypersensitivityan allergic-type reaction to a medicine6.4%258
25. Falla fall6.4%258
26. Arthropathy6.3%256
27. Drug intolerancethe medicine was not tolerated6.1%247
28. Systemic lupus erythematosuslupus, an autoimmune disease6%244
29. Pemphigus5.8%233
30. Swellingswelling5.8%233

Top 30 of 962 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. 40.7% 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 4,045 reports.

Drugs most often listed in the same reports

Other products listed in reports where Alendronate 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 Alendronate as a suspect or interacting product; reports listing it only as a concomitant medication (14,657) 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.