Applies to tirzepatide: subcutaneous solution.

Cardiovascular

In pooled placebo-controlled trials, treatment with this drug resulted in a mean increase in heart rate of 2 to 4 beats per minute compared to a mean increase of 1 beat per minute in placebo-treated patients. Episodes of sinus tachycardia (associated with a concomitant increase from baseline in heart rate of at least 15 beats per minute) were reported in up to 23% of patients. The clinical relevance of increased heart rate was uncertain.^[Ref]

Very common (10% or more): Sinus tachycardia (up to 23%)

Frequency not reported: Increased heart rate^[Ref]

Gastrointestinal

In pooled placebo-controlled trials, treatment with this drug resulted in mean increases from baseline in serum pancreatic amylase levels of up to 38% and serum lipase levels of up to 42%; placebo-treated patients had a mean increase from baseline in pancreatic amylase of 4% and no changes were observed in lipase. The clinical significance of elevations in lipase or amylase with this drug was unknown without other signs/symptoms of pancreatitis.^[Ref]

Very common (10% or more): Nausea (up to 18%), diarrhea (up to 17%)

Common (1% to 10%): Vomiting, constipation, dyspepsia, abdominal pain, eructation, flatulence, gastroesophageal reflux disease, abdominal distension

Frequency not reported: Acute pancreatitis, increased serum pancreatic amylase levels, increased serum lipase levels^[Ref]

Hepatic

Uncommon (0.1% to 1%): Acute gallbladder disease (cholelithiasis, biliary colic, cholecystectomy)^[Ref]

Hypersensitivity

Common (1% to 10%): Hypersensitivity reactions (e.g., urticaria, eczema)^[Ref]

Immunologic

Very common (10% or more): Anti-drug antibodies (up to 51%)

Common (1% to 10%): Neutralizing antibodies^[Ref]

Local

Common (1% to 10%): Injection site reactions^[Ref]

Metabolic

Very common (10% or more): Hypoglycemia (up to 19%), decreased appetite (up to 11%)^[Ref]

Hypoglycemia (glucose level less than 54 mg/dL) was more frequent when this drug was used in combination with a sulfonylurea and occurred in up to 13% of patients in a clinical trial; severe hypoglycemia occurred in up to 6% of patients.^[Ref]

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