NAMENDA XR SIDE EFFECTS
- Generic Name: memantine hydrochloride extended release capsules
- Brand Name: Namenda XR
- Drug Class: NMDA Antagonists
SIDE EFFECTS
Clinical Trials Experience
NAMENDA XR was evaluated in a double-blind placebo-controlled trial in which a total of 676 patients with moderate to severe dementia of the Alzheimer’s type (341 patients on NAMENDA XR 28 mg/day and 335 patients on placebo) were treated for up to 24 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 practice.
Adverse Reactions Leading to Discontinuation
In the placebo-controlled clinical trial of NAMENDA XR, the proportion of patients in the NAMENDA XR group and the placebo group who discontinued treatment due to adverse reactions was 10% and 6%, respectively. The most common adverse reaction that led to treatment discontinuation in the NAMENDA XR group was dizziness, at a rate of 1.5%.
Most Common Adverse Reactions
The most commonly observed adverse reactions seen in patients administered NAMENDA XR in the controlled clinical trial, defined as those occurring at a frequency of at least 5% in the NAMENDA XR group and at a frequency higher than placebo, were headache, diarrhea and dizziness.
Table 1 lists adverse reactions that were observed at an incidence of ≥ 2% in the NAMENDA XR group and occurred at a rate greater than placebo.
Table 1: Adverse reactions observed with a frequency of ≥ 2% in the NAMENDA XR group and at a rate greater than placebo
| Adverse reaction | Placebo (n = 335) % |
NAMENDA XR 28mg (n = 341) % |
| Gastrointestinal Disorders | ||
| Diarrhea | 4 | 5 |
| Constipation | 1 | 3 |
| Abdominal pain | 1 | 2 |
| Vomiting | 1 | 2 |
| Infections and infestations | ||
| Influenza | 3 | 4 |
| Investigations | ||
| Weight, increased | 1 | 3 |
| Musculoskeletal and connective tissue disorders | ||
| Back pain | 1 | 3 |
| Nervous system disorders | ||
| Headache | 5 | 6 |
| Dizziness | 1 | 5 |
| Somnolence | 1 | 3 |
| Psychiatric disorders | ||
| Anxiety | 3 | 4 |
| Depression | 1 | 3 |
| Aggression | 1 | 2 |
| Renal and urinary disorders | ||
| Urinary incontinence | 1 | 2 |
| Vascular disorders | ||
| Hypertension | 2 | 4 |
| Hypotension | 1 | 2 |
Seizure
Memantine has not been systematically evaluated in patients with a seizure disorder. In clinical trials of memantine, seizures occurred in 0.3% of patients treated with memantine and 0.6% of patients treated with placebo.
Postmarketing Experience
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:
Blood and Lymphatic System Disorders: agranulocytosis, leukopenia (including neutropenia), pancytopenia, thrombocytopenia, thrombotic thrombocytopenic purpura.
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.
SRC: NLM .