Relugolix Side Effects
Medically reviewed by Drugs.com. Last updated on Nov 5, 2024.
Applies to relugolix: oral tablet.
Precautions
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Women should not use this medicine, especially women who are pregnant or able to become pregnant. This medicine can harm an unborn baby. It can also cause birth defects if the father is using it when his sexual partner becomes pregnant. Males with female partners who can become pregnant must use an effective birth control during treatment and for at least 2 weeks after the last dose. If a pregnancy occurs while you are using this medicine, tell your doctor right away.
Some men who use this medicine have become infertile (unable to have children). Talk with your doctor before using this medicine if you plan to have children.
This medicine can cause a change in heart rhythm called prolongation of the QT interval. This condition may change the way your heart beats (faster or slower) and can cause chest pain, dizziness, fainting, or trouble breathing. Contact your doctor right away if you have any of these symptoms or any questions.
This medicine may cause serious allergic reactions, including angioedema and pharyngeal edema, which can be life threatening and require immediate medical attention. Check with your doctor right away if you have large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs or trouble breathing.
Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain tests.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Common side effects of relugolix
Some side effects of relugolix 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:
More common side effects
- bone pain
- constipation
- diarrhea
- difficulty in moving
- feeling of warmth
- fever
- lack or loss of strength
- muscle aches, cramps, pain, or stiffness
- neck pain
- pain in the joints
- redness of the face, neck, arms and occasionally, upper chest
- stomach cramps or tenderness
- swollen joints
- watery or bloody diarrhea
Less common side effects
- decreased interest in sexual intercourse
- discouragement
- feeling sad or empty
- inability to have or keep an erection
- irritability
- loss in sexual ability, desire, drive, or performance
- loss of interest or pleasure
- swelling of the breasts or breast soreness
- trouble concentrating
- trouble sleeping
Serious side effects of relugolix
Along with its needed effects, relugolix 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 relugolix:
Less common side effects
Rare side effects
- bleeding gums
- cloudy urine
- coughing up blood
- decreased frequency or amount of urine
- difficult, burning, or painful urination
- difficulty in swallowing
- dizziness
- fainting
- frequent urge to urinate
- increased menstrual flow or vaginal bleeding
- increased thirst
- loss of appetite
- lower back or side pain
- nosebleeds
- paralysis
- prolonged bleeding from cuts
- red or black, tarry stools
- red or dark brown urine
- slow, fast, pounding, or irregular heartbeat
- swelling of the face, fingers, or lower legs
- trouble breathing
- unusual tiredness or weakness
- weight gain
Incidence not known
- large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
For healthcare professionals
Applies to relugolix: oral tablet.
General adverse events
The most commonly reported side effects included hot flush, increased glucose, increased triglycerides, and musculoskeletal pain.[Ref]
Cardiovascular
- Very common (10% or more): Hot flush (up to 54%)
- Common (1% to 10%): Fatal and non-fatal myocardial infarction, stroke
- Uncommon (0.1% to 1%): Fatal myocardial infarction, arrhythmia, atrioventricular block, cardiac failure[Ref]
Dermatologic
Endocrine
- Common (1% to 10%): Gynecomastia[Ref]
Gastrointestinal
- Very common (10% or more): Constipation (up to 12%), diarrhea (up to 12%)
- Uncommon (0.1% to 1%): Abdominal pain
- Frequency not reported: Colitis[Ref]
Genitourinary
- Uncommon (0.1% to 1%): Urinary tract infection[Ref]
Hematologic
- Very common (10% or more): Decreased hemoglobin (up to 28%)
- Uncommon (0.1% to 1%): Hemorrhage[Ref]
Hepatic
- Very common (10% or more): Increased ALT (up to 27%), increased AST (up to 18%)[Ref]
Hypersensitivity
- Postmarketing reports: Hypersensitivity[Ref]
Metabolic
- Very common (10% or more): Increased glucose (up to 44%), increased triglycerides (up to 35%)
- Common (1% to 10%): Increased weight[Ref]
Musculoskeletal
- Very common (10% or more): Musculoskeletal pain (up to 30%)
- Uncommon (0.1% to 1%): Fracture
- Frequency not reported: Arthralgia, arthritis, back pain, bone pain, extremity pain, musculoskeletal chest pain, musculoskeletal discomfort, musculoskeletal stiffness, myalgia, neck pain, non-cardiac chest pain, spinal pain[Ref]
Oncologic
- Uncommon (0.1% to 1%): Metastatic lung cancer[Ref]
Other
Psychiatric
- Common (1% to 10%): Insomnia, depression, decreased libido[Ref]
Renal
- Uncommon (0.1% to 1%): Acute kidney injury[Ref]
Respiratory
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References
1. (2021) "Product Information. Orgovyx (relugolix)." Myovant Sciences, Inc.
2. (2024) "Product Information. Orgovyx (relugolix)." Myovant Sciences, Inc.
More about relugolix
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Further information
Relugolix 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.