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Oxytrol

"April 9, 2012 -- Drugs that treat incontinence caused by an overactive bladder offer modest benefits to some women, and they often come with significant side effects, a new review of research shows.

The government-funded review compar"...

Oxytrol

Oxytrol Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Oxytrol (oxybutynin transdermal) is used to treat symptoms of overactive bladder, such as frequent or urgent urination, incontinence (urine leakage), and increased nighttime urination. It is an antispasmodic. Common side effects include skin redness/itching/irritation at the application site, dry mouth, drowsiness, dizziness, blurred vision, headache, weakness, nausea or constipation.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Oxytrol in Detail - Patient Information: Side Effects

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) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Oxytrol Overview - Patient Information: Side Effects

SIDE EFFECTS: Skin redness/itching/irritation at the application site, dry mouth, drowsiness, dizziness, blurred vision, headache, weakness, nausea or constipation may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To relieve dry mouth, suck (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water or use a saliva substitute.

To prevent constipation, eat a diet adequate in fiber, drink plenty of water, and exercise. If you become constipated while using this drug, consult your pharmacist for help in selecting a laxative.

If your doctor has directed you to use this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: vision problems, difficulty urinating, signs of kidney infection (such as burning/painful/frequent urination, lower back pain), fast/irregular heartbeat, mental/mood changes (such as confusion), fever, flushed/hot/dry skin.

Get medical help right away if you have any very serious side effects, including: eye pain, signs of stomach/intestinal blockage (such as severe stomach pain, persistent nausea/vomiting, severe constipation).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Oxytrol (Oxybutynin Transdermal)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Oxytrol FDA Prescribing Information: Side Effects
(Adverse Reactions)

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 6.10% 21 16.80%
Dry mouth 11 8.30% 12 9.60%
Application site erythema 3 2.30% 7 5.60%
Application site vesicles 0 0.00% 4 3.20%
Diarrhea 3 2.30% 4 3.20%
Dysuria 0 0.00% 3 2.40%

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 4.30% 17 14.00%
Application site erythema 2 1.70% 10 8.30%
Dry mouth 2 1.70% 5 4.10%
Constipation 0 0.00% 4 3.30%
Application site rash 1 0.90% 4 3.30%
Application site macules 0 0.00% 3 2.50%
Abnormal vision 0 0.00% 3 2.50%

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.

In a controlled clinical trial of skin sensitization, none of the 103 test subjects demonstrated skin hypersensitivity to OXYTROL.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of OXYTROL: dizziness and somnolence. 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.

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

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Oxytrol - User Reviews

Oxytrol User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Oxytrol sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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