Pharmacologic class (EPC) · 8 drug pages

Cholinesterase inhibitor: adverse event reports filed with FDA

25,719 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.

25,719
reports across the class: 0.1% of all reports; 968
reports, 12 months to June 2026: 979 in the 12 months before; 88.6%
marked serious by the reporter: 57.4% across all reports; 8
drugs with a page: brand and generic names counted separately

Cholinesterase inhibitor is a pharmacologic class (an FDA Established Pharmacologic Class) with 8 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 25,719 adverse event reports received by FDA, 0.1% of the database, from January 2004 to June 2026.

968 reports arrived in the 12 months to June 2026, close to the 979 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 88.6% of the class's reports are marked serious, 23% record death among the outcomes and 36.9% record hospitalisation, as reported.

Across the class the reactions recorded most often are death (9.9%), fall (9.2%) and vomiting (5.2%). 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
ExelonRivastigmine	brand	13,663	265	92.6%	Death
AriceptDonepezil hydrochloride	brand	4,043	43	83.2%	Fall
Rivastigmine	generic	2,602	257	76.4%	Product adhesion issue
Donepezil hydrochloride	generic	1,569	136	92%	Drug interaction
Galantamine hydrobromide	generic	1,163	28	96.7%	Fall
MestinonPyridostigmine bromide	brand	960	49	71.7%	Diarrhoea
PyridostigminePyridostigmine bromide oral	brand	930	153	84.5%	Drug ineffective
Galantamine	generic	789	37	95.1%	Fall

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

Deaththe patient died; cause not stated by this term9.9%2,534
Falla fall9.2%2,378
Vomitingbeing sick5.2%1,328
Nauseafeeling sick5.1%1,312
Drug ineffectivethe medicine did not work as expected4.6%1,182
Confusional stateconfusion4.5%1,168
Dizzinesslight-headedness or unsteadiness4.4%1,124
Malaisegeneral feeling of being unwell4.3%1,103
Diarrhoealoose or frequent stools4.3%1,101
Cognitive disorderproblems with thinking or memory4%1,027
Drug interactionan interaction between medicines3.9%992
Hypotensionlow blood pressure3.8%974
Balance disorderproblems with balance3.4%874
Astheniaweakness or lack of energy3.4%863
Painpain, site not specified3.3%851
Pneumonialung infection3.3%837
Constipationconstipation3.2%820
Depressed level of consciousness3%783
Hallucinationseeing or hearing things that are not there3%761
Orthostatic hypotension2.9%757
Memory impairmentmemory problems2.8%731
Off label useused for a purpose or in a way not on the label2.8%731
Mobility decreasedreduced ability to move about2.8%729
Condition aggravatedthe condition being treated got worse2.8%712
Dyspnoeashortness of breath2.8%711

Solid bar: share of all class reports. Hollow bar: the median share across the 8 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death23%5,925

Life-threatening5.3%1,353

Hospitalisation (initial or prolonged)36.9%9,497

Disability2.3%582

Congenital anomaly0%9

Other serious49.8%12,803

Not serious11.4%2,925

Patient age

Under 20.1%24

2 to 110.2%41

12 to 170.1%31

18 to 441.5%381

45 to 644.9%1,258

65 to 7410.1%2,603

75 and over40.3%10,356

Age not given42.9%11,025

Who reported

Physician28.1%7,236

Pharmacist7%1,798

Other health professional21.8%5,616

Lawyer0%5

Consumer or non-health professional38.7%9,958

Not given4.3%1,106

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 Cholinesterase inhibitor reports

Which drugs are in the Cholinesterase inhibitor class on this site?

Exelon, Aricept, Rivastigmine, Donepezil hydrochloride, Galantamine hydrobromide and Mestinon and 2 more. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

25,719 reports through June 2026, 968 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?

death (9.9%), fall (9.2%), vomiting (5.2%), nausea (5.1%) and drug ineffective (4.6%).

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.