Xyzal

Take Xyzal exactly as prescribed.

Xyzal comes in tablet and oral solution (liquid) forms. It is usually taken once daily in the evening.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take 2 doses of Xyzal at the same time.

Contraindications

• Known hypersensitivity (e.g., urticaria, anaphylaxis) to levocetirizine or any ingredient in the formulation, or to cetirizine.1

• Adults and children ≥12 years of age with end-stage renal disease (Clcr <10 mL/minute) or undergoing hemodialysis.1

• Pediatric patients 6 months to 11 years of age with renal impairment.1

Warnings/Precautions

CNS Effects

Somnolence, fatigue, and asthenia reported.1 7 12 13 15 Avoid performing hazardous activities requiring complete mental alertness or physical coordination (e.g., operating machinery, driving a motor vehicle).1 (See Advice to Patients.)

Specific Populations

Category B.1

Expected to distribute into milk (since cetirizine is distributed into milk).1 Use not recommended.1

Safety not established in children <6 months of age.1 36

Efficacy of 1.25-mg once daily dosage (in pediatric patients 6 months to 5 years of age years of age) and 2.5-mg daily dosage (in pediatric patients 6–11 years of age) for management of allergic rhinitis is based on extrapolation of demonstrated efficacy of 5-mg daily dosage in pediatric patients ≥12 years of age and on pharmacokinetic comparisons in adults and children.1

Efficacy of 1.25-mg once daily dosage (in pediatric patients 6 months to 5 years of age years of age), 2.5-mg daily dosage (in pediatric patients 6–11 years of age), and 5-mg daily dosage (in pediatric patients ≥12 years of age) for management of chronic idiopathic urticaria is based on extrapolation of demonstrated efficacy in adults and/or on pharmacokinetic comparisons in adults and children.1

Risk of overdosage and toxicity (including death) in children <2 years of age receiving OTC preparations containing antihistamines, cough suppressants, expectorants, and nasal decongestants alone or in combination for relief of symptoms of upper respiratory tract infection. Clinicians should ask caregivers about use of nonprescription cough and cold preparations to avoid overdosage.

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.1 Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.1 (See Geriatric Patients under Dosage and Administration.) Periodic monitoring of renal function may be useful.1

Pharmacokinetics not evaluated, but clearance unlikely to be decreased.1 (See Elimination under Pharmacokinetics.) Dosage adjustment not necessary.1

Decreased clearance, resulting in increased risk of adverse effects.1 Dosage adjustment necessary based on degree of renal impairment.1 (See Renal Impairment under Dosage and Administration.)

Common Adverse Effects

Children 6–11 months of age (with 1.25-mg once daily dosage): Diarrhea,1 constipation.1

Children 1–5 years of age (with 1.25-mg twice daily dosage): Pyrexia,1 diarrhea,1 vomiting,1 otitis media.1

Children 6–12 years of age (with 5-mg daily dosage): Pyrexia,1 cough,1 somnolence,1 epistaxis.1 6

Adults and children ≥12 years of age (with 2.5- or 5-mg daily dosage): Somnolence,1 5 15 32 nasopharyngitis,1 fatigue,1 5 15 32 dry mouth,1 5 15 pharyngitis.1 32

Absorption

Bioavailability

Rapidly and extensively absorbed following oral administration, with peak plasma concentration usually attained in 0.9 hour (tablets) or 0.5 hour (oral solution).1 5 18

Onset

Antihistaminic effects occur within 1 hour.1 2 7 19 Symptomatic improvement observed as early as 1 day after initiation of therapy for allergic rhinitis1 7 8 15 or chronic idiopathic urticaria.13 14 33

Duration

Antihistaminic effects persist for at least 24 hours.1 2 6 7 8 15 19

Food

A high-fat meal reduces peak plasma concentration by about 36% and delays time to peak plasma concentration by about 1.25 hours, but does not affect AUC.1

Special Populations

In patients with renal impairment, AUC is increased by 1.8-, 3.2-, or 4.3-fold in those with mild, moderate, or severe impairment, respectively; AUC is increased by 5.7-fold in those with end-stage renal disease.1

In pediatric patients 6 months to 5 years of age, plasma concentrations following administration of 1.25 mg once daily are similar to those observed in adults receiving 5 mg once daily.1 In pediatric patients 6–11 years of age, peak plasma concentration and AUC following administration of 5-mg dose are approximately twice that in adults.1

Distribution

Extent

Average apparent volume of distribution is 0.4 L/kg, which represents distribution in total body water.1

Expected to distribute into milk.1

Plasma Protein Binding

Approximately 91–92%1 (mainly albumin).5 33

Elimination

Metabolism

Metabolized to a limited extent (<14% of dose) by aromatic oxidation, N-dealkylation, O-dealkylation, and taurine conjugation.1

Elimination Route

Excreted in urine (85.4%) (via glomerular filtration and active tubular secretion) and in feces (12.9%).1 18

<10% of dose removed by standard 4-hour hemodialysis procedure.1

Half-life

Approximately 8–9 hours in adults.1

Special Populations

In patients with renal impairment, half-life is increased by 1.4-, 2-, or 2.9-fold in those with mild, moderate, or severe impairment, respectively; half-life is increased by fourfold in those with end-stage renal disease.1 Total body clearance also progressively decreases based on severity of renal impairment.1 (See Renal Impairment under Dosage and Administration.)

In pediatric patients 6–11 years of age receiving a single 5-mg dose, total body clearance was 30% greater and elimination half-life 24% shorter than those observed in adults.1

In geriatric patients receiving 30 mg once daily for 6 days, total body clearance was 33% lower than that observed in younger adults; however, levocetirizine disposition appears to be dependent on renal function rather than on age.1

In the U.S.

• Xyzal

Available Dosage Forms:

• Solution
• Tablet

Therapeutic Class: Respiratory Agent

Pharmacologic Class: Antihistamine, Less-Sedating

Chemical Class: Piperazine (class)

If your symptoms do not improve within a few days or if they become worse, check with your doctor.

This medicine may cause some people to become dizzy, drowsy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, medicine for seizures, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor or dentist before taking any of the above while you are taking this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Xyzal is available as 2.5 mg/5 mL (0.5 mg/mL) oral solution and as 5 mg breakable (scored) tablets, allowing for the administration of 2.5 mg, if needed. Xyzal can be taken without regard to food consumption.

Perennial Allergic Rhinitis

Children 6 months to 2 Years of Age

The recommended initial dose of Xyzal is 1.25 mg (1/2 teaspoon oral solution) [2.5mL] once daily in the evening. The 1.25 mg once daily dose should not be exceeded based on comparable exposure to adults receiving 5 mg [see Clinical Pharmacology (12.3)].

Chronic Idiopathic Urticaria

Adults and Children 12 Years of Age and Older

The recommended dose of Xyzal is 5 mg (1 tablet or 2 teaspoons [10 mL] oral solution) once daily in the evening. Some patients may be adequately controlled by 2.5 mg (1/2 tablet or 1 teaspoon [5 mL] oral solution) once daily in the evening.

Children 6 to 11 Years of Age

The recommended dose of Xyzal is 2.5 mg (1/2 tablet or 1 teaspoon [5 mL] oral solution) once daily in the evening. The 2.5 mg dose should not be exceeded because the systemic exposure with 5 mg is approximately twice that of adults [see Clinical Pharmacology (12.3)].

Children 6 months to 5 Years of Age

The recommended initial dose of Xyzal is 1.25 mg (1/2 teaspoon oral solution) [2.5mL] once daily in the evening. The 1.25 mg once daily dose should not be exceeded based on comparable exposure to adults receiving 5 mg [see Clinical Pharmacology (12.3)].

Dose Adjustment for Renal and Hepatic Impairment

In adults and children 12 years of age and older with:

• Mild renal impairment (creatinine clearance [CLCR] = 50-80 mL/min): a dose of 2.5 mg once daily is recommended;
• Moderate renal impairment (CLCR = 30-50 mL/min): a dose of 2.5 mg once every other day is recommended;
• Severe renal impairment (CLCR = 10-30 mL/min): a dose of 2.5 mg twice weekly (administered once every 3-4 days) is recommended;
• End-stage renal disease patients (CLCR < 10 mL/min) and patients undergoing hemodialysis should not receive Xyzal.

No dose adjustment is needed in patients with solely hepatic impairment. In patients with both hepatic impairment and renal impairment, adjustment of the dose is recommended.

Mechanism of Action

Levocetirizine, the active enantiomer of cetirizine, is an antihistamine; its principal effects are mediated via selective inhibition of H1 receptors. The antihistaminic activity of levocetirizine has been documented in a variety of animal and human models. In vitro binding studies revealed that levocetirizine has an affinity for the human H1-receptor 2-fold higher than that of cetirizine (Ki = 3 nmol/L vs. 6 nmol/L, respectively). The clinical relevance of this finding is unknown.

Pharmacodynamics

Studies in adult healthy subjects showed that levocetirizine at doses of 2.5 mg and 5 mg inhibited the skin wheal and flare caused by the intradermal injection of histamine. In contrast, dextrocetirizine exhibited no clear change in the inhibition of the wheal and flare reaction. Levocetirizine at a dose of 5 mg inhibited the wheal and flare caused by intradermal injection of histamine in 14 pediatric subjects (aged 6 to 11 years) and the activity persisted for at least 24 hours. The clinical relevance of histamine wheal skin testing is unknown.

A QT/QTc study using a single dose of 30 mg of levocetirizine did not demonstrate an effect on the QTc interval. While a single dose of levocetirizine had no effect, the effects of levocetirizine may not be at steady state following single dose. The effect of levocetirizine on the QTc interval following multiple dose administration is unknown. Levocetirizine is not expected to have QT/QTc effects because of the results of QTc studies with cetirizine and the long post-marketing history of cetirizine without reports of QT prolongation.

Pharmacokinetics

Levocetirizine exhibited linear pharmacokinetics over the therapeutic dose range in adult healthy subjects.

Absorption

Levocetirizine is rapidly and extensively absorbed following oral administration. In adults, peak plasma concentrations are achieved 0.9 hour after administration of the oral tablet. The accumulation ratio following daily oral administration is 1.12 with steady state achieved after 2 days. Peak concentrations are typically 270 ng/mL and 308 ng/mL following a single and a repeated 5 mg once daily dose, respectively. Food had no effect on the extent of exposure (AUC) of the levocetirizine tablet, but Tmax was delayed by about 1.25 hours and Cmax was decreased by about 36% after administration with a high fat meal; therefore, levocetirizine can be administered with or without food.

A dose of 5 mg (10 mL) of Xyzal oral solution is bioequivalent to a 5 mg dose of Xyzal tablets. Following oral administration of a 5 mg dose of Xyzal oral solution to healthy adult subjects, the mean peak plasma concentrations were achieved approximately 0.5 hour post-dose.

Distribution

The mean plasma protein binding of levocetirizine in vitro ranged from 91 to 92%, independent of concentration in the range of 90-5000 ng/mL, which includes the therapeutic plasma levels observed. Following oral dosing, the average apparent volume of distribution is approximately 0.4 L/kg, representative of distribution in total body water.

Metabolism

The extent of metabolism of levocetirizine in humans is less than 14% of the dose and therefore differences resulting from genetic polymorphism or concomitant intake of hepatic drug metabolizing enzyme inhibitors are expected to be negligible. Metabolic pathways include aromatic oxidation, N- and O-dealkylation, and taurine conjugation. Dealkylation pathways are primarily mediated by CYP 3A4 while aromatic oxidation involves multiple and/or unidentified CYP isoforms.

Elimination

The plasma half-life in adult healthy subjects was about 8 to 9 hours after administration of oral tablets and oral solution, and the mean oral total body clearance for levocetirizine was approximately 0.63 mL/kg/min. The major route of excretion of levocetirizine and its metabolites is via urine, accounting for a mean of 85.4% of the dose. Excretion via feces accounts for only 12.9% of the dose. Levocetirizine is excreted both by glomerular filtration and active tubular secretion. Renal clearance of levocetirizine correlates with that of creatinine clearance. In patients with renal impairment the clearance of levocetirizine is reduced [see Dosage and Administration (2.3)].

Drug Interaction Studies

In vitro data on metabolite interaction indicate that levocetirizine is unlikely to produce, or be subject to metabolic interactions. Levocetirizine at concentrations well above Cmax level achieved within the therapeutic dose ranges is not an inhibitor of CYP isoenzymes 1A2, 2C9, 2C19, 2A1, 2D6, 2E1, and 3A4, and is not an inducer of UGT1A or CYP isoenzymes 1A2, 2C9 and 3A4.

No formal in vivo drug interaction studies have been performed with levocetirizine. Studies have been performed with the racemic cetirizine [see Drug Interactions (7)].

Pediatric Patients

Data from a pediatric pharmacokinetic study with oral administration of a single dose of 5 mg levocetirizine in 14 children age 6 to 11 years with body weight ranging between 20 and 40 kg show that Cmax and AUC values are about 2-fold greater than that reported in healthy adult subjects in a cross-study comparison. The mean Cmax was 450 ng/mL, occurring at a mean time of 1.2 hours, weight-normalized, total body clearance was 30% greater, and the elimination half-life 24% shorter in this pediatric population than in adults.

Dedicated pharmacokinetic studies have not been conducted in pediatric patients younger than 6 years of age. A retrospective population pharmacokinetic analysis was conducted in 323 subjects (181 children 1 to 5 years of age, 18 children 6 to 11 years of age, and 124 adults 18 to 55 years of age) who received single or multiple doses of levocetirizine ranging from 1.25 mg to 30 mg. Data generated from this analysis indicated that administration of 1.25 mg once daily to children 6 months to 5 years of age results in plasma concentrations similar to those of adults receiving 5 mg once daily.

Geriatric Patients

Limited pharmacokinetic data are available in elderly subjects. Following once daily repeat oral administration of 30 mg levocetirizine for 6 days in 9 elderly subjects (65–74 years of age), the total body clearance was approximately 33% lower compared to that in younger adults. The disposition of racemic cetirizine has been shown to be dependent on renal function rather than on age. This finding would also be applicable for levocetirizine, as levocetirizine and cetirizine are both predominantly excreted in urine. Therefore, the Xyzal dose should be adjusted in accordance with renal function in elderly patients [see Dosage and Administration (2)].

Gender

Pharmacokinetic results for 77 patients (40 men, 37 women) were evaluated for potential effect of gender. The half-life was slightly shorter in women (7.08 ± 1.72 hr) than in men (8.62 ± 1.84 hr); however, the body weight-adjusted oral clearance in women (0.67 ± 0.16 mL/min/kg) appears to be comparable to that in men (0.59 ± 0.12 mL/min/kg). The same daily doses and dosing intervals are applicable for men and women with normal renal function.

Race

The effect of race on levocetirizine has not been studied. As levocetirizine is primarily renally excreted, and there are no important racial differences in creatinine clearance, pharmacokinetic characteristics of levocetirizine are not expected to be different across races. No race-related differences in the kinetics of racemic cetirizine have been observed.

Renal Impairment

Levocetirizine exposure (AUC) exhibited 1.8-, 3.2-, 4.3-, and 5.7-fold increase in mild, moderate, severe, renal impaired, and end-stage renal disease patients, respectively, compared to healthy subjects. The corresponding increases of half-life estimates were 1.4-, 2.0-, 2.9-, and 4-fold, respectively.

The total body clearance of levocetirizine after oral dosing was correlated to the creatinine clearance and was progressively reduced based on severity of renal impairment. Therefore, it is recommended to adjust the dose and dosing intervals of levocetirizine based on creatinine clearance in patients with mild, moderate, or severe renal impairment. In end-stage renal disease patients (CLCR < 10 mL/min) levocetirizine is contraindicated. The amount of levocetirizine removed during a standard 4-hour hemodialysis procedure was <10%.

The dosage of Xyzal should be reduced in patients with mild renal impairment. Both the dosage and frequency of administration should be reduced in patients with moderate or severe renal impairment [see Dosage and Administration (2.4)].

Xyzal has not been studied in patients with hepatic impairment. The non-renal clearance (indicative of hepatic contribution) was found to constitute about 28% of the total body clearance in healthy adult subjects after oral administration.

As levocetirizine is mainly excreted unchanged by the kidney, it is unlikely that the clearance of levocetirizine is significantly decreased in patients with solely hepatic impairment [see Dosage and Administration (2)].

Perennial Allergic Rhinitis

Adults and Adolescents 12 Years of Age and Older

The efficacy of Xyzal was evaluated in four randomized, placebo-controlled, double-blind clinical trials in adult and adolescent patients 12 years and older with symptoms of perennial allergic rhinitis. The four clinical trials include two dose-ranging trials of 4 weeks duration and two efficacy trials (one 6-week and one 6-month) in patients with perennial allergic rhinitis.

These trials included a total of 1729 patients (752 males and 977 females) of whom 227 were adolescents 12 to 17 years of age. Efficacy was assessed using a total symptom score from patient recording of 4 symptoms (sneezing, rhinorrhea, nasal pruritus, and ocular pruritus) in three studies and 5 symptoms (sneezing, rhinorrhea, nasal pruritus, ocular pruritus, and nasal congestion) in one study. Patients recorded symptoms using a 0-3 categorical severity scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe) once daily in the evening reflective of the 24 hour treatment period. The primary endpoint was the mean total symptom score averaged over the first week and over 4 weeks for perennial allergic rhinitis trials.

The two dose-ranging trials were conducted to evaluate the efficacy of Xyzal 2.5, 5, and 10 mg once daily in the evening. These trials were 4 weeks in duration and included patients with perennial allergic rhinitis. In these trials, each of the three doses of Xyzal demonstrated greater decrease in the reflective total symptom score than placebo and the difference was statistically significant for all three doses in the two studies. Results for one of these trials are shown in Table 4.

One clinical trial evaluated the efficacy of Xyzal 5 mg once daily in the evening compared to placebo in patients with perennial allergic rhinitis over a 6-week treatment period. Another trial conducted over a 6-month treatment period assessed efficacy at 4 weeks. Xyzal 5 mg demonstrated a greater decrease from baseline in the reflective total symptom score than placebo and the difference from placebo was statistically significant. Results of the former are shown in Table 5.

Onset of action was evaluated in two environmental exposure unit studies in allergic rhinitis patients with a single dose of Xyzal 2.5 or 5 mg. Xyzal 5 mg was found to have an onset of action 1 hour after oral intake. Onset of action was also assessed from the daily recording of symptoms in the evening before dosing in the allergic rhinitis trials. In these trials, onset of effect was seen after 1 day of dosing.

Pediatric Patients Less than 12 Years of Age

There are no clinical efficacy trials with Xyzal 2.5 mg once daily in pediatric patients under 12 years of age, and no clinical efficacy trials with Xyzal 1.25 mg once daily in pediatric patients 6 months to 5 years of age. The clinical efficacy of Xyzal in pediatric patients under 12 years of age has been extrapolated from adult clinical efficacy trials based on pharmacokinetic comparisons [see Use in Specific Populations (8.4)].

Chronic Idiopathic Urticaria

Adult Patients 18 Years of Age and Older

The efficacy of Xyzal for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria was evaluated in two multi-center, randomized, placebo-controlled, double-blind clinical trials of 4 weeks duration in adult patients 18 to 85 years of age with chronic idiopathic urticaria. The two trials included one 4-week dose-ranging trial and one 4-week single-dose level efficacy trial. These trials included 423 patients (139 males and 284 females). Most patients (>90%) were Caucasian and the mean age was 41. Of these patients, 146 received Xyzal 5 mg once daily in the evening. Efficacy was assessed based on patient recording of pruritus severity on a severity score of 0–3 (0 = none to 3 = severe). The primary efficacy endpoint was the mean reflective pruritus severity score over the first week and over the entire treatment period. Additional efficacy variables were the instantaneous pruritus severity score, the number and size of wheals, and duration of pruritus.

The dose-ranging trial was conducted to evaluate the efficacy of Xyzal 2.5, 5, and 10 mg once daily in the evening. In this trial, each of the three doses of Xyzal demonstrated greater decrease in the reflective pruritus severity score than placebo and the difference was statistically significant for all three doses (see Table 6).

The single dose level trial evaluated the efficacy of Xyzal 5 mg once daily in the evening compared to placebo in patients with chronic idiopathic urticaria over a 4-week treatment period. Xyzal 5 mg demonstrated a greater decrease from baseline in the reflective pruritus severity score than placebo and the difference from placebo was statistically significant.

Duration of pruritus, number and size of wheals, and instantaneous pruritus severity score also showed significant improvement over placebo. The significant improvement in the instantaneous pruritus severity score over placebo confirmed end of dosing interval efficacy (see Table 6).

Pediatric Patients

There are no clinical efficacy trials in pediatric patients with chronic idiopathic urticaria [see Use in Specific Populations (8.4)].

Xyzal tablets are white, film-coated, oval-shaped, scored, imprinted (with the letter Y in red color on both halves of the scored tablet) and contain 5 mg levocetirizine dihydrochloride. They are supplied in unit of use HDPE bottles.

90 Tablets (NDC 50474-920-90)

Xyzal oral solution is a clear, colorless liquid containing 0.5 mg of levocetirizine dihydrochloride per mL.

Oral Solution in 5 oz polypropylene bottles (NDC 50474-921-05)

Storage:

Store at 20 to 25°C (68 to 77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].

Xyzal (levocetirizine) is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Xyzal is used to treat symptoms of year-round (perennial) allergies in adults and children children who are at least 6 months old.

Xyzal is also used to treat itching and swelling caused by chronic urticaria (hives) in adults and children who are at least 6 months old.

Usual Adult Dose for Allergic Rhinitis:

Seasonal and perennial allergic rhinitis and chronic idiopathic urticaria;
5 mg orally once daily in the evening

Usual Adult Dose for Urticaria:

Seasonal and perennial allergic rhinitis and chronic idiopathic urticaria;
5 mg orally once daily in the evening

Usual Pediatric Dose for Allergic Rhinitis:

Seasonal allergic rhinitis:
12 years or older: 5 mg orally once daily in the evening
6 to 11 years old: 2.5 mg orally once daily in the evening
2 to 5 years old: 1.25 mg orally once daily in the evening

Perennial allergic rhinitis and chronic idiopathic urticaria:
12 years or older: 5 mg orally once daily in the evening
6 to 11 years old: 2.5 mg orally once daily in the evening
6 months to 5 years old: 1.25 mg orally once daily in the evening

Usual Pediatric Dose for Urticaria:

Seasonal allergic rhinitis:
12 years or older: 5 mg orally once daily in the evening
6 to 11 years old: 2.5 mg orally once daily in the evening
2 to 5 years old: 1.25 mg orally once daily in the evening

Perennial allergic rhinitis and chronic idiopathic urticaria:
12 years or older: 5 mg orally once daily in the evening
6 to 11 years old: 2.5 mg orally once daily in the evening
6 months to 5 years old: 1.25 mg orally once daily in the evening

Applies to levocetirizine: oral solution, oral tablet

Along with its needed effects, levocetirizine (the active ingredient contained in Xyzal) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking levocetirizine:

• Bloody nose
• fever

• Anxiety
• attack, assault, or force
• blurred or loss of vision
• cough
• dark urine
• decrease in the frequency of urination
• decrease in urine volume
• difficult or labored breathing
• difficulty in passing urine (dribbling)
• difficulty with swallowing
• disturbed color perception
• dizziness
• double vision
• dry mouth
• fast, irregular, pounding, or racing heartbeat or pulse
• general tiredness and weakness
• halos around lights
• hives or welts
• hyperventilation
• irritability
• itching skin
• joint or muscle pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• light-colored stools
• nausea and vomiting
• nervousness
• night blindness
• overbright appearance of lights
• painful urination
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• redness of the skin
• restlessness
• seizures
• shaking
• skin rash
• tightness in the chest
• trouble with sleeping
• tunnel vision
• upper right abdominal or stomach pain
• yellow eyes and skin

Some side effects of levocetirizine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Headache
• muscle aches
• sleepiness or unusual drowsiness
• sore throat
• stuffy or runny nose

• Body aches or pain
• congestion
• diarrhea
• dryness or soreness of the throat
• earache
• hoarseness
• redness or swelling in the ear
• tender, swollen glands in the neck
• voice changes