Xozal

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Medically reviewed

Laura Arias

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Xozal

What is Xozal?

Xozal is a medication primarily used to manage symptoms associated with allergic conditions. It belongs to a class of drugs known as antihistamines, specifically categorized as a third-generation H1 receptor antagonist. Its primary function is to block the effects of histamine, a natural substance in the body that triggers allergic responses.

Mechanism of Action

When the body encounters an allergen—such as pollen, pet dander, or dust mites—the immune system may overreact by releasing histamine. Histamine binds to specific receptors on cells, leading to common allergy symptoms. Xozal works by selectively binding to these H1 receptors, preventing histamine from attaching to them. This action helps to reduce or prevent the physiological reactions typically associated with allergies.

Primary Uses

Xozal is typically used to address two main types of allergic concerns:

  • Allergic Rhinitis: This includes seasonal allergies (often referred to as hay fever) and perennial allergies that occur year-round. It helps alleviate symptoms such as sneezing, an itchy or runny nose, and itchy, watery eyes.
  • Chronic Urticaria: The medication is also used to treat the symptoms of chronic idiopathic urticaria, a condition characterized by the regular appearance of hives and skin itching without an identifiable external cause.

As a later-generation antihistamine, Xozal is designed to be highly selective for peripheral receptors, which generally results in a lower likelihood of causing certain systemic effects compared to earlier antihistamine generations.

Regulatory References

  1. NIH Clinical Review

What side effects are possible with Xozal?

The safety profile of levocetirizine, the active component of Xozal, is defined by adverse reactions classified according to frequency categories documented in official regulatory sources, such as the FDA and EMA prescribing information.

Frequency-Classified Adverse Reactions

The most frequently documented reactions, categorized as Common (ge 1/100 to < 1/10), primarily involve the Nervous System and general physical state. These include somnolence (sleepiness or drowsiness), headache, and fatigue. Dry mouth is also commonly reported within the Gastrointestinal Disorders grouping. Less frequent reactions, classified as Uncommon (ge 1/1,000 to < 1/100), include asthenia (lack of strength) and abdominal pain.

Serious Adverse Reactions and Safety Constraints

Official labeling documents acknowledge the potential for Serious Adverse Reactions, although these are typically reported as Rare or post-marketing events. These include Hypersensitivity Reactions such as anaphylaxis and angioedema, as well as events affecting the heart (tachycardia) and liver (hepatitis). Convulsions and urinary retention are also noted in post-marketing reports.

Levocetirizine is strictly contraindicated in individuals with known hypersensitivity to the drug and in patients with severe renal impairment (Creatinine clearance < 10 mL/min) or end-stage renal disease. The label cautions against concurrent use with alcohol or CNS depressants, as this may lead to additive effects and increased impairment of alertness. A time-related pattern noted in post-marketing reports is the potential for rebound pruritus (severe itching) following abrupt discontinuation of the medicine.

Overdose and Emergency Response

Overdose and When to Seek Help — Official Regulatory Information

The official regulatory profile describes the expected manifestations following an overdose of Xozal (levocetirizine), typically after an intake of at least five times the recommended daily dose. Immediate medical attention must be sought if an overdose is suspected, as professional management is required.

Category Official Regulatory Statements (Based on FDA/SmPC)
Documented Overdose Presentations Symptoms are mainly associated with Central Nervous System (CNS) effects (e.g., somnolence, stupor, confusion) and potential effects suggestive of an anticholinergic action (e.g., urinary retention). Other signs include tachycardia (increased heart rate), dizziness, fatigue, and restlessness.
Population-Specific Notes In children, the overdose presentation may initially involve agitation and restlessness, which is then followed by the more common manifestation of drowsiness (somnolence).
Emergency-Response Actions In the event of an overdose, symptomatic and supportive treatment is recommended. Gastric lavage may be considered shortly following ingestion.
Antidote Information There is no known specific antidote for levocetirizine. Furthermore, the drug is not effectively removed by hemodialysis.

Regulatory documents define the overdose profile by listing the expected clinical manifestations and explicitly mandating that a Poison Control Center or emergency medical services be contacted immediately due to the nature of the potential CNS and cardiac effects.

Therapeutic Uses of Xozal

What Xozal Treats: Main Uses and Benefits

Xozal (levocetirizine) is a medication that helps address symptoms related to physical discomfort often associated with various allergic conditions. It is relevant in contexts involving heightened systemic burden and may assist with symptoms linked to inflammatory or irritative states.

The primary therapeutic uses are centered on conditions characterized by periods of heightened symptoms, such as seasonal and perennial allergic rhinitis and chronic idiopathic urticaria.

This medication is relevant for easing symptom clusters that become intense or disruptive, including sneezing, a runny or itchy nose, and watery eyes. It is also applied in addressing the skin manifestations of hives. It may be part of symptomatic management in situations where patients experience itching (pruritus) and wheals (hives) associated with chronic urticaria.

The overall benefit for the patient is that it contributes to improved comfort during difficult episodes and supports general well-being during symptomatic phases.

Quick Fact: Supports: Symptoms that interfere with daily functioning

Eligibility and Restrictions for Use

Official Eligibility Rules for Xozal (Levocetirizine)

Official regulatory documents define who is eligible to use Xozal based on age, specific medical conditions, and physiological status. Eligibility is categorized into contraindications (absolute prohibitions), recommended use, and use requiring caution.


Absolute Contraindications

Xozal is contraindicated and must not be used by patients with a known hypersensitivity to levocetirizine, cetirizine, any other piperazine derivatives, or any product excipients. It is also prohibited for adults and adolescents (12 years and older) with end-stage renal disease or those undergoing hemodialysis, and for children 6 months to 11 years with any degree of impaired kidney function.


Age-Related Eligibility and Restrictions

The medicine is approved for use in adults and adolescents 12 years and older. Use is also established for children 6 to 11 years and for children 6 months to 5 years (using the oral solution formulation). Safety and efficacy are not established for infants younger than 6 months. Dose adjustment is specifically required for elderly patients with existing moderate to severe renal impairment.


Conditional Use Based on Health Status

Patients with mild to severe renal impairment require a dose adjustment based on their kidney function. Caution is advised for individuals with predisposing factors for urinary retention (e.g., prostatic hyperplasia) or for those with epilepsy or risk of convulsion. For pregnant women, use may be considered if necessary, but it is generally not recommended during lactation as the substance may pass into breast milk.

What should I know about interactions with other medicines?

Interactions with Other Medicines and Products

The official interaction profile for Xozal (levocetirizine) focuses primarily on pharmacodynamic interactions that result in additive central nervous system (CNS) impairment.

Interacting Product Categories and Substances

Category Specific Interacting Substance Interaction Implication
CNS Depressants Alcohol (ethanol), Sedatives, Tranquilizers, etc. May cause additional reductions in alertness and further impairment of CNS performance.

Interaction-Related Restrictions and Constraints

The most significant constraint is the avoidance of concurrent use with alcohol or other CNS depressants. Regulatory information explicitly states that patients should be cautioned against engaging in hazardous activities, such as driving a motor vehicle or operating machinery, when taking this product, especially when combined with these CNS-active agents.

Population-Specific Constraint

Additionally, caution is advised in patients with predisposing factors for urinary retention, such as prostatic hyperplasia or spinal cord lesions, as this medication has been reported to potentially increase this risk. Official labeling requires the discontinuation of the product if urinary retention occurs.

Mechanism of Action

Selective Histamine H1 Receptor Inverse Agonism

This primary domain involves the binding of Xozal (levocetirizine) to the peripheral H1 receptor ( H1 R), preventing the receptor's activation by histamine and stabilizing it in an inactive conformational state. This H1 R inverse agonism contributes to the non-activation of cellular responses mediated by immediate histamine release, which alters the status of H1 R-driven signaling within target tissues.


Modulation of Allergic Inflammatory Pathways

Beyond its direct H1 antagonism, Xozal engages mechanisms that modify other pro-inflammatory processes. This includes the ability to modulate the adhesion and migration of key inflammatory cells, such as eosinophils, and inhibit the release of certain chemokines (e.g., IL-8) from cellular reservoirs. This action alters the cascade resulting from excessive mediator activity and establishes a modified status within targeted inflammatory pathways, influencing subsequent systemic physiological processes.

Dosage and Administration Information

How to Use Xozal

This section outlines the standardized administration and dosage guidelines for Xozal (levocetirizine dihydrochloride).


Administration and Dosage Regimens

Xozal is an oral medication available as 5 mg scored tablets and as an oral solution (0.5 mg/mL). The medicine is typically taken once daily (qDay), with many instructions recommending administration in the evening. The medication may be taken with or without food.

Standard Labeled Dosing

The standard dose for adults and adolescents aged 12 years and older is 5 mg once daily. A lower dose of 2.5 mg once daily may be used in certain patients. For children aged 6 to 11 years, the dose is 2.5 mg once daily, and this amount should not be exceeded. Younger children, aged 6 months to 5 years, are given 1.25 mg once daily.

Procedural Notes

Tablets are scored to allow for the 2.5 mg dose. The oral solution requires accurate measurement. If a dose is missed, it should be taken as soon as possible; however, if it is nearly time for the subsequent dose, the missed dose must be skipped to avoid a double dose.

Population-Specific Adjustments

Standard guidelines mandate dose adjustment for patients with impaired kidney function, with the frequency and dose reduced according to the patient's creatinine clearance (CrCl). For instance, a patient with moderate renal impairment (CrCl 30-50 mL/min) is directed to take 2.5 mg once every other day. The medicine is not for use in adult and adolescent patients with end-stage renal disease (CrCl < 10 mL/min).

Recent Clinical Evidence

Research Evidence / Overview of Studies for Xozal

Evidence for Use in Seasonal Allergic Rhinitis (SAR)

Xozal was studied for Seasonal Allergic Rhinitis (SAR) primarily through short-term randomized, placebo-controlled trials. These studies were conducted to assess how the compound acts on the typical episodic manifestations of seasonal allergies. Outcomes related to physical discomfort were measured using standardized scores, and patient-reported outcomes describing changes in functional measures were also monitored. Findings describe patterns observed in symptom scores compared to a control group across multiple studies over follow-up periods typically ranging from two to four weeks. However, one large trial did not describe the same changes in the primary symptom score compared to the placebo, a finding noted as being inconsistent with the broader body of research. The evidence exploring the impact on nasal congestion is often less consistent across the entire research base.

Evidence for Use in Perennial Allergic Rhinitis (PAR)

Xozal was studied for Perennial Allergic Rhinitis (PAR) using both randomized controlled trials (RCTs) and several longer-term studies. This evidence was gathered to explore its role in conditions characterized by persistent, year-round symptoms. Outcomes monitored included Total Nasal Symptom Scores and changes in Health-Related Quality of Life (HRQoL) assessments. Studies report that patterns of monitored symptom score evolution were described over intermediate to long periods, including one notable trial with a six-month follow-up duration. This long-term research contributes to the broader evidence landscape for persistent symptoms.

What is Still Uncertain About Xozal Research

Certainty remains low regarding the long-term effects and durability of symptom management beyond the established follow-up durations of the clinical trials. This is particularly true for Seasonal Allergic Rhinitis research, where follow-up durations were limited. Additionally, evidence related to dose adjustments for patients who may also have impaired kidney function is still emerging. Subgroup findings are uncertain for specific difficult-to-treat patient populations, such as those with Chronic Idiopathic Urticaria who do not respond to standard management.

Frequently Asked Questions (FAQ)

Common questions about Xozal (FAQ)


Q: How long does the effect of Xozal typically last?

A: Xozal is typically administered once daily. Official product information indicates that the medicine's plasma half-life—the time it takes for the amount of drug in the body to reduce by half—is approximately 8 to 9 hours in healthy adults.

Q: Can Xozal affect sleep or cause insomnia?

A: Official labeling lists somnolence, meaning sleepiness or drowsiness, as a common side effect of Xozal. Additionally, post-marketing reports have noted insomnia (difficulty sleeping) and nightmares as less common, potential effects. Official information advises caution when engaging in activities that require mental alertness.

Q: Are there any specific foods or drinks to avoid while using Xozal?

A: Regulatory documents state that Xozal can be taken either with or without food. However, regulatory documents caution against the concurrent use of Xozal with alcohol, as this may result in additive effects that could further impair alertness and central nervous system performance.

Q: Is Xozal generally taken long-term or short-term?

A: Xozal is indicated for managing conditions that may require either short-term or longer-term treatment, depending on the specific condition. Clinical studies have supported its use for Seasonal Allergic Rhinitis (SAR) in short-term periods, and for Perennial Allergic Rhinitis (PAR) in longer-term periods, up to six months.

Q: Why is Xozal sometimes used for skin-related conditions?

A: Official regulatory documents indicate that Xozal is specifically approved for the treatment of uncomplicated skin manifestations of Chronic Idiopathic Urticaria, a form of chronic hives. This is related to the medicine's mechanism of blocking histamine, which is involved in skin-related allergic reactions.

Q: Is Xozal safe for older adults (seniors)?

A: Official information states that for older adults with normal kidney function, dose adjustment is generally not required. However, the medicine is not for use in patients with severe kidney problems, and official guidance emphasizes caution with regard to renal status.

Q: Are there any specific warnings for people with heart conditions using Xozal?

A: Xozal is generally not contraindicated based on heart conditions alone, but official labeling lists rare post-marketing adverse reactions affecting the cardiovascular system. These include tachycardia (a rapid heart rate) and hypotension (low blood pressure).

Q: Does Xozal have a risk of dependence or withdrawal symptoms?

A: Regulatory documents note a risk of rebound pruritus (severe itching) following the abrupt discontinuation of the medicine after long-term, daily use. There is no regulatory statement regarding drug dependence. Individuals should consult with their healthcare provider to determine the appropriate approach for discontinuation.

Q: Is Xozal used to prevent allergy symptoms or treat existing ones?

A: Xozal's primary action is to block the effects of histamine released during an allergic response. This action works to mitigate the physical symptoms associated with an allergic response. By modifying certain inflammatory pathways, it may also influence subsequent systemic processes.

Q: How quickly is Xozal expected to start working?

A: Studies on the medicine's absorption indicate that in adults, the peak concentration of Xozal in the bloodstream is typically achieved quickly, approximately 0.9 to 1.2 hours after taking the oral tablet. This suggests a rapid onset of systemic action.

Q: Is Xozal the same as Zyrtec or Allegra?

A: Xozal contains the active ingredient levocetirizine, which is directly derived from cetirizine (the active ingredient in Zyrtec). Levocetirizine is the purified, single-active component of cetirizine. Allegra (fexofenadine) is a distinct antihistamine compound.

Q: Is Xozal a newer type of allergy medication?

A: Xozal is classified as a second-generation H1-receptor antagonist, a class of antihistamines generally developed to be less sedating than older, first-generation medicines. This classification refers to its position in the overall development timeline of antihistamines.

Q: Does Xozal cause weight gain or changes in appetite?

A: Regulatory side effect listings include 'weight increased' and 'increased appetite' as less common adverse reactions. If an individual is concerned about these effects, they should consult a healthcare provider.

Q: Can people with liver problems use Xozal?

A: Official labeling states that dose adjustment is generally not required for a patient with solely hepatic impairment (liver problems). Adjustment is required only if both liver and kidney impairment are present.

Q: Does Xozal carry any Black Box Warnings in the official documents?

A: A review of the FDA prescribing information indicates that Xozal does not currently carry a Black Box Warning. A Black Box Warning is the strictest safety warning provided by the FDA for a drug.

Q: How does Xozal differ from medications that are sprayed into the nose?

A: Xozal is an oral tablet or solution that is swallowed, allowing the medicine to act systemically (throughout the body) to manage allergy symptoms. This differs from nasal spray medications, which are typically applied topically for a localized effect.

Q: Is Xozal available over the counter?

A: Yes, Xozal (levocetirizine) is available as an over-the-counter (OTC) medication in the United States at its original prescription strength. Regulatory status can vary depending on the country or region.

Q: Are there generic versions of Xozal available?

A: Yes, the active ingredient in Xozal, levocetirizine dihydrochloride, is available from various manufacturers as a generic product. This is common once a drug's patent has expired.

Q: What should I do if a side effect is bothering me?

A: Official patient counseling resources state that individuals should contact a healthcare professional regarding any side effects that are severe, persistent, or cause significant concern.

Q: Can Xozal affect the results of an allergy skin test?

A: Due to its antihistamine activity, regulatory guidance indicates that Xozal can inhibit the results of skin prick allergy tests. Healthcare providers typically advise discontinuing the medicine for a specified period, such as five days, prior to testing.

Q: Do official documents mention any potential for overdose with Xozal?

A: The official overdosage section describes the potential symptoms of taking too much Xozal. For adults, these may include extreme sleepiness, while children may initially show restlessness and irritability, followed by drowsiness.

Q: Can Xozal cause mood changes or depression?

A: Regulatory side effect reports list agitation, aggression, depression, and hallucinations as rare, post-marketing adverse reactions. If an individual experiences concerning changes in mood or behavior, they should consult a healthcare provider.

Q: Is Xozal commonly associated with drug recalls or safety updates?

A: While not commonly associated with a formal drug recall, the FDA did issue a Drug Safety Communication regarding the risk of severe itching (rebound pruritus) following the abrupt discontinuation of long-term use.

Q: Why do some people need a prescription for Xozal?

A: Although Xozal is now widely available over-the-counter in the U.S., it was originally only available by prescription. Furthermore, specific doses, the oral solution form, or regulatory standards in certain countries may still require a prescription.

Q: What is the appearance (color, shape) of the Xozal pill/tablet?

A: According to official product information, the 5 mg film-coated tablets are typically white to off-white, biconvex, and oval-shaped. They are also scored on both sides to allow for potential dose division.

Q: Does Xozal affect blood pressure?

A: Official regulatory side effect listings include hypotension (low blood pressure) as a post-marketing reaction. Additionally, the Rare side effects list includes tachycardia (rapid heart rate).

How should Xozal be stored and disposed of?

How to Store and Dispose of Xozal?

Strict adherence to the official storage and disposal requirements for Xozal (levocetirizine) is essential to maintain product stability and ensure environmental safety. The official label specifies clear constraints on the storage environment, packaging, stability, and disposal process.


Official Storage and Disposal Requirements

Requirement Instructions
Storage Temperature Store tablets at controlled room temperature (20 C to 25 C).
Environmental Control Keep from freezing and protect from excess heat, moisture, and direct light.
Packaging Keep the medication tightly closed in its original container.
Child Safety Keep out of the sight and reach of children and pets, securing it with safety caps.
Disposal Do not throw away unused or expired product via wastewater or household waste. Consult a pharmacist for proper disposal in accordance with local environmental regulations.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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