Drugs › Cholinesterase inhibitor
Generic name
Galantamine hydrobromide: adverse event reports filed with FDA
1,163 reports list it as a suspect or interacting product, 2005–2026. Class: Cholinesterase inhibitor. Also reported as Galantamine Hydrobromide Oral Solution, Galantamine Hydrobromide Er.
- 1,163
- reports as suspect product
- 0% of all reports · about 55 a year
- 28
- reports, 12 months to June 2026
- 25 in the 12 months before
- 96.7%
- marked serious by the reporter
- 88.6% across the class
- 5.6%
- record death among outcomes, as reported
- 65 reports · not verified by FDA
Between July 2005 and June 2026, 1,163 adverse event reports received by FDA list galantamine hydrobromide, a generic name as a suspect or interacting product. Reports that mention it only as a concomitant medication (487) are left out of every figure here.
In the 12 months to June 2026, 28 reports listed it, up 12% from 25 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 55 reports a year and 0% of the 20,646,523 reports in the database, and 4.5% of the reports for the cholinesterase inhibitor class. How many people take it is not in the data, so a count is not a rate of occurrence.
Reporters most often recorded fall (37.9%), cognitive disorder (35.2%) and constipation (34%). A report can list several reactions, so shares add to more than 100%; 242 different terms appear across these reports. Fall is recorded in 37.9% of these reports, a larger share than in the median cholinesterase inhibitor drug (7.4%).
96.7% of the reports are marked serious by the reporter (88.6% across the class); 5.6% record death among the outcomes and 59.2% record hospitalisation, as reported. 50.5% of the reports came from other health professionals, and the largest patient age group is 75 and over (55.9%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Galantamine hydrobromide reports recording the termmedian drug in cholinesterase inhibitor
- Falla fall37.9%441
- Cognitive disorderproblems with thinking or memory35.2%409
- Constipationconstipation34%395
- Orthostatic hypotension33.7%392
- Hypotensionlow blood pressure33.5%390
- Balance disorderproblems with balance33.4%388
- Sedationdrowsiness from a medicine32.4%377
- Depressed level of consciousness31.6%368
- Sedation complication30.4%354
- Creatinine renal clearance decreased30.2%351
- Blood calcium decreased30.1%350
- Mobility decreasedreduced ability to move about30.1%350
- Painpain, site not specified30.1%350
- Toxicity to various agentspoisoning or toxic effect of one or more substances28.7%334
- Drug interactionan interaction between medicines14.2%165
- Dyspnoeashortness of breath6.6%77
- Anticholinergic syndrome6.3%73
- Multiple drug therapy4.8%56
- Overdosea dose above the recommended amount4.7%55
- Renal function test abnormal4.7%55
- Product use in unapproved indicationused for a purpose not on the label4.6%54
- Off label useused for a purpose or in a way not on the label4.3%50
- Drug abusemisuse of a medicine4.2%49
- Vomitingbeing sick3.4%40
- Creatinine renal clearance increased3.2%37
- Nauseafeeling sick2.8%33
- Decreased appetitereduced appetite2.5%29
- Bradycardiaslow heart rate2.2%26
- Diarrhoealoose or frequent stools2.1%24
- Confusional stateconfusion1.9%22
Top 30 of 242 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 8 drugs in the cholinesterase inhibitor class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 25,719 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 8.4% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Dementia | 365 | 31.4% |
| Dementia alzheimer's type | 186 | 16% |
| Dementia alzheimer's type | 29 | 2.5% |
| Cognitive disorder | 10 | 0.9% |
| Vascular dementia | 8 | 0.7% |
| Memory impairment | 7 | 0.6% |
The indication field is filled in by the reporter and is often blank; shares are of all 1,163 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Galantamine hydrobromide reports |
|---|---|---|
| Amitriptyline hydrochloride | 443 | 38.1% |
| Furosemide | 431 | 37.1% |
| Carbamazepine | 420 | 36.1% |
| Levothyroxine sodium | 412 | 35.4% |
| Lactulose | 411 | 35.3% |
| Oxazepam | 406 | 34.9% |
| Acetaminophen | 402 | 34.6% |
| Acebutolol hydrochloride | 395 | 34% |
| Magnesium hydroxide | 389 | 33.4% |
| Omeprazole | 382 | 32.8% |
Other products listed in reports where Galantamine hydrobromide is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.
In context
| Measure | Galantamine hydrobromide | Cholinesterase inhibitor | All reports |
|---|---|---|---|
| Reports as suspect product | 1,163 | 25,719 | 20,646,523 |
| Share of that pool | — | 4.5% | 0% |
| Reports, latest 12 months | 28 | — | 1,332,454 |
| Marked serious | 96.7% | 88.6% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 56 | 230 | 91 |
| Hospitalisation recorded, per 1,000 reports | 592 | 369 | 213 |
| Consumer-filed share | 12.9% | 38.7% | 45.8% |
| Top term, share of reports | Fall 37.9% | median 7.4% | 1.6% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Other drugs in the cholinesterase inhibitor class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Exelon | brand | 13,663 | 265 | 92.6% |
| Aricept | brand | 4,043 | 43 | 83.2% |
| Rivastigmine | generic | 2,602 | 257 | 76.4% |
| Donepezil hydrochloride | generic | 1,569 | 136 | 92% |
| Mestinon | brand | 960 | 49 | 71.7% |
| Pyridostigmine | brand | 930 | 153 | 84.5% |
| Galantamine | generic | 789 | 37 | 95.1% |
Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.
Questions about Galantamine hydrobromide reports
How many adverse event reports has FDA received for Galantamine hydrobromide?
1,163 reports list Galantamine hydrobromide as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 28 of them arrived in the latest 12 months. Another 487 list it only as a concomitant medication.
What reactions are recorded in Galantamine hydrobromide reports?
fall (37.9%), cognitive disorder (35.2%), constipation (34%), orthostatic hypotension (33.7%) and hypotension (33.5%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Galantamine hydrobromide was responsible.
How serious are the reports?
96.7% are marked serious by the reporter. Among the outcomes recorded, 5.6% of reports include death and 59.2% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
other health professional (50.5%), physician (26.1%) and consumer or non-health professional (12.9%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Galantamine hydrobromide rising?
28 reports in the 12 months to June 2026, up 12% from 25 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Galantamine hydrobromide was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Galantamine hydrobromide?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Galantamine hydrobromide as a suspect or interacting product; reports listing it only as a concomitant medication (487) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.