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Oxytrol

Last reviewed on RxList: 8/26/2015
Oxytrol Side Effects Center

Last reviewed on RxList 02/09/2017

Oxytrol (oxybutynin transdermal) is an antispasmodic used to treat symptoms of overactive bladder, such as frequent or urgent urination, incontinence (urine leakage), and increased nighttime urination. Common side effects of Oxytrol include:

  • skin redness/itching/irritation/burning/ discoloration where the patch was worn,
  • dry mouth,
  • drowsiness,
  • dizziness,
  • blurred vision,
  • dry eyes,
  • headache,
  • weakness,
  • nausea,
  • vomiting,
  • stomach pain,
  • diarrhea,
  • constipation,
  • stuffy nose,
  • back pain,
  • restlessness,
  • sleep problems (insomnia), or
  • warmth, tingling, or redness under your skin.

Tell your doctor if you have serious side effects of Oxytrol including:

The dose of Oxytrol is one 3.9 mg/day system applied twice weekly (every 3 to 4 days). Oxytrol may interact with atropine, belladonna, clidinium, dicyclomine, glycopyrrolate, hyoscyamine, mepenzolate, methantheline, methscopolamine, propantheline, scopolamine, or antibiotics. Tell your doctor all medications you use. Oxytrol should be used only when prescribed during pregnancy. It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Our Oxytrol (oxybutynin transdermal) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Oxytrol Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using oxybutynin transdermal and call your doctor at once if you have a serious side effect such as:

  • fever with hot, dry skin;
  • uneven heart rate;
  • pain or burning when you urinate;
  • urinating less than usual or not at all; or
  • severe itching, burning, or blistering that does not clear up within several hours after removing the skin patch.

Less serious side effects may include:

  • mild skin itching, burning, redness, or discoloration where a patch was worn;
  • dizziness, drowsiness, weakness;
  • dry eyes, blurred vision;
  • dry mouth;
  • warmth, tingling, or redness under your skin;
  • nausea, vomiting, stomach pain;
  • constipation or diarrhea;
  • stuffy nose;
  • back pain;
  • feeling restless; or
  • sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Oxytrol (Oxybutynin Transdermal)

Oxytrol Professional Information

SIDE EFFECTS

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 group (Study 1).

Adverse Reaction Placebo
(N = 132)
OXYTROL (3.9 mg/day)
(N = 125)
N % N %
Application site pruritus 8 6.1% 21 16.8%
Dry mouth 11 8.3% 12 9.6%
Application site erythema 3 2.3% 7 5.6%
Application site vesicles 0 0.0% 4 3.2%
Diarrhea 3 2.3% 4 3.2%
Dysuria 0 0.0% 3 2.4%

Table 2: Number (%) of adverse reactions occurring in ≥ 2% of OXYTROL-treated patients and greater in the OXYTROL group than in the placebo group (Study 2).

Adverse Reaction Placebo
(N = 117)
OXYTROL (3.9 mg/day)
(N = 121)
N % N %
Application site pruritus 5 4.3% 17 14.0%
Application site erythema 2 1.7% 10 8.3%
Dry mouth 2 1.7% 5 4.1%
Constipation 0 0.0% 4 3.3%
Application site rash 1 0.9% 4 3.3%
Application site macules 0 0.0% 3 2.5%
Abnormal vision 0 0.0% 3 2.5%

Most adverse reactions were described as mild or moderate in intensity. Severe application site reactions were reported by 6.4% of OXYTROL-treated patients in Study 1 and by 5.0% of OXYTROL-treated patients in Study 2.

Adverse reactions that resulted in discontinuation were reported by 11.2% of OXYTROL-treated patients in Study 1 and 10.7% of OXYTROL-treated patients in Study 2. Most of these discontinuations were due to application site reaction. In the two pivotal studies, no patient discontinued OXYTROL treatment due to dry mouth.

In the open-label extension, the most common treatment-related adverse reactions were: application site pruritus, application site erythema, and dry mouth.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of OXYTROL. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Nervous System Disorders: dizziness, somnolence, confusion

Psychiatric Disorders: hallucinations

Read the entire FDA prescribing information for Oxytrol (Oxybutynin Transdermal)

Related Resources for Oxytrol

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© Oxytrol Patient Information is supplied by Cerner Multum, Inc. and Oxytrol Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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