(ethosuximide)

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What is the most important information I should know about ZARONTIN?

What is the most important information I should know about ZARONTIN?

Do not stop taking ZARONTIN without first talking to your healthcare provider.
Stopping ZARONTIN suddenly can cause serious problems.

ZARONTIN can cause serious side effects, including:

1.
Rare but serious blood problems that may be life-threatening. Call your healthcare provider right away if you have:
•
fever, swollen glands, or sore throat that come and go or do not go away
•
frequent infections or an infection that does not go away
•
easy bruising
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red or purple spots on your body
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bleeding gums or nose bleeds
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severe fatigue or weakness
2.
Drug reactions that may affect different parts of the body such as your liver, kidneys, heart, or blood cells. You may or may not have a rash with these types of reactions. These reactions can be very serious and can cause death. Call your healthcare provider right away if you have any of these symptoms:
•
joint pain and swelling
•
muscle pain
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fatigue, weakness
•
low-grade fever
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pain in the chest that is worse with breathing
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skin rash
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swollen lymph glands
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swelling of your face
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yellowing of your skin or the white part of your eyes
3.
Like other antiepileptic drugs, ZARONTIN may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.
Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:
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thoughts about suicide or dying
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attempts to commit suicide
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new or worse depression
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new or worse anxiety
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feeling agitated or restless
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panic attacks
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trouble sleeping (insomnia)
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new or worse irritability
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acting aggressive, being angry, or violent
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acting on dangerous impulses
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an extreme increase in activity and talking (mania)
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other unusual changes in behavior or mood
 
How can I watch for early symptoms of suicidal thoughts and actions?
•
Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
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Keep all follow-up visits with your healthcare provider as scheduled.
 
Call your healthcare provider between visits as needed, especially if you are worried about symptoms.
 
Do not stop ZARONTIN without first talking to a healthcare provider.
•
Stopping ZARONTIN suddenly can cause serious problems.
•
Stopping a seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus).
 
Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

Additional Resources

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If you cannot use the above website to report an adverse event related to a Pfizer medication, please call (800) 438-1985.

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatch or by calling (800) 332-1088.