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Cefepime Safety Reports submitted to FDA

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Total Cefepime reports: 30.
Cefepime FDA safety alerts: 2007 .
Reported deaths: 4    Reported hospitalizations: 16.
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FDA Reported Cefepime Side Effects: rash, status epilepticus, white blood cell count decreased, thrombocytopenia, pyrexia, leukopenia, renal failure acute, neutropenia, muscle twitching, mental status changes, pneumonia.
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Cefepime Side Effects Report #5201957-1
Health Professional from UNITED STATES reported CEFEPIME problem on Jan 04, 2007. Male patient, 53 years of age, was treated with CEFEPIME. After drug was administered, patient experienced the following problems/side effects: depressed level of consciousness, mental status changes, muscle twitching, sedation. CEFEPIME dosage: unknown. During the same period patient was treated with DOCUSATE, COMBIVENT, INSULIN ASPART, INSULIN GLARGINE, OXYCODONE, DARBEPOETIN, ALLOPURINOL, ACETAMINOPHEN. Patient recovered.

Cefepime Side Effects Report #5208937-0
CEFEPIME problem was reported by a Pharmacist from UNITED STATES on Jan 11, 2007. Male patient, 60 years of age, weighting 231.0 lb, was diagnosed with pneumonia and was treated with CEFEPIME. After drug was administered, patient experienced the following problems/side effects: neutropenia. CEFEPIME dosage: unknown. Patient was hospitalized. Patient recovered.

Cefepime Side Effects Report #5221775-8
Pharmacist from UNITED STATES reported CEFEPIME problem on Jan 25, 2007. Male patient, 58 years of age, weighting 259.7 lb, was diagnosed with infection and was treated with CEFEPIME. After drug was administered, patient experienced the following problems/side effects: nephritis interstitial, renal cyst, renal failure acute. CEFEPIME dosage: unknown. Patient was hospitalized. Patient recovered.

Cefepime Side Effects Report #5247315-5
CEFEPIME problem was reported by a Health Professional from UNITED STATES on Feb 23, 2007. Female patient, 55 years of age, was treated with CEFEPIME. After drug was administered, patient experienced the following problems/side effects: injection site pruritus, urticaria. CEFEPIME dosage: unknown. During the same period patient was treated with DARVOCET. Patient recovered.

Cefepime Side Effects Report #5257091-8
Consumer or non-health professional from BRAZIL reported CEFEPIME problem on Mar 01, 2007. Female patient, 49 years of age, was diagnosed with sepsis and was treated with CEFEPIME. After drug was administered, patient experienced the following problems/side effects: cough, erythema, leukopenia, petechiae, prostration, pyrexia. CEFEPIME dosage: unknown. Patient was hospitalized. Patient recovered.

Cefepime Side Effects Report #5282827-X
CEFEPIME problem was reported by a Pharmacist from UNITED STATES on Mar 29, 2007. Male patient, 66 years of age, was diagnosed with infection and was treated with CEFEPIME. After drug was administered, patient experienced the following problems/side effects: respiratory distress, skin exfoliation, stevens-johnson syndrome. CEFEPIME dosage: unknown. During the same period patient was treated with ACETAMINOPHEN, ALBUTEROL, CASPOFUNGIN, CASPOFUNGIN ACETATE, CHLORIDE, CYANOCOBALAMIN, VITAMIN B, THIAMINE. Patient was hospitalized. Patient died on 01/08/2007.

Cefepime Side Effects Report #5289242-3
Pharmacist from UNITED STATES reported CEFEPIME problem on Apr 03, 2007. Female patient, weighting 100.1 lb, was diagnosed with decubitus ulcer, osteomyelitis and was treated with CEFEPIME. After drug was administered, patient experienced the following problems/side effects: diarrhoea, dizziness. CEFEPIME dosage: unknown. During the same period patient was treated with VANCOMYCIN. Patient recovered.

Cefepime Side Effects Report #5291820-2
CEFEPIME problem was reported by a Pharmacist from UNITED STATES on Apr 06, 2007. Female patient, 56 years of age, was diagnosed with infection and was treated with CEFEPIME. After drug was administered, patient experienced the following problems/side effects: leukopenia, rash, thrombocytopenia. CEFEPIME dosage: unknown. Patient recovered.

Cefepime Side Effects Report #5309301-6
Pharmacist from UNITED STATES reported CEFEPIME problem on Apr 24, 2007. Female patient, 71 years of age, weighting 116.8 lb, was diagnosed with cystic fibrosis and was treated with CEFEPIME. After drug was administered, patient experienced the following problems/side effects: contusion, purpura, spider naevus. CEFEPIME dosage: unknown. Patient recovered.

Cefepime Side Effects Report #5047731-0
CEFEPIME problem was reported by a Pharmacist from UNITED STATES on July 10, 2006. Male patient, weighting 179.0 lb, was diagnosed with escherichia sepsis, urosepsis and was treated with CEFEPIME. After drug was administered, patient experienced the following problems/side effects: blister, pruritus, rash. CEFEPIME dosage: unknown. Patient recovered.

Cefepime Side Effects Report #5051724-7
Pharmacist from UNITED STATES reported CEFEPIME problem on July 14, 2006. Male patient, 60 years of age, was diagnosed with bone disorder and was treated with CEFEPIME. After drug was administered, patient experienced the following problems/side effects: rash. CEFEPIME dosage: unknown. Patient recovered.

Cefepime Side Effects Report #5052152-0
CEFEPIME problem was reported by a Pharmacist from UNITED STATES on July 12, 2006. Male patient, 59 years of age, weighting 187.0 lb, was diagnosed with catheter related infection and was treated with CEFEPIME. After drug was administered, patient experienced the following problems/side effects: rash. CEFEPIME dosage: unknown. During the same period patient was treated with VANCOMYCIN. Patient was hospitalized. Patient recovered.

Cefepime Side Effects Report #5061289-1
Health Professional from UNITED STATES reported CEFEPIME problem on July 21, 2006. Female patient, 74 years of age, was diagnosed with lung infection pseudomonal, pathogen resistance and was treated with CEFEPIME. After drug was administered, patient experienced the following problems/side effects: chills, pyrexia, white blood cell count decreased. CEFEPIME dosage: unknown. Patient was hospitalized. Patient recovered.

Cefepime Side Effects Report #5087480-6
CEFEPIME problem was reported by a Pharmacist from UNITED STATES on Aug 23, 2006. Male patient, 20 years of age, weighting 181.9 lb, was diagnosed with device related infection, wound infection and was treated with CEFEPIME. After drug was administered, patient experienced the following problems/side effects: neutropenia, white blood cell count decreased. CEFEPIME dosage: unknown. During the same period patient was treated with VANCOMYCIN. Patient was hospitalized. Patient recovered.

Cefepime Side Effects Report #5104281-0
Pharmacist from UNITED STATES reported CEFEPIME problem on Sept 12, 2006. Male patient, 46 years of age, weighting 154.3 lb, was diagnosed with pneumonia and was treated with CEFEPIME. After drug was administered, patient experienced the following problems/side effects: vasculitis. CEFEPIME dosage: unknown. Patient was hospitalized. Patient recovered.

Cefepime Side Effects Report #5120659-3
CEFEPIME problem was reported by a Pharmacist from UNITED STATES on Oct 03, 2006. Female patient, 84 years of age, weighting 205.0 lb, was diagnosed with meningitis and was treated with CEFEPIME. After drug was administered, patient experienced the following problems/side effects: rash. CEFEPIME dosage: unknown. During the same period patient was treated with VANCOMYCIN. Patient recovered.

Cefepime Side Effects Report #5122003-4
Health Professional from UNITED STATES reported CEFEPIME problem on Oct 04, 2006. Male patient, 93 years of age, weighting 123.9 lb, was treated with CEFEPIME. After drug was administered, patient experienced the following problems/side effects: bronchospasm, dyspnoea, hypertension. CEFEPIME dosage: unknown. During the same period patient was treated with DONEPEZIL, DOCUSATE, METOPROLOL SUCCINATE, PRILOSEC, DEMEROL, ASPIRIN. Patient recovered.

Cefepime Side Effects Report #5140979-6
CEFEPIME problem was reported by a Consumer or non-health professional from UNITED STATES on Oct 27, 2006. Male patient, 49 years of age, was diagnosed with nosocomial infection and was treated with CEFEPIME. After drug was administered, patient experienced the following problems/side effects: thrombocytopenia. CEFEPIME dosage: unknown. During the same period patient was treated with ACETAMINOPHEN, ALBUTEROL, CHLORDIAZEPOXIDE, CLONIDINE, FOSINOPRIL, HUMULIN R, IPRATROPIUM BR, LABETALOL. Patient was hospitalized. Patient recovered.

Cefepime Side Effects Report #5150598-3
Consumer or non-health professional from AUSTRALIA reported CEFEPIME problem on Nov 09, 2006. Female patient, 79 years of age, weighting 176.4 lb, was diagnosed with infection parasitic and was treated with CEFEPIME. After drug was administered, patient experienced the following problems/side effects: blood creatinine increased, hyperreflexia, muscle twitching, myoclonus, nervousness, renal impairment. CEFEPIME dosage: unknown. Patient was hospitalized. Patient recovered.

Cefepime Side Effects Report #5152953-4
CEFEPIME problem was reported by a Pharmacist from UNITED STATES on Nov 14, 2006. Male patient, 27 years of age, weighting 138.9 lb, was diagnosed with cystic fibrosis and was treated with CEFEPIME. After drug was administered, patient experienced the following problems/side effects: obstructive airways disorder, paraesthesia oral. CEFEPIME dosage: 3.375MG EVERY 4 HOURS IV. During the same period patient was treated with ZOSYN, ACETAMINOPHEN, CYCLOSPORINE, CELLCEPT, SOSAMAX, AMBIEN, PREDNISONE, ASPIRIN. Patient was hospitalized. Patient recovered.

Cefepime Side Effects Report #5157821-X
Pharmacist from UNITED STATES reported CEFEPIME problem on Nov 20, 2006. Male patient, 70 years of age, was diagnosed with pneumonia and was treated with CEFEPIME. After drug was administered, patient experienced the following problems/side effects: cholestasis, jaundice, liver function test abnormal. CEFEPIME dosage: unknown. Patient was hospitalized. Patient recovered.

Cefepime Side Effects Report #5179460-7
CEFEPIME problem was reported by a Health Professional from SINGAPORE on Dec 04, 2006. Female patient, 97 years of age, was diagnosed with urinary tract infection and was treated with CEFEPIME. After drug was administered, patient experienced the following problems/side effects: tuberculosis. CEFEPIME dosage: unknown. During the same period patient was treated with AUGMENTIN, ERYTHROMYCIN, CIPROFLOXACIN, PIPERACILLIN AND TAZOBACTAM. Patient recovered.

Cefepime Side Effects Report #5194688-8
Pharmacist from UNITED STATES reported CEFEPIME problem on Dec 22, 2006. Male patient, weighting 141.5 lb, was treated with CEFEPIME. After drug was administered, patient experienced the following problems/side effects: condition aggravated, systemic lupus erythematosus, toxic epidermal necrolysis. CEFEPIME dosage: unknown. During the same period patient was treated with MOXIFLOXACIN. Patient was hospitalized. Patient recovered.

Cefepime Side Effects Report #5401325-3
CEFEPIME problem was reported by a Consumer or non-health professional from TAIWAN, PROVINCE OF CHINA on July 25, 2007. Female patient, 91 years of age, was diagnosed with urinary tract infection and was treated with CEFEPIME. After drug was administered, patient experienced the following problems/side effects: altered state of consciousness, asterixis, eye disorder. CEFEPIME dosage: unknown. Patient recovered.

Cefepime Side Effects Report #5404995-9
Health Professional from UNITED STATES reported CEFEPIME problem on July 25, 2007. Male patient, 54 years of age, was diagnosed with febrile neutropenia, status epilepticus and was treated with CEFEPIME. After drug was administered, patient experienced the following problems/side effects: status epilepticus. CEFEPIME dosage: unknown. During the same period patient was treated with PHENYTOIN. Patient was hospitalized. Patient died.

Cefepime Side Effects Report #5419478-X
CEFEPIME problem was reported by a Pharmacist from UNITED STATES on Aug 17, 2007. Female patient, weighting 130.1 lb, was diagnosed with enterobacter infection and was treated with CEFEPIME. After drug was administered, patient experienced the following problems/side effects: mental status changes. CEFEPIME dosage: unknown. Patient recovered.

Cefepime Side Effects Report #5449672-3
Pharmacist from UNITED STATES reported CEFEPIME problem on Sept 10, 2007. Female patient, 23 years of age, weighting 94.14 lb, was diagnosed with urinary tract infection and was treated with CEFEPIME. After drug was administered, patient experienced the following problems/side effects: cold sweat, hyperhidrosis, syncope. CEFEPIME dosage: unknown. During the same period patient was treated with PROMETHAZINE, PREVACID, BUSPAR, ACIDOPHILIS, AMBIEN, TYLENOL. Patient recovered.

Cefepime Side Effects Report #5456456-9
CEFEPIME problem was reported by a Pharmacist from UNITED STATES on Sept 14, 2007. Male patient, 73 years of age, weighting 209.4 lb, was diagnosed with pyrexia and was treated with CEFEPIME. After drug was administered, patient experienced the following problems/side effects: convulsion, facial palsy. CEFEPIME dosage: unknown. Patient was hospitalized. Patient recovered.

Cefepime Side Effects Report #5470896-3
Health Professional from UNITED STATES reported CEFEPIME problem on Sept 26, 2007. Male patient, 54 years of age, was diagnosed with febrile neutropenia, status epilepticus and was treated with CEFEPIME. After drug was administered, patient experienced the following problems/side effects: septic shock, status epilepticus. CEFEPIME dosage: unknown. During the same period patient was treated with PHENYTOIN, PHENOBARBITAL, VANCOMYCIN, MERONEM, PIPERACILLIN AND TAZOBACTAM. Patient was hospitalized. Patient died.

Cefepime Side Effects Report #5470897-5
CEFEPIME problem was reported by a Health Professional from UNITED STATES on Sept 26, 2007. Female patient, 60 years of age, was diagnosed with febrile neutropenia, myelodysplastic syndrome, aspergillosis and was treated with CEFEPIME. After drug was administered, patient experienced the following problems/side effects: bronchopulmonary aspergillosis, epilepsy, pneumonia, renal failure. CEFEPIME dosage: unknown. During the same period patient was treated with CYTARABINE, VORICONAZOLE, CASPOFUNGIN ACETATE. Patient died.


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depressed level of consciousness, mental status changes, muscle twitching, sedation neutropenia nephritis interstitial, renal cyst, renal failure acute, was diagnosed with pneumonia and was diagnosed with infection and was diagnosed with sepsis and was diagnosed with infection and