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Wegovy Side Effects Severity Distribution by Patient Phenotype

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At a glance

  • Severity by adult age, sex or BMI / not tabulated in the label [1]
  • Severe GI reactions, adults / 4.1% on 2.4 mg vs 0.9% placebo [1]
  • Stopped for adverse reactions / 6.8% vs 3.2% (2,116 vs 1,261 adults) [1]
  • Any GI reaction / 73% vs 47% placebo [1]
  • Nausea / 44% vs 16% placebo [1]
  • Vomiting, 7.2 mg vs 2.4 mg / 22% vs 16% [1]
  • Hair loss, 7.2 mg arm / 8.4% of women vs 0.2% of men [1]
  • GI events in type 2 diabetes (STEP 2) / 63.5% vs 34.3% placebo [2]

What the label separates out

The pooled adult safety data cover 2,116 adults on Wegovy 2.4 mg weekly for up to 68 weeks and 1,261 on placebo; mean age was 48, 71% were female and 19% had type 2 diabetes [1]. Any gastrointestinal reaction occurred in 73% versus 47%; nausea 44% versus 16%, diarrhea 30% versus 16%, vomiting 24% versus 6% [1].

Beyond that pooled table, the label separates rates by dose (2.4 mg versus 7.2 mg), by diabetes status, by age group (adults versus ages 12 and older) and by formulation (injection versus tablets) [1].

How often reactions are severe

Severe gastrointestinal reactions were reported in 4.1% of adults on the injection versus 0.9% on placebo, and in 2% versus 0% on the tablets [1]. Permanent discontinuation is the other marker: 6.8% versus 3.2%, most often for nausea (1.8% versus 0.2%), vomiting (1.2% versus 0%) and diarrhea (0.7% versus 0.1%) [1].

Dose, diabetes and age group

Two 72-week trials compared 7.2 mg with 2.4 mg and placebo in 1,311, 304 and 303 adults with obesity: nausea 39%, 35% and 13%; vomiting 22%, 16% and 6%; dysesthesia (altered skin sensation such as burning or pain from touch) 22%, 6% and 0% [1]. Treatment was stopped for GI reasons in 3%, 3% and 0.3%, and the label states 18% of those with dysesthesia on 7.2 mg had not recovered by trial end [1]. Escalation is built into the schedule: 0.25 mg for weeks 1 to 4, then 0.5, 1 and 1.7 mg at four-week steps, reaching 2.4 mg from week 17 [1].

In STEP 2, GI adverse events occurred in 63.5% of adults with type 2 diabetes on semaglutide 2.4 mg versus 34.3% on placebo (1,210 adults), and glucose below 54 mg/dL in 6.2% versus 2.5% [2][1]. In adolescents aged 12 and older, vomiting was 36% versus 10% and cholelithiasis 3.8% versus 0% [1].

The one sex-specific figure

Hair loss was 6%, 3% and 1% at 7.2 mg, 2.4 mg and placebo, and within the 7.2 mg arm it was reported by 8.4% of women and 0.2% of men [1].

Frequently asked questions

Which patients have the worst Wegovy side effects?
The label does not rank patients that way. It reports rates by dose, diabetes status, age group and formulation: vomiting was 22% on 7.2 mg versus 16% on 2.4 mg, and vomiting in adolescents aged 12 and older was 36% versus 10% on placebo [1].
Are Wegovy side effects worse at higher doses?
For several reactions, yes. In two 72-week trials nausea was 39% on 7.2 mg, 35% on 2.4 mg and 13% on placebo; vomiting 22%, 16% and 6%; dysesthesia 22%, 6% and 0%. The label states dysesthesia increases with dose [1].
What percentage stop Wegovy because of side effects?
In the pooled adult trials, 6.8% on 2.4 mg stopped versus 3.2% on placebo, most often for nausea (1.8% versus 0.2%), vomiting (1.2% versus 0%) and diarrhea (0.7% versus 0.1%) [1]. In the 7.2 mg trials the figures were 5%, 5% and 2% [1].

References

  1. U.S. National Library of Medicine, DailyMed. Wegovy injection and Wegovy tablets (Novo Nordisk) prescribing information. Wegovy injection and Wegovy tablets (Novo Nordisk) label
  2. Davies M, Færch L, Jeppesen OK, Pakseresht A, Pedersen SD, Perreault L, et al. Semaglutide 2·4 mg once a week in adults with overweight or obesity, and type 2 diabetes (STEP 2): a randomised, double-blind, double-dummy, placebo-controlled, phase 3 trial. Lancet. 2021;397(10278):971-984. Semaglutide 2·4 mg once a week in adults with overweight or obesity, and type 2 diabetes (STEP 2): a randomised, double-blind, double-dummy, placebo-controlled, phase 3 trial
Evidence overview for Wegovy Side Effects Severity Distribution by Patient Phenotype