Severe Withdrawal Warning: Popular Allergy Medications Under FDA Scrutiny
The U.S. Food and Drug Administration (FDA) issued a safety alert in May 2025. The warning highlighted that patients discontinuing popular allergy medications cetirizine (Zyrtec) or levocetirizine (Xyzal) after long-term use may experience a rare, but severe itching condition, known as pruritus. This warning affects both prescription and over-the-counter versions of these widely-used antihistamines.
From April 2017 to July 2023, the FDA identified 209 cases worldwide (197 in the U.S.) of severe itching following medication discontinuation. The itching was reported by individuals who used the medicines daily for months or years, with symptoms typically appearing within 2 days of stopping.
- In 90% of cases, restarting the medication resolved the severe itching.
- 38% found success with gradual tapering.
The FDA is now updating prescribing information to include this warning and is requesting manufacturers to add warnings to over-the-counter drug labels. An estimated 26.8 million prescriptions and 62.7 million over-the-counter packages were purchased in 2022, making this a significant public health concern.
Source: FDA