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Review Ertapenem Safety Reports submitted to FDA

Total Ertapenem reports: 10.
Ertapenem FDA safety alerts: 2007 .
Reported deaths: 1    Reported hospitalizations: 9.
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FDA Reported Ertapenem Side Effects: psychotic disorder, hypotension, bradycardia, stupor, respiration abnormal, oxygen saturation abnormal, agitation, dermatitis exfoliative, clostridial infection, toxic epidermal necrolysis, osteomyelitis.
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Ertapenem Side Effects Report #5622842-7
Pharmacist from UNITED STATES reported ERTAPENEM problem on Feb 08, 2008. Female patient, 78 years of age, weighting 143.0 lb, was diagnosed with enterococcal infection, staphylococcal infection, wound infection bacterial and was treated with ERTAPENEM. After drug was administered, patient experienced the following problems/side effects: convulsion, lip swelling, mental status changes, rash, swelling face. ERTAPENEM dosage: unknown. During the same period patient was treated with LINEZOLID, BACTRIM, BACITRACIN. Patient was hospitalized. Patient recovered.

Ertapenem Side Effects Report #5636785-6
ERTAPENEM problem was reported by a Pharmacist from UNITED STATES on Feb 19, 2008. Male patient, 82 years of age, was treated with ERTAPENEM. After drug was administered, patient experienced the following problems/side effects: mental status changes. ERTAPENEM dosage: 1000MG EVERY DAY IV. Patient recovered.

Ertapenem Side Effects Report #5535788-X
Physician from SPAIN reported ERTAPENEM problem on Nov 30, 2007. Male patient, 77 years of age, was diagnosed with diabetic foot and was treated with ERTAPENEM. After drug was administered, patient experienced the following problems/side effects: cerebrovascular accident. ERTAPENEM dosage: unknown. Patient was hospitalized. Patient recovered.

Ertapenem Side Effects Report #5578489-4
ERTAPENEM problem was reported by a Health Professional from FRANCE on Dec 18, 2007. Male patient, 47 years of age, was diagnosed with pyelonephritis, atrial flutter and was treated with ERTAPENEM. After drug was administered, patient experienced the following problems/side effects: arrhythmia, transaminases increased. ERTAPENEM dosage: unknown. During the same period patient was treated with AMIODARONE HYDROCHLORIDE, AMIKACIN SULPHATE, MIDAZOLAM HYDROCHLORIDE, PREDNISOLONE METASULFOBENZOATE, ESOMEPRAZOLE MAGNESIUM, HEPARIN. Patient was hospitalized. Patient died on 11/15/2007.

Ertapenem Side Effects Report #5483908-8
Pharmacist from UNITED STATES reported ERTAPENEM problem on Oct 09, 2007. Male patient, 59 years of age, was diagnosed with osteomyelitis, depression, insomnia and was treated with ERTAPENEM. After drug was administered, patient experienced the following problems/side effects: agitation, confusional state, delirium, hallucination. ERTAPENEM dosage: unknown. During the same period patient was treated with TRAZODONE. Patient was hospitalized. Patient recovered.

Ertapenem Side Effects Report #5409442-9
ERTAPENEM problem was reported by a Pharmacist from UNITED STATES on Aug 07, 2007. Male patient, 76 years of age, was diagnosed with surgery and was treated with ERTAPENEM. After drug was administered, patient experienced the following problems/side effects: bradycardia, hypotension. ERTAPENEM dosage: unknown. Patient was hospitalized. Patient recovered.

Ertapenem Side Effects Report #5397540-8
Pharmacist from UNITED STATES reported ERTAPENEM problem on July 24, 2007. Male patient, 59 years of age, was diagnosed with cellulitis and was treated with ERTAPENEM. After drug was administered, patient experienced the following problems/side effects: dermatitis exfoliative. ERTAPENEM dosage: unknown. During the same period patient was treated with METAMUCIL, TRENTAL, TRIAMCINOLONE, PLAVIX, HYDROXYZINE, TYLENOL, PREDNISONE, CLINDAMYCIN. Patient was hospitalized. Patient recovered.

Ertapenem Side Effects Report #5400083-6
ERTAPENEM problem was reported by a Pharmacist from UNITED STATES on July 26, 2007. Male patient, 70 years of age, weighting 97.00 lb, was diagnosed with abdominal infection and was treated with ERTAPENEM. After drug was administered, patient experienced the following problems/side effects: agitation, oxygen saturation abnormal, psychotic disorder, respiration abnormal, stupor. ERTAPENEM dosage: unknown. Patient was hospitalized and became disabled. Patient recovered.

Ertapenem Side Effects Report #5397540-8
Pharmacist from UNITED STATES reported ERTAPENEM problem on July 24, 2007. Male patient, 59 years of age, was diagnosed with cellulitis and was treated with ERTAPENEM. After drug was administered, patient experienced the following problems/side effects: dermatitis exfoliative. ERTAPENEM dosage: unknown. During the same period patient was treated with METAMUCIL, TRENTAL, TRIAMCINOLONE, PLAVIX, HYDROXYZINE, TYLENOL, PREDNISONE, CLINDAMYCIN. Patient was hospitalized. Patient recovered.

Ertapenem Side Effects Report #5400083-6
ERTAPENEM problem was reported by a Pharmacist from UNITED STATES on July 26, 2007. Male patient, 70 years of age, weighting 97.00 lb, was diagnosed with abdominal infection and was treated with ERTAPENEM. After drug was administered, patient experienced the following problems/side effects: agitation, oxygen saturation abnormal, psychotic disorder, respiration abnormal, stupor. ERTAPENEM dosage: unknown. Patient was hospitalized and became disabled. Patient recovered.


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convulsion, lip swelling, mental status changes, rash, swelling face, mental status changes, cerebrovascular accident, , was diagnosed with enterococcal infection, staphylococcal infection, wound infection bacterial and