Azatadine / pseudoephedrine Side Effects
Applies to azatadine/pseudoephedrine: oral tablet extended release
Nervous system side effects have commonly occurred with azatadine administration, resulting in drowsiness in most patients. Azatadine has also caused dizziness and disrupted coordination.
Pseudoephedrine has produced nervous system stimulation, resulting in tremor, anxiety, and nervousness. Insomnia has been reported in up to 30% of pseudoephedrine-treated patients. Headache has also occurred in patients receiving pseudoephedrine.[Ref]
Nearly all patients treated with azatadine experience drowsiness. This drowsiness may subside in some patients with extended use. Patients should be warned against driving, as well as concomitant ingestion of alcohol and other sedative-hypnotic drugs, while taking azatadine.
At higher than normal doses of azatadine, dystonic reactions have occurred.[Ref]
Gastrointestinal side effects from azatadine have included dry mouth and constipation due to its anticholinergic effects. Patients have also experienced epigastric distress and nausea. Increased appetite has been reported with azatadine use.
Pseudoephedrine has caused anorexia and gastric irritation in approximately 5% of patients. Dry mouth, nose, or throat has occurred in up to 15% of patients.[Ref]
Cardiovascular side effects of pseudoephedrine have included significant increases in heart rate. Hypertension and arrhythmias have occurred in susceptible patients. Azatadine has rarely caused hypotension, tachycardia, and palpitations.[Ref]
Pseudoephedrine causes vasoconstriction which generally does not produce hypertension, but may be problematic for patients with preexisting hypertension. Arrhythmias may be produced in predisposed patients. Rarely, pseudoephedrine has been reported to cause coronary artery spasm and chest pain.[Ref]
Ocular side effects of azatadine have included blurred vision, diplopia, and dry eyes due to its anticholinergic effect.[Ref]
Genitourinary tract side effects have included dysuria, urinary hesitancy, decrease in urine flow, and, in rare cases, acute urinary retention. These effects may be due to azatadine's anticholinergic effect.[Ref]
Respiratory side effects have included thickening of bronchial secretions.[Ref]
Hypersensitivity reactions to azatadine or pseudoephedrine have occurred. Fixed drug eruptions secondary to pseudoephedrine have been reported.[Ref]
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Some side effects may not be reported. You may report them to the FDA.