"Today, the U.S. Food and Drug Administration issued a proposal designed to assist companies developing new treatments for patients in the early stages of Alzheimer's disease, before the onset of noticeable (overt) dementia.
Namenda Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Namenda (memantine hydrochloride) is used to treat moderate to severe Alzheimer's type dementia. It is an orally active NMDA receptor antagonist. Common side effects include tiredness, body aches, dizziness, constipation, and headache.
The recommended starting dose of Namenda is 5 mg once daily. The recommended target dose is 20 mg/day. Dosage is increased in 5 mg increments to 10 mg/day (5 mg twice a day), 15 mg/day (5 mg and 10 mg as separate doses), and 20 mg/day (10 mg twice a day). The minimum recommended interval between dose increases is one week. Namenda may interact with cimetidine, nicotine, ranitidine, quinidine, sodium bicarbonate, antiviral medication, cold or cough medicine containing dextromethorphan, diuretics (water pills), medicine to treat glaucoma, or oral diabetes medicine containing metformin. Tell your doctor all prescription and over-the-counter medications you use. Namenda should be used only when prescribed during pregnancy. It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
Our Namenda (memantine hydrochloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Namenda in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using memantine and call your doctor at once if you have any of these serious side effects:
- cough, chest tightness, fever, trouble breathing;
- chest pain, fast heart rate;
- confusion, hallucinations;
- sudden numbness or weakness, especially on one side of the body;
- lack of coordination;
- fainting or seizure (convulsions);
- urinating less than usual or not at all;
- pale skin, easy bruising or bleeding, unusual weakness; or
- increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure).
Less serious side effects may include:
- nausea, vomiting, diarrhea, constipation, loss of appetite;
- dizziness, tired feeling;
- weight loss;
- swelling in your hands or feet;
- fast heart rate;
- easy bruising or bleeding, unusual weakness;
- joint pain;
- anxiety, aggression;
- skin rash;
- redness or swelling of or around your eyes; or
- urinating more than usual.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Namenda (Memantine HCL) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Namenda Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Namenda (Memantine HCL)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Namenda FDA Prescribing Information: Side Effects
Clinical Trials Experience
NAMENDA was evaluated in eight double-blind placebo-controlled trials involving a total of 1862 dementia (Alzheimer's disease, vascular dementia) patients (940 patients treated with NAMENDA and 922 patients treated with placebo) for a treatment period up to 28 weeks.
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 clinical practice.
Adverse Events Leading to Discontinuation
In placebo-controlled trials in which dementia patients received doses of NAMENDA up to 20 mg/day, the likelihood of discontinuation because of an adverse reaction was the same in the NAMENDA group (10.1%) as in the placebo group (11.5%). No individual adverse reaction was associated with the discontinuation of treatment in 1% or more of NAMENDA-treated patients and at a rate greater than placebo.
Most Common Adverse Reactions
In double-blind placebo-controlled trials involving dementia patients, the most common adverse reactions (incidence ≥ 5% and higher than placebo) in patients treated with NAMENDA were dizziness, headache, confusion and constipation. Table 1 lists all adverse reactions that occurred in at least 2% of patients treated with NAMENDA and at an incidence greater than placebo.
Table 1: Adverse Reactions Reported in Controlled
Clinical Trials in at Least 2% of Patients Receiving NAMENDA and at a Higher
Frequency than Placebo-treated Patients
(N = 922) %
(N = 940) %
|Body as a Whole|
|Central and Peripheral Nervous System|
The overall profile of adverse reactions and the incidence rates for individual adverse reactions in the subpopulation of patients with moderate to severe Alzheimer's disease were not different from the profile and incidence rates described above for the overall dementia population.
NAMENDA has not been systematically evaluated in patients with a seizure disorder. In clinical trials of NAMENDA, seizures occurred in 0.2% of patients treated with NAMENDA and 0.5% of patients treated with placebo.
The following adverse reactions have been identified during post-approval use of memantine. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These reactions include:
Cardiac Disorders -cardiac failure congestive.
Gastrointestinal Disorders -pancreatitis.
Hepatobiliary Disorders - hepatitis.
Psychiatric Disorders -suicidal ideation.
Renal and Urinary Disorders -acute renal failure (including increased creatinine and renal insufficiency).
Skin Disorders -Stevens Johnson syndrome.
Read the entire FDA prescribing information for Namenda (Memantine HCL) »
Additional Namenda Information
Namenda - User Reviews
Namenda User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Get breaking medical news.