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Levocetirizine Side Effects

In Summary

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

For the Consumer

Applies to levocetirizine: oral solution, oral tablet

In addition to its needed effects, some unwanted effects may be caused by levocetirizine. In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking levocetirizine:

Less common:
  • Bloody nose
  • fever
Incidence not known:
  • 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

Minor Side Effects

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

More common:
  • Headache
  • muscle aches
  • sleepiness or unusual drowsiness
  • sore throat
  • stuffy or runny nose
Less common:
  • 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

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[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[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]

References

1. "Product Information. Xyzal (levocetirizine)." UCB Pharma Inc, Smyrna, GA.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Not all side effects for levocetirizine may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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