Levocetirizine
/api/v1/drug/levocetirizineMechanism of action
Sourced from openFDAMechanism-of-action class: Histamine H1 Receptor Antagonists.
Indications
Sourced from openFDA- 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
Dosage & administration
Sourced from openFDADirections adults 65 years of age and older ask a doctor adults and children 12-64 years of age take 1 tablet (5 mg) once daily in the evening do not take more than 1 tablet (5 mg) in 24 hours 1/2 tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms children 6-11 years of age take 1/2 tablet (2.5 mg) once daily in the evening do not take more than 1/2 tablet (2.5 mg) in 24 hours children under 6 years of age do not use consumers with kidney disease do not use
Warnings & precautions
Sourced from openFDADo not use if you have kidney disease if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing cetirizine Ask a doctor before use if you have ever had trouble urinating or emptying your bladder When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery Stop use and ask doctor if you have trouble urinating or emptying your bladder an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: ask a health professional before use Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Approval history
Sourced from openFDA- May 25, 2007NDANDA022064Chattem Sanofi
- Feb 24, 2011ANDAANDA090392Dr Reddys Labs Ltd
- Feb 24, 2011ANDAANDA090385Glenmark Pharms Ltd
- Aug 22, 2011ANDAANDA090199Teva Pharms
- Nov 7, 2011ANDAANDA091263Padagis Us
- Jun 29, 2012ANDAANDA091264Hetero Labs Ltd Iii
- Jan 31, 2017NDANDA209089Chattem Sanofi
- Jan 31, 2017NDANDA209090Chattem Sanofi
FAERS reports
- 1Drug Ineffective3,03513%
- 2Somnolence2,1299.1%
- 3Fatigue1,6977.3%
- 4Headache1,3555.8%
- 5Pruritus1,2535.4%
- 6Nausea1,1114.8%
- 7Dyspnoea1,0794.6%
- 8Diarrhoea1,0334.4%
- 9Dizziness9023.9%
- 10Cough8033.4%
- 11Rash7853.4%
- 12Arthralgia7683.3%
- 13Insomnia7683.3%
- 14Off Label Use7353.2%
- 15Pyrexia7233.1%
Clinical trials
The 10 most recently updated of 83 ClinicalTrials.gov registrations naming Levocetirizine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.
- Traditional vs. Posterior Nasal Radiofrequency Ablation for Chronic RhinitisActive not recruiting · Interventional · 60 enrolled · Chien Yu HuangNCT07323888updated 2026-05-13
- A Prospective, Single-centre, Observational Cohort Study on the Efficacy and Safety of Bacterial Lysate (OM-85) in Combination With Antihistamines for the Treatment of Chronic Spontaneous Urticaria (CSU)Not yet recruiting · Observational · 132 enrolled · The Fourth Affiliated Hospital of Zhejiang University School of MedicineNCT07557888updated 2026-05-07
- A Histamine Pharmacodynamic Biomarker to Guide Treatment in Pediatric Asthma (HAS3)Recruiting · Phase 3 · Interventional · 300 enrolled · Bridgette JonesNCT04699604updated 2026-04-22
- Clinical Study to Evaluate the Possible Efficacy and Safety of Levocetirizine in Patients With Diabetic Kidney DiseaseCompleted · Phase 2 · Interventional · 60 enrolled · Mostafa BahaaNCT05638880updated 2026-03-31
- Intravenous Immunoglobulin for the Treatment of Acute Exacerbations of Idiopathic Pulmonary FibrosisRecruiting · Phase 3 · Interventional · 196 enrolled · Argyrios TzouvelekisNCT07299695updated 2026-03-16
- Steroid Use in Treatment of Allergic Reactions to FoodRecruiting · Phase 4 · Interventional · 160 enrolled · Johannes TrueckNCT07341776updated 2026-01-27
- Efficacy of Bilastine Up-dosing (40 mg ) Versus Combination of Bilastine (20 mg )With Levocitirizine (5 mg) in the Treatment of Chronic Spontaneous UrticariaCompleted · Interventional · 60 enrolled · Derma Techno PakistanNCT07365683updated 2026-01-26
- Parallel, Double-dummy, Superiority Study Levocetirizine/Pseudoephedrine x Zina for Allergic Rhinitis in BrazilWithdrawn · Phase 3 · Interventional · 0 enrolled · Eurofarma Laboratorios S.A.NCT05637710updated 2025-12-18
- COrticosteroids in acUte uRticAria in emerGency dEpartmentCompleted · Phase 3 · Interventional · 137 enrolled · Assistance Publique - Hôpitaux de ParisNCT03545464updated 2025-09-22
- A Trial of Camrelizumab Plus Nab-paclitaxel and Levocetirizine in Metastatic or Recurrent TNBCNot yet recruiting · Phase 2 · Interventional · 60 enrolled · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityNCT06632405updated 2025-03-26
Structural analogs
Ranked by 2D fingerprint (Tanimoto) similarity over PubChem structures. Structural proximity only — not a claim of therapeutic equivalence.
Frequently asked questions
- How does Levocetirizine work?
- Mechanism-of-action class: Histamine H1 Receptor Antagonists.
- What is Levocetirizine used for?
- According to FDA labeling, Levocetirizine carries indications including: 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. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
- What class of drug is Levocetirizine?
- Levocetirizine is classified as Piperazine derivatives, Histamine-1 Receptor Antagonist, Histamine H1 Receptor Antagonists, Decreased Histamine Activity.
- What are the brand names for Levocetirizine?
- Levocetirizine is marketed under brand names including Xyzal.
levocetirizine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.