November 25, 2015
Recommended Topic Related To:


"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"...


Zonegran Side Effects Center

Medical Editor: Melissa Conrad Stöppler, MD

Last reviewed on RxList 5/15/2015

Zonegran (zonisamide) is a sulfonamide anticonvulsant and a carbonic anhydrase inhibitor indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy. Common side effects of Zonegran include drowsiness, dizziness, headache, tired feeling, loss of appetite, weight loss, loss of balance or coordination, sore throat, cough, or blurred vision. Tell the doctor immediately if you notice serious side effects of Zonegran including increased or worsening seizures, lightheadedness, shortness of breath, rapid heart rate, trouble concentrating, fever, chills, sores in your mouth and throat, severe pain in your lower back, blood in your urine, feeling very thirsty or hot, being unable to urinate, or severe skin reaction. 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.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have a serious side effect such as:

  • increased or worsening seizures;
  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;
  • fever, chills, body aches, flu symptoms, sores in your mouth and throat;
  • severe pain in your lower back, blood in your urine;
  • loss of appetite, tired feeling, problems with thinking or speech, trouble concentrating;
  • feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin without sweating;
  • the first sign of any skin rash, no matter how mild; or
  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects may include:

  • drowsiness;
  • dizziness; or
  • loss of balance or coordination.

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.

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

SIDE EFFECTS: Dizziness, drowsiness, trouble sleeping, lack of coordination, lightheadedness, loss of appetite, diarrhea, and double vision may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

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
(Adverse Reactions)


The most common adverse reactions 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 reaction 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 reaction. The most common adverse reactions leading to 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 reactions were dose-related (see WARNINGS and PRECAUTIONS).

Adverse Reaction Incidence In Controlled Clinical Trials

Table 4 lists adverse reactions 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.

Table 4: Adverse Reactions 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 placebo-treated patients)

(n=269) %
(n=230) %
  Headache 10 8
  Abdominal Pain 6 3
  Flu Syndrome 4 3
  Anorexia 13 6
  Nausea 9 6
  Diarrhea 5 2
  Dyspepsia 3 1
  Constipation 2 1
  Dry Mouth 2 1
  Ecchymosis 2 1
  Weight Loss 3 2
  Dizziness 13 7
  Ataxia 6 1
  Nystagmus 4 2
  Paresthesia 4 1
  Confusion 6 3
  Difficulty Concentrating 6 2
  Difficulty with Memory 6 2
  Mental Slowing 4 2
  Agitation/Irritability 9 4
  Depression 6 3
  Insomnia 6 3
  Anxiety 3 2
  Nervousness 2 1
  Schizophrenic/Schizophreniform Behavior 2 0
  Somnolence 17 7
  Fatigue 8 6
  Tiredness 7 5
  Speech Abnormalities 5 2
  Difficulties in Verbal Expression 2 < 1
  Rhinitis 2 1
  Rash 3 2
  Diplopia 6 3
  Taste Perversion 2 0

Other Adverse Reactions In Clinical Trials

ZONEGRAN has been administered to 1,598 individuals during all clinical trials, only some of which were placebo-controlled. 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.

Body as a Whole: Frequent: Accidental injury, asthenia. Infrequent: Chest pain, flank pain, malaise, allergic reaction, face edema, neck rigidity. Rare: Lupus erythematosus.

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.

Hematologic and Lymphatic: Infrequent: Leukopenia, anemia, immunodeficiency, lymphadenopathy. Rare: Thrombocytopenia, microcytic anemia, petechia.

Metabolic and Nutritional: Infrequent: Peripheral edema, weight gain, edema, thirst, dehydration. Rare: Hypoglycemia, hyponatremia, lactic dehydrogenase increased, SGOT increased, SGPT increased.

Musculoskeletal: Infrequent: Leg cramps, myalgia, myasthenia, arthralgia, arthritis.

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.

Respiratory: Frequent: Pharyngitis, cough increased. Infrequent: Dyspnea. Rare: Apnea, hemoptysis.

Skin and Appendages: Frequent: Pruritus. Infrequent: Maculopapular rash, acne, alopecia, dry skin, sweating, eczema, urticaria, hirsutism, pustular rash, vesiculobullous rash.

Special Senses: Frequent: Amblyopia, tinnitus. Infrequent: Conjunctivitis, parosmia, deafness, visual field defect, glaucoma. Rare: Photophobia, iritis.

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.

Post Marketing Experience

The following serious adverse reactions have been reported since approval and use of ZONEGRAN worldwide. These reactions are reported voluntarily from a population of uncertain size; therefore, it is not possible to estimate their frequency or establish a causal relationship to drug exposure.

Acute pancreatitis, rhabdomyolysis, increased creatine phosphokinase.

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)

Zonegran - User Reviews

Zonegran User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Zonegran sorted by most helpful. Patient Discussions FAQs

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.


Find tips and treatments to control seizures.