Prescription medication · Anticholinergic (Overactive Bladder)
tolterodine
Also sold as Detrol. This medicine treats overactive bladder.
Data updated 2026-05-15
- 6,323
- FDA reportsLightly reported
- 15
- InteractionsSeveral interactions
- 1
- Recall record
What the data shows
tolterodine (Detrol) is a prescription Anticholinergic (Overactive Bladder), reported less often than most tracked drugs (6,323 FDA reports), with 15 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
tolterodine (Detrol) is a prescription Anticholinergic (Overactive Bladder). This medicine treats overactive bladder.
Tolterodine extended-release capsules help control an overactive bladder. It reduces the feeling of needing to go to the bathroom often.
Verify with FDA → · CMS NADAC pricing →
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.
The sections below are summarized in plain English from tolterodine's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
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.
Side Effects (from patient reports)
Based on 6,323 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for tolterodine, by number of reports
- Fall
Fall
408 reports
- Fatigue
Fatigue
406 reports
- Dizziness
Dizziness
309 reports
- Diarrhoea
Diarrhoea
308 reports
- Nausea
Nausea
308 reports
- Headache
Headache
269 reports
- Dyspnoea
Dyspnoea
240 reports
- Drug Interaction
Drug Interaction
234 reports
- Vomiting
Vomiting
222 reports
- Asthenia
Asthenia
216 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for tolterodine each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where tolterodine sits
tolterodine has more FDA adverse-event reports than 29% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is tolterodine; the line is the median (50th percentile).
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
Reports Mentioning Death
449
7.1% of reports — not proof of cause
Hospitalization Reports
1,986
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 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 |
| 15 | CONSTIPATION | 192 |
| 16 | PNEUMONIA | 180 |
| 17 | CONFUSIONAL STATE | 170 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: 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.
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,...
Mechanism: Tolterodine does not change how the body processes omeprazole, meaning they do not have a meaningful interaction.
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.
( 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.
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.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
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?
What pregnancy or breastfeeding source fields are listed for tolterodine?
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
Related Medications in Anticholinergic (Overactive Bladder)
Other drugs grouped near tolterodine - same-class peers and common alternatives.
alfuzosin
Uroxatral
Alfuzosin is a medicine that helps men with enlarged prostate glands.
Compare with tolterodine →
bethanechol
Urecholine
Bethanechol helps you to urinate if you have trouble emptying your bladder.
Compare with tolterodine →
darifenacin
Enablex
Darifenacin (Enablex) is a medicine that helps control an overactive bladder.
Compare with tolterodine →
dutasteride
Avodart
Dutasteride and tamsulosin hydrochloride capsules contain two medicines to treat enlarged prostate in men.
Compare with tolterodine →
dutasteride/tamsulosin
Jalyn
This medicine combines two drugs to treat enlarged prostate in men.
Compare with tolterodine →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for tolterodine: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 6,323.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 7.10%.
- umeclidinium Δ 0.01 pts · 8,530 reports · Long-Acting Muscarinic Antagonist (LAMA) 7.09%death share
- penicillin V Δ 0.03 pts · 2,398 reports · Natural Penicillin 7.13%death share
- golimumab Δ 0.06 pts · 82,622 reports · TNF-Alpha Inhibitor (Biologic) 7.16%death share
- brodalumab Δ 0.06 pts · 1,890 reports · Anti-IL-17 Receptor Monoclonal Antibody 7.04%death share
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
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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 6,323 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 are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
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. This registry does not provide medication decisions.
Last updated: December 14, 2024
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
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