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Extended Side Effects summary
Total Extended reports: 11.Extended FDA safety alerts: 2004 2005 2006 2007 2008 .
Reported deaths: 4 Reported hospitalizations: 3.
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Extended Side Effects: grand mal convulsion, pyrexia, toxic epidermal necrolysis, sepsis, chorioamnionitis, condition aggravated, myalgia, systemic candida, respiratory distress, multi-organ failure, lobar pneumonia,
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Extended Side Effects reported to FDA
Extended Side Effects Report #5602071-3
Pharmacist from UNITED STATES reported EXTENDED problem on Jan 22, 2008. Male patient, 48 years of age, was diagnosed with convulsion and was treated with EXTENDED. After drug was administered, patient experienced the following problems/side effects: dizziness, malaise, nausea. EXTENDED dosage: 300 MG AM PO. Patient recovered.
Extended Side Effects Report #5574158-5
EXTENDED problem was reported by a Consumer or non-health professional from UNITED STATES on Dec 17, 2007. Female patient, 27 years of age, was diagnosed with convulsion and was treated with EXTENDED. After drug was administered, patient experienced the following problems/side effects: collapse of lung, convulsion, heart rate decreased. EXTENDED dosage: 300 MG; DAILY; ORAL, 500 MG; DAILY; ORAL. During the same period patient was treated with EXTENDED PHYENYTOIN, DEPAKOTE. Patient was hospitalized. Patient recovered.
Extended Side Effects Report #5498562-9
Pharmacist from UNITED STATES reported EXTENDED problem on Oct 24, 2007. Male patient, 31 years of age, was diagnosed with convulsion and was treated with EXTENDED. After drug was administered, patient experienced the following problems/side effects: condition aggravated, convulsion. EXTENDED dosage: 100MG QID PO. Patient recovered.
Extended Side Effects Report #5472087-9
EXTENDED problem was reported by a Consumer or non-health professional from UNITED STATES on Sept 06, 2007. Male patient, 77 years of age, was diagnosed with convulsion, fungal peritonitis and was treated with EXTENDED. After drug was administered, patient experienced the following problems/side effects: incorrect dose administered, klebsiella infection, lobar pneumonia, multi-organ failure, pyrexia, respiratory distress, systemic candida. EXTENDED dosage: unknown. During the same period patient was treated with CASPOGUNGIN. Patient was hospitalized. Patient died.

Extended Side Effects Report #5443985-7
Physician from UNITED STATES reported EXTENDED problem on Aug 17, 2007. Female patient, 36 years of age, weighting 135.0 lb, was diagnosed with convulsion prophylaxis and was treated with EXTENDED. After drug was administered, patient experienced the following problems/side effects: anaemia, catatonia, clostridium difficile colitis, conversion disorder, convulsion, hyperchloraemia, hypernatraemia, hypertension, injury. EXTENDED dosage: unknown. During the same period patient was treated with CLONAZEPAM, VALPROIC ACID, GABAPENTIN, CARBAMAZEPINE, LEVETIRACETAM, MYSOLINE, METOCLOPRAMIDE. Patient died.
Extended Side Effects Report #5391269-8
EXTENDED problem was reported by a Physician from UNITED STATES on July 02, 2007. Female patient, 17 years of age, was diagnosed with convulsion and was treated with EXTENDED. After drug was administered, patient experienced the following problems/side effects: abortion spontaneous, chorioamnionitis, sepsis, skin oedema, toxic epidermal necrolysis. EXTENDED dosage: unknown. Patient recovered.
Extended Side Effects Report #5391270-4
Physician from UNITED STATES reported EXTENDED problem on July 02, 2007. Female patient was treated with EXTENDED. After drug was administered, patient experienced the following problems/side effects: chorioamnionitis, sepsis, stillbirth, toxic epidermal necrolysis. EXTENDED dosage: unknown. Patient died.
Extended Side Effects Report #5391269-8
EXTENDED problem was reported by a Physician from UNITED STATES on July 02, 2007. Female patient, 17 years of age, was diagnosed with convulsion and was treated with EXTENDED. After drug was administered, patient experienced the following problems/side effects: abortion spontaneous, chorioamnionitis, sepsis, skin oedema, toxic epidermal necrolysis. EXTENDED dosage: unknown. Patient recovered.
Extended Side Effects Report #5391270-4
Physician from UNITED STATES reported EXTENDED problem on July 02, 2007. Female patient was treated with EXTENDED. After drug was administered, patient experienced the following problems/side effects: chorioamnionitis, sepsis, stillbirth, toxic epidermal necrolysis. EXTENDED dosage: unknown. Patient died.

Extended Side Effects Report #5771932-7
EXTENDED problem was reported by a Health Professional from UNITED STATES on June 12, 2008. Male patient, 58 years of age, weighting 187.0 lb, was diagnosed with convulsion and was treated with EXTENDED. After drug was administered, patient experienced the following problems/side effects: balance disorder, facial bones fracture, fall, labyrinthitis, nervous system disorder, vertigo positional. EXTENDED dosage: 600 MG DAILY PO. Patient recovered.
Extended Side Effects Report #5703906-6
Consumer or non-health professional from UNITED STATES reported EXTENDED problem on Apr 01, 2008. Male patient, child 12 years of age, was diagnosed with convulsion and was treated with EXTENDED. After drug was administered, patient experienced the following problems/side effects: blister, coma, cough, erythema multiforme, pyrexia, stevens-johnson syndrome. EXTENDED dosage: unknown. During the same period patient was treated with FOSPHENYTOIN. Patient was hospitalized and became disabled. Patient recovered.
Extended Side Effects


