OSMOLEX ER SIDE EFFECTS
- Generic Name: amantadine
- Brand Name: Osmolex ER
- Drug Class: Antiparkinson Agents, Dopamine Agonists, Antivirals, Influenza, Antivirals, Influenza
Last updated on MDtodate: 10/9/2022
SIDE EFFECTS
The following serious adverse reactions are described elsewhere in the labeling:
- Falling Asleep During Activities of Daily Living and Somnolence
- Suicidality and Depression
- Hallucinations/Psychotic Behavior
- Dizziness and Orthostatic Hypotension
- Withdrawal-Emergent Hyperpyrexia and Confusion
- Impulse Control/Compulsive Behaviors
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.
Immediate-Release Amantadine
The adverse reactions listed in Table 1 were identified in clinical studies of immediate-release amantadine. The most common adverse reactions reported in ≥5% of patients at the recommended dosage of immediate-release amantadine were nausea, dizziness/lightheadedness, and insomnia.
Table 1: Incidence of Adverse Reactions from Pooled Studies of Immediate-Release Amantadine
| 5 to 10% | 1 to 5% | 0.1 to 1% | Less than 0.1% |
| Nausea | Depression | Congestive heart failure | Convulsion |
| Dizziness/ lightheadedness | Anxiety and irritability | Psychosis | Leukopenia |
| Insomnia | Hallucinations | Urinary retention | Neutropenia |
| Confusion | Dyspnea | Eczematoid dermatitis | |
| Anorexia | Skin rash | Oculogyric episodes | |
| Dry mouth | Vomiting | Suicidal attempt | |
| Constipation | Weakness | Suicide | |
| Ataxia | Slurred speech | Suicidal ideation | |
| Livedo reticularis | Euphoria | ||
| Peripheral edema | Thinking abnormality | ||
| Orthostatic hypotension | Amnesia | ||
| Headache | Hyperkinesia | ||
| Somnolence | Hypertension | ||
| Nervousness | Decreased libido | ||
| Dream abnormality | Visual disturbance | ||
| Agitation | Punctate subepithelial or other corneal opacity | ||
| Dry nose | Corneal edema | ||
| Diarrhea | Decreased visual acuity | ||
| Fatigue | Sensitivity to light | ||
| Optic nerve palsy |
SRC: NLM .