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Author: Admin | 2025-04-28
To 30%), vomiting (up to 24%), constipation (up to 24%), abdominal pain (up to 20%), Common (1% to 10%): Dyspepsia, eructation, flatulence, gastroesophageal reflux disease, abdominal distention, gastroenteritis, gastroesophageal reflux disease, gastritis, gastroenteritis (viral) Uncommon (0.1% to 1%): Appendicitis Frequency not reported: Acute and necrotizing pancreatitis, chronic pancreatitisIn clinical trials for type 2 diabetes, acute pancreatitis was confirmed by adjudication in 7 (0.3 cases per 100 patient years) and 8 patients (0.27 per 100 patient years) in 2 separate trials (compared to 3 and 10 placebo treated patients, respectively). One case of chronic pancreatitis was confirmed. In clinical trials for weight loss, 4 cases of acute pancreatitis were confirmed by adjudication (vs 1 placebo case). In weight loss trials, nausea, diarrhea, vomiting, constipation, and abdominal pain were reported more frequently than in clinical trials for type 2 diabetes.HypersensitivityRare (less than 0.1%): Anaphylactic reaction Frequency not reported: AngioedemaPostmarketing reports: Ananaphylaxis, rash, urticariaOcularCommon (1% to 10%): Diabetic retinopathy complicationsIn a 2-year trial among patients with type 2 diabetes and high cardiovascular risk, patients treated with this drug experienced a great incidence of diabetic retinopathy complications (3% vs 1.8%). The absolute risk was greater in patients with a history of diabetic retinopathy at baseline (8.2%[drug] vs 5.2%[placebo]) than those without (0.7%[drug] vs 0.4%[placebo]).MetabolicVery common (10% or more): Hypoglycemia (up to 30% when used in combination with basal insulin) Common (1% to 10%): Hypoglycemia, decreased appetite, weight lossIn the weight loss clinical trials, patients without type 2 diabetes experienced episodes of hypoglycemia.LocalCommon (1% to 10%): Injection site reactionsImmunologicFrequency not reported: Development of anti-semaglutide antibodiesAs with other protein and peptide pharmaceuticals, patients receiving this drug have developed anti-semaglutide antibodies. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay, as well as other factor in handling of the sample. For these reasons, the incidence of antibodies cannot be directly compared with other products. Anti-drug antibodies to semaglutide have been reported in up to 1% of patients during clinical trials.HepaticCommon (1% to 10%): Cholelithiasis Uncommon (0.1% to 1%): CholecystitisFrequency not reported: Acute gallbladder diseaseCholelithiasis has been reported in 1.5% and 0.4% of patients receiving 0.5 mg and 1 mg weekly, respectively.OtherVery common (10% or more): Fatigue (up to 11%)Fatigue was reported in greater than 0.4% of patients.Nervous systemVery common (10% or more): Headache (up to 14%)Common (1% to 10%): DizzinessUncommon (0.1% to 1%): DysgeusiaRenalPostmarketing reports: Acute kidney injury, worsening of
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