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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.

ALENDRONIC ACID: 8,042 Adverse Event Reports & Safety Profile

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8,042
Total FAERS Reports
2,927 (36.4%)
Deaths Reported
3,993
Hospitalizations
8,042
As Primary/Secondary Suspect
2,970
Life-Threatening
3,553
Disabilities

First Report: 2004 · Latest Report: 20250911

What Are the Most Common ALENDRONIC ACID Side Effects?

#1 Most Reported
Fatigue
2,540 reports (31.6%)
#2 Most Reported
Rheumatoid arthritis
2,352 reports (29.2%)
#3 Most Reported
Pain
2,322 reports (28.9%)

All ALENDRONIC ACID Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Fatigue 2,540 31.6% 1,344 1,357
Rheumatoid arthritis 2,352 29.3% 1,135 1,365
Pain 2,322 28.9% 984 1,194
Glossodynia 2,262 28.1% 1,268 1,315
Alopecia 2,227 27.7% 1,057 1,266
Systemic lupus erythematosus 2,225 27.7% 1,194 1,280
Rash 2,221 27.6% 1,167 1,397
Abdominal discomfort 2,208 27.5% 1,051 1,249
Hand deformity 2,150 26.7% 1,232 1,283
Off label use 2,145 26.7% 1,270 1,476
Arthralgia 2,117 26.3% 1,190 1,292
Drug ineffective 2,115 26.3% 755 1,106
Pemphigus 2,069 25.7% 1,041 1,130
Swelling 2,064 25.7% 1,145 1,265
Arthropathy 2,025 25.2% 999 1,172
Wound 1,985 24.7% 1,157 1,213
Joint swelling 1,964 24.4% 1,181 1,286
Infusion related reaction 1,959 24.4% 1,135 1,295
Synovitis 1,912 23.8% 1,148 1,294
Hypersensitivity 1,825 22.7% 1,051 1,191

Who Reports ALENDRONIC ACID Side Effects? Age & Gender Data

Gender: 92.0% female, 8.0% male. Average age: 52.0 years. Most reports from: CA. View detailed demographics →

Is ALENDRONIC ACID Getting Safer? Reports by Year

YearReportsDeathsHosp.
2004 2 0 0
2005 9 0 4
2006 12 0 6
2007 12 0 7
2008 42 6 22
2009 15 0 2
2010 22 0 5
2011 26 1 10
2012 32 1 8
2013 84 0 33
2014 173 1 65
2015 256 27 99
2016 129 11 56
2017 132 7 54
2018 196 0 77
2019 143 3 46
2020 97 0 39
2021 76 0 25
2022 66 0 18
2023 65 1 14
2024 76 1 28
2025 42 0 11

View full timeline →

What Is ALENDRONIC ACID Used For?

IndicationReports
Rheumatoid arthritis 3,240
Product used for unknown indication 2,385
Osteoporosis 1,470
Osteoporosis postmenopausal 105
Osteoporosis prophylaxis 102
Osteopenia 101
Foetal exposure during pregnancy 82
Prophylaxis 47
Osteoporotic fracture 27
Ill-defined disorder 24

ALENDRONIC ACID vs Alternatives: Which Is Safer?

ALENDRONIC ACID vs ALEVE ALENDRONIC ACID vs ALEVE CAPLET ALENDRONIC ACID vs ALEVE LIQUID ALENDRONIC ACID vs ALFACALCIDOL ALENDRONIC ACID vs ALFENTANIL ALENDRONIC ACID vs ALFUZOSIN ALENDRONIC ACID vs ALGLUCOSIDASE ALFA ALENDRONIC ACID vs ALIMTA ALENDRONIC ACID vs ALIROCUMAB ALENDRONIC ACID vs ALISKIREN

Official FDA Label for ALENDRONIC ACID

Official prescribing information from the FDA-approved drug label.