Drug Safety Information for EXELON (Rivastigmine tartrate)

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

Adverse Drug Reactions for EXELON* (Rivastigmine tartrate)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with EXELON
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Death1447
2Fall926
3Confusional state702
4Vomiting*654
5Nausea*539
6Pneumonia528
7Dizziness471
8Cerebrovascular accident450
9Malaise437
10Diarrhoea388
11Hallucination*386
12Dementia alzheimer's type373
13Agitation371
14Asthenia365
15Urinary tract infection333
16Somnolence333
17Memory impairment329
18Aggression323
19Drug ineffective320
20Weight decreased*318

* This side effect also appears in "Top 10 Side Effects of EXELON " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking EXELON
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Dementia alzheimer's type15762
2Dementia*3966
3Product used for unknown indication1889
4Memory impairment1589
5Parkinson's disease735
6Amnesia490
7Dementia with lewy bodies325
8Senile dementia304
9Cognitive disorder299
10Nervous system disorder147

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for EXELON

Total Reports Filed with FDA: 41481


Number of FDA Adverse Event Reports by Patient Age for EXELON

Total Reports Filed with FDA: 41481*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Rivastigmine tartrate (Ena 713, Exelon, Rivastigmine)

Charts are based on 41481 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and EXELON Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.