ACLASTA: 1,245 Adverse Event Reports & Safety Profile
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1,245
Total FAERS Reports
382 (30.7%)
Deaths Reported
334
Hospitalizations
1,245
As Primary/Secondary Suspect
27
Life-Threatening
50
Disabilities
First Report: 2000 · Latest Report: 20140620
What Are the Most Common ACLASTA Side Effects?
#1 Most Reported
Death
233 reports (18.7%)
#2 Most Reported
Fall
138 reports (11.1%)
#3 Most Reported
Pain
82 reports (6.6%)
All ACLASTA Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Death | 233 | 18.7% | 233 | 17 |
| Fall | 138 | 11.1% | 11 | 56 |
| Pain | 82 | 6.6% | 9 | 29 |
| Pyrexia | 70 | 5.6% | 13 | 39 |
| Malaise | 65 | 5.2% | 13 | 28 |
| Pain in extremity | 54 | 4.3% | 7 | 15 |
| Arthralgia | 46 | 3.7% | 4 | 17 |
| Dyspnoea | 46 | 3.7% | 16 | 22 |
| Vomiting | 43 | 3.5% | 4 | 16 |
| Pneumonia | 40 | 3.2% | 21 | 24 |
| Cerebrovascular accident | 39 | 3.1% | 16 | 23 |
| Hip fracture | 38 | 3.1% | 4 | 14 |
| Back pain | 37 | 3.0% | 4 | 12 |
| Dizziness | 36 | 2.9% | 0 | 11 |
| Headache | 36 | 2.9% | 1 | 9 |
| Nausea | 36 | 2.9% | 3 | 19 |
| Inappropriate schedule of drug administration | 34 | 2.7% | 5 | 10 |
| Gait disturbance | 30 | 2.4% | 4 | 14 |
| Asthenia | 28 | 2.3% | 7 | 10 |
| Feeling abnormal | 28 | 2.3% | 1 | 4 |
Who Reports ACLASTA Side Effects? Age & Gender Data
Average age: 72.7 years. Most reports from: COUNTRY NOT SPECIFIED. View detailed demographics →
Is ACLASTA Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2000 | 1 | 0 | 0 |
| 2008 | 3 | 0 | 2 |
| 2009 | 6 | 0 | 0 |
| 2010 | 18 | 2 | 6 |
| 2011 | 45 | 10 | 13 |
| 2012 | 78 | 20 | 29 |
| 2013 | 326 | 105 | 98 |
| 2014 | 202 | 38 | 63 |
What Is ACLASTA Used For?
| Indication | Reports |
|---|---|
| Osteoporosis | 774 |
| Osteoporosis postmenopausal | 19 |
| Osteopenia | 15 |
| Osteoporotic fracture | 11 |
| Osteitis deformans | 8 |
| Off label use | 7 |
ACLASTA vs Alternatives: Which Is Safer?
ACLASTA vs ACLIDINIUM
ACLASTA vs ACLIDINIUM\FORMOTEROL
ACLASTA vs ACTEMRA
ACLASTA vs ACTIQ
ACLASTA vs ACTONEL
ACLASTA vs ACYCLOVIR
ACLASTA vs ADALIMUMAB
ACLASTA vs ADALIMUMAB-AACF
ACLASTA vs ADALIMUMAB-AATY
ACLASTA vs ADALIMUMAB-ADAZ
Official FDA Label for ACLASTA
Official prescribing information from the FDA-approved drug label.