Trospium / Xanomeline
Xanomeline and trospium (Cobenfy) is a combination oral medication used to treat schizophrenia in adults.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Trospium / Xanomeline: Patient Information Guide
A plain-language walkthrough of Trospium / Xanomeline — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Xanomeline/trospium is a combination medicine approved for a specific use in adults:
- Cobenfy (oral capsule) is indicated for the treatment of schizophrenia in adults.
⚙️How it works▾
Cobenfy works through a mechanism that is different from traditional antipsychotics. Xanomeline activates muscarinic acetylcholine receptors — particularly M1 and M4 subtypes — in the central nervous system (brain and spinal cord). Although the exact reason this helps schizophrenia is still not fully understood, this receptor activation is thought to be responsible for the drug's effectiveness. Trospium chloride, the second ingredient, blocks muscarinic receptors in the rest of the body (peripheral tissues), reducing the gut and bladder side effects that xanomeline would otherwise cause on its own.
💊How it's taken▾
Cobenfy is taken as an oral capsule twice daily, on an empty stomach — at least one hour before a meal or two hours after eating. Food, especially high-fat meals, can substantially reduce the absorption of trospium. Do not open the capsules. Your prescriber will start you at a lower strength and increase the dose gradually based on how you tolerate it; older adults are typically kept at a lower maximum dose. If you miss a dose, follow your prescriber's guidance — do not double up without being told to.
🤒Side effects — in detail▾
The most common side effects reported with Cobenfy include:
- Nausea
- Indigestion (dyspepsia)
- Constipation
- Vomiting
- High blood pressure
- Abdominal pain
- Diarrhea
- Fast heart rate (tachycardia)
- Dizziness
- Gastroesophageal reflux disease (acid reflux)
Serious reactions requiring prompt medical attention include urinary retention, angioedema (severe swelling of the face, tongue, or throat), significant liver injury (jaundice, severe itching, high liver enzymes), and a persistently fast heart rate. Stop taking Cobenfy and seek care right away if any of these occur.
⚠️Warnings & precautions▾
- Urinary retention: Cobenfy can make it difficult or impossible to urinate, especially in older adults and people with prostate or bladder problems. Monitor for urinary hesitancy, weak stream, or incomplete emptying.
- Liver problems: Cobenfy is contraindicated in moderate to severe liver disease. Liver enzymes and bilirubin should be checked before starting and periodically during treatment. Discontinue if signs of serious liver injury appear.
- Gallbladder and biliary disease: Cobenfy may cause transient increases in liver enzymes due to biliary contraction. It is not recommended for people with active gallstone symptoms. Report indigestion, nausea, vomiting, or upper abdominal pain to your doctor promptly.
- Angioedema: Rare but potentially life-threatening swelling of the face, lips, tongue, or throat has been reported — even after the first dose. Seek emergency help immediately.
- Increased heart rate: Heart rate should be checked at baseline and monitored during treatment.
- Kidney impairment: Cobenfy is not recommended in moderate or severe kidney impairment due to increased trospium exposure and heightened anticholinergic side effects.
- CNS effects: Dizziness and other nervous system effects may occur. Avoid driving or operating heavy machinery until you know how Cobenfy affects you.
- Narrow-angle glaucoma: Cobenfy can dilate the pupils and may trigger an acute attack in people with anatomically narrow angles. It is contraindicated in untreated narrow-angle glaucoma.
🔀What it interacts with▾
Cobenfy can interact with several types of medications — tell your prescriber and pharmacist about everything you take:
- Strong CYP2D6 inhibitors (e.g., certain antidepressants): Can increase xanomeline levels, raising the risk of side effects.
- Drugs eliminated by active tubular secretion (certain antibiotics, diabetes drugs): Compete with trospium for kidney elimination, potentially raising levels of either drug.
- Oral CYP3A4-sensitive drugs (e.g., some statins, immunosuppressants): Xanomeline locally inhibits this enzyme in the gut, which can raise blood levels of these drugs.
- Oral P-glycoprotein substrate drugs: Xanomeline transiently inhibits this gut transporter, potentially increasing absorption of co-administered drugs.
- Other antimuscarinic (anticholinergic) drugs: Combining with Cobenfy can amplify side effects like dry mouth, constipation, and urinary retention.
- Any oral medication: Because Cobenfy can slow gut motility, absorption of other drugs taken at the same time may be affected.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Do not take Cobenfy if you already have urinary retention.
- Do not take it if you have moderate or severe hepatic impairment (liver disease); it is also not recommended with mild liver impairment.
- Do not take it if you have gastric retention (food/liquid not moving through the stomach).
- Do not take it if you have untreated narrow-angle glaucoma.
- Do not take it if you have ever had a hypersensitivity reaction (including angioedema) to Cobenfy or trospium chloride.
- Use with extra caution if you have kidney disease — Cobenfy is not recommended with moderate or severe renal impairment; even mild impairment raises drug levels.
- Older adults face a higher risk of urinary retention and need a lower maximum dose and slower titration.
- Tell your doctor if you have ulcerative colitis, intestinal atony, or myasthenia gravis — use with caution in these conditions.
- If you are pregnant or planning to become pregnant, discuss the risks with your doctor; animal studies showed developmental toxicity at high doses. A pregnancy registry is available (1-866-961-2388).
- It is not known whether Cobenfy passes into human breast milk — discuss with your doctor before breastfeeding.
- Safety and effectiveness in children have not been established.
🚑If you take too much▾
Taking too much Cobenfy can cause a mix of cholinergic symptoms (from too much xanomeline activity) such as seizures, vomiting, diarrhea, excessive sweating, excessive saliva, and low blood pressure — or anticholinergic symptoms (from too much trospium effect) such as delirium, agitation, slurred speech, fast heart rate, dry mouth and eyes, blurred vision, and urinary retention. Older adults may be more susceptible to the anticholinergic effects. If an overdose is suspected, call the Poison Help Line at 1-800-222-1222 or seek emergency medical care immediately.
📡Pharmacodynamics — effects in the body▾
Xanomeline binds to all five muscarinic receptor subtypes (M1 through M5) but shows stronger activating (agonist) activity at M1 and M4 receptors in the brain. Trospium chloride blocks muscarinic receptors in peripheral tissues (outside the brain), counteracting unwanted body-wide effects of xanomeline. At the maximum recommended dose, Cobenfy does not meaningfully prolong the QT interval (the heart's electrical recovery time), which means it is not expected to cause a dangerous heart rhythm abnormality through that mechanism.
🔬Pharmacokinetics — how your body processes it▾
After an oral dose of Cobenfy, xanomeline reaches peak blood levels in about 2 hours and trospium in about 1 hour; both reach steady-state levels within 3 to 5 days of regular dosing. Food significantly reduces trospium absorption (by 85–90% with any meal) but has a smaller effect on xanomeline, which is why Cobenfy must be taken on an empty stomach. Xanomeline is metabolized primarily by liver enzymes (CYP2D6, 2B6, 1A2, 2C9, and 2C19), while trospium is mainly eliminated unchanged by the kidneys. Higher drug levels occur in people with kidney or liver impairment, which is why dose adjustments or avoidance may be needed in those groups.
📦How to store it▾
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) .
📄 Written from Trospium / Xanomeline’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Trospium / Xanomeline — the kind of thing our pharmacy team would talk through with you at the counter.
What is Cobenfy actually for? ▾
How do I take Cobenfy, and does it matter if I eat first? ▾
What side effects are most likely, and which ones should I call my doctor about right away? ▾
I'm older — is there anything special I should know? ▾
Can I take Cobenfy with my other medications? ▾
Is it safe to take Cobenfy if I'm pregnant or breastfeeding? ▾
Is Trospium / Xanomeline available over the counter? ▾
When was Trospium / Xanomeline first available? ▾
Who makes Trospium / Xanomeline? ▾
💬 Answers drafted from Trospium / Xanomeline’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Trospium / Xanomeline comes
Trospium / Xanomeline is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Capsule
How this form is used
- Cobenfy capsules are indicated for the treatment of schizophrenia in adults.
- Cobenfy capsules are taken by mouth twice daily.
- Cobenfy should be taken at least 1 hour before a meal or at least 2 hours after a meal — food significantly reduces absorption of trospium.
- Do not open Cobenfy capsules.
- Cobenfy is started at a lower dose and gradually increased; older adults have a lower recommended maximum dose — follow your prescriber's titration schedule.
📊 Trospium / Xanomeline across the U.S. market
How Trospium / Xanomeline appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Kit (4) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Trospium / Xanomeline is used
A general measure of how commonly Trospium / Xanomeline is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Trospium / Xanomeline is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Trospium / Xanomeline prescribed? Of the 1,596 medications we measure, Trospium / Xanomeline ranks #705 by Medicaid prescriptions — more than 56% of them.
Utilization by Trospium / Xanomeline product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
trospium chloride 20 MG / xanomeline 100 MG Oral Capsule Most dispensed
Summed across the 1 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2694989
trospium chloride 20 MG / xanomeline 50 MG Oral Capsule
Summed across the 1 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2694843
trospium chloride 30 MG / xanomeline 125 MG Oral Capsule
Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2694853
Other Trospium / Xanomeline products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)
Summed across the 1 of 2 listed NDC products with Medicaid activity.
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Trospium / Xanomeline, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 4 of 18 listed Trospium / Xanomeline NDCs with Medicaid activity.
🔍 Compare Trospium / Xanomeline products
A representative set of FDA-listed product records for Trospium / Xanomeline — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Capsule | ||||
| TROSPIUM CHLORIDE 20 mg/1; XANOMELINE TARTRATE 100 mg | — | Catalent Pharma Solutions, LLC | DRUG FOR FURTHER PROCESSING | View NDC → |
| XANOMELINE TARTRATE 50 mg/1; TROSPIUM CHLORIDE 20 mg | — | Catalent Pharma Solutions, LLC | DRUG FOR FURTHER PROCESSING | View NDC → |
| XANOMELINE TARTRATE 125 mg/1; TROSPIUM CHLORIDE 30 mg | — | Catalent Pharma Solutions, LLC | DRUG FOR FURTHER PROCESSING | View NDC → |
| XANOMELINE 20 mg/1; TROSPIUM CHLORIDE 50 mg | Oral | E.R. Squibb & Sons, L.L.C. | NDA | View NDC → |
| XANOMELINE 20 mg/1; TROSPIUM CHLORIDE 100 mg | Oral | E.R. Squibb & Sons, L.L.C. | NDA | View NDC → |
| XANOMELINE 30 mg/1; TROSPIUM CHLORIDE 125 mg | Oral | E.R. Squibb & Sons, L.L.C. | NDA | View NDC → |
| XANOMELINE 50 mg/1; TROSPIUM CHLORIDE 20 mg | Oral | E.R. Squibb & Sons, L.L.C. | NDA | View NDC → |
| XANOMELINE 100 mg/1; TROSPIUM CHLORIDE 20 mg | Oral | E.R. Squibb & Sons, L.L.C. | NDA | View NDC → |
| XANOMELINE 125 mg/1; TROSPIUM CHLORIDE 30 mg | Oral | E.R. Squibb & Sons, L.L.C. | NDA | View NDC → |
| 💊Kits | ||||
| — | — | E.R. Squibb & Sons, L.L.C. × 4 listings | NDA | View NDC → |
Showing 13 of 13 products — FDA National Drug Code Directory. See every product, package size and price: browse all 13 Trospium / Xanomeline NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Trospium / Xanomeline — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Trospium / Xanomeline in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Trospium / Xanomeline went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one exact multiple-ingredient concept (MIN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). A product with a different ingredient combination belongs on a different page.
RxCUI 2694836 1 dose form · 3 strengths
-
Dose form (SCDF) Oral Capsule RxCUI 2694839In current FDA listingsClinical drug / strength (SCD) trospium chloride 20 MG / xanomeline 100 MGRxCUI 2694989trospium chloride 20 MG / xanomeline 50 MGRxCUI 2694843trospium chloride 30 MG / xanomeline 125 MGRxCUI 2694853
Look up RxCUI 2694836 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Trospium / Xanomeline is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Trospium / Xanomeline belongs to the Cholinergic Muscarinic Antagonist class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. E.R. Squibb & Sons, L.L.C. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.