Ganirelix

Last reviewed on RxList: 1/4/2018
Ganirelix Side Effects Center

Last reviewed on RxList 01/04/2018

Ganirelix Acetate Injection (ganirelix) is a synthetic decapeptide, a man-made form of a protein that reduces the amount of certain hormones in the body, including estrogen, used along with other medications to regulate hormones during treatment for infertility in women. Common side effects of Ganirelix Acetate Injection include redness or pain at the injection site reactions (pain, redness, or irritation), headache, mild nausea, stomach pain, tiredness, pelvic pain (similar to menstrual cramps), or vaginal bleeding.

After initiating FSH (follicle stimulating hormone) therapy on Day 2 or 3 of the cycle, Ganirelix Acetate Injection in a dose of 250 µg may be given subcutaneously (under the skin) once daily during the mid to late portion of the follicular phase. There may be other drugs that can interact with Ganirelix. Tell your doctor all prescription and over-the-counter medications and supplements you use. Ganirelix must not be used during pregnancy because of possible harm to a fetus. If you become pregnant or think you may be pregnant, inform your doctor. It is unknown if this drug passes into breast milk. Because of the potential risk to the infant, breastfeeding while using this drug is not recommended.

Our Ganirelix Acetate Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Digestive Disorders: Common Misconceptions See Slideshow
Ganirelix Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some women using this medicine develop ovarian hyperstimulation syndrome (OHSS), a potentially life-threatening condition. Call your doctor right away if you have symptoms of OHSS:

  • stomach pain, bloating, nausea, vomiting, diarrhea;
  • rapid weight gain, especially in your face and midsection;
  • little or no urination; or
  • pain when you breathe, rapid heart rate, feeling short of breath (especially when lying down).

Common side effects may include:

  • stomach pain;
  • headache;
  • vaginal bleeding; or
  • OHSS.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Ganirelix (Ganirelix)

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Ganirelix Professional Information

SIDE EFFECTS

The safety of Ganirelix Acetate Injection (ganirelix) 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.

TABLE IV: Incidence of common adverse events (Incidence ≥ 1% in Ganirelix Acetate-treated subjects). Completed controlled clinical studies (All-subjects-treated group).

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 (see PRECAUTIONS).

Congenital Anomalies

Ongoing clinical follow-up studies of 283 newborns of women administered Ganirelix Acetate Injection (ganirelix) 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.

Read the entire FDA prescribing information for Ganirelix (Ganirelix)

© Ganirelix Patient Information is supplied by Cerner Multum, Inc. and Ganirelix Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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