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SafetyScorer

Is Loratadine safe?

Loratadine

Loratadine (Claritin, Clarityn) is a non-drowsy antihistamine sold over the counter for hay fever and hives. Serious side effects are very rare, it barely interacts with other drugs or alcohol, and single doses of 160 mg caused no harm in volunteers. Combination products with pseudoephedrine carry extra risks.

High confidence#1 of 65 medicationsUpdated
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Brands
Claritin (US, Canada), Clarityn (UK), Alavert, many generics
Adults and children 6+ (US)
10 mg once a day; no more than 10 mg in 24 hours
Children 2 to under 6 (US syrup)
5 mg (5 mL) once a day; no more than 5 mg in 24 hours
Severe liver disease
Ask a doctor; UK label starts at 10 mg every other day
Boxed warning
None
Controlled substance
No
On the US market
Since 12 April 1993; 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 27 November 2002

How the score breaks down

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

  • Serious side effects30% of score

    92 out of 100, Excellent

    In trials, side effects at 10 mg exceeded placebo in only 2% of people, mainly sleepiness (1.2%) and headache (0.6%) (UK label). Severe allergic reactions, fits and fast heartbeat are listed as very rare (under 1 in 10,000).

  • Overdose margin20% of score

    92 out of 100, Excellent

    Wide. Single doses of up to 160 mg, 16 times the daily dose, caused no ill effects in volunteer studies (Health Canada and Medsafe labels). Larger overdoses cause sleepiness, fast heartbeat and headache.

  • Interactions15% of score

    92 out of 100, Excellent

    Few. Ketoconazole, erythromycin and cimetidine raise loratadine levels without clinically significant changes, including on the ECG, and alcohol does not add to its effects in performance studies (UK label).

  • Dependence and misuse15% of score

    95 out of 100, Excellent

    Not a Controlled substanceA medicine or drug that the law restricts because it can be misused or cause dependence. Countries group them into schedules or classes.More in the glossary and not misused, with no Drug dependenceThe body's adaptation to a drug taken regularly, so that stopping it suddenly causes withdrawal symptoms. It is not the same as addiction.More in the glossary or rebound warning on current labels.

  • Regulatory warnings10% of score

    92 out of 100, Excellent

    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, no FDA safety communication and no restrictions. The FDA moved it from prescription to 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 in November 2002.

  • Track record10% of score

    92 out of 100, Excellent

    Approved in the US on 12 April 1993 (NDA 019658) and sold without prescription since 2002, with more than 30 years of wide use, including in young children and pregnancy registries.

Is loratadine safe?

Yes. Loratadine, sold as Claritin in the US and Clarityn in the UK, is a once-a-day antihistamine for hay fever, dust and pet allergies and hives, and has been sold without prescription in the US since 2002. Serious side effects are very rare, it barely interacts with other medicines, and volunteers took single doses of 160 mg without harm.

We score it 92, ahead of cetirizine (88) and far ahead of the older, sedating diphenhydramine (64). The main thing to watch is not loratadine itself but combination products that add a decongestant.

How much loratadine can you take?

The US Drug Facts doses:

WhoDose
Adults and children 6 and over10 mg once a day; no more than 10 mg in 24 hours
Children 2 to under 65 mg (5 mL of syrup, or one children's chewable) once a day; no more than 5 mg in 24 hours
Children under 2Ask a doctor
Liver or kidney diseaseAsk a doctor; the UK label starts adults with severe liver impairment on 10 mg every other day

The US label warns that taking more than directed may cause drowsiness. Do not take it if you have reacted to loratadine or desloratadine (Clarinex), its active breakdown product; the two should not be combined.

Loratadine vs cetirizine: which is safer?

Both are second-generation antihistamines with clean records, and for most people either is a reasonable choice. The differences are small but real.

Drowsiness. The New Zealand label says loratadine is no more likely than placebo to cause sedation. In trials, sleepiness was only 1.2% more common than on placebo, and the UK label says driving studies found no impairment. The cetirizine label shows drowsiness rising with dose, to 4.2% on 10 mg in children aged 6 to 11 against 1.3% on placebo. The trials were not head to head and used different age groups, so the comparison is rough.

Stopping. In May 2025 the FDA added a warning about rare, severe itching after stopping long-term cetirizine or levocetirizine. Loratadine labels carry no such warning.

Breastfeeding. The UK label does not recommend loratadine while breastfeeding, and the US cetirizine label says the same for cetirizine. If one antihistamine has not worked for you, a pharmacist can suggest another.

Overdose: a wide margin

Single doses of up to 160 mg, 16 times the daily dose, produced no ill effects in volunteer studies, according to the Health Canada and New Zealand labels. In larger overdoses the reported effects are sleepiness, a fast heartbeat and headache, with treatment aimed at symptoms; activated charcoal may be given. Loratadine is not removed by dialysis.

If a child gets into a pack, call Poison Help on 1-800-222-1222 in the US or NHS 111 in the UK. Mention if it was a Claritin-D pack, because the added pseudoephedrine has its own overdose risks.

Interactions and combination products

Loratadine is broken down by the liver enzymes CYP450 enzymesA family of liver enzymes that break down many medicines. When another drug or supplement speeds them up or slows them down, drug levels change.More in the glossary and CYP2D6. Ketoconazole, erythromycin and cimetidine raise its levels, but the UK label reports no clinically significant changes, including on heart tracings. Alcohol did not add to its effects in performance studies. That is a short list compared with most medicines.

The catch is the 'D'. Claritin-D and its generics add pseudoephedrine, a decongestant that can raise blood pressure and heart rate, keep you awake, and interact with MAO inhibitors. In the US these products are sold from behind the pharmacy counter. Anyone with high blood pressure, heart disease, glaucoma, thyroid problems or difficulty passing urine because of an enlarged prostate should ask a pharmacist before using a 'D' product. For allergies with asthma, doctors sometimes add montelukast, which has different risks of its own.

Who should be careful

Talk to your doctor or pharmacist before using loratadine if you have liver or kidney disease, are pregnant or breastfeeding, or want to give it to a child under 2. Stop and seek help at once for swelling of the face or throat, wheezing or a widespread rash, which are very rare signs of an allergic reaction. If you rely on an antihistamine every day all year, ask a doctor about the cause.

How we scored it

Every factor scores 92 or higher: serious side effects, 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, interactions, regulatory warnings and track record (all 92), and dependence (95). 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, safety communication or misuse potential. The points it loses reflect very rare allergic reactions and heart rhythm effects in overdose, and the extra risks of decongestant combinations.

Questions people ask

Is loratadine or cetirizine better?

Both treat hay fever and hives and both are safe at label doses. Cetirizine causes drowsiness more often and carries a 2025 FDA warning about itching after long-term use is stopped; loratadine labels have neither issue. Some people respond better to one than the other, so a pharmacist can help you choose.

Can I take loratadine every day?

The US label allows 10 mg once a day for as long as allergy symptoms last. If you need it all year round, it is worth asking a doctor or pharmacist what is causing the symptoms.

Can I take two loratadine tablets?

The label maximum for adults and children 6 and over is one 10 mg tablet in 24 hours, and it says more than directed may cause drowsiness. A second tablet taken by mistake is unlikely to cause harm. If one tablet is not enough, ask a pharmacist rather than doubling up.

Does loratadine make you sleepy?

Rarely. In trials, sleepiness was 1.2% more common than on placebo, and driving tests found no impairment. A few people do feel drowsy, so see how it affects you before driving.

Can I drink alcohol with Claritin?

Performance studies found that alcohol did not add to loratadine's effects, unlike with older antihistamines. Alcohol can still worsen allergy symptoms such as a stuffy nose. Claritin-D, which adds pseudoephedrine, is a different matter; ask a pharmacist.

Is loratadine safe in pregnancy?

The UK label says data from more than 1,000 pregnancies showed no sign of birth defects, but still advises avoiding it as a precaution and does not recommend it while breastfeeding. The US label says to ask a health professional. Talk to your doctor, midwife or pharmacist before using it.

Sources

  1. 1.Claritin (loratadine 10 mg) tablets, Drug Facts label (opens in a new tab) · DailyMed, 2025
  2. 2.Children's Claritin Allergy (loratadine 5 mg/5 mL) syrup, Drug Facts label (opens in a new tab) · DailyMed / Bayer, 2025
  3. 3.Clarityn Allergy 10 mg tablets, summary of product characteristics (opens in a new tab) · electronic medicines compendium (Bayer), 2018
  4. 4.Lora-Tabs Allergy & Hayfever data sheet (opens in a new tab) · Medsafe (New Zealand), 2024
  5. 5.Allertin (loratadine) product monograph (opens in a new tab) · Health Canada Drug Product Database / Apotex, 2014
  6. 6.Drugs@FDA, NDA 019658 (Claritin) (opens in a new tab) · US Food and Drug Administration, 2026
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