Drug Safety Information for NAMENDA (Memantine hydrochloride)

Safety-related Labeling Changes for NAMENDA XR (MEMANTINE HYDROCHLORIDE) Rx Drug: FDA Link

Adverse Drug Reactions for NAMENDA* (Memantine hydrochloride)

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 NAMENDA
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Confusional state*1030
2Fall788
3Dizziness739
4Somnolence*659
5Agitation*468
6Asthenia466
7Fatigue403
8Gait disturbance381
9Convulsion342
10Nausea340
11Diarrhoea336
12Decreased appetite329
13Urinary tract infection327
14Death324
15Headache315
16Drug interaction305
17Aggression300
18Constipation288
19Vomiting288
20Tremor*282

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

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

Reason # of FDA Reports
1Dementia alzheimer's type12584
2Dementia*4162
3Product used for unknown indication2461
4Memory impairment797
5Amnesia*719
6Cognitive disorder349
7Vascular dementia202
8Senile dementia181
9Parkinson's disease118
10Confusional state114

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


Types of Adverse Events for NAMENDA

Total Reports Filed with FDA: 41881


Number of FDA Adverse Event Reports by Patient Age for NAMENDA

Total Reports Filed with FDA: 41881*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Memantine hydrochloride (Namenda xr, Namenda, Ebixa, Axura, Ebixia, Memantine)

Charts are based on 41881 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 NAMENDA 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.