Travelling with an Allergy

drug allergy treatments :: Article Creator

FDA Issues Warning About Popular Allergy Medications

The U.S. Food and Drug Administration has warned that patients who stop long-term use of the popular oral allergy medications Zyrtec or Xyzal may experience "rare but severe itching," in a May 16 warning.

Newsweek reached out to Zyrtec and Xyzal's media teams via email for comment.

Why It Matters

In recent months, millions of Americans have grappled with seasonal allergies triggered by pollen and blooming plants. Many have reported sneezing, itchy eyes and runny noses, prompting a turn to prescription and over-the-counter allergy medications.

According to the American College of Allergy, Asthma and Immunology, citing data from the Centers for Disease Control and Prevention (CDC), nearly one in three U.S. Adults and more than one in four U.S. Children report having a seasonal allergy, eczema or food allergy.

The data showed that more than 100 million Americans reported having allergy symptoms. In 2021, approximately 81 million people in the U.S. Had hay fever.

In its warning, the FDA said that more than 80 million packages of the popular allergy medications were purchased in 2022.

What To Know

The FDA said that itching, known as pruritus, "has been reported in patients who used these medicines daily, typically for at least a few months and often for years." The patients did not have any itching symptoms prior to taking the allergy medications.

The itching required medical intervention. The FDA said the symptoms "may improve with restarting the medicines." The agency is revising the prescribing information for the prescription versions of cetirizine (Zyrtec) and levocetirizine (Xyzal) to include a new warning about the risk.

Cetirizine and levocetirizine are antihistamines that block histamines released by the body during allergic reactions. Both are approved to treat seasonal allergies. Cetirizine was approved as a prescription drug in 1995 and became available over the counter in 2007. Levocetirizine was approved for prescription use in 2007 and switched to over-the-counter status in 2017.

The FDA's warning is based on 209 worldwide cases, 197 in the U.S., of pruritus after halting use of the drugs. The cases were reported to the FDA between April 25, 2017, and July 6, 2023.

A man blows his nose behind birch pollen on the branch of a birch tree in Baden-W'rttemberg, Stuttgart, Germany, on April 3, 2025. A man blows his nose behind birch pollen on the branch of a birch tree in Baden-W'rttemberg, Stuttgart, Germany, on April 3, 2025. Bernd Wei'brod/picture-alliance/dpa/AP Images What People Are Saying

A spokesperson for Opella, which owns Xyzal, told Newsweek: "Xyzal has a strong track record backed by scientific research and user satisfaction. We stand by the safety and efficacy of Xyzal when used as directed."

A spokesperson for Kenvue, which owns Zyrtec, told Newsweek: "We take patient safety very seriously and actively monitor and report any adverse events to regulatory authorities. As FDA recognized, reports of itching upon discontinuation in patients who used Zyrtec medicines daily over a period of months or years are rare. We will continue to evaluate and monitor the latest science and product profile accordingly and educate consumers about product usage, in compliance with FDA guidelines."

The American Academy of Allergy, Asthma & Immunology, on X, formerly Twitter: "FDA requires warning about rare but severe itching after stopping long-term use of oral allergy medicines cetirizine or levocetirizine (Zyrtec, Xyzal, and other trade names)"

What Happens Next

The FDA advises patients to contact their health care providers if they develop severe itching after stopping their antihistamine use.

Tree pollen typically peaks in April, while grass pollen emerges in late spring and continues through the summer months, usually from May to July.

Update 5/22/25, 4:27 p.M. ET: This article was updated with comment from Kenvue.

Do You Take One Of These Common Allergy Medicines? You May Experience A Rare Side Effect, FDA Warns

Long-term use of several common allergy medications could lead to severe itching in rare cases, the U.S. Food and Drug Administration warns.

The itching is called "pruritus," and it can be caused by over the counter or prescription forms of Zyrtec (cetirizine) or Xyzal (levocetirizine), both antihistamines that treat seasonal allergies. It typically occurs within a few days of stopping the medications, the FDA said.

READ MORE: Cucumber recall expanded by FDA after salmonella outbreak in 15 states, including Alabama

People who take the oral medications every day for months or years may be susceptible to the condition in exceptional cases, the administration stated in an alert this month.

"Reported cases were rare but sometimes serious, with patients experiencing widespread, severe itching that required medical intervention," the administration said.

The FDA reported finding 209 cases worldwide, between 2017 and 2023, in people who stopped using the two medications.

READ MORE: COVID vaccine change: Shots no longer recommended for 2 groups

"Most patients who experienced pruritus after medicine discontinuation reported using these medicines for more than 3 months; however, some experienced this reaction after less than 1 month of use," the administration said. Restarting the medication and then tapering it resolved the itching problem in most people, the FDA stated.

A warning will be added to the medications. Patients using the medications long-term should check with their health care provider about whether to continue.

If you purchase a product or register for an account through a link on our site, we may receive compensation. By using this site, you consent to our User Agreement and agree that your clicks, interactions, and personal information may be collected, recorded, and/or stored by us and social media and other third-party partners in accordance with our Privacy Policy.

Search This Blog

Latex Allergies