Levetiracetam Safety Reports submitted to FDA
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More Rx Information: A B C D E F G H I J K L M N O P Q R S T U V W X Y ZTotal Levetiracetam reports: 49.
Levetiracetam FDA safety alerts: 2003 2008 .
Reported deaths: 7 Reported hospitalizations: 15.
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FDA Reported Levetiracetam Side Effects: caesarean section, premature baby, grand mal convulsion, cryptorchism, somnolence, small for dates baby, abortion induced, congenital anomaly, therapeutic agent toxicity, suicide attempt, neurosis.
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Levetiracetam Side Effects Report #5215536-3
Physician from GERMANY reported LEVETIRACETAM problem on Dec 28, 2006. Male patient, 86 years of age, weighting 66.14 lb, was diagnosed with convulsion and was treated with LEVETIRACETAM. After drug was administered, patient experienced the following problems/side effects: pneumonia, respiratory distress. LEVETIRACETAM dosage: 500 MG THREE IV. During the same period patient was treated with DIAZEPAM, RIVOTRIL, CEFTRIAXONE, ACETAMINOPHEN. Patient was hospitalized. Patient died on 11/01/2006.
Levetiracetam Side Effects Report #5223078-4
LEVETIRACETAM problem was reported by a Consumer or non-health professional from UNITED KINGDOM on Jan 08, 2007. Male patient, 55 years of age, weighting 117.3 lb, was diagnosed with epilepsy and was treated with LEVETIRACETAM. After drug was administered, patient experienced the following problems/side effects: platelet count decreased. LEVETIRACETAM dosage: 250 MG 1/D PO. During the same period patient was treated with EPILIM, TEGRETOL. Patient recovered.
Levetiracetam Side Effects Report #5223907-4
Consumer or non-health professional from UNITED KINGDOM reported LEVETIRACETAM problem on Jan 10, 2007. Male patient, weighting 6.31 lb, was diagnosed with epilepsy and was treated with LEVETIRACETAM. After drug was administered, patient experienced the following problems/side effects: caesarean section, grand mal convulsion. LEVETIRACETAM dosage: 3000 MG TRP. During the same period patient was treated with CARBAMAZEPINE, LAMOTRIGINE, CLOBAZAM. Patient recovered.
Levetiracetam Side Effects Report #5223914-1
LEVETIRACETAM problem was reported by a Consumer or non-health professional from UNITED KINGDOM on Jan 10, 2007. Female patient, weighting 6.25 lb, was diagnosed with epilepsy and was treated with LEVETIRACETAM. After drug was administered, patient experienced the following problems/side effects: congenital anomaly, spina bifida. LEVETIRACETAM dosage: 1000 MG TRP. During the same period patient was treated with VALPROATE, LAMOTRIGINE, CLOBAZAM. Patient recovered.
Levetiracetam Side Effects Report #5223915-3
Physician from UNITED KINGDOM reported LEVETIRACETAM problem on Jan 10, 2007. Female patient was diagnosed with epilepsy and was treated with LEVETIRACETAM. After drug was administered, patient experienced the following problems/side effects: abortion induced, spina bifida. LEVETIRACETAM dosage: 3000 MG TRP. During the same period patient was treated with CARBAMAZEPINE RETARD. Patient died.
Levetiracetam Side Effects Report #5223916-5
LEVETIRACETAM problem was reported by a Consumer or non-health professional from UNITED KINGDOM on Jan 10, 2007. Female patient, 25 years of age, was diagnosed with epilepsy and was treated with LEVETIRACETAM. After drug was administered, patient experienced the following problems/side effects: abortion induced, pregnancy. LEVETIRACETAM dosage: 3000 MG. During the same period patient was treated with CARBAMAZEPINE EXTENDED. Patient recovered.
Levetiracetam Side Effects Report #5223917-7
Consumer or non-health professional from UNITED KINGDOM reported LEVETIRACETAM problem on Jan 10, 2007. Female patient, weighting 7.08 lb, was diagnosed with epilepsy and was treated with LEVETIRACETAM. After drug was administered, patient experienced the following problems/side effects: grand mal convulsion, hip dysplasia. LEVETIRACETAM dosage: 2500 MG TRP. During the same period patient was treated with CARBAMAZEPINE EXTENDED, TOPIRAMATE, CLOBAZAM. Patient recovered.
Levetiracetam Side Effects Report #5223918-9
LEVETIRACETAM problem was reported by a Consumer or non-health professional from UNITED KINGDOM on Jan 10, 2007. Male patient, weighting 5.42 lb, was diagnosed with epilepsy and was treated with LEVETIRACETAM. After drug was administered, patient experienced the following problems/side effects: caesarean section, grand mal convulsion, premature baby, pyloric stenosis. LEVETIRACETAM dosage: 500 MG TRP. During the same period patient was treated with LAMOTRIGINE, TOPIRAMATE. Patient recovered.
Levetiracetam Side Effects Report #5223919-0
Consumer or non-health professional from UNITED KINGDOM reported LEVETIRACETAM problem on Jan 10, 2007. Male patient, weighting 6.48 lb, was diagnosed with epilepsy and was treated with LEVETIRACETAM. After drug was administered, patient experienced the following problems/side effects: caesarean section, umbilical hernia. LEVETIRACETAM dosage: 250 MG TRP. During the same period patient was treated with LAMOTRIGINE. Patient recovered.
Levetiracetam Side Effects Report #5223924-4
LEVETIRACETAM problem was reported by a Consumer or non-health professional from UNITED KINGDOM on Jan 10, 2007. Male patient was diagnosed with epilepsy and was treated with LEVETIRACETAM. After drug was administered, patient experienced the following problems/side effects: caesarean section, congenital anomaly, grand mal convulsion, pregnancy, premature baby, skull malformation. LEVETIRACETAM dosage: 1000 MG TRP. During the same period patient was treated with LAMOTRIGINE. Patient recovered.
Levetiracetam Side Effects Report #5224263-8
Consumer or non-health professional from UNITED KINGDOM reported LEVETIRACETAM problem on Jan 20, 2007. Male patient, weighting 5.95 lb, was diagnosed with epilepsy and was treated with LEVETIRACETAM. After drug was administered, patient experienced the following problems/side effects: talipes. LEVETIRACETAM dosage: 3000 MG TRP. During the same period patient was treated with LAMOTRIGINE. Patient recovered.
Levetiracetam Side Effects Report #5229784-X
LEVETIRACETAM problem was reported by a Consumer or non-health professional from NETHERLANDS on Jan 17, 2007. Female patient was diagnosed with epilepsy and was treated with LEVETIRACETAM. After drug was administered, patient experienced the following problems/side effects: small for dates baby. LEVETIRACETAM dosage: unknown. Patient recovered.
Levetiracetam Side Effects Report #5229785-1
Consumer or non-health professional from NETHERLANDS reported LEVETIRACETAM problem on Jan 17, 2007. Female patient was diagnosed with epilepsy and was treated with LEVETIRACETAM. After drug was administered, patient experienced the following problems/side effects: hernia congenital, inguinal hernia. LEVETIRACETAM dosage: unknown. Patient recovered.
Levetiracetam Side Effects Report #5229798-X
LEVETIRACETAM problem was reported by a Consumer or non-health professional from NETHERLANDS on Jan 17, 2007. Female patient was diagnosed with epilepsy and was treated with LEVETIRACETAM. After drug was administered, patient experienced the following problems/side effects: small for dates baby. LEVETIRACETAM dosage: unknown. Patient recovered.
Levetiracetam Side Effects Report #5230372-X
Consumer or non-health professional from NETHERLANDS reported LEVETIRACETAM problem on Jan 17, 2007. Female patient was diagnosed with epilepsy and was treated with LEVETIRACETAM. After drug was administered, patient experienced the following problems/side effects: small for dates baby. LEVETIRACETAM dosage: unknown. Patient recovered.
Levetiracetam Side Effects Report #5242782-5
LEVETIRACETAM problem was reported by a Consumer or non-health professional from UNITED KINGDOM on Jan 29, 2007. Female patient, 56 years of age, was diagnosed with epilepsy and was treated with LEVETIRACETAM. After drug was administered, patient experienced the following problems/side effects: accommodation disorder, convulsion, diplopia. LEVETIRACETAM dosage: unknown. During the same period patient was treated with TEGRETOL. Patient recovered.
Levetiracetam Side Effects Report #5281254-9
Physician from UNITED KINGDOM reported LEVETIRACETAM problem on Mar 12, 2007. Male patient, 19 years of age, was diagnosed with epilepsy and was treated with LEVETIRACETAM. After drug was administered, patient experienced the following problems/side effects: idiopathic thrombocytopenic purpura, no therapeutic response. LEVETIRACETAM dosage: 2000 MG 2/D PO. During the same period patient was treated with VALPROATE, TOPIRAMATE, LAMOTRIGINE. Patient recovered.
Levetiracetam Side Effects Report #5290578-0
LEVETIRACETAM problem was reported by a Pharmacist from UNITED STATES on Apr 05, 2007. Female patient, 54 years of age, weighting 81.00 lb, was diagnosed with convulsion and was treated with LEVETIRACETAM. After drug was administered, patient experienced the following problems/side effects: convulsion, mania. LEVETIRACETAM dosage: 1500 MG PO BID. During the same period patient was treated with DIVALPROEX, ATIVAN. Patient was hospitalized. Patient recovered.
Levetiracetam Side Effects Report #5305760-3
Consumer or non-health professional from UNITED KINGDOM reported LEVETIRACETAM problem on Mar 29, 2007. Male patient, 72 years of age, was diagnosed with convulsion and was treated with LEVETIRACETAM. After drug was administered, patient experienced the following problems/side effects: hepatitis. LEVETIRACETAM dosage: unknown. During the same period patient was treated with CLOBAZAM, PHENYTOIN, TOPAMAX, AMLODIPINE, ASPIRIN, DEXAMETHASONE, DIGOXIN. Patient was hospitalized. Patient recovered.
Levetiracetam Side Effects Report #5311571-5
LEVETIRACETAM problem was reported by a Pharmacist from UNITED STATES on Apr 26, 2007. Male patient, 58 years of age, weighting 259.0 lb, was diagnosed with convulsion and was treated with LEVETIRACETAM. After drug was administered, patient experienced the following problems/side effects: asthenia, coordination abnormal, memory impairment, mental status changes, somnolence. LEVETIRACETAM dosage: 1000 MG,BID, PO. During the same period patient was treated with SIMVASTATIN, RISPERIDONE, ALBUTEROL, CITALOPRAM HYDROBROMIDE, DIVALPROEX, FOLIC ACID, HEPARIN, IPRATROPIUM BROMIDE. Patient recovered.
Levetiracetam Side Effects Report #5328623-6
Consumer or non-health professional from ITALY reported LEVETIRACETAM problem on Apr 27, 2007. Female patient, 34 years of age, was diagnosed with epilepsy and was treated with LEVETIRACETAM. After drug was administered, patient experienced the following problems/side effects: condition aggravated, convulsion, premature baby. LEVETIRACETAM dosage: 2000 MG/D. During the same period patient was treated with CARBAMAZEPINE, DIAZEPAM, FOLIC ACID. Patient recovered.
Levetiracetam Side Effects Report #5328628-5
LEVETIRACETAM problem was reported by a Consumer or non-health professional from ITALY on Apr 27, 2007. Female patient, weighting 5.69 lb, was diagnosed with epilepsy and was treated with LEVETIRACETAM. After drug was administered, patient experienced the following problems/side effects: premature baby. LEVETIRACETAM dosage: 2000 MG/D. During the same period patient was treated with CARBAMAZEPINE, DIAZEPAM, FOLIC ACID. Patient recovered.
Levetiracetam Side Effects Report #5330924-2
Consumer or non-health professional from ISRAEL reported LEVETIRACETAM problem on May 01, 2007. Female patient, child 7 years of age, weighting 35.27 lb, was diagnosed with myoclonus and was treated with LEVETIRACETAM. After drug was administered, patient experienced the following problems/side effects: blood creatine phosphokinase increased. LEVETIRACETAM dosage: 240 MG /D. During the same period patient was treated with CLONAZEPAM, LACTULOSE, NEOMYCINE, VALPROIC ACID, CLOBAZAM, TOPIRAMATE. Patient recovered.
Levetiracetam Side Effects Report #5332131-6
LEVETIRACETAM problem was reported by a Physician from UNITED STATES on May 02, 2007. Male patient, weighting 22.05 lb, was diagnosed with convulsion and was treated with LEVETIRACETAM. After drug was administered, patient experienced the following problems/side effects: convulsion, drop attacks. LEVETIRACETAM dosage: 150 MG 2/D PO. During the same period patient was treated with TOPIRAMATE. Patient recovered.
Levetiracetam Side Effects Report #5332502-8
Consumer or non-health professional from UNITED KINGDOM reported LEVETIRACETAM problem on May 04, 2007. Male patient, 72 years of age, was diagnosed with convulsion and was treated with LEVETIRACETAM. After drug was administered, patient experienced the following problems/side effects: hepatitis. LEVETIRACETAM dosage: unknown. During the same period patient was treated with CLOBAZAM, PHENYTOIN, TOPAMAX, AMLODIPINE, ASPIRIN, DEXAMETHASONE, DIGOXIN. Patient was hospitalized. Patient recovered.
Levetiracetam Side Effects Report #5341720-4
LEVETIRACETAM problem was reported by a Physician from CZECH REPUBLIC on May 14, 2007. Female patient, 16 years of age, weighting 114.6 lb, was diagnosed with epilepsy and was treated with LEVETIRACETAM. After drug was administered, patient experienced the following problems/side effects: leukopenia. LEVETIRACETAM dosage: 750 MG 2/D PO. During the same period patient was treated with VALPROATE. Patient was hospitalized. Patient recovered.
Levetiracetam Side Effects Report #5352371-X
Consumer or non-health professional from UNITED KINGDOM reported LEVETIRACETAM problem on May 23, 2007. Female patient, 18 years of age, weighting 154.5 lb, was diagnosed with complex partial seizures, epilepsy and was treated with LEVETIRACETAM. After drug was administered, patient experienced the following problems/side effects: agitation, eating disorder, peripheral coldness, skin discolouration, somnolence, tremor, vomiting. LEVETIRACETAM dosage: 500 MG 2/D PO. During the same period patient was treated with RISPERIDONE, VALPROATE. Patient was hospitalized. Patient recovered.
Levetiracetam Side Effects Report #5371999-4
LEVETIRACETAM problem was reported by a Physician from SWEDEN on June 08, 2007. Female patient was diagnosed with epilepsy and was treated with LEVETIRACETAM. After drug was administered, patient experienced the following problems/side effects: complex partial seizures, sepsis, stillbirth. LEVETIRACETAM dosage: 1000 MG /D. During the same period patient was treated with LAMOTRIGINE. Patient recovered.
Levetiracetam Side Effects Report #5081053-7
Health Professional from GERMANY reported LEVETIRACETAM problem on Aug 11, 2006. Female patient, 22 years of age, was diagnosed with convulsion and was treated with LEVETIRACETAM. After drug was administered, patient experienced the following problems/side effects: convulsion, hepatic failure, hepatic necrosis, hepatocellular damage, poisoning, renal tubular necrosis, shock. LEVETIRACETAM dosage: unknown. During the same period patient was treated with CARBAMAZEPINE. Patient was hospitalized. Patient died.
Levetiracetam Side Effects Report #5084675-2
LEVETIRACETAM problem was reported by a Pharmacist from UNITED STATES on Aug 18, 2006. Male patient, weighting 152.0 lb, was diagnosed with complex partial seizures and was treated with LEVETIRACETAM. After drug was administered, patient experienced the following problems/side effects: hallucination, visual, psychotic disorder. LEVETIRACETAM dosage: 750 MG BID PO. During the same period patient was treated with ALBUTEROL SULPHATE AND IPRATROPIUM BROMIDE, ARIPIPRAZOLE, CARBAMAZEPINE, CITALOPRAM HYDROBROMIDE, CLINDAMYCIN, CYCLOBENZAPRINE, FOLIC ACID, HYDROCODONE. Patient recovered.
Levetiracetam Side Effects Report #5085074-X
Consumer or non-health professional from NETHERLANDS reported LEVETIRACETAM problem on Dec 15, 2005. Male patient, 68 years of age, weighting 189.6 lb, was diagnosed with epilepsy and was treated with LEVETIRACETAM. After drug was administered, patient experienced the following problems/side effects: aortic stenosis, benign prostatic hyperplasia, cardiac arrest, cardiac disorder, cardiac failure, dysuria, haematuria. LEVETIRACETAM dosage: 500 MG/D. During the same period patient was treated with AMARYL, NORVASC, SELEKTINE, METFORMIN, TRIAMTERENE, XATRAL. Patient died on 10/07/2005.
Levetiracetam Side Effects Report #5085079-9
LEVETIRACETAM problem was reported by a Consumer or non-health professional from NETHERLANDS on Dec 15, 2005. Male patient, 68 years of age, weighting 189.6 lb, was diagnosed with epilepsy and was treated with LEVETIRACETAM. After drug was administered, patient experienced the following problems/side effects: aortic stenosis, benign prostatic hyperplasia, cardiac arrest, cardiac failure, dysuria, haematuria. LEVETIRACETAM dosage: 500 MG /D. During the same period patient was treated with AMARYL, NORVASC, SELEKTINE, METFORMIN, LOPRESOR, TRIAMTERENE, XATRAL. Patient died on 10/07/2005.
Levetiracetam Side Effects Report #5092081-X
Physician from GERMANY reported LEVETIRACETAM problem on Aug 09, 2006. Female patient, 22 years of age, was diagnosed with convulsion and was treated with LEVETIRACETAM. After drug was administered, patient experienced the following problems/side effects: convulsion, hepatic cyst, hepatic failure, hepatic necrosis, hepatocellular damage, poisoning, renal tubular necrosis, shock. LEVETIRACETAM dosage: unknown. During the same period patient was treated with CARBAMAZEPINE. Patient was hospitalized. Patient died.
Levetiracetam Side Effects Report #5122533-5
LEVETIRACETAM problem was reported by a Pharmacist from UNITED STATES on Oct 04, 2006. Female patient was diagnosed with convulsion and was treated with LEVETIRACETAM. After drug was administered, patient experienced the following problems/side effects: convulsion, premature labour. LEVETIRACETAM dosage: 250 MG 1 AM, 3 PM ORAL. During the same period patient was treated with TOPIRAMATE, PRENATAL VITAMINS, FOLIC ACID. Patient recovered.
Levetiracetam Side Effects Report #5153596-9
Consumer or non-health professional from UNITED KINGDOM reported LEVETIRACETAM problem on Oct 27, 2006. Female patient, 63 years of age, weighting 112.4 lb, was treated with LEVETIRACETAM. After drug was administered, patient experienced the following problems/side effects: thrombocytopenia. LEVETIRACETAM dosage: 500 MG 2/D PO. During the same period patient was treated with CEPHALEXIN, LAMOTRIGINE, VALPROATE. Patient recovered.
Levetiracetam Side Effects Report #5175213-4
LEVETIRACETAM problem was reported by a Physician from GERMANY on Nov 06, 2006. Male patient, 86 years of age, was diagnosed with convulsion and was treated with LEVETIRACETAM. After drug was administered, patient experienced the following problems/side effects: pneumonia, respiratory distress. LEVETIRACETAM dosage: 500 MG THREE IV. During the same period patient was treated with DIAZEPAM. Patient was hospitalized. Patient died.
Levetiracetam Side Effects Report #5186574-4
Physician from NORWAY reported LEVETIRACETAM problem on Nov 27, 2006. Female patient, 57 years of age, was diagnosed with grand mal convulsion and was treated with LEVETIRACETAM. After drug was administered, patient experienced the following problems/side effects: bleeding time prolonged, ecchymosis, thrombocytopenia. LEVETIRACETAM dosage: unknown. Patient recovered.
Levetiracetam Side Effects Report #5192474-6
LEVETIRACETAM problem was reported by a Consumer or non-health professional from UNITED STATES on Dec 05, 2006. Female patient, child 3 years of age, was treated with LEVETIRACETAM. After drug was administered, patient experienced the following problems/side effects: apnoea, convulsion. LEVETIRACETAM dosage: unknown. Patient was hospitalized. Patient recovered.
Levetiracetam Side Effects Report #5192751-9
Consumer or non-health professional from INDIA reported LEVETIRACETAM problem on Dec 03, 2006. Female patient was treated with LEVETIRACETAM. After drug was administered, patient experienced the following problems/side effects: congenital anomaly. LEVETIRACETAM dosage: unknown. Patient recovered.
Levetiracetam Side Effects Report #5386521-6
LEVETIRACETAM problem was reported by a Consumer or non-health professional from UNITED STATES on Apr 19, 2007. Female patient, 22 years of age, was treated with LEVETIRACETAM. After drug was administered, patient experienced the following problems/side effects: major depression, neurosis, suicide attempt, therapeutic agent toxicity. LEVETIRACETAM dosage: unknown. During the same period patient was treated with VENLAFAXINE, LAMOTRIGINE, NAPROXEN, CYCLOBENZAPRINE, NARATRIPTAN, PROMETHAZINE, TETRACYCLINE. Patient was hospitalized. Patient recovered.
Levetiracetam Side Effects Report #5386531-9
Consumer or non-health professional from UNITED STATES reported LEVETIRACETAM problem on Apr 19, 2007. Female patient, 31 years of age, was diagnosed with convulsion and was treated with LEVETIRACETAM. After drug was administered, patient experienced the following problems/side effects: neurosis, psychotic disorder, suicide attempt, therapeutic agent toxicity. LEVETIRACETAM dosage: unknown. During the same period patient was treated with VALPROATE, PHENYTOIN, FOLIC ACID. Patient was hospitalized. Patient recovered.
Levetiracetam Side Effects Report #5387660-6
LEVETIRACETAM problem was reported by a Consumer or non-health professional from INDIA on June 26, 2007. Male patient, 40 years of age, weighting 174.2 lb, was diagnosed with epilepsy and was treated with LEVETIRACETAM. After drug was administered, patient experienced the following problems/side effects: coordination abnormal, depressed level of consciousness, somnolence. LEVETIRACETAM dosage: 500 MG 2/D PO. Patient was hospitalized. Patient recovered.
Levetiracetam Side Effects Report #5420240-2
Physician from AUSTRIA reported LEVETIRACETAM problem on July 30, 2007. Female patient, 22 years of age, was diagnosed with status epilepticus and was treated with LEVETIRACETAM. After drug was administered, patient experienced the following problems/side effects: abortion induced, enterococcal sepsis, porphyria non-acute, staphylococcal sepsis. LEVETIRACETAM dosage: unknown. During the same period patient was treated with PHENYTOIN, OXAZEPAM, VANCOMYCINE PCH, BARBITURATE. Patient was hospitalized. Patient recovered.
Levetiracetam Side Effects Report #5420411-5
LEVETIRACETAM problem was reported by a Consumer or non-health professional from UNITED STATES on July 30, 2007. Male patient was diagnosed with epilepsy and was treated with LEVETIRACETAM. After drug was administered, patient experienced the following problems/side effects: cryptorchism. LEVETIRACETAM dosage: unknown. During the same period patient was treated with FOLIC ACID. Patient recovered.
Levetiracetam Side Effects Report #5420697-7
Health Professional from SWEDEN reported LEVETIRACETAM problem on July 30, 2007. Female patient was diagnosed with epilepsy and was treated with LEVETIRACETAM. After drug was administered, patient experienced the following problems/side effects: caesarean section, complex partial seizures. LEVETIRACETAM dosage: 3000 MG/ D. During the same period patient was treated with LAMOTRIGINE. Patient recovered.
Levetiracetam Side Effects Report #5422625-7
LEVETIRACETAM problem was reported by a Consumer or non-health professional from UNITED STATES on Aug 08, 2007. Male patient was diagnosed with epilepsy and was treated with LEVETIRACETAM. After drug was administered, patient experienced the following problems/side effects: cryptorchism. LEVETIRACETAM dosage: unknown. During the same period patient was treated with FOLIC ACID. Patient recovered.
Levetiracetam Side Effects Report #5422626-9
Consumer or non-health professional from UNITED STATES reported LEVETIRACETAM problem on Aug 08, 2007. Male patient was diagnosed with epilepsy and was treated with LEVETIRACETAM. After drug was administered, patient experienced the following problems/side effects: cryptorchism. LEVETIRACETAM dosage: unknown. During the same period patient was treated with FOLIC ACID. Patient recovered.
Levetiracetam Side Effects Report #5423115-8
LEVETIRACETAM problem was reported by a Consumer or non-health professional from UNITED KINGDOM on Aug 06, 2007. Female patient, 41 years of age, weighting 94.80 lb, was diagnosed with epilepsy and was treated with LEVETIRACETAM. After drug was administered, patient experienced the following problems/side effects: myalgia, myopathy. LEVETIRACETAM dosage: 250 MG / D PO. Patient recovered.
Levetiracetam Side Effects Report #5424994-0
Consumer or non-health professional from UNITED STATES reported LEVETIRACETAM problem on Aug 07, 2007. Female patient, child 8 years of age, was diagnosed with epilepsy and was treated with LEVETIRACETAM. After drug was administered, patient experienced the following problems/side effects: interstitial lung disease, respiratory failure. LEVETIRACETAM dosage: unknown. Patient was hospitalized. Patient recovered.
Drug Information: Levetiracetam
URL of this page: http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a699059.html
(lee ve tye ra' se tam)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.
Levetiracetam is used in combination with other medications to treat certain types of seizures in people with epilepsy. Levetiracetam is in a class of medications called anticonvulsants. It works by decreasing abnormal excitement in the brain.
How should this medicine be used?
Levetiracetam comes as a solution (liquid) and a tablet to take by mouth. It is usually taken twice a day, once in the morning and once at night, with or without food. Try to take levetiracetam 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 levetiracetam exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Swallow the tablets whole; do not split, chew, or crush them.
If you are taking the oral solution, do not use a household spoon to measure your dose. You might not get the right amount of medication. Ask your doctor or pharmacist to recommend a medicine dropper, spoon, cup, or syringe and to show you how to use it to measure your medication.
Your doctor may start you on a low dose of levetiracetam and gradually increase your dose, not more often than once every 2 weeks.
Levetiracetam controls epilepsy but does not cure it. Continue to take levetiracetam even if you feel well. Do not stop taking levetiracetam without talking to your doctor. If you suddenly stop taking levetiracetam, 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 levetiracetam,
- tell your doctor and pharmacist if you are allergic to levetiracetam or any other medications.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. 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 kidney disease.
- tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking levetiracetam, call your doctor. Do not breastfeed while you are taking levetiracetam
- you should know that levetiracetam may make you dizzy or drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do if I forget a dose?
If it has only been a few hours since the time you were scheduled to take the 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.
Levetiracetam may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- drowsiness
- weakness
- unsteady walking
- coordination problems
- headache
- pain
- forgetfulness
- anxiety
- agitation or hostility
- dizziness
- moodiness
- nervousness
- numbness, burning, or tingling in the hands or feet
- loss of appetite
- vomiting
- diarrhea
- constipation
- changes in skin color
Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:
- depression
- hallucinating (hearing voices or seeing visions that do not exist)
- thoughts of killing yourself
- seizures that are worse or different than the seizures you had before
- fever, sore throat, and other signs of infection
- double vision
- itching
- rash
- swelling of the face
Levetiracetam 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:
- drowsiness
- agitation
- aggression
- decreased consciousness or loss of consciousness
- difficulty breathing
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.
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.
Brand name(s):
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