Cetirizine; Pseudoephedrine (Zyrtec-D) Adverse Reactions
- anaphylactic shock
- anaphylactoid reactions
- angina
- anorexia
- anxiety
- arrhythmia exacerbation
- colitis
- contact dermatitis
- dizziness
- drowsiness
- dysuria
- elevated hepatic enzymes
- fatigue
- hallucinations
- hepatitis
- hyperbilirubinemia
- hypertension
- insomnia
- myocardial infarction
- nausea/vomiting
- ocular hypertension
- palpitations
- photophobia
- premature ventricular contractions (PVCs)
- psychosis
- rash (unspecified)
- seizures
- sinus tachycardia
- stroke
- supraventricular tachycardia (SVT)
- xerostomia
Cetirizine; Pseudoephedrine (Zyrtec-D) Adverse Reactions
NOTE: This monograph discusses the adverse effects of cetirizine and pseudoephedrine combination products for the relief of nasal congestion, and allergic rhinitis. Clinicians may wish to consult the individual cetirizine or pseudoephedrine drug monographs for more specific information.
Cetirizine is well tolerated, with discontinuation rates due to adverse events similar to placebo (roughly 2%). Cetirizine may cause drowsiness or sedation in some patients, although not as much as the traditional antihistamines. Compared to placebo (6.3%), cetirizine has been associated with dose-related somnolence or drowsiness (13.7%). One report has noted that cetirizine exhibits a higher incidence of sedation than fexofenadine or loratadine. Concurrent use with alcohol or other CNS depressants should be avoided. Fatigue and xerostomia, also dose-related, have been reported in roughly 5% of patients versus 2% taking placebo. Dizziness and pharyngitis occurred in 2% of patients, similar to placebo. Pseudoephedrine can also be associated with adverse CNS effects, including insomnia, nervousness or anxiety. At excessively high pseudoephedrine doses, seizures, hallucinations and psychosis may occur. Due to decreased elimination and potential pseudoephedrine drug accumulation, patients with renal failure may be at increased risk for drug-related toxicity, including neurotoxicity. The dosage of cetirizine; pseudoephedrine should be reduced in patients with renal impairment (see Dosage and Precautions). Elderly patients appear to be more sensitive to the CNS stimulation effects of pseudoephedrine and may have reduced elimination of cetirizine; pseudoephedrine due to age-related declines in renal function.
There have been a few reports of abnormalities in liver function tests (elevated hepatic enzymes) with the 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 of cetirizine: 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.
As with other sympathomimetics, cardiovascular adverse effects may occur during pseudoephedrine therapy including angina, cardiac arrhythmias (or arrhythmia exacerbation), hypertension, myocardial infarction, or stroke; these effects generally occur at excessive dosage or in patients at higher risk (see Contraindications). Pseudoephedrine and phenylephrine appear to have a lower propensity to cause hypertension and potential sequelae (e.g., stroke, hypertensive crisis, intracranial bleeding) compared to ephedrine or phenylpropanolamine. Well-controlled hypertensive patients receiving pseudoephedrine at recommended doses (240 mg/day PO) do not appear at high risk for significant elevations in blood pressure, however, increased blood pressure (especially systolic hypertension) has been reported in some patients. Although infrequent, cardiac arrhythmias secondary to pseudoephedrine may occur in the general population at therapeutic doses and include palpitations, premature ventricular contractions (PVCs), supraventricular tachycardia (SVT), and sinus tachycardia.
Ocular effects can occur with pseudoephedrine products. These can include increased intraocular pressure (ocular hypertension) and photophobia.
Pseudoephedrine also can produce GI and GU effects such as nausea/vomiting, anorexia, and dysuria. Ischemic colitis has been associated with the use of pseudoephedrine and may present with symptoms of abdominal pain and bloody diarrhea. Colitis may result from reversible splanchnic arterial vasoconstriction and may occur with acute or chronic use; the ischemic symptoms usually resolve upon discontinuation of pseudoephedrine.
Several significant dermatological reactions have been reported infrequently with pseudoephedrine use. These reactions include: fixed drug eruption or exanthema, contact dermatitis, and other rash (unspecified). In general, the onset of the skin reactions occurs within 24 hours of administration and resolves in 2 - 3 days following drug discontinuation.
[ Last revised: 5/7/2004 4:16:00 PM ]
References
. Coates ML, et al. Does pseudoephedrine increase blood pressure in patients with controlled hypertension? J Fam Pract 1995;40:22 - 6.
. Hannuksela M, Kalimo K, Lammintausta K, et al. Dose ranging study: cetirizine in the treatment of atopic dermatitis in adults. Ann Allergy 1993;70:127 - 33.
. Chua SS, Benrimoj SI. Non-prescription sympathomimetic agents and hypertension. Med Toxicol Adverse Drug Exp 1988;3:387 - 417.
. Lyon CC, Turney JH. Pseudoephedrine toxicity in renal failure. Br J Clin Pract 1996;50:396 - 7.
. Sica DA, Comstock TJ. Pseudoephedrine accumulation in renal failure. Am J Med Sci 1989;298:261 - 3.
. Mann RD. Pearce GL, Dunn N et al. Sedation with “non-sedating” antihistamines: four prescription-event monitoring studies in general practice. BMJ 2000;320:1184 - 6.
. Beck RA, Mercado DL, Seguin SM, et al. Cardiovascular effects of pseudoephedrine in medically controlled hypertensive patients. Arch Intern Med 1992;152:1242 - 5.
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