FDA Finally Corrects Labeling for Zyrtec and Xyzal Withdrawal Itching

A reader of our syndicated newspaper column notified us 15 years ago that stopping the antihistamine Zyrtec (cetirizine) led to unbearable itching. It wasn’t the first such report we had received, but it was the first time we wrote about this odd outcome in our column. We had been cautious about this strange reaction because dermatologists frequently prescribe such antihistamines to treat itching. It seemed contradictory that an antihistamine could actually cause withdrawal itching (pruritis) upon discontinuation.

The Snowball That Started an Avalanche:

Here is the first letter about withdrawal itching from Zyrtec that we published (May 2010) in our newspaper column:

Q. I have had terrible trouble trying to stop taking Zyrtec (the generic is cetirizine). After using this antihistamine for about three years while having allergy shots, I first attempted to stop taking it in preparation for allergy testing. Within three days, my entire body itched. It was so horrible that I was crying and preparing to go to the hospital for relief.

Confused by the relentless itching, I forgot and took a Zyrtec by accident. Lo and behold, before I could get dressed and get in the car, my symptoms were GONE. Now, seven years later, I have tried unsuccessfully at least 10 times to quit this drug, and the reaction is more severe each time.

Today while I was researching this problem online, I found a community of thousands of people who have had the same problems I have. There should be better warnings about this withdrawal problem.

Hundreds Reported Withdrawal Itching After Stopping Zyrtec:

To our amazement, readers from all over the country responded to that and other newspaper columns we wrote about the terrible whole-body itching people reported after discontinuing cetirizine. Others wrote to say that the same thing happened to them after stopping a related antihistamine, levocetirizine (Xyzal).

As we frequently do when encountering a new or unusual adverse reaction, we contacted the Food and Drug Administration. Initially, we did not hear back. That is fairly typical of the FDA. But we don’t give up easily.

We continued to write about withdrawal itching associated with cetirizine and levocetirzine. Here are just a few of the articles we published in our newspaper column and on this website:

The Itch That Won’t Quit | Itching After Stopping Xyzal (Levocetirazine)

The Zyrtec Itch is Unberable | Where’s the FDA?

Unbearable Itching After Stopping Antihistamines Like Xyzal or Zyrtec

You get the idea. We were relentless. We nagged the FDA about this problem for years.

The FDA Responds on June 3, 2018 About Withdrawal Itching:

To our surprise the FDA finally admitted there might be a problem:

“As stated on the FDA website ‘Potential Signals of Serious Risks/New Safety Information Identified from the FDA Adverse Events Reporting System FAERS,’ the potential safety issue of rebound pruritus with cetirizine, levocetirizine, and hydroxyzine was posted July – September 2017, prompting evaluation to determine the need for regulatory action.

“As a result of this review, the prescription levocetirizine Prescribing Information was revised to include the following information about pruritus after discontinuation of cetirizine in the Adverse Reactions-Postmarketing Experience section…”

We were delighted to discover this article in the medical literature from FDA investigators. The agency discovered more than 100 cases in its FDA Adverse Event Reporting System (FAERS) database (Therapeutic Advances in Drug Safety, July 5, 2019). The article was titled:

“Pruritus after discontinuation of cetirizine”

We searched high and low for the labeling change without a lot of success. We were especially disappointed that there was no mention of withdrawal itching on OTC labels of cetirizine or levocetirizine. You can read our message to Dr. Gerald Dal Pan at this link. Dr. Dal Pan has held key positions at the FDA for many years including: Director of the Office of Drug Safety, Director of the Office of Surveillance and Epidemiology and Director of the Office of Drug Evaluation II.

A Brand New Announcement About Withdrawal Itching from the FDA:

On May 16, 2025 the agency issued an “FDA Drug Safety Communication”:

“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)”

We’re not sure how rare this problem is. Based on the number of cases of withdrawal itching reported on this website, we would surmise that this adverse reaction may not be as “rare” as the FDA thinks. Nevertheless, we are pleased that after 15 years, the agency is requiring “updated prescribing information” and labeling changes on OTC packaging:

“What is FDA doing?

“We are adding a warning about the risk of pruritus after stopping long-term use of prescription cetirizine or levocetirizine to the prescribing information to increase awareness about this rare but serious reaction. The updated prescribing information also states that pruritus symptoms may improve with restarting the medicines. We will also request that manufacturers add a warning about pruritus to the Drug Facts Label of OTC cetirizine and levocetirizine. In the meantime, we want to make the public aware of this risk. We will follow up when additional information becomes available.”

What Should Doctors and Patients Do About Withdrawal Itching?

Not surprisingly, the FDA does not offer a lot of useful information about discontinuing drugs like Zyrtec or Xyzal or generic cetirizine or levocetirizine.

“What should patients and parents/caregivers do?

“Patients should contact your health care professional if you develop severe itching after stopping prescription or OTC cetirizine or levocetirizine. Patients should know that itching typically occurred within a few days of stopping these medicines after daily use for a few months to years. Individuals planning on long-term use of cetirizine or levocetirizine, especially for more than a few months, should discuss the benefits and risks with your health care professional, who can provide advice based on your personal needs.

“What should health care professionals do?

“Health care professionals should discuss the risk of pruritus after stopping cetirizine or levocetirizine with patients when prescribing or recommending these medicines, especially if planned for chronic use, and with those who indicate they are using OTC versions. Encourage patients to contact you if they experience severe itching after stopping cetirizine or levocetirizine. Effective treatments for pruritus have not been evaluated. However, symptoms resolved in most patients who restarted the medicine and in some who tapered off the medicine after restarting it.”

One option the FDA suggests to end the itching is to restart the antihistamines. That’s a bit like telling a person who wants to stop taking a benzodiazepine such as alprazolam (Xanax), an antidepressant such as venlafaxine (Effexor) or an acid suppressing drug like omeprazole (Prilosec) to just resume taking the drug if withdrawal symptoms occur after stopping the medication. I find that advice less than satisfying.

Final Words:

It is extremely gratifying to see that the FDA has acknowledged withdrawal itching can occur when people stop taking drugs like cetirizine or levocetirizine. It took a long time…but an FDA insider implied that the new Drug Safety Communication was a result of our efforts. This individual thanked us for “advocating for patients and pushing FDA to take action.” That means an awful lot.

We think that this reaction may be more common than the FDA thinks. Hundreds of readers have suggested very gradual tapering over several weeks or months will allow people to exit such antihistamines successfully.

If you scroll to the top of this article you will see a search box. Just put cetirizine itch, Zyrtec itch or Xyzal itch in the search box and you will discover lots of articles to choose from. Readers have shared a variety of strategies for discontinuing such drugs in the comment sections of those articles.

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