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rivastigmine Side Effects

Also known as: Exelon

Analysis of 17,976 adverse event reports submitted to the FDA from 2000 to 2025.

Total Reports

17,976

Death-Related

4,544

25.3% of reports

Hospitalizations

6,537

36.4% of reports

Top Indication

Product Used For Unknown Indication

Most Reported Adverse Reactions

DEATH
2,177
FALL
1,664
HALLUCINATION
1,365
CONFUSIONAL STATE
1,258
DRUG INEFFECTIVE
896
VOMITING
885
NAUSEA
827
DIZZINESS
771
GAIT DISTURBANCE
713
PNEUMONIA
690
MALAISE
648
SOMNOLENCE
646
DIARRHOEA
640
FATIGUE
637
URINARY TRACT INFECTION
610
ASTHENIA
609
CONDITION AGGRAVATED
584
WEIGHT DECREASED
576
TREMOR
571
PARKINSON^S DISEASE
567

Who Reports Side Effects

Gender Distribution

Female 8,646 (51%)
Male 8,286 (49%)
Unknown 25

Age Distribution

0-17 53 (1%)
18-44 39 (0%)
45-64 734 (7%)
65-74 2,514 (24%)
75+ 7,025 (68%)

Reporting Trend by Year

2000 2025

Reactions in Death Reports

Top reactions reported in 4,544 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
DEATH 2,177
PNEUMONIA 348
FALL 238
GENERAL PHYSICAL HEALTH DETERIORATION 183
PARKINSON^S DISEASE 178
CEREBROVASCULAR ACCIDENT 165
CARDIAC ARREST 164
HALLUCINATION 141
DEMENTIA 136
DYSPHAGIA 134
CARDIO-RESPIRATORY ARREST 127
URINARY TRACT INFECTION 127
OFF LABEL USE 116
ASTHENIA 114
CONDITION AGGRAVATED 114
MYOCARDIAL INFARCTION 113
CONFUSIONAL STATE 110
RESPIRATORY FAILURE 109
DRUG INEFFECTIVE 105
SEPSIS 103

Reactions in Hospitalization Reports

Top reactions in 6,537 reports where hospitalization was an outcome.

Reaction Reports
FALL 1,004
CONFUSIONAL STATE 554
PNEUMONIA 475
HALLUCINATION 457
URINARY TRACT INFECTION 435
VOMITING 426
NAUSEA 339
GENERAL PHYSICAL HEALTH DETERIORATION 324
ASTHENIA 320
DIARRHOEA 294
MALAISE 293
DEHYDRATION 283
GAIT DISTURBANCE 282
DIZZINESS 274
WEIGHT DECREASED 270
DEATH 269
FATIGUE 264
AGITATION 263
AGGRESSION 259
SOMNOLENCE 258

Nearby — Related Medications

Compare rivastigmine vs acamprosate →

What the FAERS Data Reveals About rivastigmine Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 17,976 voluntary reports linked to rivastigmine and its brand equivalents (Exelon), spanning 2000 through 2025. Of those, 4,544 (25.3%) listed death as an outcome and 6,537 (36.4%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.

Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 51% were female and 49% male; age distribution skews toward 75+, with 7,025 reports in that bracket. The single most reported reaction is death with 2,177 submissions, followed by fall and hallucination.

FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.