Summary

Commonly reported side effects of cefditoren include: diarrhea. Other side effects include: vulvovaginal candidiasis and nausea. Continue reading for a comprehensive list of adverse effects.

Applies to cefditoren: oral tablet.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• severe stomach pain, diarrhea that is watery or bloody;

• pale or yellowed skin, dark colored urine, fever, confusion or weakness;

• a seizure (convulsions);

• fever, swollen glands, rash or itching, joint pain, or general ill feeling;

• swelling in your feet or ankles, feeling tired or short or breath;

• easy bruising or bleeding (nosebleeds, bleeding gums); or

• severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

• nausea, vomiting, diarrhea;

• indigestion, stomach pain;

• headache; or

• vaginal itching or discharge.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to cefditoren: oral tablet.

General

In clinical trials, cefditoren has been well tolerated. Most adverse effects were mild and self-limiting, and the overall incidence was higher with increased dosage.^[Ref]

Gastrointestinal

Gastrointestinal side effects have included diarrhea (up to 15%), nausea (up to 6%), abdominal pain (2%), dyspepsia (up to 2%), and vomiting (1%). Flatulence, pseudomembranous colitis, oral moniliasis, anorexia, constipation, dry mouth, eructation, flatulence, gastrointestinal disorder, increased appetite, stomatitis, and taste perversion have been reported in less than 1% of patients. Cephalosporins as a class have been associated with colitis.^[Ref]

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

Dermatologic

Dermatologic side effects have included pruritus, rash, sweating, and urticaria in less than 1% of patients. Stevens-Johnson syndrome, erythema multiforme, and toxic epidermal necrolysis have been reported during postmarketing experience.^[Ref]

Hypersensitivity

Hypersensitivity side effects have included allergic reaction (less than 1%). Anaphylaxis and anaphylactic shock been reported during postmarketing experience. Cephalosporins as a class have been associated with allergic reactions, anaphylaxis, Stevens-Johnson syndrome, serum sickness-like reaction, toxic epidermal necrolysis, and erythema multiforme. Patients allergic to other beta-lactam antibiotics may be allergic to cefditoren.^[Ref]

Genitourinary

Genitourinary side effects have included vaginal moniliasis (up to 6%), hematuria (up to 3.1%), and increased urine white blood cells (2.3%). Proteinuria, leukorrhea, and vaginitis have been reported in less than 1% of patients.^[Ref]

Hematologic

Hematologic side effects have included decreased hematocrit (up to 2.2%). Increased coagulation time, thrombocythemia, leukopenia, increased/decreased white blood cells, increased eosinophils, decreased neutrophils, increased lymphocytes, increased platelet count, decreased albumin, and decreased hemoglobin have been reported in less than 1% of patients. Thrombocytopenia has been reported during postmarketing experience. Cephalosporins as a class have been associated with aplastic anemia, hemolytic anemia, hemorrhage, prolonged prothrombin time, neutropenia, pancytopenia, and agranulocytosis.^[Ref]

Hepatic

Hepatic side effects have included abnormal liver function tests, increased SGPT/ALT, and increased SGOT/AST in less than 1% of patients. Cephalosporins as a class have been associated with hepatic dysfunction (including cholestasis) and elevated bilirubin.^[Ref]

Nervous system

Nervous system side effects have included headache (up to 3%). Somnolence and dizziness have been reported in less than 1% of patients. Several cephalosporins have been associated with seizures, particularly when inappropriately high doses were administered to renally impaired patients. Cephalosporins as a class have been associated with reversible hyperactivity and hypertonia.^[Ref]

Metabolic

Metabolic side effects have included increased glucose (up to 1.8%). Decreased sodium, increased potassium, decreased chloride, decreased inorganic phosphorus, decreased calcium, increased cholesterol, hyperglycemia, and thirst have been reported in less than 1% of patients. Pivalate-containing compounds have been associated with clinically significant carnitine deficiency during prolonged use due to increased renal excretion of carnitine. Short-term treatment with cefditoren has not been associated with clinical effects of decreased carnitine levels. Cephalosporins as a class have been associated with elevated alkaline phosphatase and lactate dehydrogenase.^[Ref]

Thirty percent and 46% decreases in serum carnitine levels were reported in patients after cefditoren 200 mg twice daily for 14 days and 400 mg twice daily for 14 days, respectively. Carnitine levels normalized within 7 days after discontinuation.^[Ref]

Renal

Renal side effects have included increased BUN (less than 1%). Acute renal failure has been reported during postmarketing experience. Cephalosporins as a class have been associated with increased creatinine, renal dysfunction, and toxic nephropathy.^[Ref]

Respiratory

Respiratory side effects have included asthma, pharyngitis, rhinitis, and sinusitis in less than 1% of patients. Interstitial pneumonia and acute eosinophilic pneumonia have been reported during postmarketing experience.^[Ref]

Psychiatric

Psychiatric side effects have included abnormal dreams, insomnia, and nervousness in less than 1% of patients.^[Ref]

Other

Other side effects have included asthenia, face edema, fever, fungal infection, peripheral edema, and pain in less than 1% of patients. Cephalosporins as a class have been associated with drug fever, superinfection, positive direct Coombs' test, and false-positive test for urinary glucose.^[Ref]

Musculoskeletal

Musculoskeletal side effects have included myalgia (less than 1%). Arthralgia has been reported during postmarketing experience.^[Ref]