Gelnique

Gelnique Side Effects Center

Medical Editor: Charles Patrick Davis, MD, PhD

Gelnique (oxybutynin chloride 10%) Gel is a muscarinic antagonist and antispasmotic drug prescribed for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. Drug interactions occur with Gelnique gel and should be reviewed prior to taking this medication. Side effects may include but are not limited to dry mouth, constipation, tiredness, and headache.

Gelnique contains oxybutynin at a strength of100 mg per gram of gel. Gelnique gel should not be given to pregnant women unless, in the judgment of the physician, the probable clinical benefits outweigh the possible hazards. Because many drugs are excreted in human milk, caution should be exercised when Gelnique gel is administered to a nursing woman; the drug has not been studied for safety and effectiveness in pediatric patients.

Our Gelnique (oxybutynin chloride) Gel 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.

Gelnique 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 topical and call your doctor at once if you have a serious side effect such as:

  • fever with hot, dry skin;
  • uneven heart rate;
  • pain, burning, or other difficulty when urinating; or
  • severe itching, redness, pain, rash, or other irritation where the medication was applied.

Less serious side effects may include:

  • mild skin irritation where the gel was applied;
  • cold symptoms such as stuffy nose, sneezing, sore throat;
  • dizziness, drowsiness, tired feeling;
  • headache;
  • blurred vision;
  • dry mouth;
  • constipation; or
  • nausea, vomiting, stomach cramps, diarrhea.

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 Gelnique (Oxybutynin Chloride 10 % Gel) »

What is Prescribing information?

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

Gelnique FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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 trial of another drug and may not reflect the rates observed in practice.

Clinical Studies Experience

The safety of GELNIQUE was evaluated in 789 patients (389 randomized to GELNIQUE 1 g and 400 randomized to placebo) during a randomized, placebo-controlled, double-blind, 12-week clinical efficacy and safety study. A subset of these 789 patients (N=216) participated in the 14-week open-label safety extension that followed the placebo-controlled study. Of 216 patients in the safety extension, 107 were randomized to placebo gel during the double-blind, placebo-controlled 12-week study. In the combined double-blind, placebo-controlled study and the open-label safety extension, a total of 496 patients were exposed to at least one dose of GELNIQUE. Four hundred thirty-one (431) patients received at least 12 weeks of GELNIQUE treatment and 85 patients received 26 weeks of GELNIQUE treatment. The study population primarily consisted of Caucasian women (approximately 90%) with an average age of 59 years who had overactive bladder with urge urinary incontinence.

Table 1 lists adverse reactions that were reported in the randomized, double-blind, placebo-controlled 12-week study in greater than 2% of patients treated with GELNIQUE and at an incidence greater than placebo.

Table 1: Common Adverse Reactions in the Randomized, Double-blind, Placebo-controlled 12-Week Study ( > 2% and > placebo)

Adverse Reaction GELNIQUE 1 gram
N=389
n (%)
Placebo
N=400
n (%)
Dry mouth 29 (7.5) 11 (2.8)
Urinary tract infection 27 (6.9) 17 (4.3)
Application site reactions* 21 (5.4) 4 (1.0)
Upper respiratory tract infection 21 (5.4) 20 (5.0)
Dizziness 11 (2.8) 4 (1.0)
Nasopharyngitis 11 (2.8) 9 (2.3)
Fatigue 8 (2.1) 4 (1.0)
Gastroenteritis viral 8 (2.1) 7 (1.8)
* Includes application site pruritus, dermatitis, papules, anesthesia, erythema, irritation, pain and papules

Other common adverse reactions that were reported in ≥ 1% of GELNIQUE-treated patients were headache (1.5%), constipation (1.3%), and pruritus (1.3%). Application site pruritus (2.1%) and application site dermatitis (1.8%) were the most commonly reported application site reactions. A majority of adverse reactions were described as mild or moderate in intensity, except for two patients reporting severe headache.

The most common adverse reaction leading to drug discontinuation was application site reaction (0.8% with GELNIQUE versus 0.3% with placebo).

The most common adverse reactions reported during the 14-week open-label extension study were application site reactions (6.0%) and dry mouth (1.9%). The most common reason for premature discontinuation was application site reactions (9 patients or 4.2%). Two of these 9 patients experienced application site reactions of severe intensity (dermatitis, urticaria, and erythema).

Read the entire FDA prescribing information for Gelnique (Oxybutynin Chloride 10 % Gel) »

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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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