What is RELUGOLIX used for?

RELUGOLIX (brand name Orgovyx) is a GnRH Antagonist indicated for See full prescribing information.

What are the most common side effects of RELUGOLIX?

Reported side effects vary by individual. The side-effects section on this page lists the events most frequently reported to FDA FAERS for RELUGOLIX. FAERS is voluntary reporting, so it reflects what was reported, not absolute incidence.

Is RELUGOLIX the same as Orgovyx?

Orgovyx is a brand name for RELUGOLIX. They share the same active ingredient and FDA-approved indications. Biosimilars and authorised generics may differ in inactive ingredients such as buffers or preservatives.

RELUGOLIX

Q: How does RELUGOLIX work?

RELUGOLIX works through the following mechanism: 12.1 Mechanism of Action Relugolix is a nonpeptide GnRH receptor antagonist that competitively binds to pituitary GnRH receptors, thereby, reducing the release of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), and consequently testosterone..

GnRH Antagonist

Brand names: Orgovyx

Oral

Mechanism of Action

12.1 Mechanism of Action Relugolix is a nonpeptide GnRH receptor antagonist that competitively binds to pituitary GnRH receptors, thereby, reducing the release of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), and consequently testosterone.

Indications

See full prescribing information

FDA Warnings

5 WARNINGS AND PRECAUTIONS QT/QTc Interval Prolongation: Androgen deprivation therapy may prolong the QT interval ( 5
Providers should consider whether the benefits of androgen deprivation therapy outweigh the potential risks in patients with congenital long QT syndrome, congestive heart failure, or frequent electrolyte abnormalities and in patients taking drugs known to prolong the QT interval
2 Hypersensitivity Reactions ORGOVYX is contraindicated in patients with severe hypersensitivity to relugolix or any of the product components [see Contraindications ( 4 )]
Hypersensitivity reactions, including pharyngeal edema and other serious cases of angioedema, have been reported postmarketing in patients treated with ORGOVYX

Known Side Effects

9 documented side effects by frequency

Fatigue

>10%

Weakness

1-10%

Joint Pain

0.1-1%

Diarrhea

0.1-1%

Dizziness

0.1-1%

Constipation

0.1-1%

Weight Gain

0.1-1%

Insomnia

0.1-1%

Muscle Pain

0.1-1%

Community Discussions

No community discussions found for RELUGOLIX yet.

Primary sources

Every figure on this page links back to its primary source. See data sources for full provenance.

DailyMed FDA label search → RELUGOLIX openFDA label JSON → RELUGOLIX FAERS adverse-event reports → RELUGOLIX ClinicalTrials.gov → completed Phase 2+ trials of RELUGOLIX

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Formulations

Dosage Forms

Tablet

Route

Oral