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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.

ALENDRONATE\CHOLECALCIFEROL: 2,607 Adverse Event Reports & Safety Profile

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2,607
Total FAERS Reports
918 (35.2%)
Deaths Reported
1,841
Hospitalizations
2,607
As Primary/Secondary Suspect
1,041
Life-Threatening
1,367
Disabilities

Active Ingredient: ALENDRONATE SODIUM\CHOLECALCIFEROL ·

First Report: 1995 · Latest Report: 20250605

What Are the Most Common ALENDRONATE\CHOLECALCIFEROL Side Effects?

#1 Most Reported
Fatigue
929 reports (35.6%)
#2 Most Reported
Arthralgia
841 reports (32.3%)
#3 Most Reported
Hypertension
820 reports (31.5%)

All ALENDRONATE\CHOLECALCIFEROL Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Fatigue 929 35.6% 486 698
Arthralgia 841 32.3% 465 717
Hypertension 820 31.5% 488 795
Depression 747 28.7% 379 596
Arthropathy 733 28.1% 507 661
Rash 726 27.9% 433 538
Alopecia 711 27.3% 502 620
Abdominal discomfort 705 27.0% 480 611
Confusional state 696 26.7% 525 612
Joint swelling 684 26.2% 482 581
Pain 681 26.1% 404 552
Hand deformity 677 26.0% 500 589
Dyspnoea 670 25.7% 425 575
Hepatic enzyme increased 670 25.7% 484 582
Glossodynia 666 25.6% 493 578
Stomatitis 659 25.3% 401 487
Fibromyalgia 656 25.2% 428 512
Diarrhoea 655 25.1% 401 485
Rheumatoid arthritis 653 25.1% 466 577
Abdominal pain upper 649 24.9% 393 492

Who Reports ALENDRONATE\CHOLECALCIFEROL Side Effects? Age & Gender Data

Gender: 94.6% female, 5.4% male. Average age: 55.6 years. Most reports from: CA. View detailed demographics →

Is ALENDRONATE\CHOLECALCIFEROL Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 79 1 75
2001 39 0 30
2002 48 2 45
2003 46 1 42
2004 60 12 49
2005 46 4 35
2006 45 0 42
2007 34 2 29
2008 19 0 16
2009 29 0 26
2010 36 2 24
2011 36 1 21
2012 26 0 11
2013 24 1 12
2014 50 2 11
2015 69 19 39
2016 66 3 26
2017 35 1 12
2018 52 5 18
2019 27 1 16
2020 58 0 22
2021 10 0 7
2022 14 0 6
2023 20 0 12
2024 1 0 0
2025 6 4 4

View full timeline →

What Is ALENDRONATE\CHOLECALCIFEROL Used For?

IndicationReports
Rheumatoid arthritis 954
Osteoporosis 722
Product used for unknown indication 351
Osteopenia 148
Osteoporosis postmenopausal 135
Osteoporosis prophylaxis 41
Bone density decreased 29
Foetal exposure during pregnancy 18
Exposure during pregnancy 10
Osteoporotic fracture 10

ALENDRONATE\CHOLECALCIFEROL vs Alternatives: Which Is Safer?

ALENDRONATE\CHOLECALCIFEROL vs ALENDRONIC ACID ALENDRONATE\CHOLECALCIFEROL vs ALEVE ALENDRONATE\CHOLECALCIFEROL vs ALEVE CAPLET ALENDRONATE\CHOLECALCIFEROL vs ALEVE LIQUID ALENDRONATE\CHOLECALCIFEROL vs ALFACALCIDOL ALENDRONATE\CHOLECALCIFEROL vs ALFENTANIL ALENDRONATE\CHOLECALCIFEROL vs ALFUZOSIN ALENDRONATE\CHOLECALCIFEROL vs ALGLUCOSIDASE ALFA ALENDRONATE\CHOLECALCIFEROL vs ALIMTA ALENDRONATE\CHOLECALCIFEROL vs ALIROCUMAB

Official FDA Label for ALENDRONATE\CHOLECALCIFEROL

Official prescribing information from the FDA-approved drug label.