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Table 2 Basic information on ADEs related to ganirelix from the FAERS database

From: Post-marketing safety profile of ganirelix in women: a 20-year pharmacovigilance analysis of global adverse drug event databases (2004–2024)

Characteristics

Case number

Case proportion, %

Sex

  

Female

1096

100%

Age

< 18 years

1

0.1%

18–65 years

662

60.4%

Unknown

433

39.5%

Weight

< 50 kg

26

2.4%

50–100 kg

129

11.8%

> 100 kg

51

0.5%

Unknown

937

85.5%

Reported Countries (top five)

US

597

54.5%

DE

179

16.3%

FR

127

11.6%

JPN

50

4.6%

NL

35

3.2%

Reported person

Health professionals

724

66.1%

Consumer

362

33.0%

Unknown

10

0.9%

Outcome

  

HO

359

32.8%

LT

15

1.4%

DS

5

0.5%

DE

2

0.2%

OT

143

13.0%

CA

1

0.1%

Unknown

571

52.1%

Indication (top five)

  

Infertility female

187

17.1%

In vitro fertilization

149

13.6%

Assisted reproductive technology

136

12.4%

Infertility

85

7.8%

Prevention of premature ovulation

56

5.1%

  1. US, United States; DE, Germany; FR, France; JPN, Japan; NL, Netherlands; HO, Hospitalization-initial or prolonged; LT, Life-threatening; DS, Disability; CA, Congenital anomaly; DE, Death; OT, Other serious outcome; RI, Required intervention