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Fludex Side Effects submitted to FDA

Total Fludex reports: 18.
Fludex FDA safety alerts: No.
Reported deaths: 1    Reported hospitalizations: 15.
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FDA Reported Fludex Side Effects: hyponatraemia, hypokalaemia, torsade de pointes, renal failure acute, renal failure, syncope, fall, blood osmolarity decreased, haemolytic anaemia, ventricular tachyarrhythmia, mental status changes,
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Fludex Side Effects Report #5646788-3
Consumer or non-health professional from FRANCE reported FLUDEX problem on Feb 26, 2008. Female patient, 86 years of age, was diagnosed with hypertension, arrhythmia and was treated with FLUDEX. After drug was administered, patient experienced the following problems/side effects: bradycardia, fall, hypotension. FLUDEX dosage: unknown. During the same period patient was treated with AMIODARONE, TAREG, ISOPTIN. Patient was hospitalized. Patient recovered.



Fludex Side Effects Report #5675017-X
FLUDEX problem was reported by a Physician from FRANCE on Mar 13, 2008. Female patient, 44 years of age, was treated with FLUDEX. After drug was administered, patient experienced the following problems/side effects: renal failure. FLUDEX dosage: unknown. During the same period patient was treated with CALCIUM. Patient was hospitalized. Patient recovered.



Fludex Side Effects Report #5598292-9
Consumer or non-health professional from FRANCE reported FLUDEX problem on Jan 15, 2008. Male patient, 71 years of age, was diagnosed with hypertension and was treated with FLUDEX. After drug was administered, patient experienced the following problems/side effects: renal failure acute. FLUDEX dosage: unknown. Patient was hospitalized. Patient recovered.



Fludex Side Effects Report #5517386-7
FLUDEX problem was reported by a Consumer or non-health professional from FRANCE on Nov 08, 2007. Female patient was diagnosed with dyslipidaemia and was treated with FLUDEX. After drug was administered, patient experienced the following problems/side effects: pathological fracture. FLUDEX dosage: unknown. During the same period patient was treated with ACTOS, AMARYL, GLUCOPHAGE, ZOCOR, ACUITEL, LIORESAL, MYOLASTAN, AMPECYCLAL. Patient recovered.




Fludex Side Effects Report #5518312-7
Consumer or non-health professional from FRANCE reported FLUDEX problem on Nov 08, 2007. Female patient, 80 years of age, weighting 180.8 lb, was diagnosed with hypertension and was treated with FLUDEX. After drug was administered, patient experienced the following problems/side effects: orthostatic hypotension, syncope vasovagal. FLUDEX dosage: unknown. During the same period patient was treated with SELOKEN, RAMIPRIL, TRINITRIN, TAHOR, PLAVIX. Patient was hospitalized. Patient recovered.



Fludex Side Effects Report #5524523-7
FLUDEX problem was reported by a Consumer or non-health professional from FRANCE on Nov 16, 2007. Female patient, 66 years of age, was treated with FLUDEX. After drug was administered, patient experienced the following problems/side effects: blood alkaline phosphatase increased, cholestasis, gamma-glutamyltransferase increased, glasgow coma scale abnormal, hypochloraemia, hypokalaemia, hyponatraemia, inappropriate antidiuretic hormone secretion. FLUDEX dosage: 1.5 MG, QD. During the same period patient was treated with SOTALOL, NICARDIPINE, XALATAN, TEGRETOL, RIVOTRIL. Patient was hospitalized. Patient recovered.



Fludex Side Effects Report #5525863-8
Consumer or non-health professional from FRANCE reported FLUDEX problem on Nov 17, 2007. Male patient, 80 years of age, was diagnosed with hypertension, cerebrovascular accident and was treated with FLUDEX. After drug was administered, patient experienced the following problems/side effects: duodenitis, electrolyte imbalance. FLUDEX dosage: unknown. During the same period patient was treated with PRAXILENE, RAMIPRIL, EFFERALGAN, ZAMUDOL. Patient was hospitalized. Patient recovered.



Fludex Side Effects Report #5490558-6
FLUDEX problem was reported by a Consumer or non-health professional from FRANCE on Oct 16, 2007. Male patient, 81 years of age, was treated with FLUDEX. After drug was administered, patient experienced the following problems/side effects: convulsion, hypokalaemia. FLUDEX dosage: unknown. During the same period patient was treated with SERESTA, RISPERDAL, LYRICA, NORSET, EFFEXOR, DIFFU K, FORLAX, INIPOMP. Patient recovered.



Fludex Side Effects Report #5442041-1
Consumer or non-health professional from FRANCE reported FLUDEX problem on Aug 27, 2007. Male patient, 52 years of age, was treated with FLUDEX. After drug was administered, patient experienced the following problems/side effects: renal failure acute. FLUDEX dosage: unknown. During the same period patient was treated with COVERSYL, PLAVIX, INIPOMP, STILNOX, CLONAZEPAM. Patient was hospitalized. Patient recovered.




Fludex Side Effects Report #5452631-8
FLUDEX problem was reported by a Consumer or non-health professional from FRANCE on Sept 10, 2007. Female patient, 75 years of age, was diagnosed with essential hypertension and was treated with FLUDEX. After drug was administered, patient experienced the following problems/side effects: asthenia, back pain, cerebral atrophy, confusional state, depressed level of consciousness, disorientation, fall, hyponatraemia, mental status changes. FLUDEX dosage: unknown. During the same period patient was treated with ACETAMINOPHEN, TARKA. Patient was hospitalized. Patient recovered.



Fludex Side Effects Report #5453684-3
Consumer or non-health professional from FRANCE reported FLUDEX problem on Sept 07, 2007. Male patient, 83 years of age, was treated with FLUDEX. After drug was administered, patient experienced the following problems/side effects: hypokalaemia, renal failure, syncope, torsade de pointes, ventricular tachyarrhythmia. FLUDEX dosage: unknown. During the same period patient was treated with CORDARONE, GLIBENESE, KARDEGIC, PLAVIX, PERMIXON, TRIATEC, ADANCOR, BUFLOMEDIL. Patient was hospitalized. Patient recovered.



Fludex Side Effects Report #5405031-0
FLUDEX problem was reported by a Consumer or non-health professional from on July 25, 2007. Female patient, 83 years of age, was treated with FLUDEX. After drug was administered, patient experienced the following problems/side effects: atrioventricular block first degree, dehydration, hypokalaemia, hyponatraemia, nausea, somnolence, vertigo, vomiting. FLUDEX dosage: unknown. During the same period patient was treated with FUROSEMIDE, CARBAMAZEPINE. Patient was hospitalized. Patient recovered.



Fludex Side Effects Report #5405903-7
Consumer or non-health professional from reported FLUDEX problem on July 25, 2007. Female patient, 76 years of age, was diagnosed with essential hypertension and was treated with FLUDEX. After drug was administered, patient experienced the following problems/side effects: blood osmolarity decreased, hyponatraemia, inappropriate antidiuretic hormone secretion, urine osmolarity increased. FLUDEX dosage: unknown. During the same period patient was treated with CARBAMAZEPINE. Patient was hospitalized. Patient recovered.



Fludex Side Effects Report #5782973-8
FLUDEX problem was reported by a Consumer or non-health professional from FRANCE on June 19, 2008. Female patient, 96 years of age, was diagnosed with hypertension and was treated with FLUDEX. After drug was administered, patient experienced the following problems/side effects: atrioventricular block complete, blood creatinine increased, bradycardia, hypotension. FLUDEX dosage: unknown. During the same period patient was treated with LODOZ, BURINEX, NEURONTIN, POTASSIUM CHLORIDE, PLAVIX, ALLOPURINOL, NORMISON. Patient was hospitalized. Patient recovered.




Fludex Side Effects Report #5343987-5
Consumer or non-health professional from FRANCE reported FLUDEX problem on May 25, 2007. Male patient, 71 years of age, was treated with FLUDEX. After drug was administered, patient experienced the following problems/side effects: eosinophil count increased, haemolytic anaemia, hepatitis cholestatic, rash. FLUDEX dosage: unknown. During the same period patient was treated with ROVAMYCINE, KARDEGIC, ALLOPURINOL, SOTALOL, TETRAZEPAM. Patient was hospitalized. Patient recovered.



Fludex Side Effects Report #5293238-5
FLUDEX problem was reported by a Consumer or non-health professional from on Apr 05, 2007. Male patient, 54 years of age, was treated with FLUDEX. After drug was administered, patient experienced the following problems/side effects: pulmonary oedema. FLUDEX dosage: unknown. During the same period patient was treated with EUPRESSYL, ANTINEOPLASTIC AGENTS, AVLOCARDYL, TRIATEC, TRIFLUCAN, LOXEN. Patient died on 03/10/2007.



Fludex Side Effects Report #5270948-7
Consumer or non-health professional from reported FLUDEX problem on Mar 12, 2007. Male patient, 56 years of age, weighting 185.2 lb, was diagnosed with hypertension, bronchopneumopathy and was treated with FLUDEX. After drug was administered, patient experienced the following problems/side effects: hallucination, hypokalaemia, hyponatraemia. FLUDEX dosage: unknown. During the same period patient was treated with TUSSIDANE, ALLOPURINOL, NEBIVOLOL HYDROCHLORIDE, OLMETEC, AMOXICILLIN. Patient was hospitalized. Patient recovered.



Fludex Side Effects Report #5281703-6
FLUDEX problem was reported by a Consumer or non-health professional from FRANCE on Mar 26, 2007. Male patient, 80 years of age, was treated with FLUDEX. After drug was administered, patient experienced the following problems/side effects: haemolytic anaemia. FLUDEX dosage: unknown. During the same period patient was treated with ALLOPURINOL, KALEORID, PERMIXON, OSMOGEL, PARIET, NEURONTIN, ZAMUDOL. Patient was hospitalized. Patient recovered.




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