What the label lists and what reports show
Rivastigmine side effects
Rivastigmine's FDA label: “Most common adverse reactions (greater than 5% and 2 times greater than placebo): nausea, vomiting, anorexia, dyspepsia, and asthenia ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc.” FAERS holds 19,159 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is fall (1,792 reports).
- Generic listed
- A presentation discontinued
Check it at the source: the rivastigmine FDA label on DailyMed (effective June 19, 2024, Aurobindo Pharma Limited); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of EXELON PATCH?EXELON PATCH may cause serious side effects, including: • Medication overdose. Hospitalization and rarely death may happen when people accidently wear more than 1 patch at the same time. It is important that the old EXELON PATCH be removed before you apply a new one. Do not wear more than 1 EXELON PATCH at a time. • Stomach or bowel (intestinal) problems, including: o nausea o vomiting o diarrhea o dehydration o loss of appetite o weight loss o bleeding in your stomach (ulcers) • Skin reactions. Some people have had a serious skin reaction called allergic contact dermatitis (ACD) when using EXELON PATCH. Stop using EXELON PATCH and call your healthcare provider right away if you experience reactions that spread beyond the patch size, are intense in nature and do not improve within 48 hours after the patch is removed. […]
Source: FDA drug label (Exelon), Sandoz Inc, effective May 8, 2024 (SPL set b6ed6d15-116d-4596-92ce-3414574d7ba0), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (greater than 5% and 2 times greater than placebo): nausea, vomiting, anorexia, dyspepsia, and asthenia ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc.
Table 2: Proportion of Adverse Reactions Observed with a Frequency of ≥2% and at a Rate Greater than Placebo in Clinical Trials
This table is printed in the Rivastigmine Tartrate label published by Chartwell RX, LLC of October 6, 2023; the label quoted above does not print one.
| Body System/Adverse Reaction | Rivastigmine tartrate capsules (6 to 12 mg/day) (n=1,189) | Placebo (n=868) |
|---|---|---|
| Percent of Patients with any Adverse Event | 92 | 79 |
| Increased Sweating | 4 | 1 |
| Syncope | 3 | 2 |
| Fatigue | 9 | 5 |
| Asthenia | 6 | 2 |
| Malaise | 5 | 2 |
| Decreased Weight | 3 | <1 |
| Hypertension | 3 | 2 |
| Dizziness | 21 | 11 |
| Headache | 17 | 12 |
| Somnolence | 5 | 3 |
| Tremor | 4 | 1 |
| Nausea | 47 | 12 |
| Vomiting | 31 | 6 |
| Diarrhea | 19 | 11 |
| Anorexia | 17 | 3 |
| Abdominal Pain | 13 | 6 |
| Dyspepsia | 9 | 4 |
| Insomnia | 9 | 7 |
| Confusion | 8 | 7 |
| Depression | 6 | 4 |
| Anxiety | 5 | 3 |
| Hallucination | 4 | 3 |
| Aggressive Reaction | 3 | 2 |
| Urinary Tract Infection | 7 | 6 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following adverse reactions are described below and elsewhere in the labeling: Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.1) ] Allergic Dermatitis [see Warnings and Precautions (5.2) ] Other Adverse Reactions from Increased Cholinergic Activity [see Warnings and Precautions (5.3) ] Most common adverse reactions (greater than 5% and 2 times greater than placebo): nausea, vomiting, anorexia, dyspepsia, and asthenia ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Rivastigmine tartrate has been administered to over 5,297 individuals during clinical trials worldwide. Of these, 4,326 patients have been treated for at least 3 months, 3,407 patients have been treated for at least 6 months, 2,150 patients have been treated for 1 year, 1,250 patients have been treated for 2 years, and 168 patients have been treated for over 3 years. …
Source: FDA drug label, Aurobindo Pharma Limited, effective June 19, 2024 (SPL set c246a0e5-1e77-41ee-a7b3-384f21f2f2e0), via openFDA; the full label on DailyMed
What do FAERS reports show?
19,159 reports list rivastigmine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 4,813 are coded as a death and 6,944 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 11 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Rivastigmine: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions