The U.S. Food and Drug Administration (FDA) has issued a warning about a rare but serious side effect linked to stopping the long-term use of the oral antihistamines cetirizine and levocetirizine. Patients who stop taking these drugs after months or years of daily use may experience severe itching, known as pruritus.
In a drug safety communication released in May 2025, the FDA reported cases of intense and widespread itching that required medical attention. This side effect has been observed in individuals who used these medications daily, sometimes for years. The FDA is updating the prescribing information for both cetirizine and levocetirizine to include a warning about this risk. The agency has also asked manufacturers to add this warning to their drug fact labels.
The FDA noted that patients did not have itching before starting the medication. The exact cause of this reaction remains unknown. No specific patient traits or risk factors, other than prolonged use, have been clearly identified.
This warning applies to both prescription and over-the-counter forms of cetirizine and levocetirizine. Cetirizine has been approved for oral prescription use since 1995, while levocetirizine was approved in 2007 and later became available over the counter in 2017. Both drugs are widely used to treat conditions such as seasonal and perennial allergic rhinitis and chronic idiopathic urticaria.
The FDA reviewed 209 reports of itching occurring after stopping these medications between April 2017 and July 2023. Of these, 180 cases involved cetirizine, 27 involved levocetirizine, and 2 involved both. The itching usually began about two days after stopping the drug, with most patients having used the medication for more than three months. The median duration of use before symptoms started was 33 months, with some patients using the drugs for up to 23 years.
Many patients reported that the itching was severe enough to affect their daily lives. Serious cases included 48 people becoming disabled due to intense itching, three hospitalizations, and two reports involving suicidal thoughts or self-harm. A strong link between stopping the medication and itching was shown by cases where patients restarted the drug and the itching returned in nearly all of them. Some patients were unable to fully resolve symptoms even after resuming or tapering the medication.
Published case studies support these findings. One study reviewed 146 cases and found most patients experienced itching within two days of stopping cetirizine. Nearly all who stopped the drug twice saw the itching return. Restarting the drug relieved symptoms in about 65% of patients. Another study from the Netherlands described unbearable itching after stopping long-term use of these antihistamines, with gradual dose reduction helping in some cases.
The FDA advises healthcare providers to carefully consider the benefits and risks of cetirizine and levocetirizine, especially for long-term use. Physicians and pharmacists should inform patients about the possibility of itching after stopping the drugs. Patients are encouraged to report any severe or ongoing itching after discontinuation. Although formal studies on managing this itching are lacking, anecdotal evidence suggests symptoms may improve if the medication is restarted or tapered slowly.
This warning highlights the importance of monitoring patients who use cetirizine or levocetirizine over a long period and ensuring they receive proper guidance when stopping treatment.
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