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Combactam Side Effects submitted to FDA

Total Combactam reports: 7.
Combactam FDA safety alerts: No.
Reported deaths: 6    Reported hospitalizations: 2.
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FDA Reported Combactam Side Effects: autoimmune thrombocytopenia,
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Combactam Side Effects Report #5619265-3
Physician from GERMANY reported COMBACTAM problem on Jan 15, 2008. Male patient, 62 years of age, was diagnosed with infection prophylaxis, fungal infection, prophylaxis against gastrointestinal ulcer, respiratory disorder and was treated with COMBACTAM. After drug was administered, patient experienced the following problems/side effects: hypokalaemia, nausea, oedema, sleep disorder, stevens-johnson syndrome, toxic epidermal necrolysis. COMBACTAM dosage: unknown. During the same period patient was treated with FRAGMIN, DIFLUCAN, PANTOPRAZOLE, ACETYLCYSTEINE, CIPROFLOXACIN. Patient died.



Combactam Side Effects Report #5611852-1
COMBACTAM problem was reported by a Physician from GERMANY on Jan 15, 2008. Male patient, 62 years of age, was diagnosed with infection prophylaxis, thrombosis prophylaxis, fungal infection, prophylaxis against gastrointestinal ulcer, respiratory disorder and was treated with COMBACTAM. After drug was administered, patient experienced the following problems/side effects: extrapyramidal disorder, fungal infection, gastrointestinal disorder, gastrooesophageal reflux disease, hypertension, hypokalaemia, liver transplant, liver transplant rejection, nausea. COMBACTAM dosage: unknown. During the same period patient was treated with FRAGMIN, DIFLUCAN, PANTOPRAZOLE, ACETYLCYSTEINE, CIPROFLOXACIN. Patient died.



Combactam Side Effects Report #5760276-5
Pharmacist from GERMANY reported COMBACTAM problem on May 26, 2008. Female patient was diagnosed with infection and was treated with COMBACTAM. After drug was administered, patient experienced the following problems/side effects: renal failure, sepsis. COMBACTAM dosage: unknown. During the same period patient was treated with PIPERACILLIN. Patient was hospitalized. Patient recovered.



Combactam Side Effects Report #5760280-7
COMBACTAM problem was reported by a Pharmacist from GERMANY on May 26, 2008. Male patient was diagnosed with pyrexia, leukocytosis and was treated with COMBACTAM. After drug was administered, patient experienced the following problems/side effects: renal failure acute, sepsis. COMBACTAM dosage: unknown. During the same period patient was treated with PIPERACILLIN. Patient died on 05/01/2008.




Combactam Side Effects Report #5761731-4
Pharmacist from GERMANY reported COMBACTAM problem on May 26, 2008. Male patient was diagnosed with pyelonephritis and was treated with COMBACTAM. After drug was administered, patient experienced the following problems/side effects: c-reactive protein increased, leukocytosis, pyrexia. COMBACTAM dosage: unknown. During the same period patient was treated with PIPERACILLIN. Patient recovered.



Combactam Side Effects Report #5761803-4
COMBACTAM problem was reported by a Pharmacist from GERMANY on May 26, 2008. Male patient was diagnosed with pneumonia and was treated with COMBACTAM. After drug was administered, patient experienced the following problems/side effects: c-reactive protein increased, leukocytosis. COMBACTAM dosage: unknown. During the same period patient was treated with PIPERACILLIN. Patient recovered.



Combactam Side Effects Report #5258117-8
Health Professional from GERMANY reported COMBACTAM problem on Feb 23, 2007. Male patient, weighting 253.5 lb, was diagnosed with erysipelas and was treated with COMBACTAM. After drug was administered, patient experienced the following problems/side effects: autoimmune thrombocytopenia. COMBACTAM dosage: DAILY DOSE:3000MG. During the same period patient was treated with PIPRIL, TORSEMIDE, NOVODIGAL, NEXIUM, MARCUMAR, CARVEDILOL, CLEXANE, RAMIPRIL. Patient was hospitalized. Patient recovered.




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, Combactam was diagnosed with infection prophylaxis, fungal infection, prophylaxis against gastrointestinal ulcer, respiratory disorder and