What the label lists and what reports show
Galantamine side effects
Galantamine's FDA label: “The most common adverse reactions (≥ 5%) were nausea, vomiting, diarrhea, dizziness, headache, decreased appetite, and weight decreased ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Slate Run Pharmaceuticals, LLC at 1-888-341-9214 or FDA at …” FAERS holds 3,188 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 (812 reports).
- Generic listed
Check it at the source: the galantamine FDA label on DailyMed (effective June 1, 2026, Slate Run Pharmaceuticals, LLC); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (≥ 5%) were nausea, vomiting, diarrhea, dizziness, headache, decreased appetite, and weight decreased ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Slate Run Pharmaceuticals, LLC at 1-888-341-9214 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Table 1. Adverse Reactions Reported by ≥ 1% of Galantamine-Treated Patients in Pooled Placebo-Controlled, Double-Blind Clinical Trials
| System/Organ Class Adverse Reaction | Galantamine (n = 3956) % | Placebo (n = 2546) % |
|---|---|---|
| Decreased appetite | 7.4 | 2.1 |
| Depression | 3.6 | 2.3 |
| Dizziness | 7.5 | 3.4 |
| Headache | 7.1 | 5.5 |
| Tremor | 1.6 | 0.7 |
| Somnolence | 1.5 | 0.8 |
| Syncope | 1.4 | 0.6 |
| Lethargy | 1.3 | 0.4 |
| Bradycardia | 1.0 | 0.3 |
| Nausea | 20.7 | 5.5 |
| Vomiting | 10.5 | 2.3 |
| Diarrhea | 7.4 | 4.9 |
| Abdominal pain | 3.8 | 2.0 |
| Abdominal discomfort | 2.1 | 0.7 |
| Dyspepsia | 1.5 | 1.0 |
| Muscle spasms | 1.2 | 0.5 |
| Fatigue | 3.5 | 1.8 |
| Asthenia | 2.0 | 1.5 |
| Malaise | 1.1 | 0.5 |
| Decreased weight | 4.7 | 1.5 |
| Fall | 3.9 | 3.0 |
| Laceration | 1.1 | 0.5 |
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, continuedSerious adverse reactions are discussed in more detail in the following sections of the labeling: Serious skin reactions [see Warnings and Precautions (5.1) ] Cardiovascular Conditions [see Warnings and Precautions (5.3) ] Gastrointestinal Conditions [see Warnings and Precautions (5.4) ] Genitourinary Conditions [see Warnings and Precautions (5.5) ] Neurological Conditions [see Warnings and Precautions (5.6) ] Pulmonary Conditions [see Warnings and Precautions (5.7) ] Deaths in subjects with mild cognitive impairment (MCI) [see Warnings and Precautions (5.8) ] The most common adverse reactions (≥ 5%) were nausea, vomiting, diarrhea, dizziness, headache, decreased appetite, and weight decreased ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Slate Run Pharmaceuticals, LLC at 1-888-341-9214 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. The most common adverse reactions in galantamine-treated patients from double-blind clinical trials (≥ 5%) were nausea, vomiting, diarrhea, dizziness, headache, and decreased appetite. …
Source: FDA drug label, Slate Run Pharmaceuticals, LLC, effective June 1, 2026 (SPL set 56f365e5-0a23-4f69-e054-00144ff8d46c), via openFDA; the full label on DailyMed
What do FAERS reports show?
3,188 reports list galantamine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 342 are coded as a death and 1,681 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, 4 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?
- Galantamine: 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