Zincretin 50/Zincretin 100 Adverse Reactions

Summary of the safety profile: Occurrences of pancreatitis and hypersensitivity reactions have been reported as serious adverse events. Hypoglycemia have been reported, especially in cases where sitagliptin is co-administered with sulphonylurea (ranging from 4.7% to 13.8%) and insulin (9.6%).
Tabulated list of adverse reactions: Adverse reactions are listed as follows (see Table) by system organ class and frequency. Frequencies are defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from the available data). (See Table.)

Click on icon to see table/diagram/image

Description of selected adverse reactions: In addition to the drug-related adverse experiences described previously, adverse experiences reported regardless of causal relationship to medication and occurring in at least 5% and more commonly in patients treated with sitagliptin included upper respiratory tract infection and nasopharyngitis. Additional adverse experiences reported regardless of causal relationship to medication that occurred more frequently in patients treated with sitagliptin (not reaching the 5% level, but occurring with an incidence of >0.5% higher with sitagliptin than that in the control group) included osteoarthritis and pain in extremity.
Some adverse reactions were observed more frequently in studies of combination use of sitagliptin with other anti-diabetic medicinal products than in studies of sitagliptin monotherapy. These included hypoglycaemia (frequency very common with the combination of sulphonylurea and metformin), influenza [common with insulin (with or without metformin)], nausea and vomiting (common with metformin), flatulence (common with metformin or pioglitazone), constipation (common with the combination of sulphonylurea and metformin), peripheral oedema (common with pioglitazone or the combination of pioglitazone and metformin), somnolence and diarrhoea (uncommon with metformin), and dry mouth [uncommon with insulin (with or without metformin)].
Paediatric population: In clinical trials with sitagliptin in paediatric patients with type 2 diabetes mellitus aged 10 to17 years, the profile of adverse reactions was comparable to that observed in adults.