Gelnique Side Effects Center

Last updated on RxList: 4/28/2022
Gelnique Side Effects Center

What Is Gelnique?

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.

What Are Side Effects of Gelnique?

Side effects of Gelnique Gel include:

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

  • 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.

Dosage for Gelnique

Gelnique contains oxybutynin at a strength of 100 mg per gram of gel.

What Drugs, Substances, or Supplements Interact with Gelnique?

Gelnique may interact with atropine, belladonna, benztropine, dimenhydrinate, methscopolamine, scopolamine, bladder or urinary medicines, bronchodilators, irritable bowel medicines, medications to treat osteoporosis or Paget's disease of bone, or ulcer medications. Tell your doctor all medications and supplements you use.

Gelnique During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant during treatment with Gelnique; it is not expected to be harmful to a fetus. It is unknown if Gelnique topical passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.

Additional Information

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.


Urinary Incontinence in Women: Types, Causes, and Treatments for Bladder Control See Slideshow
Gelnique Consumer Information

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

Stop using this medicine and call your doctor at once if you have:

  • little or no urination;
  • severe constipation;
  • confusion, hallucinations;
  • vomiting, severe heartburn or upper stomach pain;
  • pain or burning when you urinate; or
  • dehydration symptoms--feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin.

Common side effects may include:

  • redness, itching, or mild skin irritation where a patch was worn or the gel was applied;
  • dizziness, drowsiness;
  • dry mouth;
  • dry eyes, blurred vision; or
  • constipation, diarrhea, decreased urination.

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.

Gelnique Professional Information


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 Trials 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 ReactionGELNIQUE 1 gram
N = 389
n (%)
N = 400
n (%)
Dry mouth29 (7.5)11 (2.8)
Urinary tract infection27 (6.9)17 (4.3)
Application site reactions*21 (5.4)4 (1.0)
Upper respiratory tract infection21 (5.4)20 (5.0)
Dizziness11 (2.8)4 (1.0)
Nasopharyngitis11 (2.8)9 (2.3)
Fatigue8 (2.1)4 (1.0)
Gastroenteritis viral8 (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).

Postmarketing Experience

The following adverse reactions have been identified during post approval use of GELNIQUE. 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: Memory impairment, dizziness, somnolence, confusion

Psychiatric Disorders: Delirium, hallucinations

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

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

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