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Generic Xyzal: Uses, Dosage & Safety Information

Generic Xyzal

Generic Xyzal

Generic Xyzal

Levocetirizine dihydrochloride
Xyzal is the originator brand of levocetirizine, a second-generation antihistamine taken once daily in the evening. Generic levocetirizine at 5 mg delivers the same medicine at the same dose. The brand moved from prescription to over-the-counter status in 2017.
  • ActiveIngredient: Levocetirizine dihydrochloride
  • DosageForm: Oral tablet, oral solution
  • Dosage: 5 mg once daily in the evening
  • Indications: Seasonal and perennial allergic rhinitis; chronic idiopathic urticaria.
  • Manufacturer: Originator: UCB / Sanofi. Generics from multiple manufacturers.
  • Storage: Store at 20-25 C (68-77 F).
  • Drug Status: Over-the-Counter
Drug Status: Over-the-Counter
Description
Regulatory status
FDA-approved. Over the counter since 2017.
Generic levocetirizine is therapeutically equivalent at the same strength.

What is generic Xyzal?

Generic Xyzal is levocetirizine sold without the brand name. It is listed under allergy medicines. FDA approval of a generic requires demonstrated bioequivalence to the reference product, so the 5 mg generic tablet and the 5 mg Xyzal tablet deliver the same drug at the same rate.1

What changed in 2017

Xyzal was approved in 2007 as a prescription medicine and switched to over-the-counter status in 2017. That switch is why the same product now sits on a shelf rather than behind a counter, and why price differences between brand and generic became visible to buyers rather than absorbed by insurers.

What differs between brand and generic

Inactive ingredients, tablet colour, coating and shape may differ. The active ingredient, its quantity and its release profile do not. People occasionally report a different response after switching; where that happens, an inactive ingredient rather than the drug is the usual explanation.

What this page does not repeat

Full pharmacology, renal dosing, the complete adverse effect profile and FDA reported data live on the substance page: levocetirizine.

General Instructions

How to take generic Xyzal

One 5 mg dose once daily in the evening, with or without food.1 Never a second dose in the same 24 hours.

Switching between brand and generic

No dose adjustment and no transition period. Take the generic on the same schedule at the same strength. Tablet appearance will differ.

Kidney function first

Dosing depends on creatinine clearance, and the medicine is contraindicated below 10 mL/min. Over-the-counter availability does not remove that requirement. Full table on the levocetirizine page.

What to avoid

  • Alcohol, which adds measurably to the sedation
  • A second antihistamine, including sedating ones in cold and sleep products
  • Driving until you know how it affects you – see why drowsiness and driving matter
Side Effects

Side effects

The profile is that of levocetirizine; no separate dataset exists for generic versions.1

Reported Side Effects
FrequencyEffectNotes
CommonDrowsiness (somnolence)The defining effect of this agent within its class
CommonFatigue, dry mouth–
Common in childrenFever, cough, nosebleedReported in paediatric trials
RareRapid heartbeat, difficulty passing urine–
Emergency – stop and seek care
  • Swelling of the face, lips, tongue or throat, or difficulty breathing
  • Severe rash with blistering or peeling skin
  • Inability to pass urine
  • Seizure
Uses

What is generic Xyzal used for?

The approved indications are those of levocetirizine.1

  • Allergic rhinitis, seasonal and perennial – sneezing, runny nose, itchy or watery eyes
  • Chronic idiopathic urticaria – hives without an identified trigger

Choosing generic over brand

There is no therapeutic reason to prefer the brand. Cost is usually the deciding factor, and the gap is often several-fold. Where a specific inactive ingredient causes a problem, comparing labels between manufacturers is the practical step.

What it will not do

  • Congestion. Needs a decongestant such as pseudoephedrine.
  • Emergency reactions. Anaphylaxis requires adrenaline, not an oral antihistamine.
Safety advice

Interactions Alcohol:

Unsafe
Levocetirizine adds measurably to alcohol impairment. Avoid alcohol while taking it.

Interactions Other Medications:

Consult your doctor
Additive sedation with opioids, benzodiazepines and sedatives. Direct duplication with hydroxyzine, which metabolises to cetirizine. See Interactions.

Special Groups Pregnancy:

Consult your doctor
Human data are limited. Not approved specifically for pregnancy; discuss with a clinician rather than self-treating.

Special Groups Breastfeeding:

Consult your doctor
Expected to pass into breast milk. Drowsiness in the infant is the concern.

Special Groups Elderly:

Use with caution
No adjustment by age alone, but renal function declines with age and clearance is renal. Creatinine clearance should be known before regular use.

Special Groups Children:

Consult your doctor
Approved from 6 months at reduced doses. Contraindicated in children 6 months to 11 years with any renal impairment.

Effects on Activities Driving:

Use with caution
Drowsiness is the most reported effect. Take in the evening as directed and establish your response before driving.

Effects on Activities Operating Machinery:

Use with caution
The same applies as for driving.
Concerns

Important considerations

Bioequivalence is a measured standard, not a claim

Generic approval requires demonstrated equivalence in rate and extent of absorption against the reference product. Where someone reports a different experience after switching, the difference usually lies in inactive ingredients rather than the active drug.

Kidney function is not checked at the till

This is the only common over-the-counter antihistamine with an absolute renal contraindication. Someone with undiagnosed kidney impairment can buy it without any check.

The hydroxyzine overlap

Hydroxyzine metabolises to cetirizine, of which levocetirizine is the active half – a direct duplication that is easy to miss when one medicine is prescription and the other is not.

Warnings

Critical warnings

Contraindicated in end-stage renal disease

Must not be used where creatinine clearance is below 10 mL/min, or on dialysis. Also contraindicated in children aged 6 months to 11 years with any renal impairment.1 Over-the-counter status does not soften this.

Drowsiness and driving

The more sedating end of the second-generation class. Establish your response before driving.

Do not exceed 5 mg

Higher doses increase sedation without adding relief.

Hidden duplication

Cold, flu and sleep products frequently contain another antihistamine. Read every label.

Dosage

Generic Xyzal dosage

Approved Dosage
GroupDose
Adults and children 12 and over5 mg once daily, evening
Children 6 to 11 years2.5 mg once daily, evening
Children 6 months to 5 years1.25 mg once daily, evening (oral solution)

Renal impairment

Dose reduces stepwise as creatinine clearance falls and the medicine is contraindicated below 10 mL/min or on dialysis. In children aged 6 months to 11 years any renal impairment is a contraindication.1 Full table on the levocetirizine page.

Overdose

Drowsiness in adults; agitation followed by drowsiness in children. Seek medical assessment, particularly for a child.

Interactions

Drug interactions

Interactions are those of levocetirizine, rated on severity and documentation using the Micromedex classification.2

Significant Interactions
Interacting substanceEffect and riskSeverityDocumentation
Alcohol and CNS depressantsAdditive sedation and impaired alertnessMajorGood
Other antihistamines – including hydroxyzine, which metabolises to cetirizineDirect duplicate therapyMajorGood
Ritonavir, theophyllineIncreased levocetirizine exposureModerateFair

Full interaction detail is on the levocetirizine page.

FAQs
Yes. FDA approval of a generic requires demonstrated bioequivalence to the reference product in rate and extent of absorption. The active ingredient and dose are identical; tablet appearance and inactive ingredients may differ.
It switched from prescription to over-the-counter status in 2017. The medicine did not change; the regulatory classification did.
The approved labelling directs evening dosing because drowsiness is the most reported effect, and an evening dose places the peak during sleep. Morning dosing risks daytime drowsiness without any gain in cover.
If you have known kidney impairment, yes - dosing depends on creatinine clearance and the medicine is contraindicated below 10 mL/min. This is the only common over-the-counter antihistamine with an absolute renal contraindication.
The active ingredient and dose are the same by regulatory requirement. Inactive ingredients, coating and tablet size differ between manufacturers, and that is the usual explanation offered - though it has not been tested in trials.
Evidence and Reported Data

Evidence scope

What we know
  • Generic approval requires demonstrated bioequivalence to the reference product.
  • Efficacy in allergic rhinitis and chronic urticaria is established for levocetirizine.
  • Clearance is renal, which is why dosing follows creatinine clearance.
What remains uncertain
  • No brand-specific safety dataset exists. Adverse event reporting is filed against the active ingredient, not against individual manufacturers.
  • Whether inactive ingredients explain differing patient experience is untested. It is the usual explanation offered, without trial evidence.
  • Long-term continuous use is not characterised. Trials ran weeks to months.

Source: 1

What has been reported to the FDA

Reporting is filed against the active ingredient. FAERS has received 23,894 reports naming levocetirizine since 2004, 9,614 classified serious. Data current to 30 July 2026.3

How to read this table

These counts cover all levocetirizine products and cannot be attributed to any one manufacturer. FAERS has no denominator, so no count can become a rate. The ranked reaction table with context is on the levocetirizine page.

Who was this medicine studied in?

No FDA Drug Trials Snapshot exists. Snapshots cover new molecular entities approved from January 2015 onward; levocetirizine was approved in 2007.

Who this is and is not appropriate for

Typically considered for: people with allergic rhinitis or chronic hives, normal kidney function, dosing in the evening, who want the same medicine as the brand at lower cost.

Not appropriate for: anyone with creatinine clearance below 10 mL/min or on dialysis; children 6 months to 11 years with any renal impairment.

Where to go next

References

References and medical sources

  1. U.S. Food and Drug Administration. Levocetirizine dihydrochloride – approved labelling; Orange Book therapeutic equivalence evaluations.
    Accessed 26 August 2026
    Used for: approved indications and dosing, renal contraindication, bioequivalence requirement for generics, adverse reaction profile, OTC switch date.
    dailymed.nlm.nih.gov
  2. Micromedex. Drug interaction severity and documentation classification.
    Accessed 26 August 2026
    Used for: severity and documentation ratings in the interactions table.
  3. openFDA – FAERS. Query on generic name “levocetirizine”.
    Data through 30 July 2026 – retrieved 26 August 2026
    Used for: total and serious report counts.
    open.fda.gov

Each numbered marker links to the source supporting that specific statement.

Disclaimer

Disclaimer: The information on this page is provided for informational purposes only and is not medical advice. It does not replace professional medical consultation, diagnosis, or treatment. Do not self-medicate based on the information presented on this site. Always consult a doctor or other qualified healthcare professional before making any decisions about your health.