What the label lists and what reports show
Trospium and xanomeline side effects
Trospium and xanomeline's FDA label: “Most common adverse reactions (incidence ≥ 5% and at least twice placebo) were nausea, dyspepsia, constipation, vomiting, hypertension, abdominal pain, diarrhea, tachycardia, dizziness, and gastrointestinal reflux disease.” FAERS holds 2,089 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is nausea (441 reports).
- No generic listed
Check it at the source: the trospium and xanomeline FDA label on DailyMed (effective January 16, 2026, E.R. Squibb & Sons, L.L.C.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of COBENFY?COBENFY may cause serious side effects, including: • Problems with emptying your bladder (urinary retention). See “Do not take COBENFY if you:” COBENFY may cause your bladder to not empty completely or not empty at all. You are at increased risk for urinary retention if you are elderly, have a blockage in your bladder, have an enlarged prostate called benign prostatic hyperplasia (BPH), have bladder emptying problems from diabetes, or are taking higher doses of COBENFY. Urinary retention may increase your risk for getting a urinary tract infection. […]
Source: FDA drug label, NDA216158 (Bristol-Myers), as published by E.R. Squibb & Sons, L.L.C., effective January 16, 2026 (SPL set 8f0e73bf-6025-44f6-ab64-0983322de0df), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence ≥ 5% and at least twice placebo) were nausea, dyspepsia, constipation, vomiting, hypertension, abdominal pain, diarrhea, tachycardia, dizziness, and gastrointestinal reflux disease.
Table 1: Adverse Reactions Reported in ≥2% of COBENFY-Treated Patients and Greater than Rate of Placebo in Two 5-week Schizophrenia Trials
| Reaction | COBENFY (N=251) | Placebo (N=253) |
|---|---|---|
| Nausea | 19% | 4% |
| Dyspepsia a | 18% | 5% |
| Constipation | 17% | 7% |
| Vomiting | 15% | 1% |
| Hypertension b | 11% | 2% |
| Abdominal Pain c | 8% | 4% |
| Diarrhea | 6% | 2% |
| Tachycardia d | 5% | 2% |
| Dizziness | 5% | 2% |
| Gastroesophageal reflux disease | 5% | <1% |
| Dry mouth | 4% | 2% |
| Somnolence | 3% | 2% |
| Vision blurred | 3% | 0% |
| Salivary hypersecretion | 2% | 0% |
| Orthostatic hypotension | 2% | 1% |
| Cough e | 2% | 1% |
| Extrapyramidal symptoms (EPS), non-akathisia f | 2% | <1% |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are described elsewhere in the labeling: • Risk of Urinary Retention [see Warnings and Precautions (5.1) ] • Risk of Use in Patients with Hepatic Impairment [see Warnings and Precautions (5.2) ] • Risk of Use in Patients with Biliary Disease [see Warnings and Precautions (5.3) ] • Decreased Gastrointestinal Motility [see Warnings and Precautions (5.4) ] • Risk of Angioedema [see Warnings and Precautions (5.5) ] • Risk of Use in Patients with Narrow-angle Glaucoma [see Warnings and Precautions (5.6) ] • Increases in Heart Rate [see Warnings and Precautions (5.7) ] • Anticholinergic Adverse Reactions in Patients with Renal Impairment [see Warnings and Precautions (5.8) ] • Central Nervous System Effects [see Warnings and Precautions (5.9) ] Most common adverse reactions (incidence ≥ 5% and at least twice placebo) were nausea, dyspepsia, constipation, vomiting, hypertension, abdominal pain, diarrhea, tachycardia, dizziness, and gastrointestinal reflux disease. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers Squibb at 1-800-721-5072 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …
Source: FDA drug label, NDA216158 (Bristol-Myers), as published by E.R. Squibb & Sons, L.L.C., effective January 16, 2026 (SPL set 8f0e73bf-6025-44f6-ab64-0983322de0df), via openFDA; the full label on DailyMed
What do FAERS reports show?
2,089 reports list trospium and xanomeline among the medicines taken, each a report of something that happened, not proof the medicine caused it; 26 are coded as a death and 189 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2025 (1,254, against a median of 0 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 23 reactions below, 15 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Trospium and xanomeline: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions