Pharmacologic class (EPC) · 9 drug pages

Cholinergic muscarinic antagonist: adverse event reports filed with FDA

18,647 reports list a drug in this class as a suspect or interacting product, 2004–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

18,647
reports across the class: 0.1% of all reports; 699
reports, 12 months to June 2026: 633 in the 12 months before; 39.8%
marked serious by the reporter: 57.4% across all reports; 9
drugs with a page: brand and generic names counted separately

Cholinergic muscarinic antagonist is a pharmacologic class (an FDA Established Pharmacologic Class) with 9 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 18,647 adverse event reports received by FDA, 0.1% of the database, from January 2004 to June 2026.

699 reports arrived in the 12 months to June 2026, up 10% from 633 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 39.8% of the class's reports are marked serious, 4.2% record death among the outcomes and 13.5% record hospitalisation, as reported.

Across the class the reactions recorded most often are drug ineffective (24.4%), dry mouth (6.5%) and application site erythema (4.9%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is 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."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
Oxytrol for WomenOxybutynin	brand	6,283	80	0.9%	Drug ineffective
DetrolTolterodine tartrate	brand	4,851	15	55.8%	Drug ineffective
Oxybutynin	generic	2,996	178	61.8%	Drug ineffective
Oxybutynin chloride	generic	1,133	52	59.9%	Drug ineffective
Tolterodine tartrate	generic	942	7	63.9%	Drug ineffective
OxytrolOxybutynin	brand	803	125	23%	Drug ineffective
Solifenacin succinate	generic	575	137	87.7%	Hypotension
Tolterodine	generic	552	47	82.2%	Drug interaction
Trospium chloride	generic	512	58	72.7%	Faecaloma

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."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Drug ineffectivethe medicine did not work as expected24.4%4,549
Dry mouthdry mouth6.5%1,209
Application site erythemaredness where the product was applied4.9%912
Constipationconstipation4.5%832
Product adhesion issue4.3%801
Off label useused for a purpose or in a way not on the label4.1%768
Drug effect decreasedthe medicine had less effect3.8%707
Pruritusitching3.6%670
Dizzinesslight-headedness or unsteadiness3.6%663
Erythemaskin redness3.3%607
Application site pruritusitching where the product was applied3.2%602
Headachehead pain3.1%582
Drug interactionan interaction between medicines2.6%493
Painpain, site not specified2.6%484
Rashskin rash2.5%473
Nauseafeeling sick2.5%469
Falla fall2.3%425
Product quality issuea problem with the product itself2.2%404
Malaisegeneral feeling of being unwell2.1%398
Urinary retentionbeing unable to empty the bladder2%376
Pollakiuriapassing urine more often2%371
Fatiguetiredness1.9%350
Application site rash1.8%339
Confusional stateconfusion1.8%336
Condition aggravatedthe condition being treated got worse1.8%333

Solid bar: share of all class reports. Hollow bar: the median share across the 9 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death4.2%778

Life-threatening1.5%283

Hospitalisation (initial or prolonged)13.5%2,512

Disability1.6%292

Congenital anomaly0.2%37

Other serious29.3%5,460

Not serious60.2%11,234

Patient age

Under 20.1%24

2 to 111%179

12 to 170.4%83

18 to 443.4%635

45 to 6413.1%2,452

65 to 7412.1%2,249

75 and over16.4%3,060

Age not given53.4%9,965

Who reported

Physician11.2%2,094

Pharmacist4.5%830

Other health professional12.3%2,302

Lawyer0%8

Consumer or non-health professional66.4%12,384

Not given5.5%1,029

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Cholinergic muscarinic antagonist reports

Which drugs are in the Cholinergic muscarinic antagonist class on this site?

Oxytrol for Women, Detrol, Oxybutynin, Oxybutynin chloride, Tolterodine tartrate and Oxytrol and 3 more. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

18,647 reports through June 2026, 699 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

drug ineffective (24.4%), dry mouth (6.5%), application site erythema (4.9%), constipation (4.5%) and product adhesion issue (4.3%).

Can the members table be used to rank the drugs?

No. 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." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. 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 class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. 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.