On May 16, 2025, the Food and Drug Administration (FDA) issued a drug safety communication warning about a rare risk of severe itching that can occur after stopping long-term use of oral allergy medications, such as cetirizine. Most patients who experienced itching after stopping the drug, had been taking the drug for 3 months or longer. Although some had taken for less than 1 month. Patients should contact their healthcare provider if they develop severe itching after stopping cetirizine. For additional information see: https://www.fda.gov/drugs/drug-safety-and-availability/fda-requires-warning-about-rare-severe-itching-after-stopping-long-term-use-oral-allergy-medicines?utm_medium=email&utm_source=govdelivery
Why is this medicine prescribed?
Cetirizine is used to temporarily relieve the symptoms of allergies (sneezing; runny nose; itchy, red, watery eyes; and itchy nose or throat) due to hay fever (allergy to pollen, dust, or other substances in the air) or allergy to other substances (such as dust mites, animal dander, cockroaches, and molds). Cetirizine is also used to treat itching and redness caused by hives. However, cetirizine does not prevent hives or other allergic skin reactions. Cetirizine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.
Cetirizine is also available in combination with
Are there other uses for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
How should this medicine be used?
Cetirizine comes as a tablet, a chewable tablet, an extended release tablet, and a syrup (liquid) to take by mouth. Take once a day with or without food. Take cetirizine at around the same time every day.
Take cetirizine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Do not use cetirizine to treat hives that are bruised or blistered, that are an unusual color, or that do not itch. Call your doctor if you have these types of hives.
Stop taking cetirizine and call your doctor if your hives do not improve during the first 3 days of your treatment or if your hives last longer than 6 weeks. If you do not know the cause of your hives, call your doctor.
If you are taking cetirizine to treat hives, and you develop any of the following symptoms, get emergency medical help right away: difficulty swallowing, speaking, or breathing; swelling in and around the mouth or swelling of the tongue; wheezing; drooling; dizziness; or loss of consciousness. These may be symptoms of a life-threatening allergic reaction called anaphylaxis. If your doctor suspects that you may experience anaphylaxis with your hives, he may prescribe an epinephrine injector (EpiPen). Do not use cetirizine in place of the epinephrine injector.
What special precautions should I follow?
Before taking cetirizine,
- tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking cetirizine. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have or have ever had kidney or liver disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking cetirizine, call your doctor.
- you should know that cetirizine may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
- remember that alcohol can add to the drowsiness caused by this medication. Avoid drinking alcoholic beverages while taking this medication.
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 almost time for 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 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 https://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.
Symptoms of overdose may include:
- restlessness
- irritability
- drowsiness
What side effects can this medicine cause?
Cetirizine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- drowsiness
- excessive tiredness
- dry mouth
- stomach pain
- diarrhea
- vomiting
Some side effects can be serious. The following symptom is uncommon, but if you experience it, call your doctor immediately:
- difficulty breathing or swallowing
Cetirizine 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 ( https://www.fda.gov/Safety/MedWatch ) or by phone (
1-800-332-1088).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. https://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 https://goo.gl/c4Rm4p for more information.
What other information should I know?
Keep all appointments with your doctor.
Ask your pharmacist any questions you have about cetirizine.
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.