The U.S. Food and Drug Administration (FDA) has recently issued a warning that patients stopping the oral antihistamines cetirizine or levocetirizine after long-term use may experience severe itching (pruritus).

The U.S. FDA drug safety communication released in the month of May 2025 stated, "Pruritus has been reported in individuals who used these medications daily, typically for several months and often for years. Although rare, some cases have been severe, involving widespread and intense itching that required medical intervention." In response to the side effects, the U.S. FDA is updating the prescribing information for cetirizine and levocetirizine to include a warning about this potential risk as well as has asked the manufacturer to add a warning about pruritus in their Drug Fact Label.

Source: Medical Dialogues - June 16, 2025