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Zonisamide Side Effects

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Common Zonisamide Side Effects


The most commonly reported Zonisamide side effects (click to view or check a box to report):

Convulsion (87)
Stevens-johnson Syndrome (54)
Pyrexia (48)
Alanine Aminotransferase Increased (38)
Hepatic Function Abnormal (36)
Aspartate Aminotransferase Increased (33)
Product Substitution Issue (28)
Condition Aggravated (27)
Rash (26)
Toxic Epidermal Necrolysis (24)
Vomiting (23)
Headache (20)
Nausea (17)
White Blood Cell Count Decreased (16)
Dizziness (16)
Nephrolithiasis (15)
Gamma-glutamyltransferase Increased (15)
Fatigue (15)
Calculus Urinary (15)
Loss Of Consciousness (14)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Zonisamide Side Effects Reported to FDA



Zonisamide Side Effect Report#9991383
Toxicity To Various Agents, Psychotic Disorder, Nystagmus, Hyperreflexia, Gait Disturbance, Dizziness, Fatigue, Sleep Disorder
This is a report of a 34-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Zonisamide (dosage: 100mg At Bedtime, Then 300mg At Bedtime, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Toxicity To Various Agents, Psychotic Disorder, Nystagmus, Hyperreflexia, Gait Disturbance, Dizziness, Fatigue, Sleep Disorder after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Zonisamide treatment in male patients, resulting in Toxicity To Various Agents side effect. The patient was hospitalized.
Zonisamide Side Effect Report#9960305
Paranoia, Delusion, Sleep Disorder, Psychotic Disorder, Gait Disturbance, Palpitations, Dizziness, Asthenia, Disturbance In Attention
This report suggests a potential Zonisamide Paranoia side effect(s) that can have serious consequences. A 34-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: complex partial seizures and used Zonisamide (dosage: 100 Mg, Hs) starting NS. After starting Zonisamide the patient began experiencing various side effects, including: Paranoia, Delusion, Sleep Disorder, Psychotic Disorder, Gait Disturbance, Palpitations, Dizziness, Asthenia, Disturbance In AttentionAdditional drugs used concurrently: NA.The patient was hospitalized. Although Zonisamide demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Paranoia, may still occur.
Zonisamide Side Effect Report#9928776
Calculus Urinary
This Calculus Urinary problem was reported by a physician from JP. A 10-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: epilepsy. On 2000 this consumer started treatment with Zonisamide (dosage: NA). The following drugs were being taken at the same time: NA. When using Zonisamide, the patient experienced the following unwanted symptoms/side effects: Calculus UrinaryThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Calculus Urinary, may become evident only after a product is in use by the general population.
Zonisamide Side Effect Report#9868620
Calculus Urinary, Renal Failure Acute
This Calculus Urinary side effect was reported by a health professional from JP. A 10-year-old female patient (weight:NA) experienced the following symptoms/conditions: epilepsy.The patient was prescribed Zonisamide (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Valproic Acid
  • Phenobarbital
  • Clonazepam
.After starting to take Zonisamide the consumer reported adverse symptoms, such as: Calculus Urinary, Renal Failure AcuteThese side effects may potentially be related to Zonisamide. The patient was hospitalized.
Zonisamide Side Effect Report#9856484
Hydronephrosis, Calculus Ureteric, Crystalluria, Calculus Urinary, Renal Impairment, Haematuria, Urine Output Decreased
This is a report of a 10-year-old female patient (weight: NA) from JP, suffering from the following health symptoms/conditions: epilepsy, who was treated with Zonisamide (dosage: Unk Ukn, Unk, start time: NS), combined with:
  • Valproic Acid (Unk Ukn, Unk)
  • Phenobarbital (Unk Ukn, Unk)
  • Clonazepam (Unk Ukn, Unk)
  • Antibiotics (Unk Ukn, Unk)
and developed a serious reaction and side effect(s): Hydronephrosis, Calculus Ureteric, Crystalluria, Calculus Urinary, Renal Impairment, Haematuria, Urine Output Decreased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Zonisamide treatment in female patients, resulting in Hydronephrosis side effect. The patient was hospitalized.
Zonisamide Side Effect Report#9775516
Back Pain
This report suggests a potential Zonisamide Back Pain side effect(s) that can have serious consequences. A 83-year-old male patient (weight: NA) from JP was diagnosed with the following symptoms/conditions: dementia with lewy bodies and used Zonisamide (dosage: NA) starting
Nov 22, 2013. After starting Zonisamide the patient began experiencing various side effects, including: Back PainAdditional drugs used concurrently:
  • Donepezil (5 Mg Daily)
  • Sennoside (24 Mg Daily)
  • Lonasen (2 Mg Daily)
  • Vesicare Od (2.5 Mg Daily)
  • Madopar (450 Mg Daily)
  • Mohrus Tape
The patient was hospitalized. Although Zonisamide demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Back Pain, may still occur.
Zonisamide Side Effect Report#9736615
Stevens-johnson Syndrome
This Stevens-johnson Syndrome problem was reported by a physician from JP. A 57-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: epilepsy. On NS this consumer started treatment with Zonisamide (dosage: NA). The following drugs were being taken at the same time: NA. When using Zonisamide, the patient experienced the following unwanted symptoms/side effects: Stevens-johnson SyndromeAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Stevens-johnson Syndrome, may become evident only after a product is in use by the general population.
Zonisamide Side Effect Report#9735712
Stevens-johnson Syndrome
This Stevens-johnson Syndrome side effect was reported by a physician from JP. A 6-year-old male patient (weight:NA) experienced the following symptoms/conditions: epilepsy.The patient was prescribed Zonisamide (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Zonisamide the consumer reported adverse symptoms, such as: Stevens-johnson SyndromeThese side effects may potentially be related to Zonisamide.
Zonisamide Side Effect Report#9733867
Stevens-johnson Syndrome
This is a report of a 56-year-old male patient (weight: NA) from JP, suffering from the following health symptoms/conditions: epilepsy, who was treated with Zonisamide (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Stevens-johnson Syndrome after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Zonisamide treatment in male patients, resulting in Stevens-johnson Syndrome side effect.
Zonisamide Side Effect Report#9699562
Rash, Skin Lesion, Pyrexia, Liver Disorder, Leukocytosis, Human Herpesvirus 6 Infection, Eosinophilia, Lymphadenopathy
This report suggests a potential Zonisamide Rash side effect(s) that can have serious consequences. A 62-year-old female patient (weight: NA) from JP was diagnosed with the following symptoms/conditions: brain neoplasm and used Zonisamide (dosage: NA) starting NS. After starting Zonisamide the patient began experiencing various side effects, including: Rash, Skin Lesion, Pyrexia, Liver Disorder, Leukocytosis, Human Herpesvirus 6 Infection, Eosinophilia, LymphadenopathyAdditional drugs used concurrently: NA. Although Zonisamide demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Rash, may still occur.
Zonisamide Side Effect Report#9674536
Convulsion
This Convulsion problem was reported by a physician from US. A 39-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: epilepsy. On NS this consumer started treatment with Zonisamide (dosage: NA). The following drugs were being taken at the same time: NA. When using Zonisamide, the patient experienced the following unwanted symptoms/side effects: ConvulsionAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Convulsion, may become evident only after a product is in use by the general population.
Zonisamide Side Effect Report#9669565
Respiratory Tract Infection, Convulsion, Apathy, Somnolence
This Respiratory Tract Infection side effect was reported by a physician from NL. A 59-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Zonisamide (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Zonisamide the consumer reported adverse symptoms, such as: Respiratory Tract Infection, Convulsion, Apathy, SomnolenceThese side effects may potentially be related to Zonisamide. The patient was hospitalized.
Zonisamide Side Effect Report#9648737
Tremor, Irritability, Crying
This is a report of a female patient (weight: NA) from US, suffering from the following health symptoms/conditions: convulsion, who was treated with Zonisamide (dosage: 4 Pills Qhs/bedtime Oral, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Tremor, Irritability, Crying after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Zonisamide treatment in female patients, resulting in Tremor side effect.
Zonisamide Side Effect Report#9531602
Convulsion
This report suggests a potential Zonisamide Convulsion side effect(s) that can have serious consequences. A 26-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Zonisamide (dosage: NA) starting
Aug 09, 2013. After starting Zonisamide the patient began experiencing various side effects, including: ConvulsionAdditional drugs used concurrently: NA. Although Zonisamide demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Convulsion, may still occur.
Zonisamide Side Effect Report#9526081
Fall, Tremor
This Fall problem was reported by a pharmacist from US. A 9-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: convulsion. On
Jun 05, 2013 this consumer started treatment with Zonisamide (dosage: 100 Mg, Qd). The following drugs were being taken at the same time: NA. When using Zonisamide, the patient experienced the following unwanted symptoms/side effects: Fall, TremorAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Fall, may become evident only after a product is in use by the general population.
Zonisamide Side Effect Report#9515024
Fall
This Fall side effect was reported by a pharmacist from US. A 9-year-old female patient (weight:NA) experienced the following symptoms/conditions: convulsion.The patient was prescribed Zonisamide (drug dosage: NA), which was initiated on
May 23, 2013. Concurrently used drugs: NA..After starting to take Zonisamide the consumer reported adverse symptoms, such as: FallThese side effects may potentially be related to Zonisamide.
Zonisamide Side Effect Report#9478848
Calculus Urinary, Back Pain
This is a report of a 30-year-old male patient (weight: NA) from JP, suffering from the following health symptoms/conditions: epilepsy, who was treated with Zonisamide (dosage: 200 Mg Per Day, start time: NS), combined with:
  • Valproic Acid (600 Mg Per Day)
and developed a serious reaction and side effect(s): Calculus Urinary, Back Pain after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Zonisamide treatment in male patients, resulting in Calculus Urinary side effect.
Zonisamide Side Effect Report#9472246
Leukopenia
This report suggests a potential Zonisamide Leukopenia side effect(s) that can have serious consequences. A 38-year-old patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Zonisamide (dosage: NA) starting NS. After starting Zonisamide the patient began experiencing various side effects, including: LeukopeniaAdditional drugs used concurrently: NA. Although Zonisamide demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Leukopenia, may still occur.
Zonisamide Side Effect Report#9465084
Delirium, Persecutory Delusion, Acute Psychosis
This Delirium problem was reported by a consumer or non-health professional from Country Not Specified. A 32-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: epilepsy. On 1995 this consumer started treatment with Zonisamide (dosage: NA). The following drugs were being taken at the same time: NA. When using Zonisamide, the patient experienced the following unwanted symptoms/side effects: Delirium, Persecutory Delusion, Acute PsychosisThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Delirium, may become evident only after a product is in use by the general population.
Zonisamide Side Effect Report#9462208
Stevens-johnson Syndrome
This Stevens-johnson Syndrome side effect was reported by a physician from IN. A 14-year-old male patient (weight:NA) experienced the following symptoms/conditions: epilepsy.The patient was prescribed Zonisamide (drug dosage: NA), which was initiated on
Jul 01, 2013. Concurrently used drugs: NA..After starting to take Zonisamide the consumer reported adverse symptoms, such as: Stevens-johnson SyndromeThese side effects may potentially be related to Zonisamide. The patient was hospitalized.
Zonisamide Side Effect Report#9448085
Speech Disorder, Memory Impairment
This is a report of a 59-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: epilepsy, who was treated with Zonisamide (dosage: 300 Mg, start time: 201303), combined with:
  • Topamax
and developed a serious reaction and side effect(s): Speech Disorder, Memory Impairment after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Zonisamide treatment in male patients, resulting in Speech Disorder side effect.
Zonisamide Side Effect Report#9447999
Speech Disorder, Memory Impairment, Aphasia
This report suggests a potential Zonisamide Speech Disorder side effect(s) that can have serious consequences. A 25-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: epilepsy and used Zonisamide (dosage: NA) starting 2013. After starting Zonisamide the patient began experiencing various side effects, including: Speech Disorder, Memory Impairment, AphasiaAdditional drugs used concurrently:
  • Topamax
Although Zonisamide demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Speech Disorder, may still occur.
Zonisamide Side Effect Report#9360673
Stevens-johnson Syndrome, Toxic Epidermal Necrolysis
This Stevens-johnson Syndrome problem was reported by a consumer or non-health professional from US. A 8-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: epilepsy. On
Mar 07, 2013 this consumer started treatment with Zonisamide (dosage: 2 100 Mg Capsules; At Night). The following drugs were being taken at the same time: NA. When using Zonisamide, the patient experienced the following unwanted symptoms/side effects: Stevens-johnson Syndrome, Toxic Epidermal NecrolysisThe patient was hospitalized and became disabled.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Stevens-johnson Syndrome, may become evident only after a product is in use by the general population.
Zonisamide Side Effect Report#9357859
Abortion Induced, Exposure During Pregnancy
This Abortion Induced side effect was reported by a health professional from GB. A 23-year-old female patient (weight:NA) experienced the following symptoms/conditions: epilepsy.The patient was prescribed Zonisamide (drug dosage: NA), which was initiated on 201008. Concurrently used drugs:
  • Perfectil
.After starting to take Zonisamide the consumer reported adverse symptoms, such as: Abortion Induced, Exposure During PregnancyThese side effects may potentially be related to Zonisamide.
Zonisamide Side Effect Report#9341283
Convulsion, Product Substitution Issue
This is a report of a 19-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Zonisamide (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Convulsion, Product Substitution Issue after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Zonisamide treatment in male patients, resulting in Convulsion side effect.


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The appearance of Zonisamide on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    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.

    Zonisamide reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

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    Zonisamide Safety Alerts, Active Ingredients, Usage Information

    NDC0185-0193
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameZonisamide
    NameZonisamide
    Dosage FormCAPSULE
    RouteORAL
    On market since20051222
    LabelerEon Labs, Inc.
    Active Ingredient(s)ZONISAMIDE
    Strength(s)25
    Unit(s)mg/1
    Pharma ClassAnti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]

    Zonisamide Dosage, Warnings, Usage.

    Side Effects reported to FDA: 591

    Zonisamide safety alerts: 2009 2002

    Reported deaths: 49

    Reported hospitalizations: 301

    Zonisamide (marketed as Zonegran, and generics)

    Audience: Neurological healthcare professionals

    [Posted 02/23/2009] FDA notified healthcare professionals that updated clinical data has determined that treatment with zonisamide, indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy, can cause metabolic acidosis in some patients. Patients with predisposing conditions or therapies may be at greater risk for developing metabolic acidosis and the risk of zonisamide-induced metabolic acidosis appears to be more frequent and severe in younger patients. FDA recommends that healthcare professionals measure serum bicarbonate before starting treatment and periodically during treatment with zonisamide, even in the absence of symptoms and is working with the makers of zonisamide to revise the product labeling to reflect this new safety information. The notification includes recommendations for healthcare providers, information for patients, and a data summary.

    [February 19, 2009 - Information for Healthcare Professionals: Zonisamide (marketed as Zonegran, and generics) - FDA]

    Latest Zonisamide clinical trials