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The FDA Warns of New Zyrtec and Xyzal Side Effect. Here's What We Know About Treating It

The FDA Warns of New Zyrtec and Xyzal Side Effect. Here's What We Know About Treating It

CNET24-05-2025

Tens of millions of over-the-counter and prescription packages of cetirizine (Zyrtec) and levocetirizine (Xyzal) are purchased every year for seasonal allergies, year-round allergies and chronic hives. However, the FDA just released a warning about a new potential side effect that can occur with both medications.
If you stop taking Zyrtec or Xyzal after long-term use, you may experience rare but severe itching. Also called pruritus, this itching was experienced by patients who were taking these allergy medicines every day for several months or years.
According to the FDA, the most common, already-known side effects of cetirizine and levocetirizine are fatigue, drowsiness, sore throat, cough, dry mouth, nosebleed, fever, diarrhea and vomiting.
The FDA estimates that 62.7 million over-the-counter packages of cetirizine and levocetirizine were bought in 2022. In the same year, about 26.8 million cetirizine and levocetirizine prescriptions for OTC and prescription products were dispensed from US outpatient pharmacies. Considering that allergies are getting worse -- partly because of climate change creating longer, more intense pollen seasons -- it wouldn't be surprising if these numbers continue to climb.
The FDA decided to issue this warning after identifying 209 cases worldwide -- 180 cases for cetirizine, 27 for levocetirizine and two for both -- of this particular side effect reported between April 2017 and July 2023. In the US, 197 cases were reported. However, there may be more, because these are only those that were reported to the FDA.
Interestingly, even though most patients who experienced this severe itching had been taking these antihistamines for more than three months, some had this reaction after less than one month of use.
Because of these findings, the FDA will now include a warning on the prescribing information for prescription cetirizine and levocetirizine. The administration is also asking that manufacturers add this warning to drug facts labels for OTC versions.
When to contact your doctor
If you stop taking OTC cetirizine or levocetirizine and develop severe itching within a few days after you've been using the medicine daily for several months to years, you should contact your doctor. If you plan to take these medicines for a prolonged period of time, you should also discuss the pros and cons with your doctor before starting.
How to treat this new Zyrtec and Xyzal side effect
According to the FDA, no effective treatments for pruritus have been found. However, most patients discovered that their symptoms resolved after they restarted cetirizine or levocetirizine or after they tapered off the antihistamine after restarting it. Before you try this, consult your doctor to make sure that's the best course of action if you think you're dealing with this Zyrtec or Xyzal complication.

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