ZONISAMIDE - zonisamide capsule 
Aurobindo Pharma Limited

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MEDICATION GUIDE

Zonisamide Capsules USP

(zoe nis' a mide)


What is the most important information I should know about zonisamide capsules?

Zonisamide capsules may cause serious side effects, including:

  1. Serious skin rash that can cause death.
  2. Serious allergic reactions that may affect different parts of the body.
  3. Less sweating and increase in your body temperature (fever).
  4. Serious eye problems
  5. Suicidal thoughts or actions in some people.
  6. Increased level of acid in your blood (metabolic acidosis).
  7. Problems with your concentration, attention, memory, thinking, speech, or language.
  8. Blood cell changes such as reduced red and white blood cell counts.

These serious side effects are described below.


1. Zonisamide capsules may cause a serious skin rash that can cause death. These serious skin reactions are more likely to happen when you begin taking zonisamide capsules within the first 4 months of treatment but may occur at later times.

2. Zonisamide capsules can cause other types of allergic reactions or serious problems 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 health care provider right away if you have:


3. Zonisamide capsules may cause you to sweat less and to increase your body temperature (fever). You may need to be hospitalized for this. You should watch for decreased sweating and fever, especially when it is hot and especially in children taking zonisamide capsules.


    Call your health care provider right away if you have:

4. Zonisamide capsules may cause eye problems. Serious eye problems include:


These eye problems can lead to permanent loss of vision if not treated.


Call your healthcare provider right away if you have any new eye symptoms, including any eye pain or redness or any new problems with your vision.


5. Like other antiepileptic drugs, zonisamide capsules 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:


    How can I watch for early symptoms of suicidal thoughts and actions?


     Call your healthcare provider between visits as needed, especially if you are worried about symptoms.


     Do not stop zonisamide capsules without first talking to a healthcare provider.


Stopping zonisamide capsules 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).


6. Zonisamide capsules can increase the level of acid in your blood (metabolic acidosis). If left untreated, metabolic acidosis can cause brittle or soft bones (osteoporosis, osteomalacia, osteopenia), kidney stones and can slow the rate of growth in children. Metabolic acidosis can happen with or without symptoms. Sometimes people with metabolic acidosis will:



7. Zonisamide capsules may cause problems with your concentration, attention, memory, thinking, speech, or language.


8. Zonisamide capsules can cause blood cell changes such as reduced red and white blood cell counts. Call your healthcare provider if you develop fever, sore throat, sores in your mouth, or unusual bruising.


Zonisamide capsules can have other serious side effects. For more information ask your healthcare provider or pharmacist. Tell your healthcare provider if you have any side effect that bothers you. Be sure to read the section titled “What are the possible side effects of zonisamide capsules?”


What are zonisamide capsules?


Zonisamide capsules is a prescription medicine that is used with other medicines to treat partial seizures in adults.


It is not known if zonisamide capsules is safe or effective in children under 16 years of age.


Do not take zonisamide capsules:

Do not take zonisamide capsules if you are allergic to medicines that contain sulfa.


Before taking zonisamide capsules, tell your healthcare provider about all your medical conditions, including if you:



Tell your healthcare provider if you:



You and your healthcare provider should decide if you should take zonisamide capsules while you are pregnant.


If you become pregnant while taking zonisamide capsules, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy.



Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins or herbal supplements.


How should I take zonisamide capsules?



What should I avoid while taking zonisamide capsules?


What are the possible side effects of zonisamide capsules?

Zonisamide capsules can cause serious side effects. See “What is the most important information I should know about zonisamide capsules?”

Other serious side effects include:



The most common side effects of zonisamide capsules include:


Side effects can happen at any time, but are more likely to happen during the first several weeks after starting zonisamide capsules.


These are not all of the possible side effects of zonisamide capsules. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


How should I store zonisamide capsules?


Keep zonisamide capsules and all medicines out of the reach of children.


General Information about the safe and effective use of zonisamide capsules.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use zonisamide capsules for a condition for which it was not prescribed. Do not give zonisamide capsules to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about zonisamide capsules that is written for health professionals.


What are the ingredients in zonisamide capsules?

Active ingredient: zonisamide


Inactive ingredients in zonisamide capsules: hydrogenated vegetable oil and microcrystalline cellulose. The capsule shell contains gelatin and titanium dioxide. Imprinting ink contains black iron oxide E172, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution. In addition 100 mg zonisamide capsule shell contains black iron oxide E172 and red iron oxide E172.


Dispense with Medication Guide available at: www.aurobindousa.com/medication-guides


This Medication Guide has been approved by the U.S. Food and Drug Administration 


Distributed by:
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520

Manufactured by:
Aurobindo Pharma Limited
Hyderabad–500 038, India

Revised: 04/2020


Revised: 6/2021
Aurobindo Pharma Limited