Skip to main content

Clinical Trials

CEDAX (ceftibuten) 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 CHANGES*
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 (SCOT)  
* Changes in laboratory values with possible clinical significance regardless of whether or not the investigator thought that the change was due to drug toxicity.

CEDAX (ceftibuten) 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 than1% Diarrhea* 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  
* NOTE: 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.

LABORATORY VALUE CHANGES*
CEFTIBUTEN ORAL SUSPENSION
US CLINICAL TRIALS IN PEDIATRIC PATIENTS
Incidence equal to or greater than1% ↑ Eosinophils 3%
↑ BUN 2%
↓ Hemoglobin 1%
↑ Platelets 1%
Incidence less than 1% but greater than 0.1% ↑ ALT (SGPT)  
↑ AST (SCOT)  
↑ Alk phosphatase  
↑ Bilirubin  
↑ Creatinine  
* Changes in laboratory values with possible clinical significance regardless of whether or not the investigator thought that the change was due to drug toxicity.

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.