Topiramate Side Effects
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Topiramate Safety Reports reported to FDA
Total Topiramate reports: 64.Topiramate FDA safety alerts: 2001 2003 2005 2008 .
Reported deaths: 9 Reported hospitalizations: 28.
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Reported Topiramate Side Effects: convulsion, failure to thrive, completed suicide, confusional state, somnolence, gastrostomy tube insertion, cachexia, aspiration, uveitis, cerebellar haemorrhage, mental status changes.
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Showing 1-50 of 64 Next >
Topiramate Side Effects Report #5392536-4Physician from UNITED STATES reported TOPIRAMATE problem on July 09, 2007. Male patient, weighting 20.50 lb, was diagnosed with convulsion, pain prophylaxis, convulsion prophylaxis, gastrooesophageal reflux disease and was treated with TOPIRAMATE. After drug was administered, patient experienced the following problems/side effects: cachexia, failure to thrive, gastrostomy tube insertion. TOPIRAMATE dosage: unknown. During the same period patient was treated with IBUPROFEN, ACETAMINOPHEN, PHENOBARBITAL, ZANTAC. Patient was hospitalized. Patient recovered.
Topiramate Side Effects Report #5401073-X
TOPIRAMATE problem was reported by a Health Professional from PORTUGAL on July 19, 2007. Female patient, weighting 141.1 lb, was diagnosed with migraine prophylaxis and was treated with TOPIRAMATE. After drug was administered, patient experienced the following problems/side effects: angle closure glaucoma, choroidal detachment, eye oedema, intraocular pressure increased. TOPIRAMATE dosage: unknown. During the same period patient was treated with DIAZEPAM, SERTRALINE. Patient was hospitalized. Patient recovered.
Topiramate Side Effects Report #5403735-7
Physician from THAILAND reported TOPIRAMATE problem on July 23, 2007. Female patient, child 12 years of age, was diagnosed with epilepsy and was treated with TOPIRAMATE. After drug was administered, patient experienced the following problems/side effects: cerebellar haemorrhage, convulsion, delayed recovery from anaesthesia. TOPIRAMATE dosage: unknown. During the same period patient was treated with PHENOBARBITAL, LAMOTRIGINE. Patient recovered.
Topiramate Side Effects Report #5404871-1
TOPIRAMATE problem was reported by a Physician from THAILAND on July 23, 2007. Male patient, 15 years of age, was diagnosed with complex partial seizures, convulsion and was treated with TOPIRAMATE. After drug was administered, patient experienced the following problems/side effects: cerebellar haemorrhage, coordination abnormal, dysarthria, somnolence. TOPIRAMATE dosage: unknown. During the same period patient was treated with PHENYTOIN. Patient recovered.
Topiramate Side Effects Report #5406788-5
Physician from UNITED STATES reported TOPIRAMATE problem on Aug 02, 2007. Female patient, 26 years of age, was treated with TOPIRAMATE. After drug was administered, patient experienced the following problems/side effects: neuroleptic malignant syndrome. TOPIRAMATE dosage: unknown. During the same period patient was treated with ARIPIPRAZOLE, BUPROPION, ALPRAZOLAM, PREGABALIN. Patient recovered.
Topiramate Side Effects Report #5412381-0
TOPIRAMATE problem was reported by a Pharmacist from UNITED STATES on Aug 10, 2007. Male patient, 49 years of age, was diagnosed with bipolar i disorder, migraine prophylaxis and was treated with TOPIRAMATE. After drug was administered, patient experienced the following problems/side effects: abdominal pain, confusional state, diplopia, dissociative disorder, feeling abnormal, incorrect dose administered, suicidal behaviour, suicidal ideation, visual disturbance. TOPIRAMATE dosage: 50MG BID PO. During the same period patient was treated with GABAPENTIN, ATENOLOL, HYDROCHLOROTHIAZIDE, IBUPROFEN, LORAZEPAM, PROCHLORPERAZINE, RIBOFLAVIN. Patient was hospitalized. Patient recovered.
Topiramate Side Effects Report #5415423-1
Pharmacist from UNITED STATES reported TOPIRAMATE problem on Aug 13, 2007. Male patient, 38 years of age, was treated with TOPIRAMATE. After drug was administered, patient experienced the following problems/side effects: confusional state, memory impairment, mental status changes, pruritus, urticaria. TOPIRAMATE dosage: 50MG HS PO. Patient recovered.
Topiramate Side Effects Report #5419318-9
TOPIRAMATE problem was reported by a Physician from UNITED STATES on Aug 07, 2007. Male patient, 18 years of age, weighting 120.0 lb, was diagnosed with weight decreased and was treated with TOPIRAMATE. After drug was administered, patient experienced the following problems/side effects: hyperthyroidism. TOPIRAMATE dosage: unknown. During the same period patient was treated with CLOZAPINE, DIVALPROEX, CITALOPRAM, OMEPRAZOLE, DOXYCYCLINE. Patient recovered.
Topiramate Side Effects Report #5419350-5
Consumer or non-health professional from UNITED STATES reported TOPIRAMATE problem on Aug 15, 2007. Female patient, weighting 165.0 lb, was diagnosed with migraine and was treated with TOPIRAMATE. After drug was administered, patient experienced the following problems/side effects: epistaxis, eye haemorrhage, mouth haemorrhage. TOPIRAMATE dosage: 25MG BEFORE BED PO. Patient was hospitalized. Patient recovered.
Topiramate Side Effects Report #5429360-X
TOPIRAMATE problem was reported by a Consumer or non-health professional from TURKEY on Aug 10, 2007. Female patient, 29 years of age, was diagnosed with migraine and was treated with TOPIRAMATE. After drug was administered, patient experienced the following problems/side effects: uveitis. TOPIRAMATE dosage: 25 MG, QD, 100 MG, QD. Patient recovered.
Topiramate Side Effects Report #5444227-9
Physician from UNITED STATES reported TOPIRAMATE problem on Aug 29, 2007. Female patient, weighting 11.22 lb, was diagnosed with partial seizures and was treated with TOPIRAMATE. After drug was administered, patient experienced the following problems/side effects: aspiration, convulsion, failure to thrive. TOPIRAMATE dosage: unknown. During the same period patient was treated with PHENOBARBITAL, TEGRETOL. Patient was hospitalized. Patient recovered.
Topiramate Side Effects Report #5447344-2
TOPIRAMATE problem was reported by a Physician from TURKEY on Aug 30, 2007. Female patient, 29 years of age, was diagnosed with migraine and was treated with TOPIRAMATE. After drug was administered, patient experienced the following problems/side effects: uveitis. TOPIRAMATE dosage: PATIENT WAS GRADUALLY TITRATED FROM 25 MG.. Patient recovered.
Topiramate Side Effects Report #5469351-6
Physician from UNITED STATES reported TOPIRAMATE problem on Sept 18, 2007. Female patient, weighting 11.22 lb, was diagnosed with partial seizures and was treated with TOPIRAMATE. After drug was administered, patient experienced the following problems/side effects: aspiration, convulsion, failure to thrive, urinary tract infection. TOPIRAMATE dosage: unknown. During the same period patient was treated with PHENOBARBITAL, TEGRETOL. Patient was hospitalized. Patient recovered.
Topiramate Side Effects Report #5469388-7
TOPIRAMATE problem was reported by a Physician from UNITED STATES on Sept 18, 2007. Male patient, weighting 20.50 lb, was diagnosed with convulsion, pain prophylaxis, convulsion prophylaxis, gastrooesophageal reflux disease and was treated with TOPIRAMATE. After drug was administered, patient experienced the following problems/side effects: cachexia, failure to thrive. TOPIRAMATE dosage: unknown. During the same period patient was treated with IBUPROFEN, ACETAMINOPHEN, PHENOBARBITAL, ZANTAC. Patient was hospitalized. Patient recovered.
Showing 1-50 of 64 Next >
Drug Information: Topiramate
URL of this page: http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a697012.html
(toe pyre' a mate)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?
Topiramate is used with alone or with other medications to treat certain types of seizures in people who have epilepsy. Topiramate is also used with other medications to control seizures in people who have Lennox-Gastaut syndrome (a disorder that causes seizures and developmental delays). Topiramate is used to treat patients who continue to have seizures even when they take other anti-seizure medications. Topiramate is also used to prevent migraine headaches, but not to relieve the pain of migraine headaches when they occur. Topiramate is in a class of medications called anticonvulsants. It works by decreasing abnormal excitement in the brain.
How should this medicine be used?
Topiramate comes as a tablet and a sprinkle capsule (capsule that contains small beads of medication that can be sprinkled on food) to take by mouth. It is usually taken with or without food twice a day in the morning and evening. Take topiramate at around the same times 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 topiramate exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
There is another medication with a name similar to the brand name for topiramate. You should be sure that you receive topiramate and not the similar medication each time you fill your prescription. Be sure that the prescription your doctor gives you is clear and easy to read. Talk to your pharmacist to be sure that you are given topiramate. After you receive your medication, compare the tablets to the pictures in the manufacturer's patient information sheet. If you think you were given the wrong medication, talk to your pharmacist. Do not take any medication unless you are certain it is the medication that your doctor prescribed.
Topiramate tablets have a bitter taste and lose their effectiveness quickly when broken, so you should swallow them whole. Do not split, chew, or crush them.
Your doctor will probably start you on a low dose of topiramate and gradually increase your dose, not more than once every week.
Topiramate may control your seizures or migraines, but will not cure your condition. Continue to take topiramate even if you feel well. Do not stop taking topiramate without talking to your doctor. If you suddenly stop taking topiramate, you may have severe seizures, even if you have not had seizures in the past. Your doctor will probably decrease your dose gradually.
The sprinkle capsules may be swallowed whole or opened and poured over food. To take the sprinkle capsule with food, follow these steps:
- Prepare a teaspoonful of soft food such as applesauce, custard, ice cream, oatmeal, pudding, or yogurt.
- Hold the capsule upright over the food. You should be able to read the word 'TOP' on the capsule.
- Twist off the clear part of the capsule and pour the entire contents onto the spoonful of food.
- Swallow the entire mixture immediately without chewing.
- Drink fluids right after swallowing to wash down the mixture and to be sure that you swallow all of it.
Other uses for this medicine
Topiramate is also used for the management of alcohol dependence. Talk to your doctor about the risks of using this medication for your condition.
What special precautions should I follow?
Before taking topiramate,
- tell your doctor and pharmacist if you are allergic to topiramate 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: acetazolamide (Diamox); amitriptyline; antidepressants; antihistamines; dichlorphenamide (Daranide); digoxin (Lanoxin, Digitek); ipratropium (Atrovent); iron; isoniazid (INH, Nydrazid); hydrochlorothiazide (Microzide, Oretic); lithium (Eskalith, Lithobid); medications for anxiety, irritable bowel disease, mental illness, motion sickness, Parkinson's disease, ulcers, or urinary problems; metformin (Glucophage); methazolamide; oral contraceptives (birth control pills); other medications for seizures such as carbamazepine (Tegretol) and phenytoin (Dilantin, Phenytek); pioglitazone (Actos); risperidone (Risperdal); salicylate pain relievers such as aspirin, choline magnesium trisalicylate (Trisalate), choline salicylate (Arthropan), diflunisal (Dolobid), magnesium salicylate (Doan's, others), and salsalate (Argesic, Disalcid, Salgesic); sedatives; sleeping pills; tranquilizers; valproic acid (Depakene, Depakote); and zonisamide (Zonegran). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you or any family members have or have ever had kidney stones, if you drink or have ever drunk large amounts of alcohol, and if you have ever thought about killing yourself or tried to do so. Also tell you doctor if you have or have ever had metabolic acidosis (a disturbance in the body's acid-base balance that results in excessive acidity of the blood.); osteopenia, osteomalacia, or osteoporosis (conditions in which the bones are soft or brittle and may break easily); diabetes; glaucoma (a type of eye disease); any disease that affects your breathing such as asthma or chronic obstructive pulmonary disease (COPD); depression or abnormal moods; a growth problem; or liver or kidney disease. Also tell your doctor if you have diarrhea or if you develop diarrhea during your treatment.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking topiramate, call your doctor.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking topiramate.
- you should know that topiramate may make you drowsy, dizzy, confused, or unable to concentrate. Do not drive a car or operate machinery until you know how this medication affects you.
- if you are taking topiramate to control seizures, you should know that you may continue to have seizures during your treatment. You may need to avoid activities such as swimming, driving, and climbing so that you will not harm yourself or others if you lose consciousness during a seizure.
- ask your doctor about the safe use of alcoholic beverages while you are taking topiramate.
- if you are taking oral contraceptives (birth control pills), tell your doctor if unexpected bleeding or spotting occurs. Topiramate can decrease the effectiveness of oral contraceptives.
- you should know that topiramate 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 topiramate. Avoid exposure to heat, drink plenty of fluids and tell your doctor if you have a fever, headache, muscle cramps, or an upset stomach, or if you are not sweating as usual.
- you should know that you may be more likely to develop a kidney stone while you are taking topiramate. Drink 6-8 glasses of water every day to prevent kidney stones from forming.
What special dietary instructions should I follow?
Talk to your doctor about increasing the amount of food you eat if you lose weight while you are taking topiramate.
Talk to your doctor before changing your diet or beginning any type of weight loss program. Do not follow a ketogenic diet (a high-fat, low-carbohydrate diet used to control seizures) or any other high-fat, low-carbohydrate diet, such as the Atkins diet, while you are taking this medication.
What should I do if I forget a dose?
Take the missed dose as soon as you remember it. However, if it is less than 6 hours before you are scheduled to take your 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?
Topiramate may cause other side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- numbness, burning, or tingling in the hands or feet
- slowed reactions
- difficulty concentrating
- speech problems, especially difficulty thinking of specific words
- memory problems
- lack of coordination
- confusion
- nervousness
- aggressive behavior
- irritability
- mood swings
- depression
- headache
- drowsiness
- weakness
- excessive movement
- uncontrollable shaking of a part of the body
- uncontrollable eye movements
- extreme thirst
- weight loss
- constipation
- diarrhea
- gas
- heartburn
- change in ability to taste food
- swelling of the tongue
- overgrowth of the gums
- dry mouth
- increased saliva
- trouble swallowing
- nosebleed
- teary or dry eyes
- back, muscle, or bone pain
- missed menstrual periods
- excessive menstrual bleeding
- skin problems or changes in skin color
- dandruff
- hair loss
- growth of hair in unusual places
- ringing in the ears
- difficulty falling or staying asleep
- swelling of the hands, arms, feet, ankles, or lower legs
- difficulty urinating or pain when urinating
Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:
- blurred vision
- double vision
- eye pain
- worsening of seizures
- slow heart rate
- pounding or irregular heartbeat
- chest pain
- trouble breathing
- fast, shallow breathing
- inability to respond to things around you
- excessive tiredness
- nausea
- vomiting
- stomach pain
- loss of appetite
- intense back or side pain
- bloody, cloudy, or foul smelling urine
- constant need to urinate
- fever
- chills
Topiramate may cause osteoporosis (a condition in which bones can break more easily) in adults and rickets (abnormal, curved bone growth) in children. Topiramate may also slow the growth of children and may decrease the final height that children reach. Talk to your doctor about the risks of taking topiramate.
Topiramate 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. Tablets should be stored at room temperature and away from excess heat and moisture (not in the bathroom). Sprinkle capsules should be stored at or below 77° F. Never store broken tablets or mixtures of sprinkles and soft food. These should be used right away or thrown away. 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:
- seizures
- drowsiness
- speech problems
- blurred vision
- double vision
- trouble thinking
- tiredness
- loss of coordination
- loss of consciousness
- dizziness
- stomach pain
- vomiting
- agitation
- depression
- loss of appetite
- pounding or irregular heartbeat
- fast, shallow breathing
What other information should I know?
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to topiramate.
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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