Pharmacologic class (EPC) · 24 drug pages

Anticholinergic: adverse event reports filed with FDA

159,807 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.

159,807
reports across the class: 0.8% of all reports; 5,641
reports, 12 months to June 2026: 7,404 in the 12 months before; 39.6%
marked serious by the reporter: 57.4% across all reports; 24
drugs with a page: brand and generic names counted separately

Anticholinergic is a pharmacologic class (an FDA Established Pharmacologic Class) with 24 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 159,807 adverse event reports received by FDA, 0.8% of the database, from January 2004 to June 2026.

5,641 reports arrived in the 12 months to June 2026, down 24% from 7,404 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 39.6% of the class's reports are marked serious, 6.3% record death among the outcomes and 20.2% record hospitalisation, as reported.

Across the class the reactions recorded most often are dyspnoea (17.3%), incorrect route of drug administration (14.6%) and drug ineffective (9.1%). 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
Tiotropium bromide	generic	76,917	616	32.3%	Incorrect route of drug administration
Trelegy ElliptaFluticasone furoate, umeclidinium bromide and vilanterol trifenatate	brand	26,795	2,472	35.1%	Dyspnoea
Anoro ElliptaUmeclidinium bromide and vilanterol trifenatate	brand	12,554	346	26.3%	Dyspnoea
Ipratropium bromide	generic	8,310	400	80.2%	Asthma
Spiriva RespimatTiotropium bromide inhalation spray	brand	5,581	246	49.3%	Dyspnoea
Incruse ElliptaUmeclidinium	brand	4,575	129	36.1%	Dyspnoea
Tudorza PressairAclidinium bromide	brand	3,858	8	32.1%	Device malfunction
Stiolto RespimatTiotropium bromide and olodaterol	brand	2,899	172	25.2%	Dyspnoea
Atropine	generic	2,386	160	95.7%	Drug ineffective
Glycopyrrolate	generic	2,225	258	92.3%	Dyspnoea
Transderm ScopScopolamine	brand	1,498	15	43%	Nausea
Benztropine	generic	1,492	167	94.2%	Completed suicide
Bevespi AerosphereGlycopyrrolate and formoterol fumarate	brand	1,467	62	35.6%	Dyspnoea
Scopolamine	generic	1,260	125	68.6%	Off label use
Atropine sulfate	generic	1,168	47	84.7%	Drug ineffective
Aclidinium bromide	generic	1,013	63	98.6%	Asthma
LomotilDiphenoxylate hydrochloride and atropine sulfate	brand	836	15	55.7%	Drug ineffective
QbrexzaGlycopyrronium	brand	800	30	12.6%	Mydriasis
Ipratropium bromide and albuterol sulfate	generic	747	41	23.6%	Drug ineffective
AtroventIpratropium bromide	brand	734	34	43.6%	Bronchitis
Benztropine mesylate	generic	727	27	85.6%	Completed suicide
DicyclomineDicyclomine hydrochloride	brand	721	73	72.1%	Completed suicide
Tropicamide	generic	670	52	78.8%	Eye pain
Combivent RespimatIpratropium bromide and albuterol	brand	574	83	35.2%	Dyspnoea

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

Dyspnoeashortness of breath17.3%27,629
Incorrect route of drug administrationthe medicine was given by the wrong route14.6%23,299
Drug ineffectivethe medicine did not work as expected9.1%14,506
Asthmaasthma8.2%13,165
Coughcough6.8%10,847
Wheezingwheezing6.2%9,880
Off label useused for a purpose or in a way not on the label4.6%7,342
Pneumonialung infection4.6%7,326
Chronic obstructive pulmonary diseaseCOPD, a long-term lung disease4.5%7,245
Therapeutic product effect incomplete4.4%6,960
Product quality issuea problem with the product itself4.4%6,953
Wrong technique in device usage process3.5%5,630
Loss of personal independence in daily activities3.3%5,274
Product dose omission issuea dose was missed2.9%4,658
Deaththe patient died; cause not stated by this term2.8%4,533
Obstructive airways disorder2.8%4,500
Product complaint2.8%4,407
Productive cougha cough with phlegm2.8%4,399
Sleep disorder due to a general medical condition2.7%4,332
Malaisegeneral feeling of being unwell2.6%4,128
Condition aggravatedthe condition being treated got worse2.5%4,029
Chest discomfortchest discomfort2.5%3,963
Dysphoniaa hoarse voice2.2%3,525
Dry mouthdry mouth2.2%3,484
Dizzinesslight-headedness or unsteadiness2.1%3,372

Solid bar: share of all class reports. Hollow bar: the median share across the 24 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death6.3%9,997

Life-threatening2.1%3,291

Hospitalisation (initial or prolonged)20.2%32,264

Disability1.2%1,858

Congenital anomaly0.3%493

Other serious25.2%40,246

Not serious60.4%96,548

Patient age

Under 20.3%403

2 to 110.4%567

12 to 170.3%500

18 to 443.5%5,518

45 to 6413.3%21,194

65 to 7414.1%22,483

75 and over15.1%24,154

Age not given53.2%84,988

Who reported

Physician10.8%17,317

Pharmacist5.7%9,039

Other health professional9.8%15,629

Lawyer0%32

Consumer or non-health professional70.6%112,816

Not given3.1%4,974

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 Anticholinergic reports

Which drugs are in the Anticholinergic class on this site?

Tiotropium bromide, Trelegy Ellipta, Anoro Ellipta, Ipratropium bromide, Spiriva Respimat and Incruse Ellipta and 18 more. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

159,807 reports through June 2026, 5,641 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?

dyspnoea (17.3%), incorrect route of drug administration (14.6%), drug ineffective (9.1%), asthma (8.2%) and cough (6.8%).

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.