Cedax Side Effects

Generic Name: ceftibuten

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

Not all side effects for Cedax may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to ceftibuten: oral capsule, oral powder for suspension

In addition to its needed effects, some unwanted effects may be caused by ceftibuten (the active ingredient contained in Cedax). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when 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 of the side effects that can occur with ceftibuten may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Less common
  • Acid or sour stomach
  • belching
  • heartburn
  • indigestion
  • loose stools
  • stomach discomfort, upset, or pain
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

Ceftibuten (the active ingredient contained in Cedax) is 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

If diarrhea occurs and is unresponsive to discontinuation of the drug and/or standard therapy, pseudomembranous colitis should be considered.[Ref]

Gastrointestinal side effects have included nausea (4%), diarrhea (3%), dyspepsia (2%), abdominal pain (1%) and vomiting (1%). Anorexia, constipation, dry mouth, eructation, flatulence, loose stools and moniliasis have been reported in less than 1% of patients. Melena has been reported during postmarketing experience. Pseudomembranous colitis has been reported in patients treated with cephalosporins.[Ref]

Nervous system

Nervous system side effects have included headache in 3% of patients and dizziness in 1%. Somnolence, fatigue, agitation, hyperkinesia, irritability, insomnia, and paresthesia have been reported in less than 1% of patients. Some cephalosporins have been associated with seizures in renally impaired patients.[Ref]

Hypersensitivity

Hypersensitivity side effects have included rash and pruritus in less than 1% of patients. Serum sickness-like reactions, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported during postmarketing experience. Cephalosporin class antibiotics have been associated with anaphylaxis, drug fever, Stevens-Johnson syndrome, and erythema multiforme.[Ref]

Hematologic

Hematologic side effects have included increased eosinophils (3%), decreased hemoglobin (2%), increased or decreased platelets (less than 1%) and decreased leukocytes (less than 1%). Cephalosporins as a class have been associated with aplastic anemia, hemolytic anemia, prolonged prothrombin time, hemorrhage, neutropenia, pancytopenia, and agranulocytosis.[Ref]

Hepatic

Hepatic side effects have included increased ALT (1%), increased bilirubin (1%), increased alkaline phosphatase (less than 1%), and increased AST (less than 1%). Jaundice and transient increases in LDH have been reported during postmarketing experience. Cephalosporins as a class have been associated with hepatic dysfunction including cholestasis.[Ref]

Renal

Renal side effects have included increased BUN (1%), increased creatinine (less than 1%), and dysuria (less than 1%). Cephalosporins as a class have been associated with renal dysfunction and toxic nephropathy.[Ref]

Genitourinary

Genitourinary side effects have included dysuria, hematuria, and vaginitis in less than less than 1% of patients.[Ref]

Other

Other side effects have included taste perversion in less than 1% of patients.[Ref]

Dermatologic

Dermatologic side effects have included pruritus, rash, diaper rash, and urticaria in less than 1% of patients.[Ref]

Respiratory

Respiratory side effects have included dyspnea and nasal congestion in less than 1% of patients.[Ref]

Psychiatric

Psychiatric side effects have included reports of psychosis during postmarketing experience.[Ref]

References

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

2. 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

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

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

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

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