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FDA Warns of Rare, Surprising Side Effect of Popular Allergy Medications

Last updated: May 29, 2025 9:41 am
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FDA Warns of Rare, Surprising Side Effect of Popular Allergy Medications
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Contents
What medications are affected?What to do if you experience itchiness that could be related to your antihistamine
  • The FDA issued a warning regarding the long-term use of two allergy medications.

  • The medications are sold over-the-counter and prescribed.

  • See below for details regarding the warning.


Earlier this month, the U.S. Food and Drug Administration (FDA) issued a warning regarding two popular allergy medications. Specifically, the agency made clear that stopping long-term use of cetirizine (Zyrtec) or levocetirizine (Xyzal) may lead to “rare but severe itching.”

The uncomfortable side effect can happen as a reaction to both prescription and over-the-counter versions of the medications, the FDA said. Therefore, the agency is requiring warnings to be added to labels by manufacturers and pharmacists. The updated prescribing information will also state that itchiness may improve with the restarting of the medicines.

The itching, also called pruritus, was reported in over 200 cases in which people took the medications daily, typically for at least a few months and often for years, the FDA said. Patients did not experience itching before starting them. Reported cases were sometimes serious, with patients experiencing widespread, severe itching that required medical intervention. Some also experienced a significant, persistent impact on the quality of life and ability to function.

What medications are affected?

Cetirizine and levocetirizine are antihistamines that block histamine, a molecule that the body releases during allergic reactions and causes discomfort like a runny nose, sneezing, itchiness, or swelling. Both medicines are approved to treat seasonal allergies as well as year-round allergies and chronic hives.

What to do if you experience itchiness that could be related to your antihistamine

If you experience extreme itchiness after stopping a long-term prescription or OTC version of cetirizine or levocetirizine, the FDA says you should contact a health care professional. The widespread reaction to these medications was made known through the FDA’s Adverse Event Reporting System.

If you plan on the long-term use of cetirizine or levocetirizine, especially for more than a few months, the FDA suggests discussing the benefits and risks with your doctor, who can provide advice based on your personal needs.

After all, people respond differently to medication depending on their health, genetic factors, other medicines they take, and more, so the FDA can’t say for certain if everyone who takes the affected drugs long-term will experience the same response.

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