Levocetirizine: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: May 29, 2026🚩 Report this page

Levocetirizine

Piperazine Derivatives

Sold as ZELPATOR

GB MHRAUS FDA

Drug class: Piperazine Derivatives
Availability: Prescription and OTC
Routes: Oral
Markets covered: 2
Products on record: 16

Overview

Levocetirizine is an active pharmaceutical ingredient in the Piperazine Derivatives group (R06AE). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
GB United Kingdom	MHRA	14	May 29, 2026
US United States	FDA	2	December 11, 2025

GBUnited Kingdom· MHRA

14 products

Uses

GBOfficial regulatory label· revised July 11, 2025[1]

Levocetirizine is indicated in the symptomatic treatment of allergic rhinitis (including persistent allergic rhinitis) and urticaria in adults and children aged 6 years and above.

How to take

USUnited States· FDA

2 products

Uses

USOfficial regulatory label· revised December 10, 2025[2]

Uses temporarily relieves these symptoms due to hay fever or other respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat

How to take

Drug interactions

Known interactions involving Levocetirizine. Select one for details. This list is informational and not a complete interaction checker.

Aldesleukin Alfentanil Alprazolam Amitriptyline Amobarbital Amoxapine Apraclonidine Aripiprazole Asenapine Azatadine Azelastine Baclofen Benzhydrocodone Biperiden Brexanolone Brexpiprazole Brimonidine Brivaracetam Brompheniramine Buprenorphine Bupropion Buspirone Butabarbital Butalbital Butorphanol Candida Albicans Cannabidiol Carbamazepine Carbinoxamine Cariprazine Carisoprodol Cenobamate Chlorcyclizine Chlordiazepoxide Chlormezanone Chlorphenesin Chlorpheniramine Chlorpromazine Chlorzoxazone Citalopram Clemastine Clobazam Clomipramine Clonazepam Clonidine Clorazepate Clozapine Coccidioides Immitis Spherule Codeine Cyclizine Cyclobenzaprine Cyproheptadine Dantrolene Desipramine Desvenlafaxine Deutetrabenazine Dexbrompheniramine Dexmedetomidine Dezocine Diazepam Dichloralphenazone Difenoxin Dihydrocodeine Dimenhydrinate Diphenhydramine Diphenoxylate Doxepin Doxylamine Dronabinol Droperidol Duloxetine Entacapone Escitalopram Esketamine Estazolam Eszopiclone Ethanol Ethchlorvynol Ethosuximide Ethotoin Ezogabine Felbamate Fentanyl Flavoxate Flibanserin Fluoxetine Fluphenazine Flurazepam Fluvoxamine Fosphenytoin Gabapentin Halazepam Haloperidol Histamine Hydrocodone Hydromorphone Hydroxyzine Ifosfamide Iloperidone Imipramine Isocarboxazid Ketamine Lamotrigine Lasmiditan Lemborexant Levetiracetam Levorphanol Lithium Carbonate Lofexidine Loperamide Lorazepam Loxapine Lumateperone Lurasidone Maprotiline Meclizine Meperidine Mephenytoin Mephobarbital Meprobamate Mesoridazine Metaxalone Methadone Methdilazine Methocarbamol Methotrimeprazine Methsuximide Metoclopramide Midazolam Mirtazapine Molindone Morphine Nabilone Nalbuphine Nefazodone Nortriptyline Olanzapine Oliceridine Olopatadine Opicapone Opium Orphenadrine Oxazepam Oxcarbazepine Oxycodone Oxymorphone Paliperidone Paraldehyde Paramethadione Paroxetine Pentazocine Pentobarbital Perphenazine Phenacemide Phenelzine Phenindamine Phenobarbital Phensuximide Phenyltoloxamine Phenytoin Pimozide Pitolisant Pramipexole Pregabalin Primidone Procarbazine Prochlorperazine Procyclidine Promazine Promethazine Propiomazine Propofol Protriptyline Pyrilamine Quazepam Quetiapine Ramelteon Remifentanil Remimazolam Risperidone Ritonavir Ropinirole Rotigotine Rufinamide Secobarbital Sertraline Sibutramine Stiripentol Sufentanil Suvorexant Tapentadol Tasimelteon Temazepam Tetrabenazine Thalidomide Thiethylperazine Thiopental Thioridazine Thiothixene Tiagabine Tizanidine Tolcapone Topiramate Tramadol Tranylcypromine Trazodone Triazolam Trifluoperazine Triflupromazine Trihexyphenidyl Trimeprazine Trimethadione Trimethobenzamide Trimipramine Tripelennamine Triprolidine Valbenazine Valproate Venlafaxine Vigabatrin Zaleplon Ziconotide Ziprasidone Zolpidem Zonisamide Hyaluronidase Theophylline

Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.

Sources & citations

[1]MHRA (UK) · PL002891033 · revised July 11, 2025
[2]FDA DailyMed · 0216f644-767c-ae… · revised December 10, 2025 [PDF]

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Posology Adults and adolescents aged 12 years and above The daily recommended dose is 5 mg (1 film-coated tablet). Elderly Adjustment of the dose is recommended in elderly patients with moderate to severe renal impairment (see Renal impairment below).
Renal impairment The dosing intervals must be individualised according to renal function (eGFR – estimated Glomerular Filtration Rate). Refer to the following table and adjust the dose as indicated.
Dosing adjustments for patients with impaired renal function:
Group eGFR Dosage and frequency (ml/min) Normal renal function ≥ 90 1 tablet once daily Mildly decreased renal function 60 - < 90 1 tablet once daily Moderately decreased renal function 30 – < 60 1 tablet once every 2 days Severely decreased renal function 15 – < 30 (not requiring dialysis) 1 tablet once every 3 days End-stage renal disease (ESRD)– patients undergoing dialysis < 15 (requiring dialysis treatment) Contraindicated 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. 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 (see Renal impairment above).
Paediatric population Children aged 6 to 12 years:
The daily recommended dose is 5 mg (1 film-coated tablet). For children aged 2 to 6 years no adjusted dosage is possible with the film-coated tablet formulation. It is recommended to use a paediatric formulation of levocetirizine. Method of administration The film-coated tablet must be taken orally, swallowed whole with liquid and may be taken with or without food.
It is recommended to take the daily dose in one single intake. Duration of use 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; treatment 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.

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised July 11, 2025[1]

3% in the placebo group. 6% of these adverse drug reactions were mild to moderate. 8% (14/771) with placebo. Clinical therapeutic trials with levocetirizine included 935 subjects exposed to the medicinal product at the recommended dose of 5 mg daily.
5%) Further uncommon incidences of adverse reactions (uncommon: ≥1/1,000 to <1/100) like asthenia or abdominal pain were observed. 1%). 25mg twice daily respectively. The following incidence of adverse drug reactions was reported at rates of 1% or greater under levocetirizine or placebo.
3%) In children aged 6-12 years double blind placebo controlled studies were performed where 243 children were exposed to 5 mg levocetirizine daily for variable periods ranging from less than 1 week to 13 weeks. The following incidence of adverse drug reactions was reported at rates of 1% or greater under levocetirizine or placebo.
9%) Post-marketing experience Adverse reactions from post-marketing experience are per System Organ Class and per frequency. The frequency is defined as follows: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data) Immune system disorders Not known: hypersensitivity including anaphylaxis Metabolism and nutrition disorders Not known: increased appetite Psychiatric disorders Not known: aggression, agitation, hallucination, depression, insomnia, suicidal ideation, nightmare Nervous system disorders Not known: convulsion, paraesthesia, dizziness, syncope, tremor, dysgeusia Ear and labyrinth disorders Not known: vertigo Eye disorders Not known: visual disturbances, blurred vision, oculogyration Cardiac disorders Not known: palpitations, tachycardia Respiratory, thoracic, and mediastinal disorders Not known: dyspnoea Gastrointestinal disorders Not known: nausea, vomiting, diarrhoea Hepatobiliary disorders Not known: hepatitis Renal and urinary disorders Not known: dysuria, urinary retention Skin and subcutaneous tissue disorders Not known: angioneurotic oedema, fixed drug eruption, pruritus, rash, urticaria Musculoskeletal, connective tissues, and bone disorders Not known: myalgia, arthralgia General disorders and administration site conditions Not known: oedema Investigations Not known: weight increased, abnormal liver function tests Description of selected adverse reactions After levocetirizine discontinuation, pruritus has been reported.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

GBOfficial regulatory label· Warnings and precautions· revised July 11, 2025[1]

5). g. spinal cord lesion, prostatic hyperplasia) as levocetirizine may increase the risk of urinary retention. Caution should be taken in patients with epilepsy and patients at risk of convulsion as levocetirizine may cause seizure aggravation.
Response to allergy skin tests are inhibited by antihistamines and a wash-out period (of 3 days) is required before performing them. 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. The symptoms should resolve when the treatment is restarted. Paediatric population The use of the film-coated tablet formulation is not recommended in children aged less than 6 years since this formulation does not allow for appropriate dose adaptation.
It is recommended to use a paediatric formulation of levocetirizine. Levocetirizine 5 mg film-coated tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Excipients Lactose Levocetirizine 5 mg film-coated tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

This is not medical advice. Consult a qualified healthcare professional.