Oxybutynin is a cholinergic muscarinic antagonist sold in the U.S. under 2 brand and generic names, for neurogenic urinary bladder, urinary incontinence and dysuria. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Oxytrol (application NDA021351). Other oxybutynin products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
OXYTROL 3.9 mg/day should be applied to dry, intact skin on the abdomen, hip, or buttock twice weekly (every 3 or 4 days). A new application site should be selected with each new transdermal system to avoid re-application to the same site within 7 days. Do not divide or cut the transdermal system into pieces. Do not use if the transdermal system is damaged. Apply OXYTROL transdermal system twice weekly (every 3 to 4 days) to dry, intact skin on the abdomen, hip, or buttocks. ( 2 ) Select a new application site with each new transdermal system to avoid re-application to the same site within 7 days. ( 2 ) Do not divide or cut the transdermal system into pieces. Do not use if the transdermal system is damaged.
The most common adverse reactions (incidence > 5% and > placebo) are application site reactions and dry mouth. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie, Inc. at 1-800-678-1605 or contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety of OXYTROL was evaluated in a total of 417 patients who participated in two clinical efficacy and safety studies and an open-label extension. Additional safety information was collected in earlier phase trials. In the two pivotal studies, a total of 246 patients received OXYTROL during the 12-week treatment periods. A total of 411 patients entered the open-label extension and of those, 65 patients and 52 patients received OXYTROL for at least 24 weeks and at least 36 weeks, respectively. No deaths were reported during treatment. No serious adverse events related to treatment were reported. Adverse reactions reported in the pivotal trials are summarized in Tables 1 and 2 below. Table 1: Number (%) of adverse reactions occurring in ≥ 2% of OXYTROL-treated patients and greater in the OXYTROL group than in the placebo…
The use of OXYTROL is contraindicated in the following conditions: Urinary retention Gastric retention Uncontrolled narrow-angle glaucoma Known serious hypersensitivity reaction to OXYTROL, oxybutynin, or to any of the components of OXYTROL [ see Warnings and Precautions (5.5) ] . Urinary retention ( 4 ) Gastric retention ( 4 ) Uncontrolled narrow-angle glaucoma ( 4 ) Known serious hypersensitivity reaction to OXYTROL, oxybutynin, or to any of the components of OXYTROL ( 4 )
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
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| 1 | 70/100 | Prescription | Patch | Generic | $1 | View → | |
| 2 | 70/100 | Over-the-counter | Patch | Generic |
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| 913 | 5 mg | white | round | — |
| 0B2 | 10 mg | pink | round | — |
| EM1 | 5 mg | yellow | round | — |
| OB5 | 5 mg | blue | round | — |
| KU;271 | 10 mg | white | round | — |
| KU;270 | 5 mg | white |
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
No specific drug-drug interaction studies have been performed with OXYTROL. Other Anticholinergics (muscarinic antagonists): Concomitant use with other anticholinergic agents may increase the frequency and/or severity of dry mouth, constipation, blurred vision, and other anticholinergic pharmacological effects. ( 7.1 ) 7.1 Other Anticholinergics The concomitant use of OXYTROL with other anticholinergic drugs, or with other agents that produce dry mouth, constipation, somnolence, and/or other anticholinergic-like effects may increase the frequency and/or severity of such effects. Anticholinergic agents may potentially alter the absorption of some concomitantly administered drugs due to anticholinergic effects on gastrointestinal motility. 7.2 Cytochrome P450 Inhibitors Pharmacokinetic studies have not been performed with patients concomitantly receiving cytochrome P450 enzyme inhibitors, such as antimycotic agents (e.g., ketoconazole, itraconazole, and miconazole) or macrolide antibiotics (e.g., erythromycin and clarithromycin).
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