Safety and tolerability: Possible side effects

Summary of the safety profile

In five large long-term clinical phase 3a trials over 2,500 adult patients have received treatment with liraglutide alone or in combination with metformin, a sulfonylurea (with or without metformin) or metformin plus rosiglitazone. The most frequently reported adverse reactions during clinical trials were gastrointestinal disorders: nausea and diarrhoea were very common, whereas vomiting, constipation, abdominal pain, and dyspepsia were common. At the beginning of the therapy, these gastrointestinal adverse reactions may occur more frequently. These reactions usually diminish within a few days or weeks on continued treatment.¹

Headache and nasopharyngitis were also common. Furthermore, hypoglycaemia was common, and very common when liraglutide is used in combination with a sulfonylurea. Severe hypoglycaemia has primarily been observed when combined with a sulfonylurea.¹

Table 1 lists adverse reactions reported in long-term phase 3a controlled trials, the LEADER trial (a long-term cardiovascular outcome trial) and spontaneous (post-marketing) reports. Frequencies for all events have been calculated based on their incidence in phase 3a clinical trials¹

For further information on the description and incidence of adverse events within these trials, please refer to section 4.8 of the SmPC.¹