- What is oxybutynin (Ditropan, Ditropan XL, Urotrol)?
- What are the possible side effects of oxybutynin (Ditropan, Ditropan XL, Urotrol)?
- What is the most important information I should know about oxybutynin (Ditropan, Ditropan XL, Urotrol)?
- Best Treatments for Overactive Bladder
- Concern over high US prescribing levels of common drug linked to dementia
- Ditropan Side Effects
- For the Consumer
- For Healthcare Professionals
- Further information
- More about Ditropan (oxybutynin)
- Dose advice
- Common side effects
- Uncommon side effects
- A comparison of the effects of saliva output of oxybutynin chloride and tolterodine tartrate
Brand Names: Ditropan, Ditropan XL, Urotrol
Generic Name: oxybutynin (oral)
- What is oxybutynin (Ditropan, Ditropan XL, Urotrol)?
- What are the possible side effects of oxybutynin (Ditropan, Ditropan XL, Urotrol)?
- What is the most important information I should know about oxybutynin (Ditropan, Ditropan XL, Urotrol)?
- What should I discuss with my healthcare provider before using oxybutynin (Ditropan, Ditropan XL, Urotrol)?
- How should I take oxybutynin (Ditropan, Ditropan XL, Urotrol)?
- What happens if I miss a dose (Ditropan, Ditropan XL, Urotrol)?
- What happens if I overdose (Ditropan, Ditropan XL, Urotrol)?
- What should I avoid while using oxybutynin (Ditropan, Ditropan XL, Urotrol)?
- What other drugs will affect oxybutynin (Ditropan, Ditropan XL, Urotrol)?
- Where can I get more information (Ditropan, Ditropan XL, Urotrol)?
What is oxybutynin (Ditropan, Ditropan XL, Urotrol)?
Oxybutynin reduces muscle spasms of the bladder and urinary tract.
Oxybutynin is used to treat symptoms of overactive bladder, such as frequent or urgent urination, incontinence (urine leakage), and increased night-time urination.
Oxybutynin may also be used for purposes not listed in this medication guide.
What are the possible side effects of oxybutynin (Ditropan, Ditropan XL, Urotrol)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using oxybutynin and call your doctor at once if you have:
- feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin;
- severe stomach pain or constipation;
- blurred vision, tunnel vision, eye pain, or seeing halos around lights;
- pain or burning when you urinate; or
- little or no urinating.
Common side effects may include:
- dry mouth;
- dry eyes, blurred vision;
- mild constipation; or
- dizziness, drowsiness.
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.
You should not use oxybutynin if you have untreated or uncontrolled narrow-angle glaucoma, a blockage in your digestive tract (stomach or intestines), or if you are unable to urinate.
Best Treatments for Overactive Bladder
Abrams P., et al., Combination treatment with mirabegron and solifenacin in patients with overactive bladder: Efficacy and safety results from a randomized, double-blind, dose-ranging, phase 2 study (Symphony).European Urology, 2014;67:577-588.
Abrams P, Cardozo L, Fall M, et al. The standardisation of terminology in lower urinary tract function: report from the standardisation subcommittee of the International Continence Society. Urology. 2003;61(1):37-49.
Abrams, P., et al., Tolterodine, a new antimuscarinic agent: as effective but better tolerated than oxybutynin in patients with an overactive bladder. British Journal of Urology, 1998. 81(6): p. 801-10.
Anderson, R.U., et al. Effectiveness and tolerability of extended release oxybutynin vs. extended-release tolterodine in women with or without prior anticholinergic treatment for overactive bladder. International Urogynecology Journal, 2006. 17(5): p. 502-11.
Anderson, R.U., et al. Once daily controlled vs. Immediate release oxybutynin chloride for urge urinary incontinence. Journal of Urology, 1999. 161(6): p. 1809-1812.
Anonymous. Detrol LA package insert. 2002.
Anonymous. Ditropan XL package insert. 2004.
Anonymous. Myrbetriq package insert. 2015.
Anonymous. Trospium chloride (Sanctura): another anticholinergic for overactive bladder. Medical Letter on Drugs & Therapeutics. 2004;46(1188):63-64.
Appell, R.A., et al. Prospective randomized controlled trial of extended-release oxybutynin chloride and tolterodine tartrate in the treatment of overactive bladder: results of the OBJECT Study. Mayo Clinic Proceedings, 2001. 76(4): p. 358-63.
Armstrong, R.B., K.M. Luber, and K.M. Peters, Comparison of dry mouth in women treated with extended-release formulations of oxybutynin or tolterodine for overactive bladder. International Urology & Nephrology, 2005. 37(2): p. 247-52.
Barkin, J., et al. A randomized, double-blind, parallel-group comparison of controlled- and immediate-release oxybutynin chloride in urge urinary incontinence. Clinical Therapeutics, 2004. 26(7): p. 1026-36.
Batista, E. et al., The efficacy and safety of mirabegron compared with solifenacin in overactive bladder patients dissatisfied with previous antimuscarinic treatment due to lace of efficacy: results of a noninferiority, randomized, phase IIIb trial. Therapeutic Advances in Urology, 2015;7(4):167-179.
Beers MH, Ouslander JG, Rollingher I, Reuben DB, Brooks J, Beck JC. Explicit criteria for determining inappropriate medication use in nursing-home residents. Arch Intern Med. 1991;151(9):1825-1832.
Beers MH. Explicit criteria for determinig potentially inappropriate medication use by the elderly. An update. Arch Intern Med. 1997;157(4):1531-1537.
Birns, J., et al. A randomized controlled trial comparing the efficacy of controlled-release oxybutynin tablets (10 mg once daily) with conventional oxybutynin tablets (5 mg twice daily) in patients whose symptoms were stabilized on 5 mg twice daily of oxybutynin. BJU International, 2000. 85(7): p. 793-798.
Burgio KL, Locher JL, Goode PS, et al. Behavioral vs drug treatment for urge urinary incontinence in older women. JAMA. 1998; 280:1995-2000.
Chapple, C.R., et al., Clinical efficacy, safety, and tolerability of once-daily fesoterodine in subjects with overactive bladder. European Urology, 2007. 52:1204-1212.
Chapple, C.R. and P. Abrams, Comparison of darifenacin and oxybutynin in patients with overactive bladder: assessment of ambulatory urodynamics and impact on salivary flow. European Urology, 2005. 48(1): p. 102-9.
Chapple, C.R., et al. A comparison of the efficacy and tolerability of solifenacin succinate and extended-release tolterodine at treating overactive bladder syndrome: Results of the STAR trial. European Urology, 2005. 48(3): p. 464-70.
Chapple, C.R., et., A phase II dose-ranging study of mirabegron in patients with overactive bladder. International Urogynecology Journal. 2013. 24:1447-1458.
Chapple, C.R., et al., Randomized double-blind, active-controlled phase 3 study to assess 12-month safety and efficacy of mirabegron, a β3-adrenoceptor agonist, in overactive bladder. European Urology, 2013, 63:296-305.
Chapple, C.R., et al., Randomized, double-blind placebo- and tolterodine-controlled trial of the once-daily antimuscarinic agent solifenacin in patients with symptomatic overactive bladder. BJU International, 2004. 93:303-310.
Chapple, C.R., et al., Solifenacin appears effective and well tolerated in patients with symptomatic idiopathic detrusor overactivity in a placebo- and tolterodine-controlled phase 2 dose-finding study. BJU International, 2004. 93:71-77.
Chapple, C.R., et al. Treatment outcomes in the STAR study: a subanalysis of solifenacin 5 mg and tolterodine ER 4 mg. European Urology, 2007. 52(4): p. 1195-203.
Choo, M.-S., et al., Efficacy and safety of solifenacin succinate in Korean patients with overactive bladder: A randomized, prospective, double-blind, multicenter study. International Journal of Clinical Practice, 2008. 1675-1683.
Chu, F.M., et al. Extended-release formulations of oxybutynin and tolterodine exhibit similar central nervous system tolerability profiles: a subanalysis of data from the OPERA trial. American Journal of Obstetrics & Gynecology, 2005. 192(6): p. 1849-54.
Couture JA, Valiquette L. Urinary incontinence. Ann Pharmacother. 2000;34(5):646-655.
Davila, G.W., C.A. Daugherty, and S.W. Sanders. A short-term, multicenter, randomized double-blind dose titration study of the efficacy and anticholinergic side effects of transdermal compared to immediate release oral oxybutynin treatment of patients with urge urinary incontinence. Journal of Urology, 2001. 166(1): p. 140-145.
Diokno, A.C., et al. Prospective, randomized, double-blind study of the efficacy and tolerability of the extended-release formulations of oxybutynin and tolterodine for overactive bladder: Results of the OPERA trial. Mayo Clinic Proceedings, 2003. 78(6): p. 687-695.
Dmochowski, R.R., et al. Comparative efficacy and safety of transdermal oxybutynin and oral tolterodine vs. placebo in previously treated patients with urge and mixed urinary incontinence. Urology, 2003. 62(2): p. 237-42.
Dmochowski, R.R., et al. Randomized, double-blind study of controlled-release Oxybutynin and Tolterodine for overactive bladder (Abstract). Proceedings of the International Continence Society, 2001.
Drutz, H.P., et al. Clinical efficacy and safety of tolterodine compared to oxybutynin and placebo in patients with overactive bladder. International Urogynecology Journal, 1999. 10(5): p. 283-9.
Ercan O., et al., Comparison of solifenacin and fesoterodine in treatment of overactive bladder. Saudi Medical Journal, 2015. 36(10):1181-1185.
Fantl JA, Newman DK, Colling J, et al. Urinary incontinence in adults: acute and chronic management. Clinical Practice Guideline #2 AHCPR Publication No. 96-0682. Rockville, MD: Agency for Healthcare Policy and Research; 1996.
Garnett S, Abrams P. The natural history of the overactive bladder and detrusor overactivity. A review of the evidence regarding the long-term outcome of the overactive bladder. J Urol. 2003;169(3):843-848.
Halaska, M., et al. Controlled, double-blind, multicentre clinical trial to investigate long-term tolerability and efficacy of trospium chloride in patients with detrusor instability. World Journal of Urology, 2003. 20(6): p. 392-9.
Herschorn, S., et al. Comparison of fesoterodine and tolterodine extended release for the treatment of overactive bladder: A head-to-head placebo-controlled trial. BJU International, 2009. 105:58-66.
Herschorn, S. et al., Tolerability of 5 mg solifenacin once daily versus 5 mg oxybutynin immediate release 3 times daily: Results of the VECTOR trial. Journal of Urology, 2010. 183:1892-1898
Ho, C-H., et al., Solifenacin and tolterodine are equally effective in the treatment of overactive bladder symptoms. Journal of Formos Med Assoc, 2010. 109(10):702-708.
Homma, Y. and K. Kawabe. Health-related quality of life of Japanese patients with overactive bladder treated with extended-release tolterodine or immediate-release oxybutynin: a randomized, placebo-controlled trial. World Journal of Urology, 2004. 22(4): p. 251-6.
Homma, Y., et al. Clinical efficacy and safety of tolterodine extended-release for treatment of overactive bladder. A phase II, 12-week, randomised, double-blind, placebo- and active (oxybutynin)-controlled study in Japan and Korea (Abstract). Proceedings of the International Continence Society, 2002.
Homma, Y., et al. Clinical efficacy and tolerability of extendedrelease tolterodine and immediate-release oxybutynin in Japanese and Korean patients with an overactive bladder: a randomized, placebo-controlled trial. BJU International, 2003. 92(7): p. 741-7.
Hsiao, S.-M., et al., Comparison of urodynamic effects, therapeutic efficacy and safety of solifenacin versus tolterodine for female overactive bladder syndrome. Journal of Obstrectics and Gynaecological Research, 2011. 37(8):1084-1091.
Kaplan, S.A., et al., Superior efficacy of fesoterodine over tolterodine extended release with rapid onset: A prospective, head-to-head, placebo-controlled trial. BJU International, 2010. 107:1432-1440.
Kessler, T.M., et al., Adverse event assessment of antimuscarinics for treating overactive bladder: A network meta-analytic approach. PLoS ONE, 2011. 6(2):e16718.
Koda-Kimble, et al., eds. Applied therapeutics: the clinical use of drugs, 7th ed. Baltimore, MD: Lippincott Williams & Wilkins; 2001.
Kosilov, K., et al., A randomized, controlled trial of effectiveness and safety of management of OAB sysptoms in elderly men and women with standard-dosed combination of solifenacin and mirabegron. Archives of Gerontology and Geriatrics, 2015. 61:212-216.
Khullar, V., et al., Efficacy and tolerability of mirabegron, a β3-adrenoceptor agonist, in patients with overactive bladder: Results from a randomized European-Australian phase 3 trial. European Urology, 2013. 63:283-295.
Kuo, H-C., et al., Results of a randomized, double-blind, parallel-group, placebo- and active-controlled, multicenter study of mirabegron a β3-adrenoceptor agonist, in patients with overactive bladder in Asia. Neurology and Urodynamics, 2015. 34:685-692.
Lee, J.G., et al., Tolterodine: As effective but better tolerated than oxybutynin in Asian patients with symptoms of overactive bladder. International Journal of Urology, 2002. 9(5): p. 247-252.
Leung, H.Y., et al. A randomized controlled trial of tolterodine and oxybutynin on tolerability and clinical efficacy for treating Chinese women with an overactive bladder. BJU International, 2002. 90: p. 375-380.
Madersbacher, H., et al. Trospium chloride vs. oxybutynin: a randomized, double-blind, multicentre trial in the treatment of detrusor hyper-reflexia. British Journal of Urology, 1995. 75(4): p. 452-6.
Malone-Lee, J., et al. The comparative tolerability and efficacy of tolterodine 2 mg bid vs. oxybutynin 2.5/5 mg bid in the treatment of the overactive bladder. Neurourology & Urodynamics, 1998. 17(4): p. 163-164.
Malone-Lee, J., et al. Tolterodine: superior tolerability than and comparable efficacy to oxybutynin in individuals 50 years old or older with overactive bladder: a randomized controlled trial. Journal of Urology, 2001. 165(5): p. 1452-6.
Maman, K., et al., Comparative efficacy and safety of medical treatments for the management of overactive bladder: A systematic literagure review and mixed treatment comparison. European Urology, 2014. 65:755-765.
McEvoy, et al., eds. AHFS Drug Information 2002. Bethesda, MD: Society of Health System Pharmacists, Inc.; 2002.
Milani, R., et al. Double-blind crossover comparison of flavoxate and oxybutynin in women affected by urinary-urge syndrome. Int Urogynecol J, 1993. 4(1): p. 3-8.
Nilsson, C.G., et al. Comparison of a 10-mg controlled release oxybutynin tablet with a 5-mg oxybutynin tablet in urge incontinent patients. Neurourology & Urodynamics, 1997. 16(6): p. 533-542.
Radomski, S., et al. Preliminary evaluation of a new controlled release oxybutynin in urinary incontinence. Current Medical Research and Opinion, 2004. 20(2): p. 249-253.
Sand, P.K., et al. A comparison of extended-release oxybutynin and tolterodine for treatment of overactive bladder in women. International Urogynecology Journal, 2004. 15(4): p. 243-8.
Sand, P.K., et al., Randomized, double-blind study to compare extended-release oxybutynin and tolterodine for overactive bladder. Obstetrics & Gynecology, 2001. 97(4): p. S49.
Schmidt RA, Zermann DH, Doggweiler R. Urinary incontinence update: Bold traditions and new concepts. Adv Intern Med. 1999;44:19-57.
Sussman, D. and A. Garely. Treatment of overactive bladder with once-daily extended-release tolterodine or oxybutynin: The Antimuscarinic Clinical Effectiveness Trial (ACET). Current Medical Research & Opinion, 2002. 18(4): p. 177-184.
Swift, S., et al. A new once-daily formulation of tolterodine provides superior efficacy and is well tolerated in women with overactive bladder. International Urogynecology Journal, 2003. 14(1): p. 50-4; discussion 54-5.
Van Kerrebroeck, P., et al. Tolterodine once-daily: superior efficacy and tolerability in the treatment of the overactive bladder. Urology, 2001. 57(3): p. 414-21.
Van Kerrebroeck, P.E., G. Serment, and E. Dreher. Clinical efficacy and safety of tolterodine compared to oxybutynin in patients with overactive bladder . Neurourology & Urodynamics, 1997. 16(5): p. 478-479.
Versi, E., et al. Dry mouth with conventional and controlledrelease oxybutynin in urinary incontinence. Obstetrics & Gynecology, 2000. 95(5): p. 718-721.
Yamaguchi, O. et al., Phase III, randomized, double-blind, placebo-controlled study of the β3-adrenoceptor agonist mirabegron, 50 mg once daily, in Japanese patients with overactive bladder. BJU International. 2014, 113:951-960.
Zeegers, A.G.M., et al. Conservative therapy of frequency, urgency, and urge incontinence: A double-blind clinical trial of flavoxate hydrochloride, oxybutinin chloride, emepronium bromide, and placebo. World Journal of Urology, 1987. 5(1): p. 57-61.
Zellner, M., et al., Trospium chloride and oxybutynin hydrochloride in a German study of adults with urinary urge incontinence: Results of a 12-week, multicenter, randomized, double-blind, parallel-group, flexible-dose noninferiority trial. Clinical Therapeutics, 2009. 31(11):2519-2539.
Zinner, N., J. Tuttle, and L. Marks. Efficacy and tolerability of darifenacin, a muscarinic M3 selective receptor antagonist (M3 SRA), compared with oxybutynin in the treatment of patients with overactive bladder. World Journal of Urology, 2005. 23(4): p. 248-52.
Overactive bladder (OAB) is extremely common in persons over 65. Initial treatment is normally via behavioural modifications, which can then be followed by first-line medical treatment such as antimuscarinic medications, including oxybutynin. Antimuscarinic drugs are synthetic compounds, originally derived from mushrooms, which block the activity of the muscarinic acetylcholine receptor. They have several uses, including control of OAB. Oxybutynin is the least expensive antimuscarinic used for OAB, and so tends to be the drug of choice for health care plans such as Medicare. However, a body of evidence has shown that oxybutynin is linked to greater cognitive decline in the elderly ref1.
An international group of clinicians, led by Dr Daniel Pucheril (Vattikuti Urology Insitute, Henry Ford Hospital, Detroit), looked at evidence from the National Ambulatory Medical Care Survey, where 1,968 patients had received antimuscarinic medications. They found that oxybutynin was prescribed to 27.3% of patients aged over 65 receiving a new antimuscarinic prescription for OAB. Additionally, despite the United States Food and Drug Administration recommendation that patients starting oxybutynin be closely monitored for adverse central nervous system side effects, the authors found that only 9% of elderly persons received a neurologic exam at the time of drug prescription.
Around 16% of US adults suffer from overactive bladder, which translates into tens of millions of sufferers in the US.
According to Dr Pucheril, “We looked at a representative sample, but when you extrapolate to the US population the figures are huge. We estimate that over the six years of our analysis, 47 million individuals in the USA were taking various types of antimuscarinic drugs for OAB, with around 55% of new prescriptions going to the over 65’s.
After lifestyle modifications, antimuscarinic medications constitute the most common first line therapies. In the United States, the majority of elderly persons are insured by Medicare. Medicare insurance plans have often have tiered medication formularies to minimize drug expenses. Oxybutynin is the least expensive antimuscarinic drug available, but its pharmacologic properties may cause significant cognitive side effects in elderly persons. Despite evidence of these side effects, physicians are not commonly checking for cognitive effects in those using these medications.”
Dr Pucheril continued “We’re not saying that everyone should change from oxybutynin to another drug — it still has its uses, and coming off the drug without medical supervision is not recommended. Nevertheless, doctors need to look closely at the levels of prescribing. More than anything else, the funding bodies have to make it easier for doctors to prescribe newer antimuscarinics which are much less likely to cause cognitive dysfunction.”
Commenting, on the European situation, Professor Helmut Madsbacher (Innsbruck) said: “This new work from the US highlights a more general problem which also exists here in Europe. In Europe, oxybutynin use varies from country to country. What we find is that where a range of antimuscarinic drugs is funded, as for example happens in Germany, Austria and Switzerland, then oxybutynin use is low, at around 5% to 7%, for obvious reasons. However, in some countries only oxybutynin is funded, and this creates a problem. For example, the only antimuscarinic funded by Italian health Authorities is oxybutynin, and this leads to some areas with around 70% of antimuscarinic prescriptions being oxybutynin.”
Professor Andrea Tubaro (Sapienza Università, Roma) added: “If an alternative drug is not funded by the health system then it becomes too expensive for a patient to buy themselves. In Italy generic oxybutynin costs around €5/month, but someone wishing to pay for a different antimuscarin or an up-to-date alternative such as a beta3 agonist will end up paying around €50/month. Even in strictly economic terms, there’s no sense in saving a few Euros on a drug which risks worsening dementia, one of the most costly conditions which medicine can treat. This is a problem in Italy, but funders in all countries really need to support the use of a range of drugs.”
Ditropan Side Effects
Generic Name: oxybutynin
Medically reviewed by Drugs.com. Last updated on Dec 27, 2018.
- Side Effects
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 Ditropan.
For the Consumer
Applies to oxybutynin: oral syrup, oral tablet, oral tablet extended release
Other dosage forms:
- transdermal gel/jelly, transdermal patch extended release
Along with its needed effects, oxybutynin (the active ingredient contained in Ditropan) 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:
- Eye pain
- skin rash or hives
Get emergency help immediately if any of the following symptoms of overdose occur while taking oxybutynin:
Symptoms of overdose
- Clumsiness or unsteadiness
- drowsiness (severe)
- fast, slow, or irregular heartbeat
- 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:
- Acid or sour stomach
- decreased sweating
- difficulty having a bowel movement (stool)
- dryness of the eyes, mouth, nose, or throat
- runny nose
- stomach discomfort, upset, or pain
Less common or rare
- Blurred vision
- decreased flow of breast milk
- decreased sexual ability
- difficulty in swallowing
- feeling of warmth or heat
- 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
Uncommon (0.1% to 1%): Hypersensitivity
Frequency not reported: Anaphylactic reaction
Common (1% to 10%): Palpitations
Uncommon (0.1% to 1%): Cardiac arrhythmia tachycardia, vasodilation, hypertension, flushing
Frequency not reported: Heat stroke
Very common (10% or more): Dry skin, pruritus
Common (1% to 10%): Flushing, rash
Frequency not reported: Angioedema, hypohidrosis
Postmarketing reports: Decreased lactation
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
The most common (incidence 5% or greater) adverse reactions were dry mouth, constipation, diarrhea, headache, somnolence, and dizziness.
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
Uncommon (0.1% to 1%): Fungal infection
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
Uncommon (0.1% to 1%): Anorexia, fluid retention
Uncommon (0.1% to 1%): Back pain
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)
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
Common (1% to 10%): Fatigue
Uncommon (0.1% to 1%): Dysphonia, thirst
Frequency not reported: Falls, accidental injury
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
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
1. “Product Information. Ditropan (oxybutynin).” Hoechst Marion-Roussel Inc, Kansas City, MO.
2. Cerner Multum, Inc. “UK Summary of Product Characteristics.” O 0
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.
More about Ditropan (oxybutynin)
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- Drug class: urinary antispasmodics
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Other brands: Oxytrol, Gelnique, Anturol
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Generic Name: Oxybutynin hydrochloride
Product Name: Ditropan
Ditropan is the brand name for a drug called oxybutynin chloride. This is a smooth muscle relaxant drug mainly used to relieve bladder muscle spasm where other conservative measures have already failed. Ditropan can be used to treat a number of bladder instability disorders associated with abnormal nerve impulses to the bladder. In these cases, Ditropan reduces bladder activity and relieves symptoms of urgency, frequency, dysuria and urinary incontinence. Ditropan may also be used to treat incontinence in children older than 5 years. Note that Ditropan helps control your symptoms but does not cure your condition. Thus you will need to take it every day for a specified period of time. Note that Ditropan may have been prescribed to you for a reason other than those listed above. If you have any queries regarding why Ditropan has been prescribed, discuss them with your doctor. Furthermore, not all patients with the above conditions should be treated with Ditropan. You should discuss with your doctor whether Ditropan is suited for you and your particular circumstances.
The active component of Ditropan called oxybutynin chloride, relaxes smooth muscles in the body. It does this by a direct means and by inhibiting effects of a compound called acetylcholine. In particular, Ditropan relaxes bladder smooth muscle (detrusor muscle) in patients with involuntary contractions. This delays the initial desire and the urge to urinate.
Do not take Ditropan if you:
- Are allergic to Ditropan or any of the other inactive ingredients of the tablets.
- Have acute angle closure glaucoma or problems with the pressure in your eyes, bowel obstruction, intestinal problems (including colitis), myaesthenia gravis (a muscle disorder), urinary tract blockage or severe bleeding.
- Are pregnant or breastfeeding as Ditropan may have unwanted effects on your baby.
Before taking Ditropan you should tell your doctor:
- If you are allergic to any medications, foods or dyes- Ditropan should not be used if you are allergic to this type of medication.
- If you are pregnant or intend on becoming pregnant- Research into the use of Ditropan during pregnancy is currently limited and safety data is only based on a few animal studies. Your doctor will discuss the risks and benefits of using this medication during pregnancy.
- If you have any other medical conditions- In particular tell your doctor if you have any liver, kidney or heart problems, high blood pressure, an enlarged prostate, eye problems, intestinal or bowel problems, myaesthenia gravis, urinary tract obstruction or hiatus hernia as Ditropan may aggravate some of these conditions.
- Any other medications you are taking (including those bought from supermarkets or the chemist)- Ditropan can interact with some medications used to treat depression, psychotic disorders, Parkinson’s disease and heart arrhythmias which may affect how one or both drugs work. Your doctor will discuss which other medications are safe to use concurrently with Ditropan.
Ditropan comes as round light blue tablets containing 5mg of the active component oxybutinin hydrochloride. They are supplied in bottles of 100 tablets. Ditropan tablets are intended to be swallowed whole with a glass of water. You should always take Ditropan as prescribed by your doctor. For adults, the usual dose is one tablet 2-3 times per day (up to a maximum of four times per day). Elderly patients may require a lower dose. Children older than five years usually have one tablet two times per day. During your treatment your doctor will monitor your response and development of any side effects. They may perform regular cystometry which is a series of tests measuring your bladder function. Whilst taking Ditropan you should be careful driving and operating machinery as Ditropan can cause dizziness, drowsiness and affect your vision. Alcohol and other sedative drugs may also worsen these side effects. In addition, be careful taking Ditropan in very hot environments as it can impair your ability to sweat and hence cause overheating.
S4 (prescription required).
Common side effects
Ditropan helps most people with bladder problems but like all medications may have unwanted side effects in some people. The majority of these side effects are mild and do not require specific treatment; however some patients can have more serious side effects. In general the larger dose used, the more likely you are to experience side effects. If you experience any symptoms you may think are caused by taking Ditropan be sure to discuss them with your doctor. The most commonly reported side effects of Ditropan occurring in at least 5% of patients treated with the drug include:
- Abdominal pain.
- Dry mouth.
- Dyspepsia (a feeling of indigestion or discomfort in the upper part of the stomach).
- Blurred vision.
- Difficulty urinating.
- Burning or discomfort urinating which may be a sign of urinary tract infection.
- Facial flushing (especially in children).
Uncommon side effects
A small number of patients can experience more serious side effects that should be addressed more urgently by your doctor. The following side effects occur in less than approximately 2% of patients:
- Cardiovascular problems: if you notice a fast or irregular heartbeat tell your doctor immediately.
- Reduced sweating and overheating: this can be avoided by taking appropriate precautions such as avoiding hot weather and excessive exercise. However if you do notice a fever or heat stroke seek medical assistance urgently.
- Cognitive dysfunction: confusion, hallucinations, anxiety and paranoia (severe suspiciousness) may occur in some patients.
- Eye problems- including eye muscle dysfunction and increase intraocular pressure. These side effects may threaten your vision.
- Convulsions or fits.
- Difficulty sleeping, unusual tiredness and weakness.
- Reduced flow of breast milk during lactation.
- Difficulty breathing: this usually only occurs in acute overdose of Ditropan.
- Overdosing usually leads to a combination of symptoms such as central nervous system excitation (restlessness, tremor, irritability etc), flushing, fever, dehydration, irregular heart beat, vomiting and urinary retention. In severe overdose this can lead to respiratory failure, paralysis and coma.
Do not be alarmed by these long lists of side effects as most patients will not experience any side effects at all. It is however important that you know the most common and serious side effects so that they can be identified and treated early. You may also experience side effects other than those listed as Ditropan can affect all patients differently. If you have any queries or concerns discuss them with your doctor.
For further information talk to your doctor.
TUESDAY, Jan. 6, 2015 (HealthDay News) — A drug already used to treat overactive bladder may also someday help control weight by boosting the metabolic powers of brown fat, a small study suggests.
While white fat stores energy, brown fat burns energy to generate body heat. In the process, it can help maintain body weight and prevent obesity, at least in animals, previous studies have shown.
In the new study, researchers gave 12 healthy, lean young men a high dose of the drug mirabegron (Myrbetriq), and found that it boosted their metabolic rate.
The drug “activates the brown fat cells to burn calories and generate heat,” said study researcher Dr. Aaron Cypess. He is section head of translational physiology at the U.S. National Institute of Diabetes and Digestive and Kidney Diseases.
When the activity of the drug peaked, “the metabolic rate went up by 13 percent on average,” Cypess said. That translates to about 203 calories, he said.
However, Cypess said that doesn’t necessarily mean the men would burn an extra 203 calories a day over the long-term. The researchers don’t yet know how long the calorie-burning effect might last, as they didn’t follow the men over time.
The researchers projected the three-year weight loss would be about 22 pounds.
The study was published Jan. 6 in Cell Metabolism.
Cypess conducted the research while working at the Joslin Diabetes Center and Harvard Medical School. The study was funded by the U.S. National Institutes of Health, with no drug company involvement.
The men, whose average age was 22, took a single dose of the drug in one session and took a single dose of a placebo in another, serving as their own comparisons. The researchers measured metabolic rate by scans, including positron emission tomography (PET) and CT scans.
The effects of the drug on fat-burning, Cypess said, would be “mild to moderate if sustained.”
The drug works by activating what is known as a beta 3-adrenergic receptor, found on the surface of brown fat cells. It is also found on the urinary bladder cells, and the drug works to calm an overactive bladder by relaxing muscle cells there, he said.
A comparison of the effects of saliva output of oxybutynin chloride and tolterodine tartrate
Background: Oxybutynin chloride and tolterodine tartrate are anticholinergic agents used to suppress involuntary bladder contractions in urinary incontinence. They act by inhibiting binding of acetylcholine to the muscarinic receptors in the detrusor muscle of the bladder. The same types of muscarinic receptors are found in the salivary glands; thus anticholinergic agents may decrease saliva production and cause dry mouth, a commonly cited reason for discontinuation of therapy.
Objective: The primary objective of this study was to compare saliva output, which is an objective measure of dry mouth, in subjects taking immediate- or extended-release oxybutynin, tolterodine, or placebo.
Methods: This was a single-site, single-dose, randomized, double-blind, 4-treatment, 4-period crossover study. Subjects were randomly assigned to 1 of 4 treatment sequences that included extended-release oxybutynin 10 mg, tolterodine 2 mg, immediate-release oxybutynin 5 mg, and placebo. Saliva output was measured objectively before dosing with each treatment and at 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours after dosing.
Results: Thirty-six healthy adult volunteers (22 women and 14 men) participated in the study. They ranged in age from 19 to 42 years (mean, 27 years). Thirty-one were white, 3 Asian, and 2 black. There were no significant differences in predose saliva output between the 4 study groups. With placebo, saliva output increased throughout the day. Saliva output was maintained at predose levels throughout the day with extended-release oxybutynin. Two hours after dosing with tolterodine and immediate-release oxybutynin, saliva output decreased nearly 0.5 g in specimens collected over 2 minutes.All 3 active treatments were associated with lower saliva output compared with placebo. Extended-release oxybutynin and tolterodine were similar with respect to area under the saliva concentration-time curve but were associated with significantly greater saliva output than was immediate-release oxybutynin (P < 0.01). There were no serious adverse events (AEs) in this study. AEs were similar between treatments, although the incidence of headache was higher in the active-treatment groups than with placebo.
Conclusions: Objective assessment of saliva output in healthy adult volunteers indicated that extended-release oxybutynin and tolterodine had less impact on saliva output than did conventional immediate-release oxybutynin, suggesting that they may yield lower levels of dry mouth.