Leuprolide

Common brands: Eligard, Lupron Depot, Lupron Depot-Ped, Fensolvi, Leuprolide Acetate Depot

Top reporter: Tolmar Inc.

Androgen Receptor Inhibitor [EPC]Nonsteroidal Anti-inflammatory Drug [EPC]Corticosteroid [EPC]Provitamin D2 Compound [EPC]Platelet Aggregation Inhibitor [EPC]
76,176
Total Reports
43,539
Serious Reports
11,797
Death Reports
30
Reported Reactions
Death Report Ratio: High (15.49%)

Patient Demographics

Male
52,787
Female
15,486

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Leuprolide.

# Reaction Reports % of Total
1 HOT FLUSH 9,522
10.3%
2 INTERCEPTED PRODUCT PREPARATION ERROR 9,058
9.8%
3 DEATH 8,335
9.0%
4 SYRINGE ISSUE 7,884
8.5%
5 DEVICE LEAKAGE 6,123
6.6%
6 WRONG TECHNIQUE IN PRODUCT USAGE PROCESS 5,334
5.8%
7 FATIGUE 5,046
5.4%
8 INJECTION SITE PAIN 4,848
5.2%
9 PROSTATIC SPECIFIC ANTIGEN INCREASED 2,407
2.6%
10 ASTHENIA 2,363
2.5%
11 OFF LABEL USE 2,280
2.5%
12 DRUG INEFFECTIVE 2,263
2.4%
13 FALL 1,963
2.1%
14 ARTHRALGIA 1,945
2.1%
15 PAIN 1,915
2.1%
16 HEADACHE 1,884
2.0%
17 PROSTATE CANCER 1,801
1.9%
18 WEIGHT INCREASED 1,788
1.9%
19 DIZZINESS 1,753
1.9%
20 NAUSEA 1,708
1.8%
21 INTENTIONAL PRODUCT USE ISSUE 1,661
1.8%
22 BACK PAIN 1,403
1.5%
23 INJECTION SITE MASS 1,357
1.5%
24 INSOMNIA 1,212
1.3%
25 PAIN IN EXTREMITY 1,179
1.3%
26 ABDOMINAL PAIN 1,164
1.3%
27 WEIGHT DECREASED 1,157
1.2%
28 DYSPNOEA 1,134
1.2%
29 INTERCEPTED MEDICATION ERROR 1,129
1.2%
30 MALAISE 1,071
1.2%

Important Disclaimer

FDA adverse event reports are submitted voluntarily and do not prove causation. A reported reaction does not mean the drug caused it. Drugs with more users naturally have more reports. Always consult your doctor or pharmacist before making medication decisions.