IMPORTANT SAFETY INFORMATION
ZONISADE® (zonisamide oral suspension), 100 mg/5mL
ZONISADE is indicated as adjunctive therapy for the treatment of partial-onset seizures in adults and pediatric patients 16 years of age and older.
A calibrated measuring device is recommended to measure and deliver the prescribed dose accurately. A household teaspoon or tablespoon is not an adequate measuring device. Ask your pharmacist or doctor for assistance in the selection of a measuring device.
ADDITIONAL IMPORTANT SAFETY INFORMATION
Do not take ZONISADE if you are allergic to medicines that contain sulfa, zonisamide, or any formulation ingredients.
What is the most important information I should know about ZONISADE?
ZONISADE may cause serious side effects, including:
- Serious skin rash that can cause death
- Serious allergic reactions that may affect different parts of the body
- Less sweating and increase in your body temperature (fever)
- Serious eye problems
- Suicidal thoughts or actions in some people
- Increased level of acid in your blood (metabolic acidosis)
- Problems with your concentration, attention, memory, mood, thinking, speech, or language
- Blood cell changes such as reduced red and white blood cell counts
- Back pain, stomach pain, or blood in your urine may indicate you have a kidney stone. Drink plenty of fluids when taking ZONISADE to decrease your chances of getting kidney stones
- New or worse depression, sudden changes in mood or behavior, loss of contact with reality (sometimes associated with hearing voices or seeing things that are not really there), feeling sleepy or tired, trouble concentrating, and speech or language problems. Call your healthcare provider right away if you have any problems with the symptoms listed above
- High ammonia levels in the blood can affect your mental activities, slow your alertness, make you feel tired, or cause vomiting
Before taking ZONISADE, tell your healthcare provider about all your medical conditions, including if you:
- have or have had depression, mood problems, suicidal thoughts or behavior
- have kidney problems
- have liver problems
- have a history of too much acid in your blood (metabolic acidosis)
- have weak, brittle bones or soft bones (osteomalacia, osteopenia, or osteoporosis)
- have a growth problem
- are on a diet high in fat called a ketogenic diet
- have diarrhea
- have high blood levels of ammonia
What should I avoid while taking ZONISADE?
- Do not drink alcohol or take other drugs that make you sleepy or dizzy while taking ZONISADE until you talk to your healthcare provider. ZONISADE taken with alcohol or drugs that cause sleepiness or dizziness may make your sleepiness or dizziness worse
- Do not drive, operate heavy machinery, or do other dangerous activities until you know how ZONISADE affects you. ZONISADE can slow your thinking and motor skills
Certain reactions can be very serious and can cause death.
Watch for decreased sweating and fever, especially when it is hot and especially in children taking ZONISADE.
While taking ZONISADE, call your healthcare provider right away if you have:
- high fever, recurring fever, long-lasting fever, or less sweat than normal
- severe muscle pain
- rash
- swollen lymph glands
- swelling of your face
- unusual bruising or bleeding
- weakness or fatigue
- yellowing of your skin or the white part of your eyes
Also, 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
- have sudden changes in mood or behavior, loss of contact with reality (sometimes associated with hearing voices or seeing things that are not really there), feel sleepy or tired, have trouble concentrating, or speech and language problems
- develop a fever, sore throat, sores in your mouth, or unusual bruising
Your healthcare provider should do a blood test to measure the level of acid in your blood before and during your treatment with ZONISADE.
Like other antiepileptic drugs, ZONISADE may cause suicidal thoughts or actions. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:
- Thoughts about suicide or dying
- Attempts to commit suicide
- New or worse depression
- New or worse anxiety
- Panic attacks
- An extreme increase in activity and talking (mania)
- Feeling agitated or restless
- Trouble sleeping (insomnia)
- New or worse irritability
- Acting aggressive or being angry or violent
- Acting on dangerous impulses
- Other unusual changes in behavior or mood
Do not stop ZONISADE without first talking to a healthcare provider.
Stopping ZONISADE 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).
Tell your healthcare provider if you:
- are pregnant or plan to become pregnant. ZONISADE may harm your unborn baby. Women who can become pregnant should use effective birth control. Tell your healthcare provider right away if you become pregnant while taking ZONISADE. You and your healthcare provider should decide if you should take ZONISADE while you are pregnant. If you become pregnant while taking ZONISADE, 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
- are breastfeeding or plan to breastfeed. ZONISADE can pass into your breast milk. It is not known if ZONISADE in your breast milk can harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take ZONISADE
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
The most common side effects of ZONISADE include:
- drowsiness
- loss of appetite
- dizziness
- difficulty with memory or concentration
- trouble with walking and coordination
- agitation or irritability
Store ZONISADE at room temperature and discard unused portions 30 days after first opening.
The Important Safety Information does not include all the information needed to use ZONISADE safely and effectively. Please talk to your healthcare provider and see the complete Prescribing Information for ZONISADE.
To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1-800-461-7449, or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch.
PP-ZON-US-0061
References
- 1. Orange Book: Approved drug products with therapeutic equivalence evaluations. Accessed August 20, 2022. Access Data FDA GOV: http://www.accessdata.fda.gov/scripts/eder/ob/search_product.cfm 2. ZONISADE [package insert]. Woburn, MA: Azurity Pharmaceuticals, Inc.; 2023. 3. Current Good Manufacturing Practice (CGMP) guidelines. US Food and Drug Administration. Accessed August 27, 2022. FDA GOV: https://www.fda.gov/drugs/pharmaceutical-quality-resources/current-good-manufacturing-practice-cgmp-regulations
The ONE and ONLY ready-to-use* liquid zonisamide
*Shake well before taking.
Medication
Transformed
Of the 20+ FDA-approved oral formulations of zonisamide, ZONISADE® is the ONLY alternative formulation to capsules.1
As little as
$0
co-pay†
For eligible patients to use on their first prescription and associated refills.
Click here to see additional financial support options for ZONSIADE®
†View Eligibility Restrictions, Terms, and Conditions at Azurity Solution: azuritysolutions.com.
Azurity Pharmaceuticals is thrilled to support the work of the epilepsy community and to have the opportunity to help patients and their families. Select a support or advocacy organization and Azurity will make a $25 donation to its cause. Thank you for joining us with your support!
Select organization
Product labeling, packaging, and imagery are for representation purposes only.
ZONISADE® (zonisamide oral suspension) is an adjunctive therapy for the treatment of partial-onset seizures in adults and pediatric patients 16 years of age and older.
Adjunctive therapy is one that is added to another treatment.
Zonisamide was first approved in the United States in 2000 as adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy.2
Many adolescents and adults have trouble swallowing pills or other solid medicines. Liquid ZONISADE® is a ready-to-use* medicine that may help these patients
*Shake well before taking
Actor portrayal
Strawberry flavor
A sweet taste in an oral liquid solution
Ready-to-use
Just carefully measure your dose and drink
Remember to throw away any unused ZONISADE® 30 days after opening
Flexible dosing
So you can get the right dose your doctor prescribes, every time
ZONISADE® is a ready-to-use* oral liquid suspension
Ready-to-use*
means no need for:
- Compounding
- Crushing or mixing
*Shake well before taking.
Did you know?
Compounded medicines are not approved by the FDA.3
The FDA cannot ensure that compounded medicines are safe and effective.
Talk to your doctor to see if ZONISADE® may be right for you.
How to take ZONISADE®
-
ZONISADE® is a liquid form of zonisamide. It contains 100 mg per 5 mL of zonisamide. It is a white to off-white strawberry-flavored liquid.
-
Your doctor will tell you what your dose will be. ZONISADE® is a medicine where you start at a lower dose and then slowly increase the dose until you reach the maximum dose. Your doctor may want you to take ZONISADE® once or twice a day.
-
You can take ZONISADE® with or without food.
-
ZONISADE® is a liquid suspension, so you must shake it well before you take it. You must measure ZONISADE® carefully. A household teaspoon is not an accurate measuring device. A pharmacist will give you an appropriate device and instructions for measuring the correct dose.
-
ZONISADE® does not have to be refrigerated or kept cold. Keep ZONISADE® at room temperature and out of direct light.
Tips to help you manage epilepsy
Whether you are a patient or a caregiver, these suggestions may help make managing epilepsy a little easier.
- Work with your doctor. Talk about any questions or concerns you may have about epilepsy
- Taking your medication on time is important. Use your phone to send daily reminders when it’s time to take your medicine
- Healthy habits may help manage your epilepsy, including not missing doses of medications, getting enough sleep, and eating a healthy, balanced diet
Pharmacists can provide helpful information and support, such as:
- Explain what your medicine is for and answer questions you have on how to take it
- Provide a measuring device that you can use to measure your medicine as your doctor tells you to
Eligible commercially insured patients may pay as little as $0 co-pay*
for their first prescription and associated refills.
- Eligible patients can save with automatic co-pay support for ZONISADE® at their pharmacy—no calls, cards, or coupons necessary
- Instant co-pay savings at 70,000+ pharmacies*
*View Eligibility Restrictions, Terms, and Conditions at azuritysolutions.com.
Additional cash savings through GoodRx
- Pay in cash and receive an exclusive discounted price for ZONISADE®
- Cannot be used in conjunction with commercial or federal insurance
ZONISADE® Is Covered By Medicaid In All 50 States
Prescription coverage doesn’t have to be complicated.
For answers to your questions about ZONISADE® coverage, visit azuritysolutions.com.
Learn more
Resources
Search for a doctor by name, location, or specialty.
Find a Doctor for Epilepsy Care
SearchBy clicking Submit, you agree to disclose your personal information to Azurity and to be contacted by Azurity, its affiliates, and business partners in the future regarding products, services, and/or information related to ZONISADE®. Azurity will not sell your information to any third party for marketing purposes without your express consent.
Resources
Below are organizations that may be able to support you and your family.
CURE Epilepsy
The leading nongovernmental agency fully committed to funding research in epilepsy, CURE
Epilepsy promotes and funds patient-focused research and makes information available to
clinicians and patients.
Epilepsy Foundation
The Epilepsy Foundation, in collaboration with our community and network partners, connects the people, data, and resources, needed to address challenging health problems associated with seizures and the epilepsies—and promotes education, policy, research, and systemic change that will foster measurable and sustainable improvement for all people living with epilepsy.
Learn more
Epilepsy Alliance America
This nationwide network of community-based epilepsy organizations provides direct support to people with epilepsy and their families, caregivers, and communities through support services, information, education, advocacy, and public awareness.
Learn more
National Association of Epilepsy Centers
This nonprofit association of more than 260 specialized epilepsy centers in the United States educates public and private insurers, policymakers, and government officials about the complexities of and need for patient access to specialized epilepsy services.
Learn more
National Foundation of Swallowing Disorders
This nonprofit, patient-advocacy organization provides patient hope and improves quality of life for those suffering from all types of swallowing disorders.
Learn more
IMPORTANT SAFETY INFORMATION
ZONISADE® (zonisamide oral suspension), 100 mg/5mL
ZONISADE is indicated as adjunctive therapy for the treatment of partial-onset seizures in adults and pediatric patients 16 years of age and older.
A calibrated measuring device is recommended to measure and deliver the prescribed dose accurately. A household teaspoon or tablespoon is not an adequate measuring device. Ask your pharmacist or doctor for assistance in the selection of a measuring device.
ADDITIONAL IMPORTANT SAFETY INFORMATION
Do not take ZONISADE if you are allergic to medicines that contain sulfa, zonisamide, or any formulation ingredients.
What is the most important information I should know about ZONISADE?
ZONISADE may cause serious side effects, including:
- Serious skin rash that can cause death
- Serious allergic reactions that may affect different parts of the body
- Less sweating and increase in your body temperature (fever)
- Serious eye problems
- Suicidal thoughts or actions in some people
- Increased level of acid in your blood (metabolic acidosis)
- Problems with your concentration, attention, memory, mood, thinking, speech, or language
- Blood cell changes such as reduced red and white blood cell counts
- Back pain, stomach pain, or blood in your urine may indicate you have a kidney stone. Drink plenty of fluids when taking ZONISADE to decrease your chances of getting kidney stones
- New or worse depression, sudden changes in mood or behavior, loss of contact with reality (sometimes associated with hearing voices or seeing things that are not really there), feeling sleepy or tired, trouble concentrating, and speech or language problems. Call your healthcare provider right away if you have any problems with the symptoms listed above
- High ammonia levels in the blood can affect your mental activities, slow your alertness, make you feel tired, or cause vomiting
Before taking ZONISADE, tell your healthcare provider about all your medical conditions, including if you:
- have or have had depression, mood problems, suicidal thoughts or behavior
- have kidney problems
- have liver problems
- have a history of too much acid in your blood (metabolic acidosis)
- have weak, brittle bones or soft bones (osteomalacia, osteopenia, or osteoporosis)
- have a growth problem
- are on a diet high in fat called a ketogenic diet
- have diarrhea
- have high blood levels of ammonia
What should I avoid while taking ZONISADE?
- Do not drink alcohol or take other drugs that make you sleepy or dizzy while taking ZONISADE until you talk to your healthcare provider. ZONISADE taken with alcohol or drugs that cause sleepiness or dizziness may make your sleepiness or dizziness worse
- Do not drive, operate heavy machinery, or do other dangerous activities until you know how ZONISADE affects you. ZONISADE can slow your thinking and motor skills
Certain reactions can be very serious and can cause death.
Watch for decreased sweating and fever, especially when it is hot and especially in children taking ZONISADE.
While taking ZONISADE, call your healthcare provider right away if you have:
- high fever, recurring fever, long-lasting fever, or less sweat than normal
- severe muscle pain
- rash
- swollen lymph glands
- swelling of your face
- unusual bruising or bleeding
- weakness or fatigue
- yellowing of your skin or the white part of your eyes
Also, 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
- have sudden changes in mood or behavior, loss of contact with reality (sometimes associated with hearing voices or seeing things that are not really there), feel sleepy or tired, have trouble concentrating, or speech and language problems
- develop a fever, sore throat, sores in your mouth, or unusual bruising
Your healthcare provider should do a blood test to measure the level of acid in your blood before and during your treatment with ZONISADE.
Like other antiepileptic drugs, ZONISADE may cause suicidal thoughts or actions. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:
- Thoughts about suicide or dying
- Attempts to commit suicide
- New or worse depression
- New or worse anxiety
- Panic attacks
- An extreme increase in activity and talking (mania)
- Feeling agitated or restless
- Trouble sleeping (insomnia)
- New or worse irritability
- Acting aggressive or being angry or violent
- Acting on dangerous impulses
- Other unusual changes in behavior or mood
Do not stop ZONISADE without first talking to a healthcare provider.
Stopping ZONISADE 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).
Tell your healthcare provider if you:
- are pregnant or plan to become pregnant. ZONISADE may harm your unborn baby. Women who can become pregnant should use effective birth control. Tell your healthcare provider right away if you become pregnant while taking ZONISADE. You and your healthcare provider should decide if you should take ZONISADE while you are pregnant. If you become pregnant while taking ZONISADE, 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
- are breastfeeding or plan to breastfeed. ZONISADE can pass into your breast milk. It is not known if ZONISADE in your breast milk can harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take ZONISADE
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
The most common side effects of ZONISADE include:
- drowsiness
- loss of appetite
- dizziness
- difficulty with memory or concentration
- trouble with walking and coordination
- agitation or irritability
Store ZONISADE at room temperature and discard unused portions 30 days after first opening.
The Important Safety Information does not include all the information needed to use ZONISADE safely and effectively. Please talk to your healthcare provider and see the complete Prescribing Information for ZONISADE.
To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1-800-461-7449, or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch.
PP-ZON-US-0061
References
- 1. Orange Book: Approved drug products with therapeutic equivalence evaluations. Accessed August 20, 2022. Access Data FDA GOV: http://www.accessdata.fda.gov/scripts/eder/ob/search_product.cfm 2. ZONISADE [package insert]. Woburn, MA: Azurity Pharmaceuticals, Inc.; 2023. 3. Current Good Manufacturing Practice (CGMP) guidelines. US Food and Drug Administration. Accessed August 27, 2022. FDA GOV: https://www.fda.gov/drugs/pharmaceutical-quality-resources/current-good-manufacturing-practice-cgmp-regulations