Antagon Side Effects

Generic name: ganirelix

Note: This document contains side effect information about ganirelix. Some of the dosage forms listed on this page may not apply to the brand name Antagon.

Some side effects of Antagon may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to ganirelix: subcutaneous solution

Get emergency medical help if you have any of these signs of an allergic reaction while taking ganirelix (the active ingredient contained in Antagon) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some women using this medicine have developed a condition called ovarian hyperstimulation syndrome (OHSS), especially after the first treatment cycle. OHSS can be a life-threatening condition. Call your doctor right away if you have any of the following symptoms of OHSS:

• severe pelvic pain;

• swelling of the hands or legs;

• stomach pain and swelling;

• shortness of breath;

• weight gain;

• diarrhea;

• nausea or vomiting; or

• urinating less than usual.

Less serious side effects of ganirelix may include:

• pelvic pain (similar to menstrual cramps);

• mild nausea or stomach pain;

• headache;

• vaginal bleeding; or

• pain, redness, or irritation at the injection site.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to ganirelix: subcutaneous solution

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.

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