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Cedax (Ceftibuten) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Cedax (Ceftibuten) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (18)
Death (1)
Life Threatening Events (1)

Reports by Reaction Type

Incorrect Storage of Drug (5)Wrong Technique in Drug Usage Process (3)Haematochezia (2)Diarrhoea (2)Rhonchi (2)Abdominal Pain (1)Pancreatitis Acute (1)Pyrexia (1)Erythema (1)Idiopathic Thrombocytopenic Purpura (1)Pancreatic Disorder (1)Fatigue (1)

Possible Cedax side effects in 56 year old female

Reported by a health professional (non-physician/pharmacist) from Italy on 2012-08-03

Patient: 56 year old female

Reactions: Pemphigus

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cedax
    Dosage: 400 mg, qd, oral
    Administration route: Oral
    Indication: Oedema
    Start date: 2012-03-23
    End date: 2012-03-28

Cedax
    Dosage: 400 mg, qd, oral
    Administration route: Oral
    Indication: Erythema
    Start date: 2012-03-23
    End date: 2012-03-28

Enoxaparin Sodium
    Dosage: 4000 iu, qd subcutaneous
    Indication: Erythema
    Start date: 2012-03-23
    End date: 2012-03-28

Other drugs received by patient: Iruxol (Chloramphenico (+) Collagenase) (Chloramphenicol, Collagenase)



Possible Cedax side effects in 72 year old female

Reported by a individual with unspecified qualification from Italy on 2012-07-26

Patient: 72 year old female

Reactions: Pruritus Generalised

Drug(s) suspected as cause:
Cedax

Other drugs received by patient: Glucobay; Losartan Potassium; Ezetimibe / Simvastatin; Lasix; Lansoprazole; Metfonorm (Metformin Hydrochloride); Lyrica



Possible Cedax side effects in 9 month old female

Reported by a individual with unspecified qualification from Sweden on 2012-07-17

Patient: 9 month old female

Reactions: Pyrexia, Incorrect Storage of Drug

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cedax



Possible Cedax side effects in

Reported by a individual with unspecified qualification from Poland on 2012-06-28

Patient:

Reactions: Wrong Technique in Drug Usage Process

Drug(s) suspected as cause:
Cedax



Possible Cedax side effects in 6 month old female

Reported by a individual with unspecified qualification from Venezuela on 2012-06-27

Patient: 6 month old female

Reactions: Hypersensitivity, Rash

Drug(s) suspected as cause:
Cedax

Other drugs received by patient: Meticortelone / 00016201 / (Prednisolone); Zyrtec (Cetirizinde Hydrochloride)



Possible Cedax side effects in female

Reported by a individual with unspecified qualification from Sweden on 2012-06-19

Patient: female

Reactions: Incorrect Storage of Drug

Drug(s) suspected as cause:
Cedax



Possible Cedax side effects in 7 year old male

Reported by a individual with unspecified qualification from Poland on 2012-06-04

Patient: 7 year old male

Reactions: Wrong Technique in Drug Usage Process, Incorrect Storage of Drug

Drug(s) suspected as cause:
Cedax



Possible Cedax side effects in 4 month old male

Reported by a individual with unspecified qualification from Sweden on 2012-05-29

Patient: 4 month old male

Reactions: Fatigue, Urticaria, Incorrect Storage of Drug

Drug(s) suspected as cause:
Cedax



Possible Cedax side effects in female

Reported by a physician from Hungary on 2012-04-20

Patient: female, weighing 57.6 kg (126.7 pounds)

Reactions: Pancreatitis Acute, Abdominal Pain, Multi-Organ Failure, Pancreatic Disorder, Pancreatic Enzymes Increased, Thrombocytopenia, Hepatic Infection, Renal Failure Acute, Anuria, Pharyngitis, Oxygen Saturation Decreased, Metabolic Acidosis, Hypotension, Anaemia, Concomitant Disease Progression, Hepatic Enzyme Increased, Epstein-Barr Virus Infection, Diarrhoea, Cytomegalovirus Infection, Septic Shock, Toxic Skin Eruption

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Cedax
    Dosage: 400
    Administration route: Oral
    Start date: 2007-08-28
    End date: 2007-08-31

Cephalosporines

Mycophenolic Acid
    Dosage: 2160 mg, unk
    Administration route: Oral
    Indication: Lupus Nephritis
    Start date: 2007-05-29
    End date: 2007-09-01

Mycophenolic Acid
    Dosage: 1440 mg, unk
    Administration route: Oral
    End date: 2007-09-06



Possible Cedax side effects in 1 month old male

Reported by a individual with unspecified qualification from Sweden on 2012-04-17

Patient: 1 month old male

Reactions: Incorrect Storage of Drug

Drug(s) suspected as cause:
Cedax



Possible Cedax side effects in 5 year old

Reported by a individual with unspecified qualification from Poland on 2012-04-17

Patient: 5 year old

Reactions: Wrong Technique in Drug Usage Process

Drug(s) suspected as cause:
Cedax



Possible Cedax side effects in male

Reported by a physician from United States on 2012-03-19

Patient: male, weighing 9.5 kg (21.0 pounds)

Reactions: Idiopathic Thrombocytopenic Purpura

Drug(s) suspected as cause:
Cedax



Possible Cedax side effects in male

Reported by a individual with unspecified qualification from Slovakia (Slovak Republic) on 2012-01-31

Patient: male

Reactions: Anaphylactic Reaction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cedax



Possible Cedax side effects in 77 year old female

Reported by a individual with unspecified qualification from Singapore on 2012-01-31

Patient: 77 year old female

Reactions: Rhonchi

Drug(s) suspected as cause:
Cedax
    Administration route: Oral

Moxifloxacin HCL



Possible Cedax side effects in 5 year old male

Reported by a physician from United States on 2011-12-15

Patient: 5 year old male, weighing 15.8 kg (34.7 pounds)

Reactions: Haematochezia, Mucous Stools, Clostridial Infection

Drug(s) suspected as cause:
Cedax

Other drugs received by patient: Alahist DHC; Ventolin



Possible Cedax side effects in 77 year old female

Reported by a health professional (non-physician/pharmacist) from Singapore on 2011-11-29

Patient: 77 year old female

Reactions: Rhonchi

Drug(s) suspected as cause:
Cedax
    Administration route: Oral

Moxifloxacin



Possible Cedax side effects in 64 year old male

Reported by a health professional (non-physician/pharmacist) from Italy on 2011-10-31

Patient: 64 year old male

Reactions: Refusal of Treatment by Patient, Erythema

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cedax

Other drugs received by patient: Bentelan (Betamethasone Sodium Phosphate



Possible Cedax side effects in 5 year old female

Reported by a individual with unspecified qualification from Bulgaria on 2011-10-14

Patient: 5 year old female

Reactions: Haematochezia, Diarrhoea

Drug(s) suspected as cause:
Cedax

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