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Cedax Side Effects

Generic name: ceftibuten

Medically reviewed by Drugs.com. Last updated on Dec 15, 2023.

Note: This document contains side effect information about ceftibuten. Some dosage forms listed on this page may not apply to the brand name Cedax.

Applies to ceftibuten: oral capsule.

Serious side effects of Cedax

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

Other side effects of Cedax

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

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. 2001;PROD.

2. Owens RC, Nightingale CH, Nicolau DP. Ceftibuten: an overview. Pharmacotherapy. 1997;17:707-20.

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

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

5. 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. 1998;20:88-100.

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

7. David RP. Ceftibuten: a new expanded-spectrum oral cephalsporin. Ann Pharmacother. 1997;31:1022-33.

8. Ceftibuten--a new oral cephalosporin. Med Lett Drugs Ther. 1996;38:23-4.

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. 2000;106:1177-83.

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.