Aerius D-12 Adverse Reactions

The safety of AERIUS D-12 Tablets was studied in 414 patients who received AERIUS D-12 Tablets twice daily for up to two weeks. The majority of adverse events that occurred following treatment with AERIUS D-12 Tablets were similar in type and frequency to those observed in patients treated with pseudoephedrine alone. Treatment related adverse events reported by ≥ 2% of patients are listed in Table 1. (See Table 1.)

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The following spontaneous adverse events have been reported during the marketing of desloratadine as a single ingredient product: hypersensitivity reactions (including anaphylaxis and rash), tachycardia, palpitations, psychomotor hyperactivity, seizures and elevated liver enzymes (including bilirubin and hepatitis), and increased appetite have been reported very rarely.
Cases of severe skin reactions such as acute generalized exanthematous pustulosis (AGEP) have been reported with pseudoephedrine-containing products.