FDA

FDA flags rare but severe itching after stopping common allergy meds

May 20, 2025

FDA issued a new safety warning regarding rare but severe pruritus following the discontinuation of long-term use of oral antihistamines cetirizine (Zyrtec) and levocetirizine (Xyzal), available in both prescription and OTC forms. This reaction has been reported in patients who used these medications daily for several months to years and didn’t experience itching prior to treatment. The pruritus typically emerged within days of stopping the drug and, in some cases, was widespread and required medical intervention. In response, FDA is updating the prescribing information for both drugs to include this risk and will request that OTC product labels also carry a warning. Notably, symptoms may improve upon restarting the medication, suggesting a potential rebound mechanism. Clinicians should be aware of this adverse effect and counsel patients accordingly, especially those on long-term therapy.

Source:

(2025, May 16). FDA. 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). https://www.fda.gov/drugs/drug-safety-and-availability/fda-requires-warning-about-rare-severe-itching-after-stopping-long-term-use-oral-allergy-medicines