ELDECALCITOL: 343 Adverse Event Reports & Safety Profile
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343
Total FAERS Reports
33 (9.6%)
Deaths Reported
180
Hospitalizations
343
As Primary/Secondary Suspect
15
Life-Threatening
7
Disabilities
First Report: 2009 · Latest Report: 20250626
What Are the Most Common ELDECALCITOL Side Effects?
#1 Most Reported
Hypercalcaemia
86 reports (25.1%)
#2 Most Reported
Renal impairment
66 reports (19.2%)
#3 Most Reported
Decreased appetite
27 reports (7.9%)
All ELDECALCITOL Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Hypercalcaemia | 86 | 25.1% | 4 | 60 |
| Renal impairment | 66 | 19.2% | 9 | 23 |
| Decreased appetite | 27 | 7.9% | 8 | 23 |
| Acute kidney injury | 23 | 6.7% | 7 | 18 |
| Anaemia | 21 | 6.1% | 7 | 19 |
| Dehydration | 20 | 5.8% | 7 | 18 |
| Cardiac failure | 19 | 5.5% | 7 | 18 |
| Milk-alkali syndrome | 16 | 4.7% | 0 | 13 |
| Malaise | 15 | 4.4% | 3 | 11 |
| Hypokalaemia | 14 | 4.1% | 0 | 10 |
| Blood calcium increased | 13 | 3.8% | 0 | 5 |
| Off label use | 13 | 3.8% | 3 | 8 |
| Fall | 12 | 3.5% | 1 | 9 |
| Diarrhoea | 11 | 3.2% | 0 | 8 |
| Hypocalcaemia | 11 | 3.2% | 0 | 11 |
| Osteonecrosis of jaw | 11 | 3.2% | 0 | 3 |
| Pneumonia | 11 | 3.2% | 2 | 11 |
| Drug-induced liver injury | 10 | 2.9% | 3 | 5 |
| Gastric ulcer | 10 | 2.9% | 0 | 7 |
| Rash | 10 | 2.9% | 7 | 9 |
Who Reports ELDECALCITOL Side Effects? Age & Gender Data
Gender: 83.3% female, 16.7% male. Average age: 77.4 years. Most reports from: JP. View detailed demographics →
Is ELDECALCITOL Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2009 | 1 | 0 | 1 |
| 2011 | 1 | 0 | 0 |
| 2012 | 1 | 0 | 0 |
| 2013 | 4 | 0 | 3 |
| 2014 | 20 | 0 | 14 |
| 2015 | 26 | 2 | 13 |
| 2016 | 24 | 1 | 17 |
| 2017 | 28 | 4 | 11 |
| 2018 | 21 | 3 | 10 |
| 2019 | 51 | 10 | 24 |
| 2020 | 16 | 1 | 6 |
| 2021 | 11 | 0 | 6 |
| 2022 | 7 | 2 | 4 |
| 2023 | 10 | 0 | 5 |
| 2024 | 14 | 3 | 5 |
| 2025 | 4 | 0 | 2 |
What Is ELDECALCITOL Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 156 |
| Osteoporosis | 135 |
| Prophylaxis | 6 |
ELDECALCITOL vs Alternatives: Which Is Safer?
ELDECALCITOL vs ELECTROLYTES NOS
ELDECALCITOL vs ELECTROLYTES NOS\MINERALS
ELDECALCITOL vs ELETRIPTAN
ELDECALCITOL vs ELETRIPTAN HYDROBROMIDE
ELDECALCITOL vs ELEXACAFTOR\IVACAFTOR\TEZACAFTOR
ELDECALCITOL vs ELIGLUSTAT
ELDECALCITOL vs ELIQUIS
ELDECALCITOL vs ELOSULFASE ALFA
ELDECALCITOL vs ELOTUZUMAB
ELDECALCITOL vs ELOXATIN
Official FDA Label for ELDECALCITOL
Official prescribing information from the FDA-approved drug label.