GONADORELIN: 225 Adverse Event Reports & Safety Profile
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225
Total FAERS Reports
12 (5.3%)
Deaths Reported
86
Hospitalizations
225
As Primary/Secondary Suspect
12
Life-Threatening
3
Disabilities
Oct 10, 1989
FDA Approved
Discontinued
Status
FDA Application: 018123 ·
First Report: 20050101 · Latest Report: 20250727
What Are the Most Common GONADORELIN Side Effects?
#1 Most Reported
Ovarian hyperstimulation syndrome
32 reports (14.2%)
#2 Most Reported
Neutropenia
31 reports (13.8%)
#3 Most Reported
Metastases to bone
24 reports (10.7%)
All GONADORELIN Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Ovarian hyperstimulation syndrome | 32 | 14.2% | 0 | 21 |
| Neutropenia | 31 | 13.8% | 0 | 0 |
| Metastases to bone | 24 | 10.7% | 0 | 3 |
| Headache | 20 | 8.9% | 0 | 6 |
| Malignant neoplasm progression | 20 | 8.9% | 0 | 4 |
| White blood cell count decreased | 20 | 8.9% | 0 | 0 |
| Carcinoembryonic antigen increased | 15 | 6.7% | 0 | 0 |
| Breast cancer | 14 | 6.2% | 0 | 0 |
| Nausea | 14 | 6.2% | 0 | 9 |
| Central nervous system lesion | 13 | 5.8% | 0 | 6 |
| Neutrophil count decreased | 13 | 5.8% | 0 | 1 |
| Fatigue | 10 | 4.4% | 0 | 4 |
| Product use in unapproved indication | 10 | 4.4% | 0 | 1 |
| Rash | 10 | 4.4% | 0 | 4 |
| Recalled product administered | 10 | 4.4% | 0 | 1 |
| Alanine aminotransferase increased | 9 | 4.0% | 0 | 3 |
| Ascites | 9 | 4.0% | 0 | 7 |
| Aspartate aminotransferase increased | 9 | 4.0% | 0 | 3 |
| Constipation | 9 | 4.0% | 0 | 3 |
| Drug ineffective | 9 | 4.0% | 1 | 1 |
Who Reports GONADORELIN Side Effects? Age & Gender Data
Gender: 66.9% female, 33.1% male. Average age: 49.6 years. Most reports from: FR. View detailed demographics →
Is GONADORELIN Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2005 | 1 | 0 | 1 |
| 2009 | 1 | 0 | 0 |
| 2011 | 1 | 0 | 1 |
| 2012 | 1 | 0 | 0 |
| 2013 | 9 | 0 | 1 |
| 2014 | 9 | 0 | 1 |
| 2015 | 4 | 0 | 2 |
| 2016 | 14 | 0 | 12 |
| 2017 | 17 | 2 | 12 |
| 2018 | 14 | 0 | 6 |
| 2019 | 15 | 2 | 4 |
| 2020 | 22 | 1 | 14 |
| 2021 | 14 | 0 | 5 |
| 2022 | 21 | 0 | 6 |
| 2023 | 7 | 0 | 2 |
| 2024 | 4 | 0 | 2 |
| 2025 | 9 | 1 | 7 |
What Is GONADORELIN Used For?
GONADORELIN vs Alternatives: Which Is Safer?
GONADORELIN vs GONADOTROPHIN, CHORIONIC
GONADORELIN vs GOSERELIN
GONADORELIN vs GRAMICIDIN
GONADORELIN vs GRAMICIDIN\NEOMYCIN\POLYMYXIN B
GONADORELIN vs GRAMICIDIN\POLYMYXIN B
GONADORELIN vs GRANISETRON
GONADORELIN vs GRANULOCYTE COLONY-STIMULATING FACTOR NOS
GONADORELIN vs GRANULOCYTE-MACROPHAGE COLONY-STIMULATING FACTOR
GONADORELIN vs GRAZOPREVIR
GONADORELIN vs GRISEOFULVIN
Official FDA Label for GONADORELIN
Official prescribing information from the FDA-approved drug label.