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.
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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
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