Alendronate sodium: adverse event reports filed with FDA

18,082

reports as suspect product

0.1% of all reports · about 804 a year

1,528

reports, 12 months to June 2026

1,889 in the 12 months before

90.4%

marked serious by the reporter

90.3% across the class

20.8%

record death among outcomes, as reported

3,770 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 sodium reports recording the termmedian drug in bisphosphonate

1. Painpain, site not specified27.4%4,960
2. Femur fracture26.8%4,852
3. Fatiguetiredness24.8%4,479
4. Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease23.1%4,179
5. Drug ineffectivethe medicine did not work as expected23%4,167
6. Arthralgiajoint pain22.8%4,127
7. Abdominal discomfortstomach discomfort22.6%4,083
8. Alopeciahair loss22%3,986
9. Systemic lupus erythematosuslupus, an autoimmune disease21.7%3,916
10. Pemphigus21.4%3,878
11. Rashskin rash21.3%3,856
12. Arthropathy20.8%3,758
13. Glossodynia20.2%3,649
14. Hand deformity19.4%3,502
15. Swellingswelling19.1%3,459
16. Infusion related reactiona reaction during or soon after an infusion18.6%3,358
17. Wound18.2%3,292
18. Hypertensionhigh blood pressure18.2%3,284
19. Pericarditisinflammation of the sac around the heart17.6%3,184
20. Synovitis17.4%3,139
21. Joint swellinga swollen joint17.3%3,134
22. Hypersensitivityan allergic-type reaction17.3%3,131
23. Drug intolerancethe medicine was not tolerated16.9%3,058
24. Contraindicated product administered16.8%3,035
25. Hepatic enzyme increasedraised liver enzymes16.1%2,910
26. Off label useused for a purpose or in a way not on the label16.1%2,906
27. Discomfortdiscomfort15.7%2,832
28. Maternal exposure during pregnancythe mother took the medicine during pregnancy15.4%2,786
29. Anti-cyclic citrullinated peptide antibody positive15.4%2,781
30. Condition aggravatedthe condition being treated got worse15.2%2,741

Top 30 of 2,509 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. 41.9% 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 18,082 reports.

Drugs most often listed in the same reports

Other products listed in reports where Alendronate 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 Alendronate sodium as a suspect or interacting product; reports listing it only as a concomitant medication (15,203) 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.