Fyremadel Side Effects

Generic name: ganirelix

Medically reviewed by Drugs.com. Last updated on Apr 30, 2025.

Note: This document provides detailed information about Fyremadel.

Applies to ganirelix: subcutaneous solution Side Effects associated with ganirelix. Some dosage forms listed on this page may not apply specifically to the brand name Fyremadel.

Applies to ganirelix: subcutaneous solution.

Precautions

It is very important that your doctor check your progress often at regular visits to make sure that the medicine is working properly and to check for unwanted effects. Your doctor will probably want to follow the developing eggs inside the ovaries by doing an ultrasound examination and measuring hormones in your blood stream.

This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

The needle cover of the prefilled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions in people who are sensitive to latex. Tell your doctor if you have a latex allergy before you start using this medicine.

Serious side effects of Fyremadel

Along with its needed effects, ganirelix (the active ingredient contained in Fyremadel) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking ganirelix:

Other side effects of Fyremadel

Some side effects of ganirelix may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For healthcare professionals

Applies to ganirelix: subcutaneous solution.

General adverse events

The more commonly reported adverse reactions have included injection site redness and/or swelling, abdominal pain, and headache; rare postmarketing cases of anaphylaxis have been reported.^[Ref]

Endocrine

• Common (1% to 10%): Ovarian Hyperstimulation Syndrome, fetal death
• Frequency not reported: Congenital anomalies

Among 283 newborns of mothers receiving this drug; 3 neonates had major congenital anomalies (i.e., hydrocephalus/meningocele, omphalocele, and Beckwith-Wiedemann Syndrome) and 18 neonates experienced minor anomalies (i.e., 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). A subsequent analysis showed the incidence of congenital anomalies with this drug are comparable to another GnRH agonist.

The incidence of congenital malformations after Assisted Reproductive Technology appears to be slightly higher than after spontaneous conception; although this may be related to differences in parental characteristics and higher incidence of multiple gestations.

Genitourinary

• Common (1% to 10%): Abdominal pain (gynecological), vaginal bleeding^[Ref]

Local

• Very common (10% or more): Injection site reaction (up to 15%)^[Ref]

Following injection, between 10% and 15% of patients reported redness with or without swelling at the injection site. This normally disappeared within 4 hours after administration.^[Ref]

Hypersensitivity

• Postmarketing reports: Hypersensitivity reactions

During the postmarketing period, rare reports of anaphylaxis (including anaphylactic shock), angioedema, and urticaria have been received, as early as with the first dose.

Nervous system

• Common (1% to 10%): Headache^[Ref]

Gastrointestinal

• Common (1% to 10%): Nausea^[Ref]

Other

• Uncommon (0.1% to 1%): Malaise^[Ref]

Hematologic

• Frequency not reported: Elevated neutrophil counts, decreased hematocrit

Elevated neutrophil counts (8.3 x 10(9)/L or greater) and decreased hematocrit concentrations have been observed during therapy; however, the significance of these findings is not known.

Hepatic

• Frequency not reported: Decreased total bilirubin concentrations

Decreased total bilirubin concentrations have been observed during therapy; however, the significance of this finding is not known.

See also:

Further information

Fyremadel side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer