vibegron
Obgemsa · ATC code G04BD15
- Key facts
- Active substance
- vibegron
- ATC code
- G04BD15
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Obgemsa 75 mg film-coated tablets
- Marketing authorisation holder
- Pierre Fabre Medicament
- Information as of
- 2026-10-28
Key facts
Vibegron is a selective beta-3 adrenergic receptor agonist that relaxes the bladder muscle during filling. It is used in adults with overactive bladder.
What it is used for
- See the full official text for the authorised indication.
Dosing
- Obgemsa (75 mg film-coated tablets): recommended dose 75 mg once daily, with or without food, swallowed with a glass of water.
- The tablet may also be crushed, mixed with a tablespoon (approximately 15 mL) of soft food (e.g. applesauce) and taken immediately with water.
- Mild, moderate or severe renal impairment not requiring dialysis: no adjustment; end-stage renal disease (GFR < 15 mL/min): not recommended.
- Mild to moderate hepatic impairment: no adjustment; severe hepatic impairment (Child-Pugh C): not recommended.
- No dose adjustment with CYP3A/P-gp inhibitors or inducers.
Contraindications
- Hypersensitivity to the active substance or to any of the excipients.
Important warnings
- Urinary retention has been reported; the risk is higher with bladder outlet obstruction and with concomitant antimuscarinics. Monitor for signs of urinary retention before and during treatment; discontinue if it develops.
- Not for patients with rare hereditary galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.
Side effects
- Most frequent: urinary tract infection (6.6%), headache (5.0%), diarrhoea (3.1%) and nausea (3.0%).
- Also common: constipation and residual urine volume increased; uncommon hot flush, rash and urinary retention.
Interactions
- Digoxin: levels may rise; monitor serum digoxin and titrate the dose accordingly. Consider possible P-gp interaction with sensitive narrow-therapeutic-index P-gp substrates.
- Antimuscarinics: increased risk of urinary retention.
Pregnancy and breastfeeding
- Not recommended during pregnancy or in women of childbearing potential not using contraception; stop when pregnancy is planned or diagnosed.
- Should not be used during breast-feeding.
Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
This product has no separate US patient information.
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
- ObgemsaPierre Fabre Medicament · EMEA/H/C/005957
Source: European Medicines Agency (EMA), product information
Brand names in 3 more European countries
- Iceland
- Obgemsa
- Liechtenstein
- Obgemsa
- Norway
- Obgemsa
EMA – Article 57 product data (EU/EEA), 2026-10-29
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
Other substances in the same group
Another question about this substance?
Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- European Medicines Agency. Obgemsa – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/obgemsa-epar-product-information_en.pdf
Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.