PROLIA: 3,722 Adverse Event Reports & Safety Profile
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3,722
Total FAERS Reports
871 (23.4%)
Deaths Reported
485
Hospitalizations
3,722
As Primary/Secondary Suspect
18
Life-Threatening
44
Disabilities
First Report: 2001 · Latest Report: 20140611
What Are the Most Common PROLIA Side Effects?
#1 Most Reported
Death
705 reports (18.9%)
#2 Most Reported
Pain in extremity
289 reports (7.8%)
#3 Most Reported
Arthralgia
285 reports (7.7%)
All PROLIA Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Death | 705 | 18.9% | 705 | 20 |
| Pain in extremity | 289 | 7.8% | 0 | 27 |
| Arthralgia | 285 | 7.7% | 0 | 15 |
| Back pain | 228 | 6.1% | 3 | 30 |
| Pain | 220 | 5.9% | 2 | 25 |
| Rash | 157 | 4.2% | 0 | 13 |
| Tooth disorder | 131 | 3.5% | 0 | 3 |
| Bone pain | 130 | 3.5% | 0 | 8 |
| Malaise | 124 | 3.3% | 11 | 38 |
| Myalgia | 116 | 3.1% | 0 | 11 |
| Muscle spasms | 112 | 3.0% | 1 | 17 |
| Fatigue | 104 | 2.8% | 3 | 18 |
| Pruritus | 98 | 2.6% | 1 | 11 |
| Pain in jaw | 97 | 2.6% | 1 | 7 |
| Fall | 93 | 2.5% | 5 | 35 |
| Asthenia | 91 | 2.4% | 10 | 27 |
| Osteonecrosis of jaw | 85 | 2.3% | 1 | 8 |
| Gait disturbance | 82 | 2.2% | 1 | 13 |
| Headache | 80 | 2.2% | 1 | 7 |
| Urinary tract infection | 75 | 2.0% | 5 | 13 |
Who Reports PROLIA Side Effects? Age & Gender Data
Average age: 74.6 years. Most reports from: US. View detailed demographics →
Is PROLIA Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2001 | 1 | 0 | 0 |
| 2004 | 1 | 0 | 0 |
| 2009 | 3 | 0 | 1 |
| 2010 | 4 | 1 | 1 |
| 2011 | 23 | 1 | 3 |
| 2012 | 90 | 11 | 15 |
| 2013 | 968 | 225 | 159 |
| 2014 | 670 | 211 | 107 |
What Is PROLIA Used For?
| Indication | Reports |
|---|---|
| Osteoporosis postmenopausal | 1,775 |
| Product used for unknown indication | 1,045 |
| Osteoporosis | 734 |
| Osteopenia | 47 |
| Senile osteoporosis | 39 |
| Bone loss | 20 |
| Bone disorder | 13 |
| Prophylaxis | 10 |
| Osteoporosis prophylaxis | 7 |
| Osteoporotic fracture | 6 |
PROLIA vs Alternatives: Which Is Safer?
PROLIA vs PROMACTA
PROLIA vs PROMAZINE
PROLIA vs PROMETHAZINE
PROLIA vs PROMETHAZINE\PROMETHAZINE
PROLIA vs PROMETHAZINE\THIOUREA
PROLIA vs PROPAFENONE
PROLIA vs PROPARACAINE
PROLIA vs PROPECIA
PROLIA vs PROPIOMAZINE
PROLIA vs PROPOFOL
Official FDA Label for PROLIA
Official prescribing information from the FDA-approved drug label.