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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

FOSAMAX: 959 Adverse Event Reports & Safety Profile

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959
Total FAERS Reports
47 (4.9%)
Deaths Reported
616
Hospitalizations
959
As Primary/Secondary Suspect
4
Life-Threatening
298
Disabilities

First Report: 1995 · Latest Report: 20140622

What Are the Most Common FOSAMAX Side Effects?

#1 Most Reported
Femur fracture
676 reports (70.5%)
#2 Most Reported
Intramedullary rod insertion
372 reports (38.8%)
#3 Most Reported
Osteoarthritis
322 reports (33.6%)

All FOSAMAX Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Femur fracture 676 70.5% 21 511
Intramedullary rod insertion 372 38.8% 12 364
Osteoarthritis 322 33.6% 14 312
Fall 298 31.1% 12 290
Low turnover osteopathy 259 27.0% 16 236
Hypertension 249 26.0% 9 240
Arthralgia 198 20.7% 6 177
Gastrooesophageal reflux disease 196 20.4% 7 181
Depression 170 17.7% 7 162
Osteoporosis 168 17.5% 9 149
Back pain 165 17.2% 9 151
Osteopenia 165 17.2% 6 159
Anxiety 164 17.1% 9 145
Pain in extremity 160 16.7% 5 147
Spinal osteoarthritis 152 15.9% 8 142
Pain 148 15.4% 10 122
Arthritis 131 13.7% 5 126
Open reduction of fracture 125 13.0% 3 123
Anaemia 124 12.9% 7 121
Constipation 113 11.8% 6 102

Who Reports FOSAMAX Side Effects? Age & Gender Data

Average age: 69.6 years. Most reports from: US. View detailed demographics →

Is FOSAMAX Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 57 0 54
2001 52 5 50
2002 57 5 55
2003 49 4 45
2004 43 4 39
2005 34 1 33
2006 38 1 33
2007 36 3 29
2008 27 0 22
2009 30 0 18
2010 40 3 29
2011 40 2 26
2012 36 2 13
2013 31 0 9
2014 25 0 6

View full timeline →

What Is FOSAMAX Used For?

IndicationReports
Osteoporosis 557
Osteopenia 253
Osteoporosis prophylaxis 62
Product used for unknown indication 19
Prophylaxis 16
Bone loss 11
Bone density decreased 8
Osteoporosis postmenopausal 8
Bone disorder 5
Rheumatoid arthritis 5

FOSAMAX vs Alternatives: Which Is Safer?

FOSAMAX vs FOSAMAX PLUS D FOSAMAX vs FOSAMPRENAVIR FOSAMAX vs FOSAPREPITANT FOSAMAX vs FOSAPREPITANT DIMEGLUMINE FOSAMAX vs FOSCARBIDOPA\FOSLEVODOPA FOSAMAX vs FOSCARNET FOSAMAX vs FOSFOMYCIN FOSAMAX vs FOSFOMYCIN TROMETHAMINE FOSAMAX vs FOSINOPRIL FOSAMAX vs FOSPHENYTOIN

Official FDA Label for FOSAMAX

Official prescribing information from the FDA-approved drug label.