Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
ADVERSE REACTIONS The most frequently occurring early side effects are ataxia and vertigo.
These tend to disappear with continued therapy, or with reduction of initial dosage.
Occasionally, the following have been reported: nausea, anorexia, vomiting, fatigue, hyperirritability, emotional disturbances, sexual impotency, diplopia, nystagmus, drowsiness and morbilliform skin eruptions.
Granulocytopenia, agranulocytosis, and red-cell hypoplasia and aplasia, have been reported rarely.
These and, occasionally, other persistent or severe side effects may necessitate withdrawal of the drug.
Megaloblastic anemia may occur as a rare idiosyncrasy to primidone and to other anticonvulsants.
The anemia responds to folic acid without necessity of discontinuing medication.
To report SUSPECTED ADVERSE REACTIONS, contact Oxford Pharmaceuticals, LLC at 1-844-508-1455, 8:00 AM to 4.30 PM ET, Monday – Friday or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
WARNINGS The abrupt withdrawal of antiepileptic medication may precipitate status epilepticus.
The therapeutic efficacy of a dosage regimen takes several weeks before it can be assessed.
Suicidal Behavior and Ideation Antiepileptic drugs (AEDs), including primidone, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication.
Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.
Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) of 11 different AEDs showed that patients randomized to one of the AEDs had approximately twice the risk (adjusted Relative Risk 1.8, 95% CI:1.2, 2.7) of suicidal thinking or behavior compared to patients randomized to placebo.
Like all medications, Primidone can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: