FDA Adverse Events Reports (FAERS) Summary for EXELON

These tables and charts are based on 17,828 total reports for EXELON (RIVASTIGMINE TARTRATE) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through July 30, 2026.

This FAERS total includes 17,736 pharmaceutical company-submitted and non-U.S. FAERS reports and 92 U.S. consumer or healthcare provider-submitted MedWatch reports. Adverse events listed on this page represent serious and sometimes rare adverse events reported to pharmaceutical companies, and often do not represent typical side effects for the medication. Find common side effects in the most recent official drug label.

For a separate summary of the 92 U.S. reports filed via the FDA MedWatch voluntary reporting system, view our FDA MedWatch EXELON summary report. (See notes section below for explanation of FDA’s mandatory and voluntary reporting system.)

Top 20 Adverse Effects Associated with EXELON (reported in FAERS Database)

 Side Effect# of FDA Reports
1DEATH2725
2FALL1424
3CONFUSIONAL STATE973
4PNEUMONIA889
5VOMITING885
6MALAISE837
7NAUSEA768
8HALLUCINATION747
9DRUG INEFFECTIVE704
10DIZZINESS686
11STROKE675
12LACK OF STRENGTH AND ENERGY (ASTHENIA)631
13MEMORY IMPAIRMENT627
14WEIGHT DECREASED595
15GAIT DISTURBANCE573
16URINARY TRACT INFECTION569
17DIARRHEA568
18DEMENTIA553
19DROWSINESS552
20DEMENTIA ALZHEIMER^S TYPE545

Latest Known Outcomes for Reactions Reported for EXELON

Latest Known Outcome for Reported ReactionsNumber of Cases
1Unknown Outcome6481
2Patient died3788
3Patient recovered2875
4Patient has not recovered/symtoms have not resolved2550
5Patient is recovering/symptoms resolving1607
6Patient has recovered but has consequent health issues113

Yearly FDA Adverse Event Reports (Table)

YearNumber of Reports
20001
20014
2004313
2005226
2006191
2007214
2008630
2009908
2010916
20111304
20121782
20131485
20141379
20151475
20161652
20171287
2018929
2019630
2020514
2021420
2022412
2023343
2024234
2025397
2026182

Reports by Patient Age Group (Table)

Age GroupNumber of Reports
0-1010
11-204
21-306
31-4017
41-5058
51-60230
61-701091
71-803196
81-903772
91+781

Based on 9165 reports that included a patient age.

EXELON Total Reports

 Male    Female    Unknown    Total  
 7545    9528    755    17,828  

Top Countries Reporting

 Country  Number of Reports
United States  3579
Brazil  2846
Japan  1088
Mexico  1022
France  546
Germany  308
Bangladesh  272
Argentina  217
Canada  167
10 India  146

Outcomes for Reports

Serious: 15938
Not Serious: 1890
Note: A serious outcome means the adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition.

Top Indications      
Product used for unknown indication
Dementia Alzheimer's type
Dementia
Dementia with Lewy bodies
Senile dementia

Top Companies Reporting

   SANDOZ

Safety-Related FDA Updates

FDA Approval Date: 2000-04-21

EXELON (RIVASTIGMINE TARTRATE) Rx Drug:
Safety-related Labeling Changes


Have experience (good or bad) with EXELON? Rate EXELON at Ask a Patient.

For serious adverse events, report them to the FDA by contacting the drug manufacturer or report directly through the MedWatch voluntary reporting form.

Notes

Events listed on this page represent serious and often rare adverse events reported to pharmaceutical companies, and do not represent typical side effects for the medication. Find common side effects on the most recent official drug label This report, created by AskaPatient.com, is derived from the cases for EXELON reported to the United States Food and Drug Administration (FDA) FDA Safety Information and Adverse Event Reporting System (FAERS) and obtained from Open FDA. Data was last updated with reports received through July 30, 2026.

This summary includes ALL reports where the drug is a "primary OR secondary OR suspected interacting" drug. Typically, reports are filed for the most serious type or "event" and do not represent incidental or minor side effects. The majority of these reports are mandatory reports submitted by pharmaceutical companies, who receive complaints from consumers. The reactions, side effects, or "adverse events," represent up to the 20 most frequently occuring events in the database for a drug related to the event. This report also features counts of latest known outcomes associated with reported side effects, but does not provide the specific outcomes for specific adverse events.

Adverse Event Reports are submitted to the FAERS database by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers). Health care providers such as doctors (voluntary reporting), and patients themselves (voluntary reporting) report to the FDA directly through the MedWatch program. Those MedWatch reports are coded and included in the FAERS database. This report mainly consists of the mandatory reports, because the MedWatch reports are a small percentage (3 - 5%) of total reports. Link to the MedWatch summary report at the top of the page for a summary of the directly reported (voluntary) adverse events for this drug.The number of reports included here might differ somewhat from the number of reports in the downloadable quarterly FAERS reports and in the online FAERS dashboard, due to lags in reporting, drug name differences, duplicates, and other factors. Open FDA states that it only includes the most recent version of a case report. It also adds the disclaimer: "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."

FDA uses the "MedDRA" classification system to describe reported adverse reactions. MedDRA is a standardized medical terminology that facilitates sharing of regulatory information internationally. In some cases, "patient friendly" terms for the layman designated by MedDRA have been substituted for medical jargon. Please contact us with questions or comments about this report.