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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.

ACTONEL: 153 Adverse Event Reports & Safety Profile

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153
Total FAERS Reports
6 (3.9%)
Deaths Reported
98
Hospitalizations
153
As Primary/Secondary Suspect
3
Life-Threatening
33
Disabilities

First Report: 1997 · Latest Report: 20140605

What Are the Most Common ACTONEL Side Effects?

#1 Most Reported
Femur fracture
69 reports (45.1%)
#2 Most Reported
Low turnover osteopathy
45 reports (29.4%)
#3 Most Reported
Fall
43 reports (28.1%)

All ACTONEL Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Femur fracture 69 45.1% 1 61
Low turnover osteopathy 45 29.4% 0 40
Fall 43 28.1% 0 40
Pain in extremity 33 21.6% 0 27
Arthralgia 31 20.3% 0 25
Osteoarthritis 29 19.0% 0 27
Stress fracture 28 18.3% 0 23
Intramedullary rod insertion 25 16.3% 0 25
Hypertension 20 13.1% 0 19
Pain 18 11.8% 0 16
Fracture displacement 17 11.1% 0 17
Pathological fracture 17 11.1% 0 15
Bone disorder 16 10.5% 0 12
Gastrooesophageal reflux disease 15 9.8% 0 12
Arthritis 14 9.2% 0 13
Fracture nonunion 14 9.2% 0 13
Atypical femur fracture 13 8.5% 0 6
Back pain 13 8.5% 0 11
Depression 13 8.5% 0 11
Anaemia 12 7.8% 0 12

Who Reports ACTONEL Side Effects? Age & Gender Data

Average age: 69.1 years. Most reports from: US. View detailed demographics →

Is ACTONEL Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 3 0 3
2001 5 0 5
2002 6 0 4
2003 3 0 3
2004 1 0 0
2005 3 0 3
2006 6 0 5
2007 7 0 4
2008 6 0 5
2009 12 0 11
2010 10 1 7
2011 11 1 10
2012 9 0 8
2013 15 0 8
2014 12 1 7

View full timeline →

What Is ACTONEL Used For?

IndicationReports
Osteoporosis 84
Osteopenia 30
Osteoporosis prophylaxis 11
Product used for unknown indication 6

ACTONEL vs Alternatives: Which Is Safer?

ACTONEL vs ACYCLOVIR ACTONEL vs AD26.COV2.S ACTONEL vs ADAGRASIB ACTONEL vs ADALIMUMAB ACTONEL vs ADALIMUMAB-AACF ACTONEL vs ADALIMUMAB-AATY ACTONEL vs ADALIMUMAB-ADAZ ACTONEL vs ADALIMUMAB-ADBM ACTONEL vs ADALIMUMAB-AFZB ACTONEL vs ADALIMUMAB-ATTO

Official FDA Label for ACTONEL

Official prescribing information from the FDA-approved drug label.