GONAL-F: 61 Adverse Event Reports & Safety Profile
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61
Total FAERS Reports
3 (4.9%)
Deaths Reported
38
Hospitalizations
61
As Primary/Secondary Suspect
2
Life-Threatening
First Report: 200804 · Latest Report: 20140502
What Are the Most Common GONAL-F Side Effects?
#1 Most Reported
Ovarian hyperstimulation syndrome
29 reports (47.5%)
#2 Most Reported
Ascites
19 reports (31.1%)
#3 Most Reported
Haematocrit increased
14 reports (23.0%)
All GONAL-F Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Ovarian hyperstimulation syndrome | 29 | 47.5% | 1 | 29 |
| Ascites | 19 | 31.2% | 0 | 19 |
| Haematocrit increased | 14 | 23.0% | 0 | 14 |
| Abortion spontaneous | 8 | 13.1% | 0 | 1 |
| Hyponatraemia | 8 | 13.1% | 0 | 8 |
Who Reports GONAL-F Side Effects? Age & Gender Data
Average age: 30.6 years. Most reports from: FR. View detailed demographics →
Is GONAL-F Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2008 | 1 | 0 | 0 |
| 2011 | 1 | 0 | 1 |
| 2012 | 8 | 0 | 4 |
| 2013 | 28 | 0 | 26 |
| 2014 | 8 | 0 | 6 |
What Is GONAL-F Used For?
| Indication | Reports |
|---|---|
| In vitro fertilisation | 31 |
| Product used for unknown indication | 13 |
| Ovulation induction | 5 |
Official FDA Label for GONAL-F
Official prescribing information from the FDA-approved drug label.