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Review Cefaclor Safety Reports submitted to FDA

Total Cefaclor reports: 13.
Cefaclor FDA safety alerts: No.
Reported deaths: 2    Reported hospitalizations: 7.
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FDA Reported Cefaclor Side Effects: liver disorder, renal disorder, lymphocyte stimulation test positive, atrial fibrillation, urticaria, rash erythematous, pyrexia, purpura, pain in extremity, leukocytoclastic vasculitis, ecchymosis.
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Cefaclor Side Effects Report #5653642-X
Physician from CHINA reported CEFACLOR problem on Feb 26, 2008. Male patient, weighting 8.82 lb, was diagnosed with nasopharyngitis and was treated with CEFACLOR. After drug was administered, patient experienced the following problems/side effects: overdose. CEFACLOR dosage: 250 MG, DAILY (1/D). Patient recovered.

Cefaclor Side Effects Report #5661201-8
CEFACLOR problem was reported by a Health Professional from UNITED KINGDOM on Feb 28, 2008. Female patient was diagnosed with lower respiratory tract infection, angina pectoris and was treated with CEFACLOR. After drug was administered, patient experienced the following problems/side effects: dyspnoea, erythema, hyperhidrosis. CEFACLOR dosage: 375 MG, QD. During the same period patient was treated with ASPIRIN, CLOPIDOGREL, RAMIPRIL, SIMVASTATIN. Patient was hospitalized. Patient recovered.

Cefaclor Side Effects Report #5683094-5
Health Professional from UNITED KINGDOM reported CEFACLOR problem on Mar 18, 2008. Male patient, 77 years of age, was diagnosed with lower respiratory tract infection, angina pectoris and was treated with CEFACLOR. After drug was administered, patient experienced the following problems/side effects: dyspnoea, erythema, hyperhidrosis. CEFACLOR dosage: 375 MG, DAILY (1/D). During the same period patient was treated with ASPIRIN, CLOPIDOGREL, RAMIPRIL, SIMVASTATIN. Patient was hospitalized. Patient recovered.

Cefaclor Side Effects Report #5581866-9
CEFACLOR problem was reported by a Physician from JAPAN on Dec 26, 2007. Female patient was diagnosed with otitis media acute and was treated with CEFACLOR. After drug was administered, patient experienced the following problems/side effects: hepatitis fulminant. CEFACLOR dosage: 210 MG, DAILY (1/D). During the same period patient was treated with VENETLIN, ASVERIN, MUCOSOLATE, PERIACTIN. Patient recovered.

Cefaclor Side Effects Report #5591932-X
Physician from JAPAN reported CEFACLOR problem on Jan 09, 2008. Female patient was diagnosed with otitis media acute and was treated with CEFACLOR. After drug was administered, patient experienced the following problems/side effects: hepatitis fulminant. CEFACLOR dosage: 210 MG, DAILY (1/D). During the same period patient was treated with VENETLIN, ASVERIN, MUCOSOLATE, PERIACTIN. Patient died.

Cefaclor Side Effects Report #5604765-2
CEFACLOR problem was reported by a Physician from UNITED KINGDOM on Jan 16, 2008. Male patient, child 1 years of age, was treated with CEFACLOR. After drug was administered, patient experienced the following problems/side effects: arthropathy, erythema multiforme. CEFACLOR dosage: 125 MG, 3/D. During the same period patient was treated with BECLOMETHASONE DIPROPIONATE, PARACETAMOL, PIRITON, ALBUTEROL. Patient was hospitalized and became disabled. Patient recovered.

Cefaclor Side Effects Report #5511174-3
Consumer or non-health professional from GERMANY reported CEFACLOR problem on Oct 25, 2007. Male patient was treated with CEFACLOR. After drug was administered, patient experienced the following problems/side effects: monoplegia. CEFACLOR dosage: 500 MG, 3/D. Patient recovered.

Cefaclor Side Effects Report #5520487-0
CEFACLOR problem was reported by a Physician from JAPAN on Nov 07, 2007. Male patient was diagnosed with toothache, schizophrenia and was treated with CEFACLOR. After drug was administered, patient experienced the following problems/side effects: toxic epidermal necrolysis. CEFACLOR dosage: 750 MG, DAILY (1/D). During the same period patient was treated with TELESMIN, SERENACE, RISPERDAL, LOXONIN, CRAVIT. Patient died on 05/20/2006.

Cefaclor Side Effects Report #5528919-9
Physician from GERMANY reported CEFACLOR problem on Nov 15, 2007. Male patient was treated with CEFACLOR. After drug was administered, patient experienced the following problems/side effects: monoplegia. CEFACLOR dosage: 500 MG, 3/D. Patient recovered.

Cefaclor Side Effects Report #5468098-X
CEFACLOR problem was reported by a Health Professional from SINGAPORE on Sept 05, 2007. Female patient, 72 years of age, was diagnosed with skin ulcer and was treated with CEFACLOR. After drug was administered, patient experienced the following problems/side effects: culture urine positive, cystitis haemorrhagic, enterobacter infection, escherichia infection, pathogen resistance, type iv hypersensitivity reaction. CEFACLOR dosage: unknown. During the same period patient was treated with ERYTHROMYCIN ETHYLSUCCINATE, ERYTHROMYCIN ETHYLSUCCINATE, BACTRIM, MEROPENEM. Patient was hospitalized. Patient recovered.

Cefaclor Side Effects Report #5470885-9
Health Professional from JAPAN reported CEFACLOR problem on Sept 10, 2007. Male patient, 63 years of age, was diagnosed with animal bite and was treated with CEFACLOR. After drug was administered, patient experienced the following problems/side effects: blister, ecchymosis, leukocytoclastic vasculitis, pain in extremity, purpura, pyrexia, rash erythematous, urticaria. CEFACLOR dosage: 250 MG, 20 MG. Patient was hospitalized. Patient recovered.

Cefaclor Side Effects Report #5408328-3
CEFACLOR problem was reported by a Health Professional from UNITED KINGDOM on July 05, 2007. Male patient, 74 years of age, was diagnosed with bronchitis and was treated with CEFACLOR. After drug was administered, patient experienced the following problems/side effects: chest discomfort, dizziness, dyspnoea, hyperhidrosis. CEFACLOR dosage: 375 MG, ORAL. During the same period patient was treated with PREDNISOLONE, VENTOLON. Patient was hospitalized. Patient recovered.

Cefaclor Side Effects Report #5422515-X
Consumer or non-health professional from GERMANY reported CEFACLOR problem on Aug 09, 2007. Male patient was treated with CEFACLOR. After drug was administered, patient experienced the following problems/side effects: monoplegia. CEFACLOR dosage: 500 MG, 3/D. Patient recovered.


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overdose, dyspnoea, erythema, hyperhidrosis, dyspnoea, erythema, hyperhidrosis, hepatitis fulminant, , was diagnosed with nasopharyngitis and was diagnosed with lower respiratory tract infection, angina pectoris and