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Ceftibuten Side Effects

Medically reviewed by Drugs.com. Last updated on Sep 7, 2020.

In Summary

More frequently reported side effects include: nausea. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to ceftibuten: oral capsules, oral for suspension

Side effects include:

GI effects (e.g., nausea, diarrhea, dyspepsia, vomiting, abdominal pain), headache, dizziness, increased BUN concentrations, eosinophilia.

For Healthcare Professionals

Applies to ceftibuten: oral capsule, oral powder for reconstitution

General

This drug was generally well tolerated. In clinical trials, 2% of patients discontinued medication due to adverse events, primarily diarrhea, nausea, or vomiting, and 0.3% discontinued due to rash or pruritus.[Ref]

Gastrointestinal

The onset of pseudomembranous colitis symptoms has been reported during or after antibacterial therapy.[Ref]

Common (1% to 10%): Nausea, diarrhea, dyspepsia, abdominal pain, vomiting

Uncommon (0.1% to 1%): Constipation, dry mouth, eructation, flatulence, loose stools

Postmarketing reports: Melena

Cephalosporin-class:

-Frequency not reported: Pseudomembranous colitis[Ref]

Nervous system

Some cephalosporins have been associated with seizures, especially in patients with renal dysfunction whose dose was not reduced.[Ref]

Common (1% to 10%): Headache, dizziness

Uncommon (0.1% to 1%): Somnolence, taste perversion, paresthesia

Frequency not reported: Hyperkinesia

Postmarketing reports: Aphasia

Cephalosporin-class:

-Frequency not reported: Seizures[Ref]

Hepatic

Common (1% to 10%): Increased ALT, increased bilirubin

Uncommon (0.1% to 1%): Increased AST

Postmarketing reports: Jaundice

Cephalosporin-class:

-Frequency not reported: Hepatic cholestasis[Ref]

Hematologic

Common (1% to 10%): Increased eosinophils, decreased hemoglobin

Uncommon (0.1% to 1%): Increased platelets, decreased platelets, decreased leukocytes

Cephalosporin-class:

-Frequency not reported: Aplastic anemia, hemolytic anemia, prolonged prothrombin time, hemorrhage, neutropenia, pancytopenia, agranulocytosis[Ref]

Renal

Common (1% to 10%): Increased BUN

Uncommon (0.1% to 1%): Increased creatinine

Cephalosporin-class:

-Frequency not reported: Renal dysfunction, toxic nephropathy[Ref]

Dermatologic

Uncommon (0.1% to 1%): Pruritus, rash, urticaria

Frequency not reported: Diaper dermatitis

Postmarketing reports: Stevens-Johnson syndrome, toxic epidermal necrolysis

Cephalosporin-class:

-Frequency not reported: Stevens-Johnson syndrome, erythema multiforme[Ref]

Other

Uncommon (0.1% to 1%): Fatigue, moniliasis, increased alkaline phosphatase

Frequency not reported: Fever, rigors, transient increases in lactate dehydrogenase

Cephalosporin-class:

-Frequency not reported: Drug fever[Ref]

Metabolic

Uncommon (0.1% to 1%): Anorexia

Frequency not reported: Dehydration

Cephalosporin-class:

-Frequency not reported: False-positive test for urinary glucose[Ref]

Respiratory

Uncommon (0.1% to 1%): Dyspnea, nasal congestion

Postmarketing reports: Stridor[Ref]

Genitourinary

Uncommon (0.1% to 1%): Dysuria, vaginitis

Frequency not reported: Hematuria[Ref]

Psychiatric

Frequency not reported: Agitation, irritability, insomnia

Postmarketing reports: Psychosis[Ref]

Hypersensitivity

Postmarketing reports: Serum sickness-like reactions

Cephalosporin-class:

-Frequency not reported: Allergic reactions, anaphylaxis[Ref]

References

1. "Product Information. Cedax (ceftibuten)." Schering-Plough, Liberty Corner, NJ.

2. Aubier MA "Comparison of ceftibuten versus amoxicillin/clavulanate in the treatment of acute exacerbations of chronic bronchitis." Chemotherapy 43 (1997): 297-302

3. McAdoo MA, Rice K, Gordon GR, Sahn SA "Comparison of ceftibuten once daily and amoxicillin-clavulanate three times daily in the treatment of acute exacerbations of chronic bronchitis." Clin Ther 20 (1998): 88-100

4. Owens RC, Nightingale CH, Nicolau DP "Ceftibuten: an overview." Pharmacotherapy 17 (1997): 707-20

5. Sterkers O "Efficacy and tolerability of ceftibuten versus amoxicillin/clavulanate in the treatment of acute sinusitis." Chemotherapy 43 (1997): 352-7

6. Schatz BS, Karavokiros KT, Taeubel MA, Itokazu GS "Comparison of cefprozil, cefpodoxime proxetil, loracarbef, cefixime, and ceftibuten." Ann Pharmacother 30 (1996): 258-68

7. "Ceftibuten--a new oral cephalosporin." Med Lett Drugs Ther 38 (1996): 23-4

8. David RP "Ceftibuten: a new expanded-spectrum oral cephalsporin." Ann Pharmacother 31 (1997): 1022-33

9. Romano A, Mayorga C, Torres MJ, Artesani MC, Suau R, Sanchez F, Perez E, Venuti A, Blanca M "Immediate allergic reactions to cephalosporins: Cross-reactivity and selective responses." J Allerg Clin Immunol 106 (2000): 1177-83

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.