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Fezolinetant may cause serious or life threatening liver damage. Tell your doctor if you have or ever have had cirrhosis (scarring and damage to your liver) or liver disease. Your doctor may tell you not to take fezolinetant. If you experience any of the following symptoms, stop taking fezolinetant and call your doctor immediately: extreme tiredness, loss of appetite, nausea, vomiting, itching, yellowing of the skin or eyes, dark yellow or brown-colored urine, pale stools, or pain in the upper right part of the stomach.
Your doctor will order a blood test to be sure your liver is working normally before and during your treatment with fezolinetant. Based on the results, your doctor may tell you not to take or to stop taking fezolinetant. Keep all appointments with your doctor and the laboratory.
WHY is this medicine prescribed?
Fezolinetant is used to treat hot flashes (hot flushes; sudden strong feelings of heat and sweating) due to menopause. Fezolinetant is in a class of medications called neurokinin 3 (NK3) receptor antagonist. It works by altering the nerve response that triggers the thermoregulatory center causing vasomotor symptoms.
HOW should this medicine be used?
Fezolinetant comes as a tablet to take by mouth. It is usually taken once a day with or without food. Take fezolinetant at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take fezolinetant exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Swallow the tablets whole with liquids; do not split, chew, or crush them.
As your pharmacist or doctor for a copy of the manufacturer's information for the patient.
Are there OTHER USES for this medication?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What SPECIAL PRECAUTIONS should I follow?
Before taking fezolinetant,
What SPECIAL DIETARY instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do IF I FORGET to take a dose?
Take the missed dose as soon as you remember it. However, if it is less than 12 hours until the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What SIDE EFFECTS can this medicine cause?
Fezolinetant may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
Fezolinetant may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).
What should I do in case of OVERDOSE?
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at http://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
What should I know about STORAGE and DISPOSAL of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).
Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location - one that is up and away and out of their sight and reach. http://www.upandaway.org
Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website http://goo.gl/c4Rm4p for more information.
What OTHER INFORMATION should I know?
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to fezolinetant.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS® Patient Medication Information™ Copyright, 2025. The American Society of Health-System Pharmacists®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.
Selected Revisions: February 15, 2025.