Side Effects of Gemtesa (Vibegron)
Gemtesa (vibegron) has a favorable side effect profile with the most common adverse reactions including headache, nasopharyngitis, diarrhea, nausea, and upper respiratory tract infection, occurring in ≥2% of patients. 1
Common Side Effects
- Headache (4.0% vs 2.4% for placebo) 1
- Nasopharyngitis/nasal congestion (2.8% vs 1.7% for placebo) 1
- Diarrhea (2.2% vs 1.1% for placebo) 1
- Nausea (2.2% vs 1.1% for placebo) 1
- Upper respiratory tract infection (2.0% vs 0.7% for placebo) 1
- Urinary tract infection (reported in long-term studies at 6.6%) 1
Less Common Side Effects (<2%)
- Gastrointestinal disorders:
- Urologic disorders:
- Vascular disorders:
- Hot flush 1
Long-Term Safety Profile
- In long-term studies (up to 52 weeks), vibegron maintained a favorable safety profile with the following additional adverse events reported: 2
- The incidence of dry mouth was notably lower with vibegron (1.8%) compared to antimuscarinic agents like tolterodine (5.2%) 2
Post-Marketing Adverse Events
The following adverse events have been reported in post-marketing surveillance: 1
Comparison to Other OAB Medications
- As a β3-adrenergic receptor agonist, vibegron has a more favorable side effect profile compared to antimuscarinic agents 3
- Unlike antimuscarinic medications, vibegron is associated with lower rates of: 4, 3
- Vibegron does not interact with cytochrome P450 enzymes, resulting in fewer drug interactions compared to other OAB medications 5
Special Considerations
- Drug interactions: Vibegron increases digoxin concentrations, requiring monitoring of serum digoxin levels when used concomitantly 1
- Elderly patients: Efficacy and safety profile maintained in patients ≥65 years of age 5
- Cardiovascular effects: Unlike some other OAB medications, vibegron has not been associated with clinically meaningful effects on blood pressure or heart rate in dedicated studies 3
Clinical Implications
- Vibegron represents a valuable treatment option for overactive bladder with a favorable side effect profile 3
- The low incidence of antimuscarinic-type side effects (dry mouth, constipation, cognitive effects) may improve medication adherence compared to traditional OAB treatments 5, 3
- The once-daily dosing regimen may enhance patient compliance 5
Vibegron's side effect profile makes it a particularly good option for patients who cannot tolerate the anticholinergic side effects of traditional OAB medications or who have concerns about potential cognitive effects of antimuscarinic agents 3.