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Colistin Side Effects submitted to FDA

Total Colistin reports: 8.
Colistin FDA safety alerts: No.
Reported deaths: 1    Reported hospitalizations: 5.
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FDA Reported Colistin Side Effects: renal failure acute, respiratory failure, tachycardia, pyrexia, oxygen saturation decreased, lung infiltration, lobar pneumonia, dyspnoea, cystic fibrosis, condition aggravated, multi-organ failure,
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Colistin Side Effects Report #5573376-X
Pharmacist from UNITED STATES reported COLISTIN problem on Dec 20, 2007. Female patient, 55 years of age, weighting 147.0 lb, was diagnosed with pneumonia and was treated with COLISTIN. After drug was administered, patient experienced the following problems/side effects: pneumothorax. COLISTIN dosage: 75MG 8 ENDOTRACHEAL. Patient recovered.



Colistin Side Effects Report #5527850-2
COLISTIN problem was reported by a Physician from UNITED STATES on Nov 26, 2007. Female patient, weighting 132.3 lb, was diagnosed with cystic fibrosis and was treated with COLISTIN. After drug was administered, patient experienced the following problems/side effects: paraesthesia, renal failure acute. COLISTIN dosage: 500 MG Q 8 HR IV. Patient recovered.



Colistin Side Effects Report #5378660-0
Pharmacist from UNITED STATES reported COLISTIN problem on July 02, 2007. Male patient, 54 years of age, weighting 205.0 lb, was diagnosed with pancreatitis and was treated with COLISTIN. After drug was administered, patient experienced the following problems/side effects: renal failure acute. COLISTIN dosage: 160MG Q12H IV. Patient was hospitalized. Patient recovered.



Colistin Side Effects Report #5402786-6
COLISTIN problem was reported by a Physician from UNITED STATES on July 30, 2007. Female patient, 37 years of age, weighting 130.0 lb, was treated with COLISTIN. After drug was administered, patient experienced the following problems/side effects: condition aggravated, cystic fibrosis, dyspnoea, lobar pneumonia, lung infiltration, oxygen saturation decreased, pyrexia, tachycardia. COLISTIN dosage: unknown. Patient was hospitalized. Patient recovered.




Colistin Side Effects Report #5378660-0
Pharmacist from UNITED STATES reported COLISTIN problem on July 02, 2007. Male patient, 54 years of age, weighting 205.0 lb, was diagnosed with pancreatitis and was treated with COLISTIN. After drug was administered, patient experienced the following problems/side effects: renal failure acute. COLISTIN dosage: 160MG Q12H IV. Patient was hospitalized. Patient recovered.



Colistin Side Effects Report #5402786-6
COLISTIN problem was reported by a Physician from UNITED STATES on July 30, 2007. Female patient, 37 years of age, weighting 130.0 lb, was treated with COLISTIN. After drug was administered, patient experienced the following problems/side effects: condition aggravated, cystic fibrosis, dyspnoea, lobar pneumonia, lung infiltration, oxygen saturation decreased, pyrexia, tachycardia. COLISTIN dosage: unknown. Patient was hospitalized. Patient recovered.



Colistin Side Effects Report #5361970-0
Consumer or non-health professional from UNITED STATES reported COLISTIN problem on June 19, 2007. Female patient, 29 years of age, was treated with COLISTIN. After drug was administered, patient experienced the following problems/side effects: acute respiratory distress syndrome, multi-organ failure, respiratory failure. COLISTIN dosage: 75 MG BID. Patient died on 05/18/2007.



Colistin Side Effects Report #5341508-4
COLISTIN problem was reported by a Pharmacist from UNITED STATES on May 30, 2007. Male patient, 45 years of age, weighting 224.9 lb, was treated with COLISTIN. After drug was administered, patient experienced the following problems/side effects: acute respiratory failure, pancreatitis, renal failure acute. COLISTIN dosage: 250MG Q12H IV. During the same period patient was treated with CLONIDINE, LISINOPRIL, PREMIX, DOCUSATE, BACLOFEN, TEGRETOL, NSAID. Patient was hospitalized. Patient recovered.




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, Colistin was diagnosed with pneumonia and Colistin was diagnosed with cystic fibrosis and Colistin was diagnosed with pancreatitis and