Age Restrictions for Semaglutide Use

Semaglutide is approved for use only in adults 18 years of age and older, and should not be used in pediatric patients under 18 years. 1, 2

Adult Use (18+ years)

Semaglutide is FDA-approved for adults 18 years and older with obesity or overweight with weight-related complications 2
Clinical trials consistently included adult participants with a minimum age of 18 years 2
Mexican clinical practice guidelines specifically address GLP-1 agonist use (including semaglutide) only in "adults 18 years of age or older" with overweight or obesity 2
FDA labeling explicitly states "Safety and efficacy of OZEMPIC have not been established in pediatric patients (younger than 18 years)" 1

No upper age limit exists for semaglutide use, but considerations differ by age group 2, 3
Older adults (65+ years) were well-represented in clinical trials with 23.6% of participants being 65 years or older 1
In the SUSTAIN 6 cardiovascular outcome trial, 48% of semaglutide-treated patients were 65 years or older 1
FDA labeling notes: "No overall differences in safety or efficacy were detected between these [older] patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out" 1
Real-world data suggests that while semaglutide remains effective in older populations, those ≥75 years may have:
- Higher risk of excessive HbA1c reduction when used with insulin or insulin secretagogues 3
- Higher rates of medication discontinuation due to adverse events 3

While the STEP TEENS study investigated semaglutide for obesity in teenagers and showed efficacy for weight loss (17% decrease in BMI compared to placebo), this has not yet led to FDA approval for this age group 4
The drug remains officially unapproved for patients under 18 years 1

Semaglutide is contraindicated during pregnancy 1
Women should discontinue semaglutide at least 2 months before a planned pregnancy due to its long washout period 1
Common adverse effects include gastrointestinal disorders (particularly nausea), which occur in approximately 47% of patients 2
Serious adverse events are 38% more common with semaglutide versus placebo 2

When considering semaglutide for adults with obesity or type 2 diabetes, ensure the patient is at least 18 years old 2, 1
For older adults (especially those ≥75 years), monitor closely for:
- Potential hypoglycemia if used with insulin or insulin secretagogues 3
- Gastrointestinal adverse events that may lead to discontinuation 3
Despite promising research in adolescents, use in patients under 18 years should be limited to research settings only 1, 4