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SafetyScorer

Is Cetirizine safe?

Cetirizine

Cetirizine (Zyrtec, Reactine, Piriteze) is one of the safer everyday medicines. Serious harm is rare, overdoses mostly cause sleepiness and interactions are few. It sedates more than some other non-drowsy antihistamines, and US labels now warn of rare, severe itching after stopping long-term use.

High confidence#3 of 65 medicationsUpdated
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Brands
Zyrtec (US); Reactine (Canada); Piriteze, Benadryl One a Day (UK); generic cetirizine
Adults and children 6+
10 mg once a day, no more than 10 mg in 24 hours; 5 mg may be enough
Children 2 to under 6
2.5 mg once a day, up to 5 mg in 24 hours
Adults 65+ (children's products)
5 mg once a day, no more than 5 mg in 24 hours
Boxed warning
None
FDA warning
Rare severe itching after stopping long-term use (May 2025)
Controlled substance
No
On the market
US since December 1995; Over-the-counterA medicine you can buy without a prescription, in a pharmacy or shop, with directions on the pack for safe use without a doctor.More in the glossary since 2007

How the score breaks down

The overall score is the weighted average of these factors. Scoring rules

  • Serious side effects30% of score

    88 out of 100, Excellent

    Serious reactions are rare. Drowsiness is the main side effect and rises with dose (4.2% on 10 mg vs 1.3% on placebo in children aged 6 to 11, label). The FDA found 209 cases of severe itching after stopping long-term use (2017 to 2023).

  • Overdose margin20% of score

    90 out of 100, Excellent

    Wide. The label reports an adult who took 150 mg, 15 times the daily dose, and was only sleepy; a toddler who swallowed about 180 mg was restless, then drowsy. No antidote is needed in most cases.

  • Interactions15% of score

    88 out of 100, Excellent

    Few. Cetirizine is barely processed by liver enzymes; the label found no important interactions with ketoconazole, erythromycin, azithromycin or pseudoephedrine. Alcohol and sedatives add to drowsiness.

  • Dependence and misuse15% of score

    85 out of 100, Excellent

    Not controlled and not misused. The one dependence-like effect is rebound itching after stopping daily use for months, which the FDA says can be severe and improves on restarting.

  • Regulatory warnings10% of score

    80 out of 100, Good

    No Boxed warningThe strongest safety warning the US FDA puts on a medicine's label, printed inside a black border at the top.More in the glossary or restrictions. A May 2025 FDA Drug Safety Communication added a warning about itching after stopping cetirizine or levocetirizine to prescription and Drug Facts labels.

  • Track record10% of score

    92 out of 100, Excellent

    Approved in the US on 8 December 1995 and sold Over-the-counterA medicine you can buy without a prescription, in a pharmacy or shop, with directions on the pack for safe use without a doctor.More in the glossary since 2007, with three decades of wide use worldwide, including in young children.

Is cetirizine safe?

Yes, for nearly everyone at the label dose. Cetirizine (Zyrtec in the US) is a second-generation antihistamine taken once a day for hay fever, dust or pet allergies and hives. In 30 years of wide use it has built one of the cleanest safety records of any medicine on our list: overdoses usually mean a long sleep, and drug interactions are few.

It has two catches. It is more likely to make people sleepy than the other non-drowsy antihistamines, and in May 2025 the FDA added a warning about rare but severe itching after stopping long-term use. We score it 88, far above the older antihistamine diphenhydramine at 64.

What dose of cetirizine is safe?

The US label doses:

WhoDose
Adults and children 6 and over10 mg once a day; no more than 10 mg in 24 hours (5 mg may be enough for milder symptoms)
Adults 65 and overAsk a doctor; children's products say 5 mg once a day, no more than 5 mg in 24 hours
Children 2 to under 62.5 mg once a day, up to 5 mg a day (5 mg once or 2.5 mg every 12 hours)
Children under 2Ask a doctor
Liver or kidney diseaseAsk a doctor; a lower dose may be needed

Do not take it if you have ever reacted to cetirizine or to hydroxyzine, the older drug it comes from. Levocetirizine (Xyzal) is the active half of the same molecule, so do not combine the two.

Does cetirizine make you sleepy?

Some people, yes. It crosses into the brain less than diphenhydramine but more than loratadine or fexofenadine. In the label's trials in children aged 6 to 11, drowsiness rose with dose, from 1.3% on placebo to 1.9% on 5 mg and 4.2% on 10 mg.

The label warns that drowsiness may occur, says to avoid alcohol, and asks you to take care driving or using machinery. Alcohol, sleeping pills, opioids and other sedatives add to the effect. If cetirizine makes you groggy, taking it in the evening or switching to another antihistamine are common options to discuss with a pharmacist.

Itching after you stop: the 2025 warning

In May 2025 the FDA reported 209 cases worldwide, 197 of them in the US, of pruritus (itching) after people stopped cetirizine or levocetirizine. Most had taken the drug daily for months or years; a few for about a month. The itching started a median of 2 days after the last dose, was sometimes widespread and severe enough to need treatment, and often eased when the drug was restarted. The FDA concluded that stopping the drug likely caused it, though the mechanism is unknown.

Two things follow. The risk is real but rare against the many millions of users. And it mainly concerns daily, long-term use. Anyone who has taken cetirizine every day for months and wants to stop should talk to their doctor or pharmacist about how to do it, especially if a previous attempt brought on itching. How to stop is a decision to make with a professional.

Overdose and interactions

Cetirizine has a wide margin. The prescription label describes an adult who took 150 mg, 15 times the daily dose, and was sleepy but otherwise well, and an 18-month-old who swallowed about 180 mg and became restless, then drowsy. Young children may become agitated before they get sleepy. Call Poison Help on 1-800-222-1222 in the US or NHS 111 in the UK if a child gets into the pack.

Because the liver barely processes it, cetirizine avoids most enzyme-based interactions. The label found no important effects with ketoconazole, erythromycin, azithromycin or pseudoephedrine, and only a small change with high-dose theophylline. The combinations to watch are with other sedating drugs and alcohol.

Combination products deserve a look. Zyrtec-D adds pseudoephedrine, a decongestant with its own warnings for high blood pressure, heart disease and sleep. For allergy symptoms that also include asthma, doctors sometimes add montelukast, which has very different risks.

Who should be careful

Talk to your doctor or pharmacist before taking cetirizine if you are over 65, have kidney or liver disease, are pregnant or breastfeeding (the US label does not recommend it while breastfeeding), or take sedatives, sleeping pills or opioids. Ask before giving it to a child under 2. If you need an antihistamine every day all year, it is worth asking a doctor what is driving the symptoms.

How we scored it

Overdose marginHow far a normal dose is from a harmful one. A wide margin means an accidental extra dose is unlikely to cause serious harm.More in the glossary (90), track record (92) and serious side effects (88) are all strong. Regulatory warnings (80) is the lowest factor, reflecting the 2025 FDA itching warning; there is no Boxed warningThe strongest safety warning the US FDA puts on a medicine's label, printed inside a black border at the top.More in the glossary or restriction. Dependence (85) accounts for the rebound itching, not any addiction risk.

Questions people ask

Is it safe to take cetirizine every day?

Yes, for most people the label allows 10 mg once a day for as long as allergy symptoms last. The main issue with months or years of daily use is the rare rebound itching some people get when they stop. If you need it all year, talk to your doctor or pharmacist about the cause of your symptoms.

Why do I itch after stopping Zyrtec?

The FDA reviewed 209 reports of intense itching that began a median of 2 days after stopping cetirizine or levocetirizine, usually after months of daily use. Many people improved when they restarted. Tell your doctor or pharmacist before restarting or changing how you take it.

Does cetirizine make you drowsy?

It can, and more often than loratadine or fexofenadine. The label warns that drowsiness may occur and asks you to take care driving and avoid alcohol. Try it first at a time when you do not need to drive.

Can I take two cetirizine tablets in one day?

The label maximum for adults and children 6 and over is 10 mg in 24 hours. If one tablet does not control your symptoms, ask a pharmacist or doctor rather than doubling up. Taking a second tablet by mistake is unlikely to cause harm beyond sleepiness, but call Poison Help (1-800-222-1222) in the US or NHS 111 in the UK if a child swallows extra.

Is cetirizine safe in pregnancy and breastfeeding?

The US label says to ask a health professional before use in pregnancy and that it is not recommended while breastfeeding. Doctors do sometimes recommend it in both situations, so talk to your doctor, midwife or pharmacist.

Sources

  1. 1.ZYRTEC (cetirizine HCl 10 mg) tablets, Drug Facts label (opens in a new tab) · DailyMed / Kenvue, 2026
  2. 2.Children's ZYRTEC Allergy (cetirizine 5 mg/5 mL) syrup, Drug Facts label (opens in a new tab) · DailyMed / Kenvue, 2026
  3. 3.Cetirizine hydrochloride oral solution, prescription label (adverse reactions, overdosage) (opens in a new tab) · DailyMed, 2026
  4. 4.FDA requires warning about rare but severe itching after stopping long-term use of oral allergy medicines cetirizine or levocetirizine (opens in a new tab) · US Food and Drug Administration, 2025
  5. 5.Drugs@FDA, NDA 019835 (Zyrtec) (opens in a new tab) · US Food and Drug Administration, 2026
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