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Zepbound Side Effects: Severity Distribution by Patient Phenotype

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At a glance

  • Most common reactions / nausea, diarrhea, vomiting, constipation, dyspepsia [1]
  • Severe GI reactions / 1.7% (5 mg), 2.5% (10 mg), 3.1% (15 mg) vs 1% placebo [1]
  • Any GI reaction / 56% on every Zepbound dose vs 30% placebo [1]
  • Stopped for any adverse reaction / 4.8% (5 mg), 6.3% (10 mg), 6.7% (15 mg) vs 3.4% placebo [1]
  • Hair loss by sex / 7.1% women vs 0.5% men on Zepbound [1]
  • Severe gastroparesis / Zepbound is not recommended [1]
  • Maintenance doses / 5, 10 or 15 mg once weekly [1]

How severe are Zepbound side effects?

The label reports severe gastrointestinal adverse reactions in 1.7% of patients on 5 mg, 2.5% on 10 mg and 3.1% on 15 mg, versus 1% on placebo, in the pooled weight-reduction trials [1]. Overall GI reactions were much more common than severe ones: 56% at each Zepbound dose versus 30% on placebo [1]. The label says most nausea, vomiting and diarrhea occurred during dose escalation and decreased over time [1]. Stopping for any adverse reaction occurred in 4.8% (5 mg), 6.3% (10 mg) and 6.7% (15 mg) versus 3.4% on placebo; stopping for GI reasons was 1.9%, 3.3% and 4.3% versus 0.5% [1].

Which side effects are most common, and does dose change them?

Nausea: 25%, 29% and 28% at 5, 10 and 15 mg versus 8% placebo [1]. Diarrhea: 19%, 21% and 23% versus 8% [1]. Vomiting: 8%, 11% and 13% versus 2% [1]. Constipation: 17%, 14% and 11% versus 5% [1]. Dyspepsia: 9%, 9% and 10% versus 4% [1]. Injection-site reactions were 6%, 8% and 8% versus 2%; fatigue 5%, 6% and 7% versus 3%; hypersensitivity reactions 5%, 5% and 5% versus 3% [1]. Dose changes the picture unevenly: diarrhea and vomiting rise from 5 to 15 mg, nausea peaks at 10 mg (29%), and constipation is highest at 5 mg and lowest at 15 mg [1].

Is severity different by patient phenotype?

The main adverse-reaction table covers the pooled weight-trial population by dose, not by age, sex or body weight. That pool included adults with obesity or overweight, with or without type 2 diabetes; 25% had type 2 diabetes [1]. Hair loss is split by sex in the label: 7.1% of women versus 0.5% of men on Zepbound, and 1.3% of women versus 0% of men on placebo [1]. The label says hair loss was associated with weight reduction; no Zepbound patient stopped treatment for it, while one placebo patient did [1].

What serious risks does the label flag?

The label says Zepbound is not recommended in patients with severe gastroparesis [1]. It also warns about acute kidney injury from volume depletion and says renal function should be monitored in patients with reactions that could lead to volume depletion [1]. Severe GI reactions have also been reported postmarketing with GLP-1 receptor agonists [1].

Frequently asked questions

How common are severe GI side effects with Zepbound?
In pooled weight-reduction trials, severe GI reactions occurred in 1.7% of patients on 5 mg, 2.5% on 10 mg and 3.1% on 15 mg, versus 1% on placebo [1].
Are Zepbound side effects worse at higher doses?
Nausea, diarrhea and vomiting were generally more frequent at 10 and 15 mg than at 5 mg, and severe GI reactions rose from 1.7% at 5 mg to 3.1% at 15 mg [1]. Stopping for GI reasons was 1.9% at 5 mg, 3.3% at 10 mg and 4.3% at 15 mg versus 0.5% on placebo [1].
Does Zepbound hair loss differ between women and men?
Yes. Hair loss was reported in 7.1% of women and 0.5% of men on Zepbound, and in 1.3% of women and 0% of men on placebo; the label says it was associated with weight reduction [1].
Are side effects different in people with type 2 diabetes?
The Zepbound weight-trial pool included people with and without type 2 diabetes; 25% had type 2 diabetes, and the label reports one dose-based table for the pooled group [1].

References

  1. U.S. National Library of Medicine, DailyMed. Zepbound injection (tirzepatide) prescribing information. Zepbound injection (tirzepatide) label
Evidence overview for Zepbound Side Effects: Severity Distribution by Patient Phenotype