"The U.S. Food and Drug Administration today approved a device to help reduce the frequency of seizures in epilepsy patients who have not responded well to medications.
The RNS Stimulator consists of a small neurostimulator implanted within "...
Zonegran Side Effects Center
Medical Editor: Melissa Conrad Stöppler, MD
Zonegran (zonisamide) is indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy. Zonisamide is a sulfonamide anticonvulsant and a carbonic anhydrase inhibitor. Some common side effects associated with Zonegran may include: drowsiness, dizziness, headache, tired feeling; mild loss of appetite, weight loss; loss of balance or coordination; sore throat, cough; or blurred vision. Tell the doctor immediately if you notice any of these side effects. This is not a complete list of side effects, and others may occur.
Zonegran is administered orally in the form of capsules. Zonegran should be used with caution if used in combination with alcohol or other CNS depressants. Zonegran may cause serious adverse fetal effects, based on clinical and nonclinical data.
Our Zonegran 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.
Zonegran in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: any form of skin rash; 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, 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:
- fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
- the first sign of any skin rash, no matter how mild;
- increased or worsening seizures;
- rapid breathing or feeling short of breath with dry mouth, confusion, dizziness or weakness, numbness or tingling, chest pain;;
- fast, pounding, or uneven heartbeats;
- pale skin, easy bruising or bleeding, unusual weakness;
- fever, chills, body aches, flu symptoms, white patches or sores inside your mouth or on your lips;
- problems with thinking or speech, trouble concentrating;
- nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
- dizziness or weakness and hot, dry skin without sweating;
- urinating less than usual or not at all; or
- sudden back pain, stomach or side pain, pain or bleeding when urinating, bloody or dark urine.
Less serious side effects may include:
- drowsiness, dizziness, headache, tired feeling;
- mild loss of appetite, weight loss;
- loss of balance or coordination;
- sore throat, cough; or
- blurred vision, ringing in your ears.
Read the entire detailed patient monograph for Zonegran (Zonisamide) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Zonegran Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any unlikely but serious side effects, including: easy bruising/bleeding, signs of infection (such as fever, persistent sore throat), mental/mood problems (such as confusion, difficulty concentrating, memory problems, agitation, irritability), speech problems, decreased sweating, sudden back/side/abdominal pain, painful urination, pink/bloody urine.
A small number of people who take anticonvulsants for any condition (such as seizure, bipolar disorder, pain) may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor right away if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior including signs of depression, suicidal thoughts/attempts, thoughts about harming yourself.
This medication may cause a serious metabolic problem (metabolic acidosis). Get medical help right away if you have any of the following symptoms: bone pain/breakage, rapid breathing, fast/irregular heartbeat, sudden/unexplained tiredness, severe drowsiness/difficulty staying awake.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Zonegran (Zonisamide)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Zonegran FDA Prescribing Information: Side Effects
The most commonly observed adverse events related to treatment with ZONEGRAN (an incidence at least 4% greater than placebo) in controlled clinical trials and shown in descending order of frequency were somnolence, anorexia, dizziness, ataxia, agitation/irritability, and difficulty with memory and/or concentration.
In controlled clinical trials, 12% of patients receiving ZONEGRAN as adjunctive therapy discontinued due to an adverse event compared to 6% receiving placebo. Approximately 21% of the 1,336 patients with epilepsy who received ZONEGRAN in clinical studies discontinued treatment because of an adverse event. The adverse events most commonly associated with discontinuation were somnolence, fatigue and/or ataxia (6%), anorexia (3%), difficulty concentrating (2%), difficulty with memory, mental slowing, nausea/vomiting (2%), and weight loss (1%). Many of these adverse events were dose-related (see WARNINGS and PRECAUTIONS).
Adverse Event Incidence in Controlled Clinical Trials
Table 4 lists treatment-emergent adverse events that occurred in at least 2% of patients treated with ZONEGRAN in controlled clinical trials that were numerically more common in the ZONEGRAN group. In these studies, either ZONEGRAN or placebo was added to the patient's current AED therapy. Adverse events were usually mild or moderate in intensity.
The prescriber should be aware that these figures, obtained when ZONEGRAN was added to concurrent AED therapy, cannot be used to predict the frequency of adverse events in the course of usual medical practice when patient characteristics and other factors may differ from those prevailing during clinical studies. Similarly, the cited frequencies cannot be directly compared with figures obtained from other clinical investigations involving different treatments, uses, or investigators. An inspection of these frequencies, however, does provide the prescriber with one basis by which to estimate the relative contribution of drug and non-drug factors to the adverse event incidences in the population studied.
Table 4. Incidence (%) of Treatment-Emergent Adverse Events
in Placebo-Controlled, Add-On Trials (Events that occurred in at least 2% of
ZONEGRAN-treated patients and occurred more frequently in ZONEGRAN-treated than
|BODY SYSTEM/PREFERRED TERM|| ZONEGRAN
|BODY AS A WHOLE|
|HEMATOLOGIS AND LYMPHATIC|
|METABOLIC AND NUTRITIONAL|
|NEUROPSYCHIATRIC AND COGNITIVE DYSFUNCTION-ALTERED COGNITIVE FUNCTION|
|Difficulty with Memory||6||2|
|NEUROPSYCHIATRIC AND COGNITIVE DYSFUNCTION-BEHAVIORAL ABNORMALITIES (NON-PYSCHOSIS- RELATED)|
|NEUROPSYCHIATRIC AND COGNITIVE DYSFUNCTION-BEHAVIORAL ABNORMALITIES (PYSCHOSIS-RELATED)|
|NEUROPSYCHIATRIC AND COGNITIVE DYSFUNCTION-CNS DEPRESSION|
|NEUROPSYCHIATRIC AND COGNITIVE DYSFUNCTION-SPEECH AND LANGUAGE ABNORMALITIES|
|Difficulties in Verbal Expression||2||< 1|
|SKIN AND APPENDAGES|
Other Adverse Events Observed During Clinical Trials
ZONEGRAN has been administered to 1,598 individuals during all clinical trials, only some of which were placebo-controlled. During these trials, all events were recorded by the investigators using their own terms. To provide a useful estimate of the proportion of individuals having adverse events, similar events have been grouped into a smaller number of standardized categories using a modified COSTART dictionary. The frequencies represent the proportion of the 1,598 individuals exposed to ZONEGRAN who experienced an event on at least one occasion. All events are included except those already listed in the previous table or discussed in WARNINGS or PRECAUTIONS, trivial events, those too general to be informative, and those not reasonably associated with ZONEGRAN.
Events are further classified within each category and listed in order of decreasing frequency as follows: frequent occurring in at least 1:100 patient; infrequent occurring in 1:100 to 1:1000 patients; rare occurring in fewer than 1:1000 patients.
Cardiovascular: Infrequent: Palpitation, tachycardia, vascular insufficiency, hypotension, hypertension, thrombophlebitis, syncope, bradycardia. Rare: Atrial fibrillation, heart failure, pulmonary embolus, ventricular extrasystoles.
Digestive: Frequent: Vomiting. Infrequent: Flatulence, gingivitis, gum hyperplasia, gastritis, gastroenteritis, stomatitis, cholelithiasis, glossitis, melena, rectal hemorrhage, ulcerative stomatitis, gastro-duodenal ulcer, dysphagia, gum hemorrhage. Rare: Cholangitis, hematemesis, cholecystitis, cholestatic jaundice, colitis, duodenitis, esophagitis, fecal incontinence, mouth ulceration.
Nervous System: Frequent: Tremor, convulsion, abnormal gait, hyperesthesia, incoordination. Infrequent: Hypertonia, twitching, abnormal dreams, vertigo, libido decreased, neuropathy, hyperkinesia, movement disorder, dysarthria, cerebrovascular accident, hypotonia, peripheral neuritis, reflexes increased. Rare: Dyskinesia, dystonia, encephalopathy, facial paralysis, hypokinesia, hyperesthesia, myoclonus, oculogyric crisis.
Behavioral Abnormalities -Non-Psychosis-Related: Infrequent: Euphoria.
Urogenital: Infrequent: Urinary frequency, dysuria, urinary incontinence, hematuria, impotence, urinary retention, urinary urgency, amenorrhea, polyuria, nocturia. Rare: Albuminuria, enuresis, bladder pain, bladder calculus, gynecomastia, mastitis, menorrhagia.
Drug Abuse And Dependence
The abuse and dependence potential of ZONEGRAN has not been evaluated in human studies (see WARNINGS, Cognitive/Neuropsychiatric Adverse Events subsection). In a series of animal studies, zonisamide did not demonstrate abuse liability and dependence potential. Monkeys did not self-administer zonisamide in a standard reinforcing paradigm. Rats exposed to zonisamide did not exhibit signs of physical dependence of the CNS-depressant type. Rats did not generalize the effects of diazepam to zonisamide in a standard discrimination paradigm after training, suggesting that zonisamide does not have abuse potential of the benzodiazepine-CNS depressant type.
Read the entire FDA prescribing information for Zonegran (Zonisamide) »
Additional Zonegran Information
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