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Non-sedating H1 antihistamine Pregnancy: May be considered in pregnancy if necessary; caution in breast-feeding. §4.6, verbatim: 'There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of levocetirizine in pregnant women. However, for cetirizine, the racemate of levocetirizine, a large amount of data (more than 1000 pregnancy outcomes) on pregnant women indicate no malformative or feto/neonatal toxicity... The use of levocetirizine may be considered during pregnancy, if necessary.' Breast-feeding: 'Cetirizine, the racemate of levocetirizine, has been shown to be excreted in human. Therefore, the excretion of levocetirizine in human milk is likely. Adverse reactions associated with levocetirizine may be observed in breastfed infants. Therefore, caution should be exercised when prescribing levocetirizine to lactating women.' Fertility: 'For levocetirizine no clinical data are available.'

Levocetirizine hydrochloride

Brand names: Xyzal

Levocetirizine is a non-sedating second-generation oral antihistamine, the active enantiomer of cetirizine, used to treat allergic rhinitis and chronic urticaria.

Adult dose

Dose: Allergic rhinitis and chronic urticaria — adults and adolescents 12 years and above: 5 mg once daily. §4.2, verbatim: 'Adults and adolescents 12 years and above: The daily recommended dose is 5 mg (10 ml of solution).' (Figures are from the 0.5 mg/ml oral solution SPC; 10 ml of that solution = 5 mg.)
Route: Oral. §4.2: 'An oral syringe is included in the package. The appropriate volume of oral solution should be measured with the oral syringe, and poured in a spoon or in a glass of water. The oral solution must be taken orally immediately after dilution, and may be taken with or without food.'
Frequency: Once daily in normal or mildly decreased renal function. The dosing interval — not the strength — is what changes in renal impairment: 5 mg once every 2 days at eGFR 30 to <60, and once every 3 days at eGFR 15 to <30. See renalAdjustment.
Max: 5 mg (10 ml of solution) in 24 hours. The SPC states one recommended adult dose — 'The daily recommended dose is 5 mg (10 ml of solution)' — and contains no higher dose and no titration step for any indication. In renal impairment the same 5 mg is given LESS OFTEN (every 2 or 3 days), never at a larger single dose.
ELDERLY (§4.2, verbatim, and it is the whole of that paragraph): 'Adjustment of the dose is recommended in elderly patients with moderate to severe renal impairment (see Renal impairment below).' There is no separate elderly milligram dose — the adjustment is the renal one. || DURATION OF USE (§4.2, verbatim): 'Intermittent allergic rhinitis (symptoms experienced for less than four days a week or for less than four weeks a year) has to be treated according to the disease and its history; it can be stopped once the symptoms have disappeared and can be restarted again when symptoms reappear. In case of persistent allergic rhinitis (symptoms experienced for more than four days a week or for more than four weeks a year), continuous therapy can be proposed to the patient during the period of exposure to allergens. There is clinical experience with the use of levocetirizine for treatment periods of at least 6 months. In chronic urticaria and chronic allergic rhinitis, there is clinical experience of use of cetirizine (racemate) for up to one year.' || HEPATIC IMPAIRMENT: 'No dose adjustment is needed in patients with solely hepatic impairment. In patients with hepatic impairment and renal impairment, adjustment of the dose is recommended.' || ⚠️ AN INTERNAL DISCREPANCY IN THE SPC ITSELF, REPORTED AS FOUND AND NOT RECONCILED: §4.3 contraindicates 'Patients with end stage renal disease with estimated Glomerular Filtration Rate (eGFR) below 10 ml/min (requiring dialysis treatment)', while the §4.2 renal table contraindicates the ESRD row at 'eGFR < 15 (requiring dialysis treatment)'. Both thresholds are quoted verbatim in this draft; neither has been altered to agree with the other. || The live renalAdjustment reads 'CrCl 30–50: 5mg every other day; <10: avoid' — the SPC's table is stated in eGFR, not CrCl, and its bands are 30 to <60 (every 2 days) and 15 to <30 (every 3 days), so the live band boundaries are NOT what this SPC says; the sourced table replaces them. The live paediatric age bands ('1.25mg BD' for 24–72 months and '2.5mg BD or 5mg OD' for 72–144 months) are only partly supported: the SPC gives 1.25 mg twice daily for 2 to 6 years and 5 mg ONCE daily for 6 to 12 years, with no twice-daily 2.5 mg option in that older band. || §4.4 also notes: 'Response to allergy skin tests are inhibited by antihistamines and a wash-out period (of 3 days) is required before performing them.'

Paediatric dose

Route: Oral — measured with the oral syringe supplied, poured into a spoon or a glass of water and taken immediately after dilution, with or without food
Frequency: Children 6 to 12 years: once daily. Children 2 to 6 years: twice daily (the 2.5 mg daily dose is split into 2 intakes of 1.25 mg).
Max: 5 mg (10 ml) daily for children aged 6 to 12 years; 2.5 mg daily for children aged 2 to 6 years. Not to be given under 2 years of age.
Concentration: 0.5 mg/ml
NOT WEIGHT-BASED — the SPC doses by age band in fixed milligrams, so dosePerKg is null and no weight calculation applies. §4.2, verbatim: 'Children aged 6 to 12 years: The daily recommended dose is 5 mg (10 ml of solution). Children aged 2 to 6 years: The daily recommended dose is 2.5 mg to be administered in 2 intakes of 1.25 mg (2.5 ml of solution twice daily). Even if some clinical data are available in children aged 6 months to 12 years (see section 4.8, 5.1 and 5.2), these data are not sufficient to support the administration of levocetirizine to infants and toddlers aged less than 2 years.' §4.4 repeats that under-2 restriction. These are the label's own paediatric figures — nothing has been scaled from the adult dose. The concentration of 0.5 mg/ml is the fetched product's own strength ('Xyzal 0.5 mg/ml oral solution') and is confirmed by the SPC's own volumes: 5 mg = 10 ml and 1.25 mg = 2.5 ml. PAEDIATRIC RENAL IMPAIRMENT: 'In paediatric patients suffering from renal impairment, the dose will have to be adjusted on an individual basis taking into account the renal clearance of the patient and his body weight. There are no specific data for children with renal impairment.'

Dose adjustments

Renal

§4.2, verbatim: 'The dosing intervals must be individualised according to renal function (eGFR – estimated Glomerular Filtration Rate).' Normal renal function (eGFR ≥ 90): 5 mg once daily. Mildly decreased (60 to < 90): 5 mg once daily. Moderately decreased (30 to < 60): 5 mg once every 2 days. Severely decreased (15 to < 30, not requiring dialysis): 5 mg once every 3 days. End stage renal disease (< 15, requiring dialysis treatment): contraindicated. Note the §4.3/§4.2 threshold discrepancy recorded in adultDose.notes (§4.3 gives the contraindication as eGFR below 10 ml/min).

Hepatic

§4.2: 'No dose adjustment is needed in patients with solely hepatic impairment. In patients with hepatic impairment and renal impairment, adjustment of the dose is recommended (see Renal impairment above).'

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substance, to cetirizine, to hydroxyzine, to any other piperazine derivatives or to any of the other excipients listed in section 6.1 (§4.3)
  • Patients with end stage renal disease with estimated Glomerular Filtration Rate (eGFR) below 10 ml/min (requiring dialysis treatment) (§4.3) — note the §4.2 renal table instead contraindicates the ESRD row at eGFR < 15 requiring dialysis; both are quoted as found
  • Not to be given to infants and toddlers aged less than 2 years — the available data 'are not sufficient to support the administration of levocetirizine' in that group (§4.2 and §4.4)
  • Patients with rare hereditary problems of fructose intolerance should not take this medicine, as it contains maltitol liquid (§4.4)

Side effects

  • Common in adults and adolescents over 12 at the 5 mg dose (incidence ≥ 1%, from 935 exposed subjects): somnolence 5.2% (vs 1.4% placebo), headache 2.6% (vs 3.2% placebo), dry mouth 2.6% (vs 1.6% placebo), fatigue 2.5% (vs 1.2% placebo)
  • 'The incidence of sedating adverse drug reactions such as somnolence, fatigue, and asthenia was altogether more common (8.1%) under levocetirizine 5 mg than under placebo (3.1%)' — relevant to the page's 'non-sedating' category label
  • Uncommon: asthenia, abdominal pain
  • In children aged 6 to 12 years (243 exposed to 5 mg daily): somnolence 2.9% (vs 0.4% placebo), headache 0.8% (vs 2.1% placebo)
  • In children under 6 years (159 exposed): diarrhoea 1.9%, somnolence 1.9%, constipation 1.3%, sleep disorder 1.3%, vomiting 0.6%
  • Pruritus on stopping treatment — §4.4: 'Pruritus may occur when levocetirizine is stopped even if those symptoms were not present before treatment initiation. The symptoms may resolve spontaneously. In some cases, the symptoms may be intense and may require treatment to be restarted.'
  • Allergic reactions (possibly delayed) attributable to the methyl and propyl parahydroxybenzoate excipients of the oral solution (§4.4)
  • NOTE: §4.8 is cut off at the source-fetch limit at the beginning of the post-marketing list, so the post-marketing adverse reactions are NOT included here

Monitoring

  • §4.4: 'Caution should be taken in patients with epilepsy and patients at risk of convulsion as levocetirizine may cause seizure aggravation.'
  • §4.4: 'Caution should be taken in patients with predisposing factors of urinary retention (e.g. spinal cord lesion, prostatic hyperplasia) as levocetirizine may increase the risk of urinary retention.'
  • §4.4: 'Precaution is recommended with concurrent intake of alcohol.' §4.5 adds: 'In sensitive patients, the concurrent administration of cetirizine or levocetirizine and alcohol or other CNS depressants may cause additional reductions in alertness and impairment of performance.'
  • §4.4, before allergy testing: 'Response to allergy skin tests are inhibited by antihistamines and a wash-out period (of 3 days) is required before performing them.'
  • §4.2: renal function (eGFR) determines the dosing interval and must be established before dosing; in children with renal impairment the dose is individualised on renal clearance and body weight

Clinical monograph

How it works

It is a selective peripheral histamine H1-receptor antagonist that blocks histamine-mediated allergic responses such as itch, sneezing, rhinorrhoea, and wheal formation.

Prescribing in practice

  • Although classed as non-sedating, drowsiness can still occur and patients should assess their response before driving or operating machinery, and be cautious with alcohol and other sedatives.
  • Dose reduction or extended dosing interval is required in renal impairment; consult the SPC for adjustment and for paediatric dosing use a children's formulary.
  • Generally avoided where there is significant renal impairment without adjustment; review prescribing references for contraindications.

Monitoring

Routine laboratory monitoring is not required; assess symptom control and any sedative effect, particularly in renal impairment.

Counselling the patient

  • Most people are not affected, but if it makes you drowsy avoid driving and avoid alcohol.
  • It can be taken to relieve ongoing allergy symptoms; take it regularly during your allergy season if advised.

Evidence & guidelines

Second-generation antihistamines such as levocetirizine are recommended as first-line pharmacological treatment for allergic rhinitis and chronic urticaria in NICE and international allergy guidance.

Reference: BSACI rhinitis/urticaria guidelines; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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