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Ceftibuten Side Effects

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 powder for suspension

Along with its needed effects, ceftibuten may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking ceftibuten:

Rare

  • Burning while urinating
  • confusion
  • decreased urination
  • difficult or labored breathing
  • difficult or painful urination
  • dizziness
  • dry mouth
  • fainting
  • fever
  • increase in heart rate
  • lightheadedness
  • rapid breathing
  • shortness of breath
  • sunken eyes
  • thirst
  • tightness in the chest
  • unusual tiredness or weakness
  • wheezing
  • wrinkled skin

Incidence Not Known

  • Abdominal or stomach cramps or tenderness
  • back, leg, or stomach pains
  • bleeding gums
  • blistering, peeling, or loosening of the skin
  • bloating
  • bloody or cloudy urine
  • bloody, black, or tarry stools
  • chest pain
  • chills
  • clay-colored stools
  • cloudy urine
  • cough or hoarseness
  • coughing up blood
  • dark urine
  • decrease in urine output or decrease in urine-concentrating ability
  • diarrhea
  • diarrhea, watery and severe, which may also be bloody
  • difficulty with breathing or swallowing
  • fast heartbeat
  • feeling of discomfort
  • feeling that others are watching you or controlling your behavior
  • feeling that others can hear your thoughts
  • feeling, seeing, or hearing things that are not there
  • fever with or without chills
  • general body swelling
  • general feeling of tiredness or weakness
  • high fever
  • hives
  • increased menstrual flow or vaginal bleeding
  • increased thirst
  • inflammation of the joints
  • itching
  • joint or muscle pain
  • loss of appetite
  • lower back or side pain
  • muscle aches
  • nausea or vomiting
  • noisy breathing
  • nosebleeds
  • pain
  • pale skin
  • paralysis
  • problems with speech or speaking
  • prolonged bleeding from cuts
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • red or black, tarry stools
  • red or dark brown urine
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • seizures
  • severe mood or mental changes
  • skin rash
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • sudden decrease in the amount of urine
  • swollen lymph glands
  • swollen or painful glands
  • unpleasant breath odor
  • unusual behavior
  • unusual bleeding or bruising
  • unusual weight loss
  • vomiting of blood
  • wheezing
  • yellowing of the eyes or skin

Some side effects of ceftibuten may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less Common

Rare

  • Agitation
  • bad, unusual, or unpleasant (after) taste
  • bloated, full feeling
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • change in taste
  • constipation
  • cracks in the skin at the corners of the mouth
  • dry mouth
  • excess air or gas in the stomach or intestines
  • feeling unusually cold
  • full feeling
  • headache
  • hives or welts
  • increase in the body movements
  • irritability
  • itching of the vagina or genital area
  • pain during sexual intercourse
  • passing gas
  • redness of the skin
  • shivering
  • sleepiness or unusual drowsiness
  • sleeplessness
  • soreness or redness around the fingernails and toenails
  • stuffy nose
  • thick, white vaginal discharge with no odor or with a mild odor
  • trouble with sleeping
  • unable to sleep
  • weight loss

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

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]

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

Nervous system

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]

Some cephalosporins have been associated with seizures, especially in patients with renal dysfunction whose dose was not reduced.[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. David RP "Ceftibuten: a new expanded-spectrum oral cephalsporin." Ann Pharmacother 31 (1997): 1022-33

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

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