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Excegran Side Effects submitted to FDA

Total Excegran reports: 12.
Excegran FDA safety alerts: No.
Reported deaths: 1    Reported hospitalizations: 10.
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FDA Reported Excegran Side Effects: convulsion, calculus ureteric, pallor, international normalised ratio increased, haemoglobin decreased, haematocrit decreased, duodenal ulcer haemorrhage, brain tumour operation, pneumonia cytomegaloviral, pneumocystis jiroveci pneumonia, nephrolithiasis,
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Excegran Side Effects Report #5614093-7
Physician from JAPAN reported EXCEGRAN problem on Jan 15, 2008. Male patient, 60 years of age, was diagnosed with epilepsy and was treated with EXCEGRAN. After drug was administered, patient experienced the following problems/side effects: conjunctivitis, refusal of treatment by patient, visual acuity reduced. EXCEGRAN dosage: 200 MG, 1 IN 1 D, ORAL. During the same period patient was treated with SPIRIVA, FLUTIDE DISKUS, VERAPAMIL HYDROCHLORIDE, DIGOXIN, ASPIRIN, FAMOTIDINE. Patient was hospitalized. Patient recovered.



Excegran Side Effects Report #5732544-4
EXCEGRAN problem was reported by a Physician from JAPAN on Apr 22, 2008. Female patient, 28 years of age, was diagnosed with epilepsy and was treated with EXCEGRAN. After drug was administered, patient experienced the following problems/side effects: erythema, eye discharge, face oedema, feeling abnormal, feeling hot, malaise, oral disorder, pyrexia, rash papular. EXCEGRAN dosage: 200 MG, 1 IN 1 D, ORAL. During the same period patient was treated with FOLIC ACID. Patient was hospitalized. Patient recovered.



Excegran Side Effects Report #5755942-1
Physician from JAPAN reported EXCEGRAN problem on May 13, 2008. Male patient, child 11 years of age, was diagnosed with convulsion and was treated with EXCEGRAN. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, convulsion, dermatitis exfoliative, encephalitis, encephalopathy, hepatic enzyme increased, hepatic function abnormal, loss of consciousness. EXCEGRAN dosage: 80 MG, ORAL; 120 MG, ORAL; 150 MG, ORAL; 180 MG, ORAL; 210 MG, ORAL; 250 MG, ORAL. During the same period patient was treated with PHENYTOIN. Patient was hospitalized. Patient recovered.



Excegran Side Effects Report #5724466-X
EXCEGRAN problem was reported by a Physician from JAPAN on Apr 15, 2008. Female patient, 66 years of age, was diagnosed with parkinson's disease and was treated with EXCEGRAN. After drug was administered, patient experienced the following problems/side effects: arthralgia, articular calcification, chondrocalcinosis pyrophosphate, dry skin, dysstasia, erythromelalgia, gait disturbance, hypoaesthesia, pain in extremity. EXCEGRAN dosage: 200 MG, ORAL. During the same period patient was treated with DOPS, PURSENNID, SINEMET. Patient was hospitalized. Patient recovered.




Excegran Side Effects Report #5724474-9
Physician from JAPAN reported EXCEGRAN problem on Apr 22, 2008. Male patient, 65 years of age, was diagnosed with convulsion, head injury and was treated with EXCEGRAN. After drug was administered, patient experienced the following problems/side effects: erythema, granulocytopenia, metabolic acidosis, white blood cell count decreased. EXCEGRAN dosage: 200 MG, 2 IN 1 D, ORAL, 400 MG, 2 IN 1 D, ORAL. During the same period patient was treated with VANCOMYCIN HYDROCHLORIDE, CIPROFLOXACIN, PERDIPINE LA, ENALAPRIL MALEATE, FAMOTIDINE. Patient recovered.



Excegran Side Effects Report #5290407-5
EXCEGRAN problem was reported by a Physician from JAPAN on Mar 20, 2007. Male patient, 65 years of age, was diagnosed with epilepsy and was treated with EXCEGRAN. After drug was administered, patient experienced the following problems/side effects: anuria, calculus ureteric, convulsion, hydronephrosis, nephrolithiasis, pyrexia. EXCEGRAN dosage: unknown. During the same period patient was treated with TSUMURA DAIOKANZOTO, PURSENNID, BLOSTARM M. Patient was hospitalized. Patient recovered.



Excegran Side Effects Report #5258696-0
Physician from JAPAN reported EXCEGRAN problem on Feb 19, 2007. Female patient, 64 years of age, was diagnosed with prophylaxis and was treated with EXCEGRAN. After drug was administered, patient experienced the following problems/side effects: anorexia, convulsion, immunodeficiency, pneumocystis jiroveci pneumonia, pneumonia cytomegaloviral, staphylococcal sepsis, stevens-johnson syndrome. EXCEGRAN dosage: 200 MG, 1IN 1 D, ORAL. During the same period patient was treated with VOLTAREN, CARBENIN. Patient was hospitalized. Patient died on 01/27/2007.



Excegran Side Effects Report #5258738-2
EXCEGRAN problem was reported by a Physician from JAPAN on Feb 19, 2007. Male patient, 60 years of age, was diagnosed with convulsion, atrial fibrillation, mitral valve stenosis and was treated with EXCEGRAN. After drug was administered, patient experienced the following problems/side effects: brain tumour operation, convulsion, dizziness, duodenal ulcer haemorrhage, haematocrit decreased, haemoglobin decreased, international normalised ratio increased, pallor. EXCEGRAN dosage: 200 MG, 2 IN 1 D, ORAL. During the same period patient was treated with WARFARIN, DIGOXIN. Patient was hospitalized. Patient recovered.



Excegran Side Effects Report #5268267-8
Physician from JAPAN reported EXCEGRAN problem on Mar 05, 2007. Male patient was diagnosed with convulsion, atrial fibrillation, mitral valve stenosis and was treated with EXCEGRAN. After drug was administered, patient experienced the following problems/side effects: blood pressure decreased, brain tumour operation, duodenal ulcer, gastrointestinal haemorrhage, haematocrit decreased, haemoglobin decreased, international normalised ratio increased, pallor. EXCEGRAN dosage: 200 MG, 2 IN 1 D, ORAL. During the same period patient was treated with WARFARIN. Patient was hospitalized. Patient recovered.




Excegran Side Effects Report #5268625-1
EXCEGRAN problem was reported by a Physician from JAPAN on Mar 02, 2007. Male patient, 65 years of age, was diagnosed with post-traumatic epilepsy and was treated with EXCEGRAN. After drug was administered, patient experienced the following problems/side effects: calculus ureteric. EXCEGRAN dosage: 800 MG, ORAL. During the same period patient was treated with TSUMURA DAIOKANZOTO, PURSENNID, BLOSTARM M. Patient was hospitalized. Patient recovered.



Excegran Side Effects Report #5278293-0
Physician from JAPAN reported EXCEGRAN problem on Mar 12, 2007. Female patient, 70 years of age, was diagnosed with convulsion prophylaxis, bacterial infection, fungal infection and was treated with EXCEGRAN. After drug was administered, patient experienced the following problems/side effects: anaemia, condition aggravated, convulsion, disseminated intravascular coagulation, fibrin degradation products increased, fungal infection, hypotension, hypoxia, interstitial lung disease. EXCEGRAN dosage: 200 MG, 1 IN 1 D, ORAL. During the same period patient was treated with CARBENIN, PRODIF, NIZATIDINE, DECADRON, PIPERACILLIN, HEAVY MAGNESIUM OXIDE, ZANTAC, BACTRIM. Patient was hospitalized. Patient recovered.



Excegran Side Effects Report #5281825-X
EXCEGRAN problem was reported by a Physician from JAPAN on Mar 14, 2007. Male patient, child 1 years of age, was diagnosed with epilepsy and was treated with EXCEGRAN. After drug was administered, patient experienced the following problems/side effects: alopecia, disease recurrence, haemorrhage, human herpesvirus 6 infection, thrombocytopenic purpura. EXCEGRAN dosage: unknown. During the same period patient was treated with VALPROATE. Patient recovered.




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, Excegran was diagnosed with epilepsy and Excegran was diagnosed with epilepsy and Excegran was diagnosed with convulsion and