PlainMeds provides educational information only. This is not medical advice. Always consult your doctor or pharmacist.

tolterodine

Verify with FDA → · CMS NADAC pricing →

Brand names: Detrol

Anticholinergic (Overactive Bladder) Rx

Tolterodine extended-release capsules help control an overactive bladder. It reduces the feeling of needing to go to the bathroom often.

Drug Pricing (NADAC)

Generic Price

$0.36/unit

Generic Available

Yes (12 manufacturers)

Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →

What it does

This medicine treats overactive bladder.

Common side effects

Dry mouth, Headache, Constipation

Key warnings

Anaphylaxis and angioedema (severe allergic reactions) have happened with this drug.

How It Works

Tolterodine belongs to a class of drugs called antimuscarinics. It works by blocking certain nerve signals to the bladder. This helps to relax the bladder muscles and reduce the urge to urinate.

How to Take It

Take one capsule of tolterodine each day. Swallow the capsule whole with water. You can take it with or without food. Your doctor may lower your dose to 2 mg daily based on how you respond to the medicine.

Pregnancy & Breastfeeding

It is not known if tolterodine is safe to use during pregnancy. Talk to your doctor if you are pregnant or plan to become pregnant. It is also not known if tolterodine passes into breast milk. Talk to your doctor about the best way to feed your baby if you are taking this medicine.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule.

Storage

Store tolterodine capsules at room temperature (68°–77°F) and protect them from light.

Side Effects (from patient reports)

Based on 3,169 FDA adverse event reports.

The medicine is not working
466
Falling down
407
Feeling tired
406
Feeling lightheaded
309
Loose stools
308
Feeling sick to your stomach
308
Pain in your head
269
Difficulty breathing
240
The medicine is interacting with another medicine
234
Throwing up
222

FDA Adverse Event Report Analysis

Detailed analysis of 6,323 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2003–2025.

Total Reports

6,323

Death-Related Reports

449

Hospitalization Reports

1,986

Top Indication

Product Used For Unknown Indication

Gender Distribution

Female 3,997 (69%)
Male 1,755 (30%)

Age Distribution

0–17 57
18–44 355
45–64 1,283
65–74 1,131
75+ 1,350

Most Reported Adverse Reactions (FAERS)

# Reaction Reports
1 DRUG INEFFECTIVE 466
2 FALL 408
3 FATIGUE 406
4 DIZZINESS 309
5 DIARRHOEA 308
6 NAUSEA 308
7 HEADACHE 269
8 DYSPNOEA 240
9 DRUG INTERACTION 234
10 VOMITING 222
11 ASTHENIA 216
12 PAIN 212
13 URINARY TRACT INFECTION 204
14 OFF LABEL USE 202
15 CONSTIPATION 192

Reactions in Death Reports

DEATH 151
PNEUMONIA 40
COMPLETED SUICIDE 35
FALL 27
ASTHENIA 20
DYSPNOEA 19
URINARY TRACT INFECTION 19
RESPIRATORY FAILURE 18
SEPSIS 17
CARDIAC ARREST 16

Reactions in Hospitalization Reports

FALL 238
PNEUMONIA 148
VOMITING 129
DIARRHOEA 114
URINARY TRACT INFECTION 114
CONFUSIONAL STATE 111
ASTHENIA 108
NAUSEA 106
DYSPNOEA 102
DIZZINESS 99

Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation

Serious Warnings

Anaphylaxis and angioedema (severe allergic reactions) have happened with this drug. These reactions can cause difficulty breathing and require emergency treatment. Use caution if you have bladder problems, gastrointestinal issues, or glaucoma. This medicine can cause sleepiness, so be careful driving or operating heavy machinery.

Known Drug Interactions

Lurasidone: [See Contraindications ( 4.7 )] Antispasmodics: Tolterodine (patients deficient in CYP2D6 activity) Use With Caution Tolterodine: The primary route of metabolism for tolterodine is via CYP2D6. In this population subset, inhibition of CYP3A results in significantly higher serum concentrations of tolterodine. Tolterodine 1 mg twice daily is recommended in patients deficient in CYP2D6 activity (poor metabolizers) when co-administered with clarithromycin.

Mechanism: Clarithromycin stops the body from breaking down tolterodine, leading to higher levels of the drug in your system. This is more likely to happen if your body already processes certain medicines slowly.

What to do: Your doctor should lower your tolterodine dose to 1 mg twice a day if you are taking these together.

7.4 Other Drugs Metabolized by Cytochrome P450 Isoenzymes In vivo drug-interaction data show that tolterodine immediate release does not result in clinically relevant inhibition of CYP1A2, 2D6, 2C9, 2C19, or 3A4 as evidenced by lack of influence on the marker drugs caffeine, debrisoquine, S-warfarin, and omeprazole [see Clinical Pharmacology (12.3) ] . In vivo drug-interaction data show that tolterodine immediate release does not result in clinically relevant inhibition of CYP1A2, 2D6, 2C9, 2C19, or 3A4 as evidenced by lack of influence on the marker drugs caffeine, debrisoquine, S-warfarin...

Mechanism: Tolterodine does not change how the body processes omeprazole, meaning they do not have a meaningful interaction.

What to do: You can take these medications together as prescribed without needing any special dose changes.

Diuretics Coadministration of tolterodine immediate release up to 8 mg (4 mg bid) for up to 12 weeks with diuretic agents, such as indapamide, hydrochlorothiazide, triamterene, bendroflumethiazide, chlorothiazide, methylchlorothiazide, or furosemide, did not cause any adverse electrocardiographic (ECG) effects.

Mechanism: Studies show that taking these two drugs together does not cause any dangerous changes to your heart rhythm.

What to do: No dosage adjustments are necessary when using these two medications at the same time.

( 7.6 ) 7.1 Potent CYP2D6 Inhibitors Fluoxetine, a potent inhibitor of CYP2D6 activity, significantly inhibited the metabolism of tolterodine immediate release in CYP2D6 extensive metabolizers, resulting in a 4.8-fold increase in tolterodine AUC. No dose adjustment is required when tolterodine and fluoxetine are co-administered [see Clinical Pharmacology (12.3) ] . Drug Interactions Potent CYP2D6 Inhibitors Fluoxetine is a selective serotonin reuptake inhibitor and a potent inhibitor of CYP2D6 activity.

Mechanism: Fluoxetine slows down the process your body uses to get rid of tolterodine, leading to higher levels of the drug in your blood.

What to do: Even though drug levels increase, your doctor does not need to change your dose when these are used together.

Diuretics Coadministration of tolterodine immediate release up to 8 mg (4 mg bid) for up to 12 weeks with diuretic agents, such as indapamide, hydrochlorothiazide, triamterene, bendroflumethiazide, chlorothiazide, methylchlorothiazide, or furosemide, did not cause any adverse electrocardiographic (ECG) effects.

Mechanism: There is no known interaction between these drugs, and they do not cause any harmful effects on the heart when taken together.

What to do: You can continue taking both medications as prescribed without any special monitoring.

Check all your medications →

Common Questions

Can I drive while taking tolterodine?
Tolterodine can cause dizziness or sleepiness. Do not drive or operate heavy machinery until you know how it affects you.
What should I do if I have difficulty breathing after taking tolterodine?
Stop taking tolterodine and get medical help right away.
Can I take tolterodine if I have glaucoma?
Use caution if you are being treated for narrow-angle glaucoma.
What if I have kidney problems?
If you have severe kidney problems, your doctor may prescribe a lower dose.
What if I have liver problems?
If you have mild to moderate liver problems, your doctor may prescribe a lower dose. This medicine is not recommended for severe liver problems.
Can I take tolterodine with other medicines?
Tell your doctor about all the medicines you take, including prescription and over-the-counter drugs, vitamins, and herbal supplements.
What are the signs of an allergic reaction?
Signs of an allergic reaction may include rash, itching, swelling, dizziness, and trouble breathing.
How long does it take for tolterodine to start working?
It may take a few weeks to see the full effects of tolterodine.
Can I drink alcohol while taking tolterodine?
Alcohol may worsen some side effects of tolterodine, such as dizziness and sleepiness. Talk to your doctor about whether it is safe for you to drink alcohol while taking this medicine.
What should I do if I experience severe constipation?
Talk to your doctor if you experience severe constipation. They may recommend a stool softener or other treatment.
What are the common side effects of tolterodine?
The most commonly reported side effects of tolterodine include Dry mouth, Headache, Constipation, Abdominal pain. Based on 3,169 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does tolterodine interact with other medications?
Yes, tolterodine has 15 known drug interactions. Notable interactions include clarithromycin, omeprazole, hydrochlorothiazide. Always inform your doctor about all medications you are taking.
What drug class is tolterodine?
tolterodine belongs to the Anticholinergic (Overactive Bladder) drug class. It requires a prescription (Rx). This medicine treats overactive bladder.
Is tolterodine safe during pregnancy?
It is not known if tolterodine is safe to use during pregnancy. Talk to your doctor if you are pregnant or plan to become pregnant. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.
Has tolterodine been recalled?
There is 1 recall associated with tolterodine products. Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution. Check the recalls section below for full details and affected products.

Active Recalls

Class III March 4, 2025

Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Related Medications in Anticholinergic (Overactive Bladder)

Other drugs grouped near tolterodine — same-class peers and common alternatives.

Compare tolterodine vs alfuzosin side-by-side →

Medication Guides

Related Health & Safety Data

Save on tolterodine

Compare prices and find discounts at pharmacies near you. Free coupons can save up to 80% on prescriptions.

Disclosure: This link may earn us a commission at no extra cost to you. See our terms.

What the FDA Data Shows for tolterodine

The FDA label for tolterodine (sold under brand names such as Detrol) classifies it as a prescription-only medication in the Anticholinergic (Overactive Bladder) class. This medicine treats overactive bladder. Official labeling lists 4 commonly reported side effects, including Dry mouth, Headache, Constipation.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 3,169 voluntary reports. The database also lists 15 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS shows a generic unit cost of $0.36.

Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 1 recall record on file), and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.

Data Sources

Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).

FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.

Last updated: December 14, 2024

All federal data sources used on this page