Last reviewed · How we verify

Mysoline (PRIMIDONE)

Bausch Health · FDA-approved approved Small molecule Quality 45/100

Mysoline (Primidone) is an anti-epileptic agent developed by Valeant, targeting the transient receptor potential cation channel subfamily M member 3. It is a small molecule modality approved by the FDA in 1954 for various seizure disorders, including epilepsy and bipolar disorder in remission. Mysoline is available as a generic medication, with multiple manufacturers, and is off-patent. As an anti-epileptic agent, Mysoline is used to control seizures and prevent their recurrence. It is essential to monitor patients for potential side effects and interactions.

At a glance

Generic namePRIMIDONE
SponsorBausch Health
Drug classAnti-epileptic Agent [EPC]
TargetTransient receptor potential cation channel subfamily M member 3
ModalitySmall molecule
Therapeutic areaMetabolic
PhaseFDA-approved
First approval1954

Approved indications

Common side effects

Drug interactions

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
FDA labelMechanism, indications, dosing, boxed warnings, drug interactions
ClinicalTrials.govTrial enrolment, design, endpoints, results