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Ganirelix

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Ganirelix Acetate Injection

Ganirelix Acetate Injection

Ganirelix Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Ganirelix Acetate Injection is used along with other medications to regulate hormones during treatment for infertility in women. It is a man-made form of a protein that reduces the amount of certain hormones in the body, including estrogen. Common side effects include redness or pain at the injection site, headache, mild nausea/stomach pain, and tiredness.

After initiating FSH (follicle stimulating hormone) therapy on Day 2 or 3 of the cycle, Ganirelix Acetate Injection in a dose of 250 g 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, breast-feeding 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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Ganirelix in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: 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 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. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Ganirelix (Ganirelix) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Ganirelix Overview - Patient Information: Side Effects

SIDE EFFECTS: Redness or pain at the injection site, headache, mild nausea/stomach pain, and tiredness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: unusual vaginal bleeding.

This medication may cause a condition known as Ovarian Hyperstimulation Syndrome (OHSS). This condition may occur during therapy and after treatment has been discontinued. Rarely, serious OHSS causes fluid to suddenly build up in the stomach, chest, and heart area. Seek immediate medical attention if you develop the following side effects: severe pain or swelling in the lower abdominal (pelvic) area, severe nausea/vomiting, sudden/rapid weight gain, or change in the amount of urine.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Ganirelix (Ganirelix)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Ganirelix FDA Prescribing Information: Side Effects
(Adverse Reactions)

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) »

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Ganirelix Acetate Injection - User Reviews

Ganirelix Acetate Injection User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Ganirelix Acetate Injection sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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