Fosamaxalendronate
According to the FDA label: FOSAMAX is a bisphosphonate indicated for: Treatment and prevention of osteoporosis in postmenopausal women ( 1.1 , 1.2 ) Treatment to increase bone mass in men with osteoporosis ( 1.3 ) Treatment of glucocorticoid-induced osteoporosis ( 1.4 ) Treatment of Paget's disease of bone ( 1.5 ) Limitations of use : Optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use.
81,799 adverse event reports submitted to the FDA (2003–2026)
Top Reported Adverse Events
The most frequently reported events in association with Fosamax in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Pain 12,743 reports
A general report of physical discomfort, used when no more specific location is given.
Full definition in the glossary →Fatigue 11,850 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Drug Ineffective 11,477 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →- Femur Fracture 11,041 reports
Arthralgia 10,200 reports
Rheumatoid Arthritis 9,798 reports
An autoimmune condition where the immune system attacks the joints, causing pain and swelling. It often appears in reports because it is a condition being treated, not always a reaction.
Full definition in the glossary →Alopecia 9,722 reports
Abdominal Discomfort 9,669 reports
A general unease or mild pain in the belly area.
Full definition in the glossary →Systemic Lupus Erythematosus 9,050 reports
An autoimmune condition, often called lupus, where the immune system attacks the body's own tissues, affecting joints, skin, and organs. It often appears in reports because it is a condition being treated, not always a reaction.
Full definition in the glossary →Pemphigus 8,767 reports
A rare autoimmune condition that causes blistering of the skin and the moist linings of the body such as the mouth.
Full definition in the glossary →Rash 8,437 reports
An area of irritated, red, or bumpy skin.
Full definition in the glossary → See all drugs reporting this event →Glossodynia 8,151 reports
Pain or a burning sensation in the tongue.
Full definition in the glossary →Arthropathy 8,036 reports
Any disease or disorder of a joint.
Full definition in the glossary →Swelling 7,563 reports
A general report of a body part becoming enlarged, often from fluid or inflammation.
Full definition in the glossary →Hypertension 7,389 reports
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 65,759 |
| Male | 8,976 |
| Unknown | 365 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 201 |
| 18-34 | 521 |
| 35-49 | 7,918 |
| 50-64 | 13,379 |
| 65-74 | 12,242 |
| 75+ | 12,480 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Fosamax. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Other Serious | 47,575 |
| Hospitalization | 31,440 |
| Non-Serious | 16,098 |
| Disability | 15,337 |
| Death | 10,021 |
| Life-Threatening | 7,754 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Fosamax. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2003 | 1 |
| 2004 | 3,092 |
| 2005 | 3,438 |
| 2006 | 3,303 |
| 2007 | 3,751 |
| 2008 | 3,254 |
| 2009 | 3,261 |
| 2010 | 4,089 |
| 2011 | 4,620 |
| 2012 | 8,031 |
| 2013 | 3,907 |
| 2014 | 2,882 |
| 2015 | 2,893 |
| 2016 | 2,519 |
| 2017 | 2,434 |
| 2018 | 2,492 |
| 2019 | 2,769 |
| 2020 | 3,385 |
| 2021 | 4,877 |
| 2022 | 4,271 |
| 2023 | 2,981 |
| 2024 | 4,667 |
| 2025 | 4,208 |
| 2026 (partial) | 674 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Fosamax
In FDA adverse event reports that mention Fosamax, these medications appeared most often in the same report.
- Prednisone (20,492 reports)
- Methotrexate (18,610 reports)
- Folic Acid (17,787 reports)
- Adalimumab (16,624 reports)
- Leflunomide (14,385 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026