New FDA Alert: Rare but Intense Itching Linked to Discontinuation of Common Allergy Drugs, including cetirizine or levocetirizine

The Food and Drug Administration (FDA) in the United States (U.S) cautions that individuals who quit oral allergy medicines such as levocetirizine (Xyzal) and cetirizine (Zyrtec) after prolonged use may experience occasional itching. As per reports, individuals who have taken these medications daily for at least a few months to years have experienced pruritus or itching.

In rare, severe cases, patients experienced intense itching that spread rapidly and required immediate medical attention. A new safety warning should be added to the prescribing of cetirizine and levocetirizine. In adults and children, both of these medicines are approved to treat seasonal allergies, also known as seasonal allergic rhinitis. The medications are used to treat chronic hives and year-round allergies in patients aged six months and older. Cetirizine and levocetirizine are antihistamines that work by blocking the effects of histamine, a substance involved in allergic reactions.

In December 1995, cetirizine was approved for oral use with a prescription under the brand name of Zyrtec. In November 2007, the over-the-counter (OTC) use of this medication was allowed. In May 2007, levocetirizine was allowed for oral use with a prescription under the brand name of Xyzal. In January 2017, it was approved for over-the-counter (OTC) use. Patients should be aware that itching may begin a few days to several months after stopping the daily use of these medications. The advantages and disadvantages of long-term usage of cetirizine or levocetirizine for more than a few months should be discussed with a healthcare provider (HCP).

Patients who discontinue taking cetirizine or levocetirizine and experience severe itching are advised to contact their healthcare provider (HCP). Researchers observed that from April 25, 2017, to July 6, 2023, the FDA received reports of a total of 209 cases, including 197 in the United States, of pruritus following the withdrawal of cetirizine (n = 180), levocetirizine (n = 27), or both (n = 2).

This research identifies a consistent link between discontinuing cetirizine or levocetirizine and the onset of pruritus, although the underlying mechanism remains unknown. While some patients noticed this reaction after less than a month, most patients who developed pruritus after stopping their medications reported using them for more than three months. Depending on their health, genetics, and a host of other variables, people may respond to medications in different ways.

Researchers should request that manufacturers include a warning on the OTC versions of the Drug Facts label regarding pruritus that may occur after discontinuing cetirizine and levocetirizine. The range of medication use before pruritus occurred after quitting cetirizine or levocetirizine was 1 week to 23 years, with an average of 33 months. Serious adverse effects included hospitalization (n = 3), suicidal or self-harming ideas (n = 2), and disability (n = 48), along with debilitating itching cases. Nine out of 24 people who attempted this method reported that their pruritus was relieved after restarting, while 71 out of 79 people reported that their pruritus was better after restarting the medication.

Reference: FDA requires a warning about rare but severe itching after stopping long-term use of oral allergy medicines cetirizine or levocetirizine (Zyrtec, Xyzal, and other trade names). FDA. May 16, 2025. Accessed May 26, 2025. 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) | FDA

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