Mysoline Side Effects

Generic name: primidone

Generic Name: Primidone

Please note - some side effects for Mysoline may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Mysoline - for the consumer

Mysoline

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Mysoline:

Dizziness; drowsiness; incoordination; lightheadedness; loss of appetite; nausea; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); decreased sexual ability; double vision or unusual eye movements; fever; mood or mental changes; unusual tiredness or weakness.

For the professional

Mysoline

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 redcell 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 Mysoline and to other anticonvulsants. The anemia responds to folic acid without necessity of discontinuing medication.

By body system

Nervous system side effects

Nervous system effects including ataxia and vertigo have been reported most frequently.

Ataxia and vertigo tend to disappear either with continued therapy or with the reduction of the initial dosage.

Gastrointestinal side effects

Gastrointestinal effects including nausea, anorexia, and vomiting have been reported occasionally.

General side effects

General effects including fatigue, hyperirritability, and drowsiness have been reported occasionally.

Psychiatric side effects

Psychiatric effects including emotional disturbances have been reported occasionally. A case of primidone induced catatonic schizophrenia has also been reported.

Genitourinary side effects

Massive crystalluria has also been rarely been reported following acute overdoses of primidone.

Genitourinary effects including sexual impotency have been reported occasionally. A case of massive crystalluria has been reported in a patient receiving maintenance doses of primidone.

Ocular side effects

Ocular effects including diplopia and nystagmus have been reported occasionally.

Dermatologic side effects

Dermatologic effects including morbilliform skin eruptions have been reported occasionally.

Hematologic side effects

The anemia may respond to folic acid without the necessity to discontinue the primidone. The phenobarbital metabolite of primidone has been reported to have potentiated porphyrias.

Hematologic effects including granulocytopenia, agranulocytosis, red cell hypoplasia, thrombocytopenia, and aplasia have been reported rarely. The manufacturer has reported that megaloblastic anemia may occur as a rare idiosyncrasy to primidone.

Other side effects

Rheumatologic side effects include drug induced lupus, frozen shoulder, and Dupuytren's contractures.

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