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

Applies to relugolix: oral tablets.

Side effects include:

Adverse effects or laboratory abnormalities reported in ≥10 or ≥15%, respectively: Hot flush, musculoskeletal pain, fatigue, constipation, increased glucose concentrations, increased triglyceride concentrations, decreased hemoglobin, increased ALT and AST concentrations.

For Healthcare Professionals

Applies to relugolix: oral tablet.

Hematologic

Very common (10% or more): Decreased hemoglobin (28%)

Uncommon (0.1% to 1%): hemorrhage (0.3%)^[Ref]

Musculoskeletal

Very common (10% or more): Musculoskeletal pain (30%)

Uncommon (0.1% to 1%): Fracture (0.3%)^[Ref]

Metabolic

Very common (10% or more): Increased glucose (44%), increased triglycerides (35%)

Common (1% to 10%): Increased weight^[Ref]

Psychiatric

Common (1% to 10%): Insomnia, depression, decreased libido^[Ref]

Genitourinary

Uncommon (0.1% to 1%): Urinary tract infection (0.5%)^[Ref]

Hepatic

Very common (10% or more): Increased alanine aminotransferase (27%), increased aspartate aminotransferase (18%)^[Ref]

Oncologic

Uncommon (0.1% to 1%): Metastatic lung cancer (0.3%)^[Ref]

Respiratory

Uncommon (0.1% to 1%): Pneumonia (0.3%)^[Ref]

General

Very common (10% or more): Fatigue (26%)^[Ref]

Renal

Uncommon (0.1% to 1%): Acute kidney injury up to 0.6%), urinary tract infection (0.5%)^[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Myocardial infarction (up to 0.8%), arrhythmia (0.6%), atrioventricular block (0.3%), cardiac failure (0.3%)

Frequency not reported: Fatal and non-fatal myocardial infarction, stroke^[Ref]

Dermatologic

Common (1% to 10%): Hyperhidrosis^[Ref]

Endocrine

Very common (10% or more): Hot flash (54%)

Common (1% to 10%): Gynecomastia^[Ref]

Gastrointestinal

Very common (10% or more): Constipation (12%), diarrhea (12%)

Uncommon (0.1% to 1%): Abdominal pain (0.3%)^[Ref]