Zonisamide Safety Questions, Zonisamide Answers
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Zonisamide Safety Reports
Total Zonisamide reports: 112.Zonisamide FDA safety alerts: 2002 2008 .
Reported deaths: 5 Reported hospitalizations: 58.
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Reported Zonisamide Side Effects: pyrexia, convulsion, alanine aminotransferase increased, hepatic function abnormal, stevens-johnson syndrome, aspartate aminotransferase increased, white blood cell count decreased, lymphadenopathy, toxic epidermal necrolysis, rash erythematous, blood lactate dehydrogenase increased.
Zonisamide Usage.
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Zonisamide Side Effects Report #5412149-5Physician from UNITED STATES reported ZONISAMIDE problem on July 24, 2007. Male patient, 35 years of age, was diagnosed with weight decreased and was treated with ZONISAMIDE. After drug was administered, patient experienced the following problems/side effects: cholestasis, vanishing bile duct syndrome, weight decreased. ZONISAMIDE dosage: unknown. During the same period patient was treated with PHENTERMINE, TOPIRAMATE. Patient recovered.
Zonisamide Side Effects Report #5416517-7
ZONISAMIDE problem was reported by a Physician from JAPAN on Aug 09, 2007. Female patient, 40 years of age, was diagnosed with convulsion prophylaxis, epilepsy, post procedural complication and was treated with ZONISAMIDE. After drug was administered, patient experienced the following problems/side effects: anaemia, post procedural complication, pyrexia, white blood cell count decreased. ZONISAMIDE dosage: 150 MG, ORAL. During the same period patient was treated with RECOGNAN, ROXATIDINE ACETATE, PENMALIN, PHENOBARBITAL, ALUMINUM HYDROXIDE AND MAGNESIUM TRISILICATE. Patient was hospitalized. Patient recovered.
Zonisamide Side Effects Report #5416520-7
Physician from JAPAN reported ZONISAMIDE problem on Aug 08, 2007. Male patient, 56 years of age, was diagnosed with convulsion prophylaxis, subarachnoid haemorrhage and was treated with ZONISAMIDE. After drug was administered, patient experienced the following problems/side effects: rash erythematous. ZONISAMIDE dosage: 200 MG, ORAL. During the same period patient was treated with CEFAMEZIN ALPHA, LOXONIN. Patient was hospitalized. Patient recovered.
Zonisamide Side Effects Report #5416646-8
ZONISAMIDE problem was reported by a Physician from JAPAN on Aug 06, 2007. Male patient, 61 years of age, was diagnosed with cerebral haemorrhage and was treated with ZONISAMIDE. After drug was administered, patient experienced the following problems/side effects: blood potassium increased, depressed level of consciousness, diabetic ketoacidosis, gastroduodenal ulcer, melaena, metabolic acidosis, pyrexia, tachypnoea. ZONISAMIDE dosage: 200 MG, 1 IN 1 D, ORAL. During the same period patient was treated with ADALAT, FAMOTIDINE, PALGIN, GRAMALIL, RISPERDAL, BLOPRESS, DIAZEPAM, MYSLEE. Patient was hospitalized and became disabled. Patient recovered.
Zonisamide Side Effects Report #5419203-2
Consumer or non-health professional from reported ZONISAMIDE problem on Aug 13, 2007. Female patient, 50 years of age, was diagnosed with migraine prophylaxis and was treated with ZONISAMIDE. After drug was administered, patient experienced the following problems/side effects: insomnia, no therapeutic response, restless legs syndrome. ZONISAMIDE dosage: unknown. During the same period patient was treated with PROPRANOLOL, FLUNARIZINE, TOPIRAMATE, VALPROIC ACID, TRYPTIZOL, MAGNESIUM SULPHATE. Patient recovered.
Zonisamide Side Effects Report #5434293-9
ZONISAMIDE problem was reported by a Physician from JAPAN on July 31, 2007. Female patient, 63 years of age, was diagnosed with convulsion prophylaxis and was treated with ZONISAMIDE. After drug was administered, patient experienced the following problems/side effects: swelling, white blood cell count decreased. ZONISAMIDE dosage: 150 MG, ORAL. During the same period patient was treated with PENMALIN, RECOGNAN, CLINDAMYCIN, SYMMETREL, ALTAT, CEROCRAL, METHYCOBAL. Patient recovered.
Zonisamide Side Effects Report #5434294-0
Physician from JAPAN reported ZONISAMIDE problem on Aug 22, 2007. Male patient, 66 years of age, was diagnosed with epilepsy and was treated with ZONISAMIDE. After drug was administered, patient experienced the following problems/side effects: stevens-johnson syndrome. ZONISAMIDE dosage: 300 MG, 1 IN 1 D, ORAL. During the same period patient was treated with ASPIRIN, URINORM, URALYT, GRAMALIL, MUCOSTA, ROHYPNOL, PURSENNID. Patient recovered.
Zonisamide Side Effects Report #5448240-7
ZONISAMIDE problem was reported by a Physician from JAPAN on Aug 30, 2007. Male patient, 66 years of age, was diagnosed with epilepsy and was treated with ZONISAMIDE. After drug was administered, patient experienced the following problems/side effects: stevens-johnson syndrome. ZONISAMIDE dosage: 300 MG, 1 IN 1 D, ORAL. During the same period patient was treated with BAYASPIRIN, URINORM, URALYT, GRAMALIL, MUCOSTA, MAGMITT, VALPROATE. Patient recovered.
Zonisamide Side Effects Report #5451799-7
Physician from JAPAN reported ZONISAMIDE problem on Aug 31, 2007. Female patient, 48 years of age, was diagnosed with epilepsy and was treated with ZONISAMIDE. After drug was administered, patient experienced the following problems/side effects: leukopenia, oral candidiasis. ZONISAMIDE dosage: unknown. Patient was hospitalized. Patient recovered.
Zonisamide Side Effects Report #5458024-1
ZONISAMIDE problem was reported by a Health Professional from UNITED STATES on Sept 17, 2007. Female patient, weighting 202.0 lb, was treated with ZONISAMIDE. After drug was administered, patient experienced the following problems/side effects: facial bones fracture, fall, myoclonic epilepsy. ZONISAMIDE dosage: unknown. Patient recovered.
Zonisamide Side Effects Report #5458190-8
Physician from JAPAN reported ZONISAMIDE problem on Sept 05, 2007. Female patient, 32 years of age, was diagnosed with epilepsy and was treated with ZONISAMIDE. After drug was administered, patient experienced the following problems/side effects: asthma, liver disorder, lymphocytic infiltration. ZONISAMIDE dosage: unknown. Patient was hospitalized. Patient recovered.
Zonisamide Side Effects Report #5468379-X
ZONISAMIDE problem was reported by a Physician from JAPAN on Sept 12, 2007. Male patient, 59 years of age, was treated with ZONISAMIDE. After drug was administered, patient experienced the following problems/side effects: hepatic function abnormal, pyrexia. ZONISAMIDE dosage: unknown. Patient recovered.
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Drug Information: Zonisamide
URL of this page: http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a603008.html
(zoe nis' a mide)IMPORTANT WARNING:
| [Posted 01/31/2008] FDA informed healthcare professionals that the Agency has analyzed reports of suicidality (suicidal behavior or ideation) from placebo-controlled clinical studies of eleven drugs used to treat epilepsy as well as psychiatric disorders, and other conditions. In the FDA's analysis, patients receiving antiepileptic drugs had approximately twice the risk of suicidal behavior or ideation (0.43%) compared to patients receiving placebo (0.22%). The increased risk of suicidal behavior and suicidal ideation was observed as early as one week after starting the antiepileptic drug and continued through 24 weeks. The results were generally consistent among the eleven drugs. The relative risk for suicidality was higher in patients with epilepsy compared to patients who were given one of the drugs in the class for psychiatric or other conditions.Healthcare professionals should closely monitor all patients currently taking or starting any antiepileptic drug for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression.The drugs included in the analyses include (some of these drugs are also available in generic form): Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)Felbamate (marketed as Felbatol)Gabapentin (marketed as Neurontin) Lamotrigine (marketed as Lamictal) Levetiracetam (marketed as Keppra) Oxcarbazepine (marketed as Trileptal)Pregabalin (marketed as Lyrica) Tiagabine (marketed as Gabitril)Topiramate (marketed as Topamax) Valproate (marketed as Depakote, Depakote ER, Depakene, Depacon) Zonisamide (marketed as Zonegran) Although the 11 drugs listed above were the ones included in the analysis, FDA expects that the increased risk of suicidality is shared by all antiepileptic drugs and anticipates that the class labeling changes will be applied broadly. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Antiepileptic and http://www.fda.gov/cder/drug/InfoSheets/HCP/antiepilepticsHCP.htm. |
Why is this medication prescribed?
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Zonisamide is used in combination with other medications to treat seizures in adults with epilepsy. Zonisamide is in a class of medications called anticonvulsants. It works by decreasing abnormal excitement in the brain.
How should this medicine be used?
Zonisamide comes as a capsule to take by mouth. It is usually taken once or twice a day with or without food. To help you remember to take zonisamide, take it around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take zonisamide exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Swallow the capsules whole; do not split, chew, or crush them.
Your doctor will probably start you on a low dose of zonisamide and gradually increase your dose, not more than once every 2 weeks.
Zonisamide controls epilepsy but does not cure it. It may take 2 weeks or longer before you feel the full benefit of zonisamide. Continue to take zonisamide even if you feel well. Do not stop taking zonisamide without talking to your doctor. If you suddenly stop taking zonisamide, your seizures may become worse. Your doctor will probably decrease your dose gradually.
Other uses for this medicine
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow?
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Before taking zonisamide,
- tell your doctor and pharmacist if you are allergic to zonisamide, celecoxib (Celebrex), diuretics ('water pills'), oral medications for diabetes, sulfa drugs, or any other medications.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: antifungals such as fluconazole (Diflucan), itraconazole (Sporanox), and ketoconazole (Nizoral); antihistamines; carbamazepine (Carbatrol, Tegretol), cimetidine (Tagamet); clarithromycin (Biaxin); cyclosporine (Neoral, Sandimmune); danazol (Danocrine); delavirdine (Rescriptor); dexamethasone (Decadron, Dexpak), diltiazem (Cardizem, Dilacor, Tiazac); ethosuximide (Zarontin), erythromycin (E.E.S., E-Mycin, Erythrocin); fluoxetine (Prozac, Sarafem); fluvoxamine (Luvox); HIV protease inhibitors such as indinavir (Crixivan) and ritonavir (Norvir); ipratropium (Atrovent); isoniazid (INH, Nydrazid); medications for irritable bowel disease, motion sickness, Parkinson's disease, ulcers, or urinary problems; metronidazole (Flagyl); nefazodone (Serzone); oral contraceptives (birth control pills); oral medications for glaucoma such as acetazolamide (Diamox); phenobarbital (Luminal, Solfoton); phenytoin (Dilantin); primidone (Mysoline); rifabutin (Mycobutin), rifampin (Rifadin, Rimactane); troglitazone (Rezulin); troleandomycin (TAO); valproic acid (Depakene, Depakote); verapamil (Calan, Covera, Isoptin, Verelan); and zafirlukast (Accolate). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have or have ever had liver or kidney disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking zonisamide, call your doctor. Zonisamide may harm the fetus.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking zonisamide.
- you should know that zonisamide may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
- remember that alcohol can add to the drowsiness caused by this medication.
- you should know that you may be more likely to develop kidney stones while taking zonisamide. You should drink 6-8 glasses of water daily to help prevent kidney stones from forming.
- you should know that zonisamide can prevent you from sweating and make it harder for your body to cool down when it gets very hot. This happens most often in warm weather and to children who take zonisamide. (Children should not normally take zonisamide, but in some cases, a doctor will decide whether it is the best choice.) You should avoid exposure to heat and notify your doctor if you have a fever and/or are not sweating as usual.
What special dietary instructions should I follow?
Talk to your doctor about drinking grapefruit juice while taking this medicine.
What should I do if I forget a dose?
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What side effects can this medication cause?
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Zonisamide may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- drowsiness
- loss of appetite
- upset stomach
- vomiting
- weight loss
- changes in taste
- dizziness
- constipation
- dry mouth
- headache
- confusion
- irritability
- difficulty falling asleep or staying asleep
- difficulty with memory
- pain, burning, or tingling in the hands or feet
- difficulty focusing eyes
- double vision
- sneezing
- runny nose
Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately:
- rash
- worsening or longer lasting seizures
- sudden back pain
- stomach pain
- pain when urinating
- bloody or dark urine
- fever
- sore throat
- sores in mouth
- easy bruising
- depression
- unusual thoughts
- difficulty thinking of words or trouble speaking
- difficulty thinking or concentrating
- lack of coordination
- difficulty walking
Zonisamide may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/index.html] or by phone [1-800-332-1088].
What storage conditions are needed for this medicine?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
In case of emergency/overdose
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Symptoms of overdose may include:
- slow heartbeat
- difficulty breathing
- dizziness
- fainting
- loss of consciousness
What other information should I know?
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to zonisamide.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
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