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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