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Two medicines, side by side

Mirabegron vs tolterodine

Mirabegron and tolterodine are both labeled for overactive bladder. Drugs@FDA records approvals of mirabegron since 2012 and of tolterodine since 1998. Pharmacies paid $9.39 per mirabegron ER 50 mg tablet and $0.268 per tolterodine tart ER 2 mg capsule (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. In FDA's classes, mirabegron is a beta3-adrenergic agonist and tolterodine a cholinergic muscarinic antagonist.

Check it at the source: the mirabegron FDA label on DailyMed (effective December 24, 2025); the tolterodine FDA label on DailyMed (effective February 9, 2026).

Highlights of the mirabegron record

Mirabegron (Myrbetriq) · label of December 24, 2025

Used for

From the label: indications

Mirabegron extended-release tablets are beta-3 adrenergic agonist indicated for the treatment of: Overactive bladder (OAB) in adult patients with symptoms of urge urinary incontinence, urgency, and urinary frequency. […]

On the market

Earliest approval on file
June 28, 2012
Generic labelers
8 labelers
Pharmacy cost
$9.39 per tablet

Supply and safety

Shortage
No current entry
Recalls
1

Highlights of the tolterodine record

Tolterodine (Detrol) · label of February 9, 2026

Used for

From the label: indications

Tolterodine tartrate extended-release capsules are an antimuscarinic indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. ( 1 ) Tolterodine tartrate extended-release capsules are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency [ see CLINICAL STUDIES ( 14 ) ].

On the market

Earliest approval on file
March 25, 1998
Generic labelers
14 labelers
Pharmacy cost
$0.268 per capsule

Supply and safety

Shortage
No current entry
Recalls
4

Source: FDA drug labels via openFDA (Mirabegron label of December 24, 2025, Tolterodine label of February 9, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)

How do mirabegron and tolterodine differ on the record?

In FDA's classes, mirabegron is a beta3-adrenergic agonist and tolterodine a cholinergic muscarinic antagonist.

Generics: mirabegron since 2019; tolterodine since 2012 (Drugs@FDA).

MirabegronTolterodine
Labeled forOveractive bladderOveractive bladder
Pharmacologic classbeta3-Adrenergic AgonistCholinergic Muscarinic Antagonist
How it works (label)Mirabegron is an agonist of the human beta-3 adrenergic receptor (AR) as demonstrated by in vitro laboratory experiments using the cloned human beta-3 AR.n/a
Half-life (label)Elimination Mirabegron Extended-Release Tablets Monotherapy for Adult OAB: The terminal elimination half-life (t 1/2 ) of mirabegron is approximately 50 hours in patients.n/a
Earliest approval on file (Drugs@FDA)June 28, 2012March 25, 1998
First generic approvedDecember 27, 2019September 25, 2012
Generic labelers (NDC)8 labelers14 labelers
Pharmacy cost (NADAC, each one's most listed form; strengths differ)$9.39 per tablet (Mirabegron ER 50 mg tablet)$0.268 per capsule (Tolterodine tart ER 2 mg capsule)
12-month price change-2%-27%
Boxed warningNoNo
Shortage nowNo current entryNo current entry
Recalls recorded14
FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used)38,46612,383
DEA schedulenonenone

Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)

What do the labels say about using others of their kind?

Tolterodine label, drug interactions

Concomitant use with other anticholinergic agents may increase the frequency and/or severity of dry mouth, constipation, blurred vision, and other anticholinergic pharmacological effects.

Source: FDA drug labels via openFDA

What next?

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