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Urotrol Side Effects

Generic Name: oxybutynin

Note: This document contains side effect information about oxybutynin. Some of the dosage forms listed on this page may not apply to the brand name Urotrol.

For the Consumer

Applies to oxybutynin: oral syrup, oral tablet, oral tablet extended release

Other dosage forms:

Along with its needed effects, oxybutynin (the active ingredient contained in Urotrol) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking oxybutynin:

Rare

Get emergency help immediately if any of the following symptoms of overdose occur while taking oxybutynin:

Symptoms of Overdose

  • Clumsiness or unsteadiness
  • confusion
  • convulsions
  • dizziness
  • drowsiness (severe)
  • fainting
  • fast, slow, or irregular heartbeat
  • fever
  • flushing or redness of the face
  • hallucinations (seeing, hearing, or feeling things that are not there)
  • troubled breathing
  • unusual excitement, nervousness, restlessness, or irritability

Some side effects of oxybutynin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common

Less common or rare

  • Blurred vision
  • decreased flow of breast milk
  • decreased sexual ability
  • difficulty in swallowing
  • feeling of warmth or heat
  • headache
  • increased sensitivity of the eyes to light
  • nausea or vomiting
  • trouble with sleeping
  • unusual tiredness or weakness

Incidence Not Known

- Observed during clinical practice with oxybutynin; estimates of frequency cannot be determined
  • Bloating or swelling of the face, arms, hands, lower legs, or feet
  • decreased interest in sexual intercourse
  • inability to have or keep an erection
  • loss in sexual ability, desire, drive, or performance
  • rapid weight gain
  • tingling of the hands or feet
  • unusual weight gain or loss

For Healthcare Professionals

Applies to oxybutynin: oral syrup, oral tablet, oral tablet extended release, transdermal film extended release, transdermal gel

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity

Frequency not reported: Anaphylactic reaction[Ref]

Cardiovascular

Common (1% to 10%): Palpitations

Uncommon (0.1% to 1%): Cardiac arrhythmia tachycardia, vasodilation, hypertension, flushing

Frequency not reported: Heat stroke[Ref]

Dermatologic

Very common (10% or more): Dry skin, pruritus

Common (1% to 10%): Flushing, rash

Frequency not reported: Angioedema, hypohidrosis[Ref]

Endocrine

Postmarketing reports: Decreased lactation[Ref]

Gastrointestinal

Very common (10% or more): Dry mouth (up to 72%), constipation (up to 15%), nausea

Common (1% to 10%): Diarrhea, dyspepsia, abdominal pain, vomiting, flatulence, gastroesophageal reflux disease

Uncommon (0.1% to 1%): Abdominal discomfort

Frequency not reported: Pseudo-obstruction in patients at risk (elderly or patients with constipation and treated with other drugs that decrease intestinal motility), decreased GI motility[Ref]

General

The most common (incidence 5% or greater) adverse reactions were dry mouth, constipation, diarrhea, headache, somnolence, and dizziness.[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection, urinary hesitation, urinary retention, dysuria, increased post void retention

Frequency not reported: Impotence, suppression of lactation, cystitis, aggravation of prostatic hypertrophy[Ref]

Immunologic

Uncommon (0.1% to 1%): Fungal infection[Ref]

Local

Very common (10% or more): Application site pruritus (16.8%)

Common (1% to 10%): Application site erythema, application site vesicles, application site rash, application site macules[Ref]

Metabolic

Uncommon (0.1% to 1%): Anorexia, fluid retention[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Back pain[Ref]

Nervous system

Very common (10% or more): Dizziness (up to 17%), somnolence (up to 14%), headache, drowsiness, confusion

Common (1% to 10%): Dysgeusia

Uncommon (0.1% to 1%): Dysphagia, convulsions

Frequency not reported: Cognitive disorders in elderly, convulsions, agitation, nightmares, anxiety, paranoia, symptoms of depression, hallucinations, asthenia, insomnia, restlessness, dependence to this drug (in patients with history of drug or substance abuse)[Ref]

Ocular

Common (1% to 10%): Blurred vision, dry eye, abnormal vision

Uncommon (0.1% to 1%): Angle closure glaucoma

Frequency not reported: Onset of narrow-angle glaucoma, mydriasis, intraocular hypertension, amblyopia, cycloplegia, decreased lacrimation[Ref]

Other

Common (1% to 10%): Fatigue

Uncommon (0.1% to 1%): Dysphonia, thirst

Frequency not reported: Falls, accidental injury[Ref]

Psychiatric

Common (1% to 10%): Insomnia, nervousness

Uncommon (0.1% to 1%): Hallucinations, confusional state, agitation, memory impairment

Frequency not reported: Psychotic disorder, anxiety, nightmares, paranoia[Ref]

Respiratory

Common (1% to 10%): Cough, oropharyngeal pain, dry throat, nasal dryness

Uncommon (0.1% to 1%): Upper respiratory tract infection, rhinitis, chest discomfort, hoarseness

Rare (0.01% to 0.1%): Nasal congestion, throat irritation[Ref]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL: http://www.appco.com.au/appguide/default.asp." ([2006]):

3. "Product Information. Ditropan (oxybutynin)." Hoechst Marion-Roussel Inc, Kansas City, MO.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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