ONGLYZA® (saxagliptin)

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Onglyza: Summary of adverse reactions from clinical trial and post-marketing data1

Most common adverse reactions1

Summary of adverse reactions
Summary of adverse reactions

Post-marketing experience

During post-marketing experience the following adverse reactions have been reported: hypersensitivity reactions (uncommon), anaphylactic reactions including anaphylactic shock (rare), angioedema (rare), dermatitis (uncommon), pruritis (uncommon), rash (common), urticaria (uncommon), diarrhoea (common), nausea (common), abdominal pain (common) and pancreatitis (uncommon). If pancreatitis or a serious hypersensitivity reaction to Onglyza is suspected, discontinue Onglyza. Please consult the SmPC for further information.

Contraindications

Hypersensitivity to the active substance or to any of the excipients, or history of a serious hypersensitivity reaction, including anaphylactic reaction, anaphylactic shock, and angioedema, to any dipeptidyl peptidase 4 (DPP-4) inhibitor. 

*Frequency of hypoglycaemia shown is based on treatment regimens where Onglyza is used in combination with a sulphonylurea, metformin plus a sulphonylurea, and when used with insulin (+/- metformin).
Only in initial combination with metformin (Onglyza is not indicated for use in initial combination therapy with metformin).
Peripheral oedema seen when used in combination with thiazolidinedione. All of the reported drug reactions of peripheral oedema were of mild to moderate intensity and none resulted in study drug discontinuation.

1. ONGLYZA® Summary of Product Characteristics. http://www.medicines.org.uk/emc/medicine/22315 (Last accessed August 2017).