FOSAMAX FDA MedWatch Direct Reports Summary

These tables and charts are created from 868 voluntary U.S. reports for FOSAMAX (ALENDRONATE SODIUM) reported by individuals to the FDA via the MedWatch Reporting System from 2004 through April 28, 2026.

For a summary of adverse events including mandatory reports submitted by pharmaceutical companies (all countries and all reporter types) to the FAERS database, View FDA FAERS FOSAMAX Report.

Top Adverse Effects Associated with FOSAMAX (from U.S. FDA Medwatch Reports)

	Side Effect	# of FDA Reports
1	FEMUR FRACTURE	72
2	JOINT PAIN	50
3	PAIN	49
4	FALL	39
5	NAUSEA	34
6	PAIN IN EXTREMITY	34
7	DEATH	32
8	FATIGUE	32
9	DIZZINESS	31
10	DRUG INEFFECTIVE	29
11	LACK OF STRENGTH AND ENERGY (ASTHENIA)	28
12	THERAPY CESSATION	27
13	SHORTNESS OF BREATH	26
14	RASH	26
15	GAIT DISTURBANCE	25
16	BACK PAIN	24
17	HEADACHE	24
18	MUSCLE PAIN	23
19	INSOMNIA	21
20	URINARY TRACT INFECTION	21
21	DIARRHEA	19
22	MUSCLE SPASMS	18
23	THERAPY INTERRUPTED	18
24	BONE PAIN	17
25	CONDITION AGGRAVATED	17

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FOSAMAX Total Medwatch Safety Reports by Patient Sex

Male	Female	Unknown	Total
126	699	43	868

Medwatch Reporter Type	Count
Consumer	306
Physician	37
Pharmacist	195
Other Health Professional	123

Top Indications

Rheumatoid arthritis
Osteoporosis
Product used for unknown indication
Osteoporosis postmenopausal
Osteopenia

Type of Outcome Reported
Serious: 634
Not Serious: 234
Note: A serious outcome means the adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition.

Suspected Role
Primary Suspect: 868
Concomitant Drugs: 706
Note: A single MedWatch report can list more than one drug. This summary includes FOSAMAX identified as the suspect drug or as a concomitantly taken drug.

FDA Safety-Related Labeling Changes

FOSAMAX (ALENDRONATE SODIUM) Rx Drug:
FDA Safety-related Labeling Changes

Atypical fractures of bones other than the femur have been reported.Concomitant treatment with glucocorticoids (like prednisone) may also induce these fractures.

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For serious adverse events, report them to the FDA by contacting the drug manufacturer or report directly through the MedWatch voluntary reporting form.

NOTES

This report, created by AskaPatient.com, is derived from U.S. drug-related adverse event cases that were reported directly to the FDA using the voluntary MedWatch online or paper reporting system. MedWatch is the voluntary FDA system for consumers, physicians, and others to directly report adverse reactions. The Medwatch initiative was launched in 1993 as a voluntary reporting program for consumers, physicians and other healthcare practitioners.

After processing the received forms, the FDA adds the MedWatch reports to the FDA Adverse Events Reporting System(or FAERS database.) Click here for the complete FAERS report summary, which includes mandatory reports submitted by pharmaceutical companies (worldwide) combined with the MedWatch reports. MedWatch Reports only represent about 5% of the FAERS database. For more, read "Does the FDA's Rapidly Growing Database of Adverse Events Improve Drug Safety?"

The data in this report was obtained from Open FDA. Data was last updated to include reports through January 27, 2026. The reactions, side effects, or "adverse events," represent up to the 20 most frequently occuring events in the database for a drug related to the event.

Open FDA states that it only includes the most recent version of a case report. It also adds the disclaimer: "Do not rely on Open FDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated."

FDA uses the "MedDRA" classification system to describe reported adverse reactions. MedDRA is a standardized medical terminology that facilitates sharing of regulatory information internationally. In some cases, "patient friendly" terms for the layman designated by MedDRA have been substituted for medical jargon. Please contact us with questions about this report.