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Frontiers in pharmacology, 10, 1328

Gastrointestinal Very common (10% or more): Gastrointestinal adverse reactions (up to 73%), nausea (up to 44%), vomiting (up to 36%), diarrhea (up to 30%), constipation (up to 24.2%), abdominal pain (up to 20%) Common (1% to 10%): Dyspepsia, abdominal distension, eructation, flatulence, gastroenteritis, gastroesophageal reflux disease, gastritis, viral gastroenteritis, increased amylase, increased lipase, dry mouth, severe gastrointestinal adverse reactions, delayed gastric emptying Uncommon (0.1% to 1%): Acute pancreatitis, appendicitis Frequency not reported : Hemorrhoids, hiccups Postmarketing reports : Ileus, intestinal obstruction, severe constipation, hiccups, acute pancreatitis, necrotizing pancreatitis In clinical trials in adults using the subcutaneous injection for weight reduction, 73% of treated patients reported gastrointestinal adverse reactions, including severe reactions (4.1%)

Novo Nordisk declined to explain the timing of these submissions, but a spokesperson said the company is committed to addressing all the reporting issues found during last years FDA inspection of Novo Nordisk facilities and mentioned again in this new warning letter