tolterodine
Brand names: Detrol
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.
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
Age Distribution
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
Reactions in Hospitalization Reports
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.
Common Questions
Can I drive while taking tolterodine?
What should I do if I have difficulty breathing after taking tolterodine?
Can I take tolterodine if I have glaucoma?
What if I have kidney problems?
What if I have liver problems?
Can I take tolterodine with other medicines?
What are the signs of an allergic reaction?
How long does it take for tolterodine to start working?
Can I drink alcohol while taking tolterodine?
What should I do if I experience severe constipation?
What are the common side effects of tolterodine?
Does tolterodine interact with other medications?
What drug class is tolterodine?
Is tolterodine safe during pregnancy?
Has tolterodine been recalled?
Active Recalls
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
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Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
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Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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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
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- FDA Orange Book — approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed — NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) — post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm — standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files — federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database — current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages