The FDA Warns of New Zyrtec and Xyzal Side Effect. What Is Pruritus?
According to the FDA, 62.7 million over-the-counter packages of Zyrtec (cetirizine) and Xyzal (levocetirizine) were purchased in 2022. Since allergies are getting worse -- partly because of climate change creating longer, more intense pollen seasons -- these numbers have likely climbed in the last three years as more people purchase the antihistamines to cope with allergy symptoms like a stuffy nose, watery, red, itchy eyes and hives.
For the millions of people who take these drugs, it's important to know that the FDA recently published a warning about a newly discovered side effect that may occur after taking both Zyrtec and Xyzal.
If you stop taking Zyrtec or Xyzal after long-term use, you might experience "rare but severe" itching. Also called pruritus, this itching was experienced by patients who had been taking these allergy medicines every day for several months or years and then stopped.
What is the FDA going to do?
The FDA decided to issue this warning after identifying 209 cases worldwide -- 180 cases for cetirizine, 27 for levocetirizine and two for both -- of this particular side effect reported between April 2017 and July 2023. In the US, 197 cases were reported. However, there may be more, because these are only those that were reported to the FDA.
Interestingly, even though most patients who experienced this severe itching had been taking these antihistamines for more than three months, some had this reaction after less than one month of use.
Because of these findings, the FDA will now include a warning on the prescribing information for prescription cetirizine and levocetirizine. The administration is also asking that manufacturers add this warning to drug facts labels for OTC versions.
When to contact your doctor
If you stop taking OTC cetirizine or levocetirizine and develop severe itching within a few days after you've been using the medicine daily for several months to years, you should contact your doctor. If you plan to take these medicines for a prolonged period of time, you should also discuss the pros and cons with your doctor before starting.
How to treat this new Zyrtec and Xyzal side effect
According to the FDA, no effective treatments for pruritus have been found. However, most patients discovered that their symptoms resolved after they restarted cetirizine or levocetirizine or after they tapered off the antihistamine after restarting it. Before you try this, consult your doctor to make sure that's the best course of action if you think you're dealing with this Zyrtec or Xyzal complication.
According to the FDA, the most common, already-known side effects of cetirizine and levocetirizine are fatigue, drowsiness, sore throat, cough, dry mouth, nosebleed, fever, diarrhea and vomiting.
What is pruritus? Plus, additional symptoms to know
The Cleveland Clinic reports that pruritus is the medical term for "itchiness." It can be painful or irritating and spread to multiple areas of the body. Other symptoms of pruritus can include a rash, blisters, large bumps, small pimple-like bumps and skin discoloration.
Scratching the skin can cause additional symptoms, such as skin breaks and bleeds, scratch marks, dry or cracked skin, broken skin that leaks a yellow to white fluid (infection), localized pain where the skin itches and a thick, leathery patch. That is why it's important to do what you can to manage your itching under the care of a doctor.
Dry skin, pregnancy, contact with an allergen and a reaction medication are common causes of pruritus. If it occurs for over six weeks, it can be considered chronic.
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