LUPRON DEPOT: 769 Adverse Event Reports & Safety Profile
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769
Total FAERS Reports
64 (8.3%)
Deaths Reported
89
Hospitalizations
769
As Primary/Secondary Suspect
5
Life-Threatening
3
Disabilities
First Report: 1990 · Latest Report: 20140620
What Are the Most Common LUPRON DEPOT Side Effects?
#1 Most Reported
Hot flush
160 reports (20.8%)
#2 Most Reported
Pain
63 reports (8.2%)
#3 Most Reported
Vaginal haemorrhage
56 reports (7.3%)
All LUPRON DEPOT Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Hot flush | 160 | 20.8% | 0 | 4 |
| Pain | 63 | 8.2% | 1 | 7 |
| Vaginal haemorrhage | 56 | 7.3% | 0 | 1 |
| Abdominal pain | 52 | 6.8% | 0 | 5 |
| Headache | 47 | 6.1% | 0 | 2 |
| Pelvic pain | 46 | 6.0% | 0 | 3 |
| Endometriosis | 45 | 5.9% | 0 | 2 |
| Menorrhagia | 40 | 5.2% | 1 | 5 |
| Fatigue | 38 | 4.9% | 0 | 4 |
| Mood swings | 38 | 4.9% | 0 | 0 |
| Nausea | 37 | 4.8% | 1 | 1 |
| Death | 34 | 4.4% | 34 | 5 |
| Dizziness | 34 | 4.4% | 1 | 6 |
| Drug ineffective | 31 | 4.0% | 0 | 2 |
| Muscle spasms | 31 | 4.0% | 0 | 2 |
| Arthralgia | 30 | 3.9% | 0 | 2 |
| Weight increased | 27 | 3.5% | 0 | 2 |
| Depression | 24 | 3.1% | 0 | 1 |
| Insomnia | 24 | 3.1% | 0 | 3 |
| Pain in extremity | 24 | 3.1% | 0 | 4 |
Who Reports LUPRON DEPOT Side Effects? Age & Gender Data
Average age: 42.4 years. Most reports from: COUNTRY NOT SPECIFIED. View detailed demographics →
Is LUPRON DEPOT Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2000 | 2 | 0 | 1 |
| 2002 | 2 | 0 | 1 |
| 2003 | 1 | 0 | 0 |
| 2004 | 3 | 0 | 0 |
| 2005 | 3 | 0 | 0 |
| 2006 | 5 | 0 | 0 |
| 2007 | 3 | 0 | 0 |
| 2008 | 3 | 0 | 0 |
| 2009 | 4 | 0 | 0 |
| 2010 | 14 | 0 | 3 |
| 2011 | 16 | 1 | 1 |
| 2012 | 44 | 2 | 3 |
| 2013 | 346 | 15 | 33 |
| 2014 | 86 | 16 | 29 |
What Is LUPRON DEPOT Used For?
| Indication | Reports |
|---|---|
| Endometriosis | 356 |
| Prostate cancer | 163 |
| Product used for unknown indication | 112 |
| Uterine leiomyoma | 97 |
| Menorrhagia | 6 |
| Off label use | 6 |
| Pelvic pain | 6 |
| Haemorrhage | 5 |
| Maternal exposure timing unspecified | 5 |
| Vaginal haemorrhage | 5 |
LUPRON DEPOT vs Alternatives: Which Is Safer?
LUPRON DEPOT vs LUPRON DEPOT-PED
LUPRON DEPOT vs LURASIDONE
LUPRON DEPOT vs LURBINECTEDIN
LUPRON DEPOT vs LUSPATERCEPT
LUPRON DEPOT vs LUSPATERCEPT-AAMT
LUPRON DEPOT vs LUTEIN
LUPRON DEPOT vs LUTETIUM LU-177
LUPRON DEPOT vs LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN
LUPRON DEPOT vs LUTETIUM OXODOTREOTIDE LU-177
LUPRON DEPOT vs LUTROPIN ALFA
Official FDA Label for LUPRON DEPOT
Official prescribing information from the FDA-approved drug label.