Ganirelix Side Effects

Please note - some side effects for Ganirelix may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Ganirelix - for the Consumer

Ganirelix

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Ganirelix:

Headache; mild vaginal bleeding.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark urine; decreased urination; diarrhea; nausea; shortness of breath; stomach pain, bloating, or swelling; sudden weight gain; vomiting.

Ganirelix Side Effects - for the Professional

Ganirelix

The safety of Ganirelix Acetate Injection was evaluated in two randomized, parallel-group, multicenter controlled clinical studies. Treatment duration for Ganirelix Acetate ranged from 1 to 14 days. Table IV represents adverse events (AEs) from first day of Ganirelix Acetate administration until confirmation of pregnancy by ultrasound at an incidence of ≥ 1% in Ganirelix Acetate-treated subjects without regard to causality.

Congenital Anomalies

Ongoing clinical follow-up studies of 283 newborns of women administered Ganirelix Acetate Injection were reviewed. There were three neonates with major congenital anomalies and 18 neonates with minor congenital anomalies. The major congenital anomalies were: hydrocephalus/meningocele, omphalocele, and Beckwith-Wiedemann Syndrome. The minor congenital anomalies were: nevus, skin tags, sacral sinus, hemangioma, torticollis/asymmetric skull, talipes, supernumerary digit finger, hip subluxation, torticollis/high palate, occiput/abnormal hand crease, hernia umbilicalis, hernia inguinalis, hydrocele, undescended testis, and hydronephrosis. The causal relationship between these congenital anomalies and Ganirelix Acetate is unknown. Multiple factors, genetic and others (including, but not limited to ICSI, IVF, gonadotropins, progesterone) may confound ART (Assisted Reproductive Technology) procedures.

Side Effects by Body System

Genitourinary

Genitourinary symptoms of abdominal pain (4.8%), ovarian hyperstimulation (2.4%), and vaginal bleeding (1.8%) have been reported.

Nervous system

Nervous systems side effects have been limited to headache in 3% of patients.

Local

Local side effects have included non-specific injection site reactions (1.1%).

Gastrointestinal

Gastrointestinal side effects of nausea and abdominal pain have occurred in 1.1% and 1% of patients, respectively.

Other

Follow-up studies of 282 newborns revealed 3 neonates with major and 18 with minor congenital anomalies. The major anomalies included hydrocephalus/meningocele, omphalocele, and Beckwith-Wiedemann Syndrome. Minor dermal, skeletal, muscular, and organ (angioma, hernia , testes, and renal) anomalies were reported.

Neonatal congenital anomalies have been reported. The causal relationship of the anomalies and ganirelix therapy is unknown. Multiple factors may confound assisted reproductive procedures.

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