Summary

More frequently reported side effects include: drowsiness, fatigue, and nasopharyngitis. Continue reading for a comprehensive list of adverse effects.

Applies to levocetirizine: oral tablets and oral solution.

Side effects include:

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

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

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

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

For Healthcare Professionals

Applies to levocetirizine: oral solution, oral tablet.

General

The most frequently reported side effects were: somnolence, nasopharyngitis, fatigue, dry mouth, and pharyngitis (in 12 years and older); pyrexia, somnolence, cough, and epistaxis (in patients 6 to 12 years); pyrexia, diarrhea, vomiting, and otitis media (in patients 1 to 5 years); diarrhea and constipation (in patients 6 to 11 months).^[Ref]

Nervous system

Common (1% to 10%): Somnolence, dizziness, headache

Uncommon (0.1% to 1%): Paresthesia, syncope

Rare (0.01% to 0.1%): Convulsion, movement disorder

Very rare (less than 0.01%): Dysgeusia, tremor, dystonia, dyskinesia

Frequency not reported: Orofacial dyskinesia, myoclonus, extrapyramidal symptoms

Postmarketing reports: Febrile seizure^[Ref]

Ocular

Very rare (less than 0.01%): Accommodation disorder, vision blurred, oculogyration

Postmarketing reports: Visual disturbance^[Ref]

Respiratory

Common (1% to 10%): Nasopharyngitis, pharyngitis, cough, epistaxis, rhinitis

Postmarketing reports: Dyspnea^[Ref]

Gastrointestinal

Common (1% to 10%): Dry mouth, diarrhea, vomiting, constipation, abdominal pain

Postmarketing reports: Nausea^[Ref]

Other

Common (1% to 10%): Fatigue, pyrexia, otitis media

Uncommon (0.1% to 1%): Weight increased, asthenia, malaise

Rare (less than 0.1%): Edema

Frequency not reported: Stillbirth

Postmarketing reports: Vertigo^[Ref]

Psychiatric

Uncommon (0.1% to 1%): Agitation

Rare (0.01% to 0.1%): Aggression, confusion, depression, hallucination, insomnia

Very rare (less than 0.01%): Tic, enuresis

Postmarketing reports: Suicidal ideation, nightmare^[Ref]

Genitourinary

Very rare (less than 0.01%): Dysuria

Postmarketing reports: Urinary retention^[Ref]

Cardiovascular

Rare (less than 0.1%): Tachycardia

Frequency not reported: Severe hypotension

Postmarketing reports: Palpitation^[Ref]

Dermatologic

Uncommon (0.1% to 1%): Pruritus, rash

Rare (0.01% to 0.1%): Urticaria

Very rare (less than 0.01%): Angioedema, fixed drug eruption

Frequency not reported: Acute generalized exanthematous pustulosis^[Ref]

Hepatic

Rare (less than 0.1%): Hepatic function abnormal, transaminases increased, bilirubin increased

Frequency not reported: Cholestasis

Postmarketing reports: Hepatitis^[Ref]

Hematologic

Very rare (less than 0.01%): Thrombocytopenia^[Ref]

Immunologic

Rare (0.01% to 0.1%): Hypersensitivity

Very rare (less than 0.01%): Anaphylactic shock^[Ref]

Renal

Frequency not reported: Glomerulonephritis^[Ref]

Metabolic

Postmarketing reports: Appetite increased^[Ref]

Musculoskeletal

Postmarketing reports: Myalgia, arthralgia^[Ref]