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Mysoline

"The U.S. Food and Drug Administration today approved Aptiom (eslicarbazepine acetate) as an add-on medication to treat seizures associated with epilepsy.

Epilepsy is a brain disorder caused by abnormal or excessive activity in the brain"...

Mysoline

Mysoline Side Effects Center

Medical Editor: Melissa Conrad Stöppler, MD

Mysoline (primidone) is an anticonvulsant drug used to control seizures. It is taken orally in tablet form, and the total daily dosage should not exceed 2 g. Side effects can include, but are not limited to, dizziness, blurred vision, skin rash, irritability, and skin rash.

The effects of Mysoline (primidone) in human pregnancy and nursing infants are unknown, and these effects are currently under study. The drug is known to be excreted in human milk.

Our Mysoline Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Mysoline in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have any of these serious side effects:

  • slurred speech;
  • loss of balance or coordination;
  • easy bruising or bleeding; or
  • unusual weakness.

Less serious side effects may include:

  • dizziness, drowsiness, spinning sensation;
  • nausea, vomiting, loss of appetite;
  • feeling irritable;
  • blurred vision;
  • mild skin rash; or
  • impotence, loss of interest in sex.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Mysoline (Primidone) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Mysoline FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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 persistant or severe side effects may necessitate withdrawal of the drug. Megaloblastic anemia may occur as a rare idiosyncrasy to Mysoline (primidone) and to other anticonvulsants. The anemia responds to folic acid without necessity of discontinuing medication.

Read the entire FDA prescribing information for Mysoline (Primidone) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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