Analysis of Tirzepatide-Linked Side Effects Reported to the FDA

A total of 8,096 adverse events were associated with tirzepatide use from a dataset of 638,153 reported events.

• Tirzepatide was linked to 98 preferred terms identified as positive signals for adverse events.
• Commonly reported expected adverse events included injection site pain, nausea, injection site hemorrhage, diarrhea, and vomiting.
• Unexpected adverse events frequently included incorrect doses, off-label use, extra doses, inappropriate administration schedules, and increased blood glucose.
• The findings highlight the potential for novel adverse event signals associated with tirzepatide use.
• Real-world disproportionality analysis is emphasized as a vital tool for assessing the safety profile of new medications.

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