Reclast: adverse event reports filed with FDA

10,382

reports as suspect product

0.1% of all reports · about 544 a year

402

reports, 12 months to June 2026

424 in the 12 months before

81%

marked serious by the reporter

90.3% across the class

18.3%

record death among outcomes, as reported

1,899 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 Reclast reports recording the termmedian drug in bisphosphonate

1. Arthralgiajoint pain15.9%1,647
2. Painpain, site not specified14.9%1,552
3. Deaththe patient died; cause not stated by this term14.1%1,469
4. Pyrexiafever10.9%1,132
5. Headachehead pain10%1,034
6. Myalgiamuscle pain10%1,034
7. Pain in extremitypain in an arm or leg8.5%882
8. Nauseafeeling sick8.4%873
9. Influenza like illnessflu-like symptoms8.4%870
10. Bone painbone pain8.4%868
11. Fatiguetiredness6.3%654
12. Chillschills or shivering6.1%638
13. Back painback pain5.8%601
14. Vomitingbeing sick5.5%569
15. Astheniaweakness or lack of energy5.4%558
16. Malaisegeneral feeling of being unwell5%522
17. Gait disturbancedifficulty walking4.8%501
18. Dyspnoeashortness of breath4.4%456
19. Falla fall4.4%453
20. Dizzinesslight-headedness or unsteadiness4.2%439
21. Feeling abnormalfeeling odd or not right4.1%428
22. Chest painchest pain3.9%404
23. Diarrhoealoose or frequent stools3.6%370
24. Muscle spasmsmuscle cramps3.5%367
25. Pain in jaw3.3%343
26. Joint swellinga swollen joint3%313
27. Femur fracture3%309
28. Neck painneck pain2.8%294
29. Musculoskeletal painpain in muscles or bones2.4%254
30. Oedema peripheralswelling of the legs, ankles or hands2.4%244

Top 30 of 1,148 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. 87.3% 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 10,382 reports.

Drugs most often listed in the same reports

Other products listed in reports where Reclast 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 Reclast as a suspect or interacting product; reports listing it only as a concomitant medication (3,045) 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.