Zyrtec Adverse Reactions
- abdominal pain
- anaphylactic shock
- anaphylactoid reactions
- anorexia
- anxiety
- bronchospasm
- cough
- dizziness
- drowsiness
- dysuria
- elevated hepatic enzymes
- epistaxis
- fatigue
- headache
- hepatitis
- hyperbilirubinemia
- hypertension
- insomnia
- nausea/vomiting
- pharyngitis
- rash (unspecified)
- sinus tachycardia
- xerostomia
Cetirizine Adverse Reactions
Cetirizine appears to cause few serious adverse reactions, and discontinuation rates are similar to placebo (2.9% vs. 2.4%, respectively). Side effects from cetirizine reported in placebo-controlled trials in adults and children aged 12 years and older include drowsiness; sedation was found to be dose related. The incidence was 11% at a dose of 5 mg/day. With a 10-mg/day dose, the incidence rose to about 14% and to 21% at 20 mg/day. The incidence of cetirizine-induced sedation compared with other antihistamines and placebo has been studied. Overall results suggest that cetirizine may be more sedating than fexofenadine, loratadine, terfenadine, or placebo but that the drug is less sedating than older antihistamines. Other side effects reported in >= 2% include xerostomia (5%), fatigue (5.9%), pharyngitis (2%) and dizziness (2%). Adverse reaction profiles are similar regardless of the indication being treated. Side effects listed occurred at an incidence greater than with placebo, although pharyngitis occurred at a similar incidence.
In pediatric patients, adverse reactions have been reported to be mild or moderate; discontinuation is uncommon (0.4% with cetirizine vs. 1% for placebo). Side effects from cetirizine reported in controlled trials in children 6 - 11 years of age are as follows, similar rates of these side effects were reported in trials of children < 6 years receiving a 5 mg/day dosage: (rates are reported for 5 mg and 10 mg dose vs. placebo): headache (11% and 14% vs placebo 12.3%); pharyngitis (6.2% and 2.8% vs. placebo 2.9%); abdominal pain (4.4% and 5.6% vs. placebo 2%); cough (4.4% and 2.8% vs. placebo 3.9%); somnolence (1.9% and 4.2% vs. placebo 1.3%); diarrhea (3.1% and 1.9% vs. placebo 1.3%); epistaxis (3.7% and 1.9% vs. placebo 2.9%); bronchospasm ((3.1% and 1.9% vs. placebo 1.9%); and nausea/vomiting (roughly 2 - 3% vs. placebo 1 - 2%).
There have been a few reports of abnormalities in liver function tests (elevated hepatic enzymes) with use of cetirizine. Most of these events resolved spontaneously. Hepatitis with significant changes in LFTs and hyperbilirubinemia has been reported rarely.
Post-marketing reports have shown the following rare but serious events in clinical use: anaphylactoid reactions, anaphylactic shock, cholestasis, glomerulonephritis, hemolytic anemia, hepatitis, orofacial dyskinesia, severe hypotension, stillbirth (fetal demise), thrombocytopenia, aggressive behavior, and convulsions (seizures). A causal relationship of cetirizine to such events, and others observed in open label studies in < 2% of patients, has not been determined. There has been no suggestion that cetirizine has any arrhythmogenic potential. There have not been any reports of changes in ECG recordings or other cardiac abnormalities.
The following INFREQUENT events have been observed in <= 2% by pooling data in all patient age groups, including in open-label studies; exact incidence rates cannot be determined. A causal relationship to the drug cetirizine has NOT been established for these reports, which are listed by organ system. Body as a Whole: accidental injury, asthenia, back pain, chest pain (unspecified), face edema, enlarged abdomen, fever, generalized edema, hot flashes, increased weight, leg edema, malaise, nasal polyp, pain, pallor, periorbital edema, peripheral edema, rigors. Autonomic nervous system: anorexia, flushing, hypersalivation, and urinary retention. Cardiovascular: heart failure, hypertension, palpitations, and sinus tachycardia. CNS and peripheral nervous system: abnormal coordination, ataxia, confusion, dysphonia, hyperesthesia, hyperkinesia, hypertonia, hypoesthesia, leg cramps, migraine, myelitis, paralysis, paresthesias, ptosis, syncope, tremor, twitching, vertigo, visual impairment (visual field defect). GI: abnormal hepatic function, aggravated tooth caries, constipation, dyspepsia, eructation, flatulence, gastritis, hemorrhoids, increased appetite (polyphagia), melena, rectal hemorrhage, stomatitis, ulcerative stomatitis, tongue discoloration, tongue edema. Genitourinary: cystitis, dysuria, hematuria, increased frequency of urination, polyuria, urinary incontinence, and urinary tract infection. Hearing and Vestibular: deafness, earache, ototoxicity, and tinnitus. Metabolic/Nutritional: dehydration, hyperglycemia, thirst (polydipsia). Musculoskeletal: arthralgia, arthritis, arthrosis, muscle weakness, and myalgia. Psychiatric: abnormal thinking (impaired cognition), agitation, amnesia, anxiety, libido decrease, depersonalization, depression, emotional lability, euphoria, insomnia, nervousness, paranoia, sleep disorder. Reproductive: dysmenorrhea, mastalgia (females), intermenstrual bleeding, leukorrhea, menorrhagia, and vaginitis. Respiratory system: bronchitis, dyspnea, hyperventilation, increased phlegm, pneumonia, respiratory disorder (unspecified), rhinitis, sinusitis, upper respiratory tract infection. Skin: acne, alopecia, angioedema, bullous eruption, dermatitis, dry skin, eczema, erythematous rash, furunculosis, hyperkeratosis, increased sweating, maculopapular rash, photosensitivity reaction, pruritus, purpura, rash (unspecified), seborrhea, skin disorder (unspecified), and urticaria. Special senses: parosmia, taste loss, and dysgeusia. Vision: blindness, conjunctivitis, eye pain, glaucoma, loss of accommodation, ocular hemorrhage, and xerophthalmia.
[ Last revised: 5/7/2004 4:16:00 PM ]
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