What the label lists and what reports show
Amantadine side effects
Amantadine's FDA label lists its adverse reactions in its own words. FAERS holds 20,181 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is fall (2,155 reports).
- Generic listed
Check it at the source: the amantadine FDA label on DailyMed (effective January 30, 2026, Strides Pharma Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of GOCOVRI?GOCOVRI may cause serious side effects, including: falling asleep during normal activities. You may fall asleep while doing normal activities such as driving a car, talking, or eating while taking GOCOVRI or other medicines that treat Parkinson's disease. You may fall asleep without being drowsy or without warning. This may result in having accidents. Your chances of falling asleep while doing normal activities while taking GOCOVRI are greater if you take other medicines that cause drowsiness. Tell your healthcare provider right away if this happens. suicidal thoughts or actions and depression. Some people taking GOCOVRI have had suicidal thoughts, attempted suicide, or have had depression. Tell your healthcare provider if you have new or sudden changes in mood, behaviors, thoughts, or feelings, including thoughts about hurting yourself or ending your life. hallucinations. […]
Source: FDA drug label (GOCOVRI), Adamas Pharma, LLC, effective September 8, 2026 (SPL set 82ff865f-78f3-4c94-b6a9-727a54944b28), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe adverse reactions reported most frequently at the recommended dose of amantadine (5 to 10%) are: nausea, dizziness (lightheadedness), and insomnia. Less frequently (1 to 5%) reported adverse reactions are: depression, anxiety and irritability, hallucinations, confusion, anorexia, dry mouth, constipation, ataxia, livedo reticularis, peripheral edema, orthostatic hypotension, headache, somnolence, nervousness, dream abnormality, agitation, dry nose, diarrhea and fatigue. Infrequently (0.1 to 1%) occurring adverse reactions are: congestive heart failure, psychosis, urinary retention, dyspnea, skin rash, vomiting, weakness, slurred speech, euphoria, thinking abnormality, amnesia, hyperkinesia, hypertension, decreased libido, and visual disturbance, including punctate subepithelial or other corneal opacity, corneal edema, decreased visual acuity, sensitivity to light, and optic nerve …
Table 1: Adverse Reactions Reported for ≥ 3% of Patients Treated with 274 mg GOCOVRI in Study 1 and Study 2 (Pooled Analysis)
This table is printed in the GOCOVRI label published by Adamas Pharma, LLC of September 8, 2026; the label quoted above does not print one.
| Adverse Reactions | GOCOVRI 274 mg N=100 % | Placebo N=98 % |
|---|---|---|
| Hallucinations a | 21 | 3 |
| Anxiety b | 7 | 3 |
| Insomnia | 7 | 2 |
| Depression/Depressed mood | 6 | 1 |
| Abnormal dreams | 4 | 2 |
| Confusional state | 3 | 2 |
| Dizziness | 16 | 1 |
| Headache | 6 | 4 |
| Dystonia | 3 | 1 |
| Dry mouth | 16 | 1 |
| Constipation | 13 | 3 |
| Nausea | 8 | 3 |
| Vomiting | 3 | 0 |
| Peripheral edema | 16 | 1 |
| Gait disturbance | 3 | 0 |
| Fall | 13 | 7 |
| Contusion | 6 | 1 |
| Urinary tract infection | 10 | 5 |
| Livedo reticularis | 6 | 0 |
| Pigmentation disorder | 3 | 0 |
| Decreased appetite | 6 | 1 |
| Orthostatic hypotension c | 13 | 1 |
| Blurred vision | 4 | 1 |
| Cataract | 3 | 1 |
| Dry eye | 3 | 0 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
Source: FDA drug label, Strides Pharma Inc., effective January 30, 2026 (SPL set e4d8f36f-d668-4728-8dca-b1c22bd9aedb), via openFDA; the full label on DailyMed
What do FAERS reports show?
20,181 reports list amantadine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 2,112 are coded as a death and 6,573 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 13 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Amantadine: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions