Safety
Adverse reactions
Common adverse reactions reported at a frequency of ≥2% in a randomized, double-blind, active-controlled, comparative study of normal ovulatory women undergoing controlled ovarian stimulation as part of an in vitro fertilization or intracytoplasmic sperm injection cycle
System organ class | Adverse reactions |
FOLLISTIM AQ Cartridge treatment (N=751)
na (%)
|
---|---|---|
Nervous system disorders | Headache | 55 (7.3%) |
Gastrointestinal disorders | Nausea | 29 (3.9%) |
Reproductive system and breast disorders | Ovarian hyperstimulation syndrome | 48 (6.4%) |
Pelvic discomfort | 62 (8.3%) | |
Pelvic pain | 41 (5.5%) | |
General disorders and administration site conditions | Fatigue | 17 (2.3%) |
(a) n=number of women with the adverse reaction.