FDA Issues Warning About Popular Allergy Medications
Based on facts, either observed and verified firsthand by the reporter, or reported and verified from knowledgeable sources.
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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."
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)"
Zyrtec, on X: "The allergens are potent this year and normally we're a cut above!"
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.
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