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Adverse Events

In clinical trials, the overall incidence of adverse events in patients receiving KUVAN® was similar to that reported with patients receiving placebo.1



Adverse Events1

Clinical trials found that the most commonly reported adverse reactions in patients receiving KUVAN® were headache, upper respiratory tract infection, and rhinorrhoea. Other side effects included pharyngolaryngeal pain, diarrhoea, vomiting, rash, dyspepsia, gastritis, nausea, oesophageal pain, oropharyngeal pain, pharyngitis, and oesophagitis.

In a clinical trial involving children who were treated with KUVAN®, the most commonly reported adverse reactions were hypophenylalaninaemia, vomiting, and rhinitis.

Please refer to KUVAN® Product Information for more information.

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