FDA Warns About Rare, Severe Itching After Stopping Cetirizine or Levocetirizine

On May 16, 2025, the US Food and Drug Administration (FDA) announced it will be adding a warning about the pruritus risk after stopping long-term use of cetirizine or levocetirizine to the prescribing information.1 The label will say that pruritus symptoms may improve with restarting the medications.

In addition, the FDA is requesting manufacturers add a pruritus warning to the Drug Facts label of over-the-counter cetirizine and levocetirizine.

The itching was reported in patients who used these medications daily for at least a few months but often for years. They did not experience itching before starting these treatments.

Although reports of pruritus were rare, some patients experienced serious cases requiring medical intervention.

Cetirizine (Zyrtec) and levocetirizine (Xyzal) are both antihistamines that block histamine, approved to treat seasonal allergic rhinitis in children aged ≥ 2 years and adults. They are also approved to treat perennial allergic rhinitis and chronic idiopathic urticaria in patients aged ≥ 6 months.

Health care professionals should tell patients that itching typically occurs within a few days of stopping these medications after daily use for months or years. They should also go over the benefits and risks of these medications before prescribing these treatments.

“Encourage patients to contact you if they experience severe itching after stopping cetirizine or levocetirizine,” the FDA wrote on its site.

The FDA identified 209 global cases of pruritus after discontinuation of long-term use of cetirizine (n=180), levocetirizine (n=27), or both (n=2) between April 25, 2017, and July 6, 2023. Of these, 197 cases occurred in the United States. Most of these antihistamines are available over the counter, with more than 60 million purchases reported in 2022. According to Numerator, nearly two-thirds (64%) of US households in purchased over-the-counter allergic rhinitis medications from May 2023 to 2024.2

Although the exact mechanism is unknown, the FDA believes there is a causal link between stopping cetirizine or levocetirizine and the onset of pruritus.1

Patients commonly reported experiencing pruritus after discontinuing the medications following 3 months of use, though some cases occurred after just 1 month of use.

“When prescribing or recommending these medicines, especially if planned for chronic use, discuss with patients the risk of pruritus after stopping cetirizine or levocetirizine,” the FDA wrote. “This risk should also be discussed with patients who indicate they are taking [over-the-counter] cetirizine or levocetirizine.”

References

1. 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). US Food and Drug Administration. May 16, 2025. https://www.fda.gov/drugs/drug-safety-and-availability/fda-requires-warning-about-rare-severe-itching-after-stopping-long-term-use-oral-allergy-medicines. Accessed May 20, 2025.

2. 64% of U.S. Households Buy Seasonal Allergy Medication; 72% of Buyers Say Brand Name and Private Label Offer Same Quality, Numerator Reports. Numerator. May 13, 2024. https://www.numerator.com/press/64-of-u-s-households-buy-seasonal-allergy-medication-72-of-buyers-say-brand-name-and-private-label-offer-same-quality-numerator-reports/#:~:text=Nearly%20two-thirds%20of%20households,15%25%20purchased%20children's%20allergy%20meds.. Accessed May 20, 2025.