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Cedax (Ceftibuten Dihydrate) - Side Effects and Adverse Reactions

 
 



ADVERSE EVENTS

Clinical Trials

CEDAX CAPSULES (adult patients)

In clinical trials, 1728 adult patients (1092 US and 636 international) were treated with the recommended dose of ceftibuten capsules (400 mg per day). There were no deaths or permanent disabilities thought due to drug toxicity in any of the patients in these studies. Thirty-six of 1728 (2%) patients discontinued medication due to adverse events thought by the investigators to be possibly, probably, or almost certainly related to drug toxicity. The discontinuations were primarily for gastrointestinal disturbances, usually diarrhea, vomiting, or nausea. Six of 1728 (0.3%) patients were discontinued due to rash or pruritus thought related to ceftibuten administration.

In the US trials, the following adverse events were thought by the investigators to be possibly, probably, or almost certainly related to ceftibuten capsules in multipledose clinical trials (n = 1092 ceftibuten-treated patients).

ADVERSE REACTIONS
CEFTIBUTEN CAPSULES
US CLINICAL TRIALS IN ADULT PATIENTS
(n = 1092)
Incidence equal to or greater than 1% Nausea 4%
Headache 3%
Diarrhea 3%
Dyspepsia 2%
Dizziness 1%
Abdominal pain 1%
Vomiting 1%
Incidence less than 1% but greater than 0.1% Anorexia, Constipation, Dry mouth, Dyspnea, Dysuria, Eructation, Fatigue, Flatulence, Loose stools, Moniliasis, Nasal congestion, Paresthesia, Pruritus, Rash, Somnolence, Taste perversion, Urticaria, Vaginitis
LABORATORY VALUE CHANGESChanges in laboratory values with possible clinical significance regardless of whether or not the investigator thought that the change was due to drug toxicity.
CEFTIBUTEN CAPSULES
US CLINICAL TRIALS IN ADULT PATIENTS
Incidence equal to or greater than 1% ↑ BUN 4%
↑ Eosinophils 3%
↓ Hemoglobin 2%
↑ ALT (SGPT) 1%
↑ Bilirubin 1%
Incidence less than 1% but greater than 0.1% ↑ Alk phosphatase
↑ Creatinine
↑ Platelets
↓ Platelets
↓ Leukocytes
↑ AST (SGOT)

CEDAX ORAL SUSPENSION (pediatric patients)

In clinical trials, 1152 pediatric patients (772 US and 380 international), 97% of whom were younger than 12 years of age, were treated with the recommended dose of ceftibuten (9 mg/kg once daily up to a maximum dose of 400 mg per day) for 10 days. There were no deaths, life-threatening adverse events, or permanent disabilities in any of the patients in these studies. Eight of 1152 (<1%) patients discontinued medication due to adverse events thought by the investigators to be possibly, probably, or almost certainly related to drug toxicity. The discontinuations were primarily (7 out of 8) for gastrointestinal disturbances, usually diarrhea or vomiting. One patient was discontinued due to a cutaneous rash thought possibly related to ceftibuten administration.

In the US trials, the following adverse events were thought by the investigators to be possibly, probably, or almost certainly related to ceftibuten oral suspension in multipledose clinical trials (n = 772 ceftibuten-treated patients).

ADVERSE REACTIONS
CEFTIBUTEN ORAL SUSPENSION
US CLINICAL TRIALS IN PEDIATRIC PATIENTS
(n = 772)
Incidence equal to or greater than 1% DiarrheaNOTE: The incidence of diarrhea in pediatric patients ≤2 years old was 8% (23/301) compared with 2% (9/471) in pediatric patients >2 years old. 4%
Vomiting 2%
Abdominal pain 2%
Loose stools 2%
Incidence less than 1% but greater than 0.1% Agitation, Anorexia, Dehydration, Diaper dermatitis, Dizziness, Dyspepsia, Fever, Headache, Hematuria, Hyperkinesia, Insomnia, Irritability, Nausea, Pruritus, Rash, Rigors, Urticaria
LABORATORY VALUE CHANGESChanges in laboratory values with possible clinical significance regardless of whether or not the investigator thought that the change was due to drug toxicity.
CEFTIBUTEN ORAL SUSPENSION
US CLINICAL TRIALS IN PEDIATRIC PATIENTS
Incidence equal to or greater than 1% ↑ Eosinophils 3%
↑ BUN 2%
↓ Hemoglobin 1%
↑ Platelets 1%
Incidence less than 1% but greater than 0.1% ↑ ALT (SGPT)
↑ AST (SGOT)
↑ Alk phosphatase
↑ Bilirubin
↑ Creatinine

In Post-marketing Experience

The following adverse experiences have been reported during worldwide post-marketing surveillance: aphasia, jaundice, melena, psychosis, serum sickness-like reactions, stridor, Stevens-Johnson syndrome, and toxic epidermal necrolysis.

Cephalosporin-class Adverse Reactions

In addition to the adverse reactions listed above that have been observed in patients treated with ceftibuten capsules, the following adverse events and altered laboratory tests have been reported for cephalosporin-class antibiotics:

  •  allergic reactions, anaphylaxis, drug fever, Stevens-Johnson syndrome, renal dysfunction, toxic nephropathy, hepatic cholestasis, aplastic anemia, hemolytic anemia, hemorrhage, false-positive test for urinary glucose, neutropenia, pancytopenia, and agranulocytosis. Pseudomembranous colitis; onset of symptoms may occur during or after antibiotic treatment (see WARNINGS).

Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced (see DOSAGE AND ADMINISTRATION and OVERDOSAGE). If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.



REPORTS OF SUSPECTED CEDAX SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Cedax. The information is not vetted and should not be considered as verified clinical evidence.

Possible Cedax side effects / adverse reactions 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

Suspect drug(s):
Cedax



Possible Cedax side effects / adverse reactions 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

Suspect drug(s):
Cedax

Other drugs received by patient: Bentelan (Betamethasone Sodium Phosphate



Possible Cedax side effects / adverse reactions 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

Suspect drug(s):
Cedax
    Administration route: Oral

Moxifloxacin



See index of all Cedax side effect reports >>

Drug label data at the top of this Page last updated: 2013-06-20

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