Pharmacologic class (EPC) · 4 drug pages

Cholinergic receptor agonist: adverse event reports filed with FDA

6,746 reports list a drug in this class as a suspect or interacting product, 2007–2026.

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.

6,746
reports across the class: 0% of all reports; 1,035
reports, 12 months to June 2026: 558 in the 12 months before; 19.5%
marked serious by the reporter: 57.4% across all reports; 4
drugs with a page: brand and generic names counted separately

Cholinergic receptor agonist is a pharmacologic class (an FDA Established Pharmacologic Class) with 4 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 6,746 adverse event reports received by FDA, 0% of the database, from January 2007 to June 2026.

1,035 reports arrived in the 12 months to June 2026, up 85% from 558 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 19.5% of the class's reports are marked serious, 0.7% record death among the outcomes and 4.3% record hospitalisation, as reported.

Across the class the reactions recorded most often are sneezing (11%), drug ineffective (10.2%) and headache (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
Varenicline	generic	2,680	335	38.2%	Nausea
TyrvayaVarenicline	brand	2,608	95	5.7%	Sneezing
VuityPilocarpine hydrochloride	brand	862	9	14.3%	Headache
VizzAceclidine	brand	596	596	3.4%	Ocular hyperaemia

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

Sneezing11%739
Drug ineffectivethe medicine did not work as expected10.2%689
Headachehead pain9.1%613
Nauseafeeling sick8.8%597
Visual impairmentreduced vision5.8%394
Ocular hyperaemiaa red eye5.7%385
Depressionlow mood5.2%354
Vomitingbeing sick5.2%354
Vision blurredblurred vision4.2%282
Nasal discomfort3.9%263
Product delivery mechanism issue3.7%251
Rhinorrhoeaa runny nose3.4%228
Suicidal ideationthoughts of suicide3.3%221
Abnormal dreamsunusual dreams3.2%214
Nightmarenightmares3.1%210
Instillation site irritation3.1%209
Dizzinesslight-headedness or unsteadiness3%201
Insomniadifficulty sleeping2.7%183
Eye irritationeye irritation2.7%180
Throat irritationan irritated throat2.6%176
Coughcough2.5%171
Epistaxisnosebleed2.5%170
Agitationrestlessness2.3%156
Anxietyanxiety2%138
Off label useused for a purpose or in a way not on the label2%134

Solid bar: share of all class reports. Hollow bar: the median share across the 4 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death0.7%46

Life-threatening1.1%73

Hospitalisation (initial or prolonged)4.3%291

Disability0.7%50

Congenital anomaly0%2

Other serious15.3%1,030

Not serious80.5%5,431

Patient age

Under 20%1

2 to 110%1

12 to 170.1%5

18 to 446.8%459

45 to 6427.9%1,881

65 to 749.6%648

75 and over4.6%311

Age not given51%3,440

Who reported

Physician12.6%852

Pharmacist22.7%1,532

Other health professional13.4%901

Lawyer0%3

Consumer or non-health professional50.6%3,414

Not given0.7%44

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 receptor agonist reports

Which drugs are in the Cholinergic receptor agonist class on this site?

Varenicline, Tyrvaya, Vuity and Vizz. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

6,746 reports through June 2026, 1,035 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?

sneezing (11%), drug ineffective (10.2%), headache (9.1%), nausea (8.8%) and visual impairment (5.8%).

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.