Drugs › Cholinergic muscarinic antagonist
Generic name
Trospium chloride: adverse event reports filed with FDA
512 reports list it as a suspect or interacting product, 2004–2026. Class: Cholinergic muscarinic antagonist. Also reported as Trospium Chloride Er, Trospium Chloride Tablets, Trospium Chloride Extended Release.
- 512
- reports as suspect product
- 0% of all reports · about 23 a year
- 58
- reports, 12 months to June 2026
- 73 in the 12 months before
- 72.7%
- marked serious by the reporter
- 39.8% across the class
- 4.9%
- record death among outcomes, as reported
- 25 reports · not verified by FDA
Between January 2004 and June 2026, 512 adverse event reports received by FDA list trospium chloride, a generic name as a suspect or interacting product. Reports that mention it only as a concomitant medication (1,808) are left out of every figure here.
In the 12 months to June 2026, 58 reports listed it, down 21% from 73 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 23 reports a year and 0% of the 20,646,523 reports in the database, and 2.7% of the reports for the cholinergic muscarinic antagonist class. How many people take it is not in the data, so a count is not a rate of occurrence.
Reporters most often recorded faecaloma (8.4%), drug ineffective (8%) and acute kidney injury (7.6%). A report can list several reactions, so shares add to more than 100%; 248 different terms appear across these reports. Faecaloma is recorded in 8.4% of these reports, with no counterpart in the median cholinergic muscarinic antagonist drug (0%).
72.7% of the reports are marked serious by the reporter (39.8% across the class); 4.9% record death among the outcomes and 41% record hospitalisation, as reported. 38.5% of the reports came from consumers, and the largest patient age group is 75 and over (26.8%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Trospium chloride reports recording the termmedian drug in cholinergic muscarinic antagonist
- Faecaloma8.4%43
- Drug ineffectivethe medicine did not work as expected8%41
- Acute kidney injurysudden loss of kidney function7.6%39
- Urinary retentionbeing unable to empty the bladder7.6%39
- Falla fall7.2%37
- General physical health deteriorationgeneral decline in health7%36
- Oedema peripheralswelling of the legs, ankles or hands6.6%34
- Myocardial infarctionheart attack6.3%32
- Vomitingbeing sick6.3%32
- Aortic valve stenosis6.1%31
- Arthralgiajoint pain5.9%30
- Hyponatraemialow blood sodium5.9%30
- Anaemialow red blood cells5.7%29
- Haematuriablood in the urine5.7%29
- Urinary tract infectionbladder or urinary infection5.7%29
- Decreased appetitereduced appetite5.5%28
- Cardiogenic shockshock from the heart failing to pump5.3%27
- Dyspepsiaindigestion5.3%27
- Eructation5.3%27
- Gait disturbancedifficulty walking5.3%27
- Gastrointestinal haemorrhagebleeding in the stomach or bowel5.3%27
- Groin pain5.3%27
- Joint dislocationa dislocated joint5.3%27
- Pulmonary hypertensionhigh pressure in the lung arteries5.3%27
- Diverticulum intestinal5.1%26
- Dry mouthdry mouth5.1%26
- Dyspnoeashortness of breath5.1%26
- Escherichia infection5.1%26
- Peripheral swellingswelling of the arms or legs5.1%26
Top 30 of 248 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 9 drugs in the cholinergic muscarinic antagonist class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 18,647 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 36.3% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Urinary incontinence | 66 | 12.9% |
| Hypertonic bladder | 28 | 5.5% |
| Micturition urgency | 24 | 4.7% |
| Neurogenic bladder | 6 | 1.2% |
| Cystitis interstitial | 5 | 1% |
| Micturition disorder | 4 | 0.8% |
The indication field is filled in by the reporter and is often blank; shares are of all 512 reports.
In context
| Measure | Trospium chloride | Cholinergic muscarinic antagonist | All reports |
|---|---|---|---|
| Reports as suspect product | 512 | 18,647 | 20,646,523 |
| Share of that pool | — | 2.7% | 0% |
| Reports, latest 12 months | 58 | — | 1,332,454 |
| Marked serious | 72.7% | 39.8% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 49 | 42 | 91 |
| Hospitalisation recorded, per 1,000 reports | 410 | 135 | 213 |
| Consumer-filed share | 38.5% | 66.4% | 45.8% |
| Top term, share of reports | Faecaloma 8.4% | median 0% | 0% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Other drugs in the cholinergic muscarinic antagonist class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Oxytrol for Women | brand | 6,283 | 80 | 0.9% |
| Detrol | brand | 4,851 | 15 | 55.8% |
| Oxybutynin | generic | 2,996 | 178 | 61.8% |
| Oxybutynin chloride | generic | 1,133 | 52 | 59.9% |
| Tolterodine tartrate | generic | 942 | 7 | 63.9% |
| Oxytrol | brand | 803 | 125 | 23% |
| Solifenacin succinate | generic | 575 | 137 | 87.7% |
| Tolterodine | generic | 552 | 47 | 82.2% |
Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.
Questions about Trospium chloride reports
How many adverse event reports has FDA received for Trospium chloride?
512 reports list Trospium chloride as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 58 of them arrived in the latest 12 months. Another 1,808 list it only as a concomitant medication.
What reactions are recorded in Trospium chloride reports?
faecaloma (8.4%), drug ineffective (8%), acute kidney injury (7.6%), urinary retention (7.6%) and fall (7.2%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Trospium chloride was responsible.
How serious are the reports?
72.7% are marked serious by the reporter. Among the outcomes recorded, 4.9% of reports include death and 41% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
consumer or non-health professional (38.5%), physician (26.8%) and pharmacist (17.4%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Trospium chloride rising?
58 reports in the 12 months to June 2026, down 21% from 73 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Trospium chloride was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Trospium chloride?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Trospium chloride as a suspect or interacting product; reports listing it only as a concomitant medication (1,808) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.