Levocetirizine Side Effects

Some side effects of levocetirizine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to levocetirizine: oral solution, oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking levocetirizine: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using levocetirizine and call your doctor at once if you have a serious side effect such as:

• feeling like you might pass out;

• nosebleed (especially in a child);

• pain or fullness in your ear, hearing problems;

• depression, agitation, aggression, hallucinations;

• numbness or tingling around your lips or mouth;

• jaundice (yellowing of your skin or eyes);

• painful or difficult urination;

• dark-colored urine, foul-smelling stools; or

• fever, stomach pain, loss of appetite.

Other common side effects may include:

• drowsiness, weakness;

• tired feeling;

• stuffy nose, sinus pain, sore throat, cough;

• vomiting, diarrhea, constipation;

• dry mouth; or

• weight gain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to levocetirizine: oral solution, oral tablet

Cardiovascular

Postmarketing reports: Palpitations, tachycardia

Dermatologic

Postmarketing reports: Fixed drug eruption, pruritus, rash, urticaria

Gastrointestinal

Very common (10% or more): Dry mouth
Common (1% to 10%): Diarrhea, vomiting, constipation
Postmarketing reports: Nausea

Hypersensitivity

Frequency not reported: Anaphylaxis
Postmarketing reports: Angioedema

Nervous system

Very common (10% or more): Somnolence, fatigue
Common (1% to 10%): Asthenia
Postmarketing reports: Convulsions, paresthesia, dizziness, tremors, vertigo

Hepatic

Uncommon (0.1% to 1%): Elevations of blood bilirubin and transaminases
Postmarketing reports: Hepatitis

Ocular

Postmarketing reports: Visual disturbances, blurred vision

Respiratory

Very common (10% or more): Nasopharyngitis, pharyngitis,
Common (1% to 10%): Cough, epistaxis
Postmarketing reports: Dyspnea

Psychiatric

Postmarketing reports: Aggression, agitation, hallucinations, suicidal ideation, dysgeusia, insomnia

Musculoskeletal

Postmarketing reports: Myalgia

Genitourinary

Postmarketing reports: Urinary retention, dysuria

General

The most common adverse reactions were: somnolence, nasopharyngitis, fatigue, dry mouth and pharyngitis (in 12 years and older); pyrexia, somnolence, cough and epistaxis (in 6 to 12 year olds); pyrexia, diarrhea, vomiting, and otitis media (in 1 to 5 year olds); diarrhea and constipation (in 6 to 11 months of age)

Other

Common (1% to 10%): Pyrexia
Uncommon (0.1% to 1%): Otitis Media
Postmarketing reports: Increased appetite, edema

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