Vibegron
ویبگرون
🚻 Genito Urinary System And Sex HormonesBeta-3 adrenergic agonist
Market / country: 🇺🇸 USA
Gemtesa (US)
🧮 Dose calculator
Overactive bladder · Regimen source: FDA Gemtesa · 2.1
- • With or without food; in adults may be crushed into applesauce. FDA Gemtesa · 2.1
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Hypersensitivity to vibegron (angioedema). FDA Gemtesa · 4
Warnings
- • Urinary retention (especially with outlet obstruction or with antimuscarinics); angioedema. FDA Gemtesa · 5
Formulations
- 75 mg tablet — tablet 🇺🇸 USA FDA Gemtesa · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Gemtesa · 8.1
“Risk Summary There are no available data on GEMTESA use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Gemtesa · 8.2
“Risk Summary There are no data on the presence of vibegron in human milk, the effects of the drug on the breastfed infant, or the effects on milk production.”
- 👶 ChildrenSafety not established
Label: safety and effectiveness in children have not been established. FDA Gemtesa · 8.4
“The safety and effectiveness of GEMTESA in pediatric patients have not been established.”
- 👴 Older adultsNo specific problem stated
Label: no specific difference or dose adjustment stated for older adults. FDA Gemtesa · 8.5
“No overall differences in safety or effectiveness of GEMTESA have been observed between patients 65 years of age and older and younger adult patients.”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)NDA213006
- DailyMed (FDA label)FDA Gemtesa
- MedlinePlus (NIH)Vibegron
- WHO ATC/DDDG04BD15
- Darooyab (Iran)❌ None
🇮🇷 Not found in Iran list Darooyab · search
Darooyab lists no registered dosage form or brand for this drug. This does not prove it is unavailable.
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Gemtesa · 3FDA Gemtesa · 2.1FDA Gemtesa · 4FDA Gemtesa · 5FDA Gemtesa · SPL approval / marketing categoryFDA Gemtesa · 8.1FDA Gemtesa · 8.2FDA Gemtesa · 8.4FDA Gemtesa · 8.5
- UK SmPC (eMC / MHRA)❌ Not present
- Published guideline❌ Not present
- Licensed reference (medical school)❌ Not present
- Iranian leaflet (IFDA)❌ Not present
- Pharmacy website (secondary, unreliable)✅ PresentDarooyab · search
- Clinical review⚠ Unverified