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.
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:
Seek medical attention right away if any of these SEVERE side effects occur 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.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
TopGanirelix 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.
| Adverse Events Occurring in ≥ 1% | Ganirelix Acetate N=794 % (n) |
|---|---|
| Abdominal Pain (gynecological) | 4.8 (38) |
| Death Fetal | 3.7 (29) |
| Headache | 3.0 (24) |
| Ovarian Hyperstimulation Syndrome | 2.4 (19) |
| Vaginal Bleeding | 1.8 (14) |
| Injection Site Reaction | 1.1 (9) |
| Nausea | 1.1 (9) |
| Abdominal Pain (gastrointestinal) | 1.0 (8) |
During post-marketing surveillance, rare cases of hypersensitivity reactions, including anaphylactoid reactions with the first dose, have been reported.
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.
TopSide Effects by Body System - for Healthcare Professionals
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.
Hypersensitivity
Hypersensitivity side effects have included postmarketing reports of hypersensitivity reactions, including anaphylactoid reactions with the first dose.
TopMore Ganirelix resources
- ganirelix Concise Consumer Information (Cerner Multum)
- ganirelix Subcutaneous Advanced Consumer (Micromedex) - Includes Dosage Information
- Ganirelix Prescribing Information (FDA)
- Ganirelix MedFacts Consumer Leaflet (Wolters Kluwer)
- Ganirelix Acetate Monograph (AHFS DI)
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