Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

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Oxybutynin Hydrochloride Tablets 2.5 mg

⚠ This medicine appears to have been discontinued

The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.

If you were prescribed this medicine, other products containing Oxybutynin hydrochloride may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.

Active substance: Oxybutynin hydrochloride

Equivalent medicines (same active substance, strength and form)

Source: electronic medicines compendium (emc)
Official leaflet: Read the PIL on emc

What it is and what it is used for

FOR Oxybutynin Hydrochloride Tablets contain an active ingredient called Oxybutynin hydrochloride. This belongs to two groups of medicines called "anticholinergics and "antispasmodics". This medicine relaxes and prevents spasms (contractions) of the muscle of the bladder, and helps to control the release of urine. Oxybutynin Hydrochloride Tablets are used to treat the following in adults:

  • Loss of control in passing urine (urinary incontinence)
  • Increased need or urgency to pass urine
  • Problems passing urine due to multiple sclerosis and spina bifida. Oxybutynin Hydrochloride Tablets can be used in children 5 years and older to treat:
  • Loss of control in passing urine (urinary incontinence)
  • Increased need or urgency to pass urine
  • Night time bedwetting, when other treatments have not worked.

little water before you take one of these tablets.

  • Heart disease or high blood pressure
  • A fever or are in a hot environment as Oxybutynin Hydrochloride Tablets may reduce the amount you sweat and this may increase your chance of heat stroke.
  • If oxybutynin is used in hot climate there is a risk for heat prostration due to decreased sweating. Check with your doctor or pharmacist before taking this medicine if:
  • The person taking this medicine is a child (use is not recommended under 5 years of age).
  • You are 65 years of age or older Reduced saliva due to Oxybutynin Hydrochloride Tablets may increase dental caries or oral infection. Regular dental check-ups are advisable during long-term treatment. If you notice vision changes or suffer from any pain in the eye whilst using Oxybutynin Hydrochloride Tablets tell your doctor who may do a vision test. Oxybutynin Hydrochloride Tablets may affect your central nervous system. If you have hallucinations, agitation, confusion or sleepiness you should tell your doctor. Other medicines and Oxybutynin Hydrochloride Tablets Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Oxybutynin hydrochloride Tablets can affect the way some other medicines work. Also some medicines can affect the way Oxybutynin hydrochloride Tablets works, especially any of the following:
  • Other medicines to treat urinary disorders such as propiverine or tolterodine
  • Atropine, compounds related to atropine (used for treatment of cramps) or other anticholinergic medicines (used for treatment in stomach disorders such as irritable bowel syndrome)
  • Any other medicines which act in the same way as Oxybutynin, these are called anticholinergic medicines. Examples include atropine used in glaucoma, hyoscine for nausea
  • Medicines to stop vomiting such as phenothiazines (e.g. prochlorperazine), metoclopramide and domperidone
  • Medicines to treat Parkinson's disease such as amantadine, levodopa or benzotropine mesylate
  • Medicines called anticholinesterases used for Alzheimer's disease (e.g. memantine)
  • Medicines to treat heart conditions such as digitalis (digoxin)
  • Antihistamines used for allergies
  • Quinidine (used to treat heart problems)
  • Medicines to treat psychotic disorders including schizophrenia such as butyrophenones (e.g. benperidol) or clozapine
  • Haloperidol, beneridol or other butyrophenones (Medicines used to treat certain mental illness)
  • Medicines used to correct disturbances in the rhythm of the heart such as Quinidine
  • Medicines called Monoamine Oxidase Inhibitors (MAOIs) or tricyclic antidepressants used to treat depression (e.g. Isocarboxazid and moclobemide)
  • Medicines to prevent blood clots such as dipyridamole
  • Medicines to treat fungal infections (ketoconazole, itraconazole or fluconazole)
  • Medicines to treat bacterial infections (erythromycin or other macrolide antibiotics). Oxybutynin Hydrochloride Tablets and alcohol These tablets can cause drowsiness or blurred vision. Drowsiness may be enhanced if you consume alcohol. Pregnancy, breast-feeding and fertility If you are pregnant or breast feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will decide whether you need to take this medicine during pregnancy and whether it is safe to do so. You should not breast-feed whilst taking oxybutynin as it passes into your milk. Driving and using machines: As Oxybutynin Hydrochloride Tablets may cause drowsiness or blurred vision in some people, do not drive or operate machinery, if affected. Oxybutynin Hydrochloride Tablets contain Lactose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product Oxybutynin Hydrochloride Tablets contain Sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e. is essentially 'sodium-free'.

Difficulty passing water (urine) Excitation Agitation Anxiety Becoming dependent on Oxybutynin Hydrochloride Tablets

  • Feeling excessively suspicious and distrustful of others
  • Mental Health disorders
  • Seeing or hearing things that are not there (hallucinations)
  • Nightmares
  • Fits (convulsions)
  • Depression
  • Increased heart beat (tachycardia)
  • Irregular heart beat (arrhythmia)
  • Dilation of pupil (mydriasis)
  • Itchy, lumpy rash (urticaria)
  • Absence of sweating (hypohidrosis)
  • Severe impairment in the ability of the intestines to push food through (pseudo-obstruction)
  • Paranoia
  • Cognitive disorders in elderly
  • Cognitive dysfunction
  • Narrow angle closure glaucoma
  • Ocular hypertension
  • Angioedema
  • Rash (allergic reaction). If you get any of these side effects, please consult your doctor as he may decrease your dose to reduce the effects. The following may be detected in blood tests performed by your doctor
  • Changes in the number blood cells or platelets
  • Increased blood sugar
  • Increase or decrease in blood pressure
  • Inflammation of a vein under the skin
  • Changes in the hormone, chemical and enzyme levels in the body. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

What you need to know before you take it

E OXYBUTYNIN HYDROCHLORIDE TABLETS Do not take Oxybutynin Hydrochloride Tablets if you:

  • Are allergic to oxybutynin hydrochloride or any of the ingredients of this medicine, (listed in Section 6)
  • Have myasthenia gravis (muscle weakness)
  • Suffer with glaucoma (high pressure and pain in the eyes)
  • Have diseases of the intestine (gut) including obstructions of the bowel
  • Have toxic megacolon (dilated colon accompanied by fever and abdominal pain)
  • Have undergone surgeries like ileostomy or colostomy (surgical opening in the abdominal wall)
  • Have severe ulcerative colitis (a form of inflammatory bowel disease)
  • Have a blocked urinary tract causing a poor flow of urine
  • Have porphyria which is a disorder of the skin and nervous system
  • Have frequent urination at night caused by heart or kidney disease. Do not take this medicine if any one of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Oxybutynin Hydrochloride Tablets. Warnings and precautions Talk to your doctor or pharmacist before taking Oxybutynin Hydrochloride Tablets if you suffer from:
  • Diseases of the nervous system (autonomic neuropathy) such as those with Parkinson's disease
  • Liver or kidney problems
  • Severe diarrhoea or constipation
  • An overactive thyroid (hyperthyroidism)
  • Heart disease, heart failure, a fast or irregular heart beat
  • Cognitive disorders such as amnesia, dementia, and delirium
  • An enlarged prostate gland
  • Diseases of the oesophagus (food pipe) including a hiatus hernia, or if you are taking medicines (e.g. bisphosphonates) that could worsen oesophagitis (inflamed oesophagus)
  • Oxybutynin must be used with caution in elderly patients due to the risk of side effects that affect cognitive function, the ability to think and memory.
  • If you are taking medicines for angina (called nitrates) that have to be dissolved under the tongue, it is also important that you moisten your mouth with your tongue or with a

How to take it

OXYBUTYNIN HYDROCHLORIDE TABLETS Always take this medicine exactly as your doctor or

180 x 320 mm

Front Page

NON PRINTING COLOUR Oxybutynin Hydrochloride 2.5 mg / 5 mg Strides Pharma UK Ltd.

Pack Insert —-

180 x 320 mm 1054350

1047065

Black PC-ODF/2026/103 – Record Number: 487438 Front & Back Page Printing. To be supplied in the folded size of 180 x 160 mm. 60 GSM Paper PRINTING CLARITY TO BE CLEAR AND SHARP.

1 8.0

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Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Allergic reactions: If you experience an allergic reaction which may include symptoms such as swelling of the face, neck, throat or body, a rash which may be itchy, swallowing or difficulty breathing; stop taking the tablets and contact your doctor immediately. Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days: Very common (affects more than 1 in 10 people)

  • Constipation
  • Nausea
  • Dry mouth
  • Dry skin/decreased sweating
  • Headache
  • Somnolence (feeling drowsy or sleepy)
  • Dizziness
  • Blurring of vision
  • Decreased tear production/dry eyes
  • Facial flushing especially in children
  • Difficulty emptying the bladder (Urinary retention) Common (affects 1 to 10 people in 100 people)
  • Diarrhoea
  • Indigestion
  • Being sick (vomiting)
  • Confusion
  • Dry eyes
  • Urinary retention
  • a forceful heartbeat that may be rapid or irregular Uncommon (affects 1 to 10 people in a 1,000)
  • Stomach pain
  • Loss of appetite (anorexia)
  • Drowsiness
  • Light hypersensitivity
  • Difficulty in swallowing (dysphagia) Rare (may affect up to 1 in 1,000 people)
  • Restlessness
  • Erectile dysfunction
  • Disorientation, difficulties in concentration
  • Skin that is more sensitive to the sun (photosensitivity).
  • excitation Frequency unknown
  • Increased pressure in the eyes sometimes sudden and painful with blurred vision or loss of vision (glaucoma)
  • Indigestion or heartburn (acid reflux)
  • Urinary tract infection
  • Heat stroke

• • • • •

1054350

pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is Adults The usual initial dose is 2.5mg three times a day. This dose may be increased to a maximum of 5mg four times a day. Elderly Initially 2.5mg twice a day increased to 5mg twice a day according to response. Use in children (over 5 years) and adolescents Urinary incontinence: The usual dose is 2.5mg twice a day. This may be increased to 5mg two or three times a day. Bed wetting: The usual dose is 2.5mg twice a day, increased to 5mg two or three times a day, with the last dose given before bedtime. Children under 5 years Not recommended. Swallow the tablet whole with a glass of water. The dose recommendations given above are a guideline only. Your doctor may prescribe a different dose. If you take more Oxybutynin Hydrochloride Tablets than you should: An overdose of this medicine may be harmful. Symptoms of overdose include restlessness, excitement, abnormal behaviour, flushing, fall in blood pressure, problems with your circulation, breathing problems, paralysis and coma. If you or someone else, have taken too much of your medicine tell your doctor or pharmacist, or go to the nearest hospital casualty department immediately. Take the medicine pack with you, to inform the doctor what you have taken. If you forget to take Oxybutynin Hydrochloride Tablets: If you forget to take a dose at the right time, take it as soon as you remember, then go on as before. However you must take care not to take two doses at the same time. Do not take a double dose to make up for a forgotten dose. If you stop taking Oxybutynin Hydrochloride Tablets Do not stop or change the treatment before talking to your doctor as desired effect of the medicine may not be achieved. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

How to store it

OXYBUTYNIN HYDROCHLORIDE TABLETS Keep this medicine out of the sight and reach of children. Do not store above 25°C. Do not use this medicine after the expiry date which is stated on the label. The expiry refers to the last day of that month. Do not use this medicine if you notice visible signs of deterioration. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

Contents of the pack and other information

What Oxybutynin Hydrochloride Tablets contain The active substance(s) is Oxybutynin Hydrochloride/ Oxybutynin Chloride BP/Ph.Eur. The other ingredients are: Lactose monohydrate, Microcrystalline cellulose, Calcium stearate, Indigo carmine (aluminium lake) E132 What Oxybutynin Hydrochloride Tablets look like and contents of the pack Description: Oxybutynin Hydrochloride Tablets 2.5 mg: Blue, biconvex, uncoated capsule-shaped tablets, marked "OB" scoreline "2.5" on one side and plain on the other side. Oxybutynin Hydrochloride Tablets 5 mg: Blue, round, biconvex, uncoated tablets, marked "OB" breakline "5" on one side and plain on the other side. Contents of pack: Blister pack containing 56 or 84 tablets. 7 tablets in a blister, 8 or 12 blisters in a carton. Marketing Authorisation Holder and Manufacturer Strides Pharma UK Ltd. Unit 4, The Metro Centre, Dwight Road, Watford , WD18 9SS United Kingdom, This leaflet was last revised in March 2026.

180 x 320 mm

Back Page

12034

NON PRINTING COLOUR Oxybutynin Hydrochloride 2.5 mg / 5 mg Strides Pharma UK Ltd.

Pack Insert —-

180 x 320 mm 1054350

1047065

Black PC-ODF/2026/103 – Record Number: 487438 Front & Back Page Printing. To be supplied in the folded size of 180 x 160 mm. 60 GSM Paper PRINTING CLARITY TO BE CLEAR AND SHARP.

1 8.0

12034

Frequently asked questions about Oxybutynin Hydrochloride Tablets 2.5 mg

How do I take Oxybutynin Hydrochloride Tablets 2.5 mg?

Oxybutynin Hydrochloride Tablets 2.5 mg comes as tablet containing 2.5mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.

What is the active substance in Oxybutynin Hydrochloride Tablets 2.5 mg?

The active substance in Oxybutynin Hydrochloride Tablets 2.5 mg is oxybutynin hydrochloride.

Are there equivalent medicines to Oxybutynin Hydrochloride Tablets 2.5 mg?

Medicines with the same active substance, strength and form include: Ditropan 2.5mg Tablets, Oxybutynin Hydrochloride 2.5mg Tablets. They are interchangeable only if your prescriber or pharmacist says so.

Where does this information come from?

This leaflet reproduces the patient information leaflet approved for Oxybutynin Hydrochloride Tablets 2.5 mg, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.

Can I get Oxybutynin Hydrochloride Tablets 2.5 mg without a prescription?

Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.

About this leaflet

The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Oxybutynin hydrochloride (16 medicines)
See every medicine containing this substance, or browse the full A–Z of active substances.
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

Adults

Urinary incontinence, urgency and frequency in unstable bladder conditions due to idiopathic detrusor instability (motor urge incontinence) or neurogenic bladder disorders (detrusor hyperreflexia) in conditions such as multiple sclerosis and spina bifida.

Paediatric population

Oxybutynin hydrochloride is indicated in children over 5 years of age for:

• Urinary incontinence, urgency and frequency in unstable bladder conditions due to idiopathic overactive bladder or neurogenic bladder disorders (detrusor over activity)

• Nocturnal enuresis associated with detrusor over activity, in conjunction with non-drug therapy, when other treatment has failed

4.2. Posology and method of administration

The dosage should be adapted individually. Unless otherwise specified, the following recommendations apply:

Adults

The usual initial dose is 2.5mg three times a day. This dose may be increased to a maximum dose of 5mg four times a day to obtain a clinical response provided that the side effects are well-tolerated.

Elderly (including frail elderly)

A lower dose is recommended because the elimination half-life is increased in the elderly. A dose of 2.5mg twice a day is likely to be adequate, particularly if the patient is frail. This dose may be increased if necessary to 5mg twice a day provided that the side effects are well tolerated.

Children (under 5 years of age)

Not recommended

Children (over 5 years of age)

Neurogenic bladder instability: The usual dose is 2.5mg twice a day. Thereafter, the lowest effective dose should be selected. The maximum dose, which is related to body weight (0.3 – 0.4 mg / kg / day), is expressed in the following table:

Age

Dosage

5-9 years

2.5 mg three times daily

9-12 years

5 mg 2 times daily

Over 12 years

5 mg three times daily

Nocturnal enuresis: The usual dose is 2.5mg twice a day. This dose may be increased, if necessary, to 5mg two or three times daily provided that the side effects are well-tolerated. The last dose should be given before bedtime.

Method of administration

Oral use.

The tablets are swallowed with plenty of fluid (approx. 1 glass of water), also recommended because the tablets have an unpleasant taste.

The duration of treatment is guided by the occurrence of symptoms.

4.3. Contraindications

Oxybutynin hydrochloride tablets are contraindicated in patients with:

- hypersensitivity to oxybutynin hydrochloride or any of the excipients listed in section 6.1.

- myasthenia gravis

- narrow-angle glaucoma or shallow anterior chamber.

- pollakiuria or nycturia due to cardiac or renal insufficiency.

- gastrointestinal obstruction including pyloric stenosis, paralytic ileus and intestinal atony.

- ileostomy, colostomy, toxic megacolon, severe ulcerative colitis.

- bladder flow obstruction where urinary retention may be precipitated.

- porphyria

- frequent urination at night caused by heart or kidney disease

- hiatus hernia with reflux oesophagitis

4.4. Special warnings and precautions for use

Oxybutynin hydrochloride tablets should be used with caution in the frail elderly and children who may be more sensitive to the effects of the product and in patients with autonomic neuropathy (such as those with Parkinson's disease), severe gastrointestinal motility disorders, hepatic or renal impairment and hiatus hernia or other severe gastro-intestinal motility disorders (also see section 4.3).

Anticholinergics should be used with caution in elderly patients due to the risk of cognitive impairment.

Gastrointestinal disorders: Anticholinergic medicinal products may decrease gastrointestinal motility and should be used with caution in patients with gastrointestinal obstructive disorders, intestinal atony and ulcerative colitis.

Oxybutynin may aggravate tachycardia (and thus be cautious in case of hyperthyroidism, congestive heart failure, cardiac arrhythmia, coronary heart disease, hypertension), cognitive disorders and symptoms of prostatic hypertrophy.

Anticholinergic central nervous system (CNS) effects (e.g. hallucinations, agitation, confusion, somnolence) have been reported; monitoring recommended especially in first few months after initiating therapy or increasing the dose; consider discontinuing therapy or reducing the dose if anticholinergic CNS effects develop.

Since oxybutynin can cause narrow-angle glaucoma, patients should be advised to contact a physician immediately if they are aware of a sudden loss of visual acuity or ocular pain.

In the event of a urinary tract infection during treatment with oxybutynin, appropriate antibacterial treatment must be initiated.

Oxybutynin may reduce salivary secretions which could result in dental caries, parodontosis or oral candidiasis. Regular dental check-ups are therefore advisable during long-term treatment.

Anticholinergic medicinal products should be used with caution in patients who have hiatus hernia/gastro-oesophageal reflux and/or who are concurrently taking medicinal products (such as bisphosphonates) that can cause or exacerbate oesophagitis.

When oxybutynin is used in high environmental temperatures, this can cause heat prostration due to decreased sweating.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Paediatric population

The use of oxybutynin in children under 5 years of age is not recommended; it has not been established whether oxybutynin can be safely used in this age group.

There is limited evidence supporting the use of oxybutynin in children with monosymptomatic nocturnal enuresis (not related to detrusor over activity).

In children over 5 years of age, oxybutynin hydrochloride should be used with caution as they may be more sensitive to the effects of the product, particularly the CNS and psychiatric adverse reactions.

4.5. Interaction with other medicinal products and other forms of interaction

Enhanced effect with other anticholinergics

Care should be taken if other anticholinergic agents are administered together with oxybutynin, as potentiation of anticholinergic effects may occur Concomitant treatment can also lead to confusion in the elderly.

The anticholinergic activity of oxybutynin is increased by concurrent use of other anticholinergics or medicinal products with anticholinergic activity, such as amantadine and other anticholinergic anti-Parkinsonian medicinal products (e.g. biperiden, levodopa), antihistamines, antipsychotics (e.g. phenothiazines, butyrophenones, clozapine), quinidine, digitalis, tricyclic antidepressants, atropine and related compounds like atropinic antispasmodics and dipyridamole.

By reducing gastric motility, oxybutynin may affect the absorption of other drugs. Oxybutynin is metabolised by cytochrome P 450 isoenzyme CYP 3A4. Concomitant administration with a CYP3A4 inhibitor can inhibit oxybutynin metabolism and increase oxybutynin exposure (e.g. ketoconazole, itraconazole, erythromycin). Oxybutynin may antagonise prokinetic therapies (e.g. metoclopramide and domperidone).

Concomitant use with cholinesterase inhibitors may result in reduced cholinesterase inhibitor efficacy.

Patients should be informed that alcohol may enhance the drowsiness caused by anticholinergic agents such as oxybutynin (see section 4.7).

Reduced effect due to oxybutynin

By reducing gastric motility, Oxybutynin may affect the absorption of other drugs. Oxybutynin may also counteract the gastrointestinal effect if metoclopramide and domperidone.

Mutual Effect Mitigation

Oxybutynin is metabolised by cytochrome P 450 isoenzyme CYP 3A4. Concomitant administration with a CYP 3A4 inhibitor can inhibit oxybutynin metabolism and increase oxybutynin exposure (e.g. ketoconazole, itraconazole, erythromycin).

Other interactions

The ability to dissolve sublingual tablets under the tongue may be worsened due to dry mouth. Patients who take sublingual nitrates must therefore be advised to moisten their mouth with their tongue or with a little water before taking a sublingual tablet.

An interaction has been demonstrated between oxybutynin and itraconazole, which leads to a doubling of plasma oxybutynin levels but only a 10% increase in levels of the active metabolite. This appears to be of minor clinical significance.

4.6. Fertility, pregnancy and lactation

Pregnancy:

There are no adequate data from the use of oxybutynin in pregnant women. Studies in animals have shown minor reproductive toxicity (see section 5.3). Animal studies are insufficient with respect to effects on pregnancy, embryonic / foetal development, parturition or postnatal development (see section 5.3). The potential risk for humans is unknown. Oxybutynin should not be used in pregnancy unless clearly necessary.

Breast-feeding:

Oxybutynin in small amount is excreted in breast milk during lactation. Oxybutynin should not be used during breast-feeding.

Fertility:

There are no data regarding effects on human fertility. Studies in animals have shown impaired fertility in females.

4.7. Effects on ability to drive and use machines

Oxybutynin hydrochloride tablets can cause drowsiness or blurred vision and patients should be cautioned regarding activities requiring mental alertness such as driving, operating machinery or performing hazardous work.

4.8. Undesirable effects

In clinical trials involving more than 3000 patients exposed to oxybutynin hydrochloride, side effects were caused mainly by anticholinergic effects of oxybutynin. Dry mouth was the most commonly reported side effect.

Frequency of adverse reactions is based on safety data from clinical studies with oxybutynin hydrochloride 2.5 mg and 5 mg, and the experience gained after the drug has been marketed.

Classification of expected frequencies:

Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); not known (cannot be estimated from the available data).

The following adverse events (marked with an asterisk *), which has not been observed in clinical trials but reported after the drug has been marketed, has been ranked in the frequency of "rare/unknown".

Very Common

Common

Uncommon

Rare

Not Known

Infections and infestations

urinary tract infection

Immune System Disorders

hypersensitivity

Psychiatric disorders

confusional state

Restlessness*, disorientation, concentration difficulties, excitation.

Agitation anxiety, hallucinations, nightmares*, paranoia, agitation, cognitive disorders in elderly, symptoms of depression, dependence to oxybutynin (in patients with history of drug or substance abuse)

Nervous System Disorders

somnolence, fatigue, headache, dizziness

drowsiness

Cognitive disorders*, convulsions*, disorientation

Eye disorders

decreased tear production /Dry eyes

light hypersensitivity

Narrow angle closure glaucoma*, mydriasis, ocular hypertension, blurred vision

Cardiac disorders

palpitation

cardiac arrhythmias, tachycardia

Vascular disorders

flushing which may be more marked in children

Gastrointestinal Disorders

dry mouth, nausea, constipation

diarrhoea, vomiting, dyspepsia

anorexia, dysphagia, abdominal discomfort/pain, decreased appetite

gastroesophageal reflux disease, pseudo-obstruction in patients at risk (elderly or patients with constipation and treated with other drugs that decrease intestinal motility)

Skin and subcutaneous tissue disorders

dry skin/ decreased sweating

phototoxicity

angioedema, rash, urticaria, hypohidrosis,

Renal and urinary disorders

Urinary retention

difficulty in micturition

Reproductive system and breast disorders

erectile dysfunction*

Injury, poisoning and procedural complications

heat stroke

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9. Overdose

The symptoms of over dosage with oxybutynin progress from an intensification of the usual side effects of CNS disturbances (from restlessness confusion, hallucinations including psychotic behaviour, ataxia, bewilderment, nervousness), circulatory changes (hot feeling, flushing, fall in blood pressure, light-headedness, circulatory failure, arrhythmia, tachycardia, facial redness.), respiratory failure, paralysis and coma.

Measures to be taken are:

1. Immediate gastric lavage and administration of actual charcoal

2. Physostigmine by slow intravenous injection

Adults: 0.5 to 2.0 mg of physostigmine by slow intravenous administration. Repeat after 5 minutes, if necessary up to a maximum total dose of 5mg.

Children: 30 micrograms/kg of physostigmine by slow intravenous administration. Repeat after 5 minutes, if necessary up to a maximum total dose of 2mg.

Fever should be treated symptomatically with tepid sponging or ice packs.

In pronounced restlessness or excitation, diazepam 10mg may be given by intravenous injection, tachycardia may be treated by intravenous injection of propranolol and urinary retention can be managed by bladder catheterisation.

In the event of progression of the curare-like effect to the paralysis of the respiratory muscles, mechanical ventilation will be required.

💬 Ask about this leaflet

Ask anything about Oxybutynin Hydrochloride Tablets 2.5 mg. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.

Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.

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