Spectracef Side Effects

Please note - some side effects for Spectracef may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Spectracef - for the Consumer

Spectracef

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Spectracef:

Headache; mild diarrhea; nausea; stomach pain or upset; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; decreased urination; easy bruising or bleeding; fever; hoarseness; red, swollen, or blistered skin; seizures; severe diarrhea; severe nausea or vomiting; severe stomach pain/cramping; unusual tiredness; vaginal discharge or itching; white spots in the mouth; yellowing of the skin or eyes.

Side Effects by Body System

General

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

Gastrointestinal

Gastrointestinal adverse effects reported include diarrhea (11% to 15%), nausea (4% to 6%), abdominal pain (2%), dyspepsia (1% 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.

Dermatologic

Dermatologic side effects have included pruritus, rash, and urticaria in less than 1% of patients. Stevens-Johnson syndrome, erythema multiforme, and toxic epidermal necrolysis have also been reported.

Hypersensitivity

Hypersensitivity adverse effects reported for cephalosporins include 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.

Genitourinary

Genitourinary adverse effects have included vaginal moniliasis (3% to 6%), leukorrhea (less than 1%), and vaginitis (less than 1%).

Hepatic

Hepatic adverse effects have included abnormal liver function tests (less than 1%). Cephalosporins as a class have been associated with hepatic dysfunction including cholestasis.

Hematologic

Hematologic side effects have included increased coagulation time, thrombocythemia, leukopenia, and thrombocytopenia in less than 1% of patients. Cephalosporins as a class have been associated with aplastic anemia, hemolytic anemia, hemorrhage, neutropenia, pancytopenia, and agranulocytosis.

Nervous system

Nervous system side effects have included headache (2% to 3%); insomnia, nervousness, asthenia, somnolence, and dizziness (less than 1%). Some cephalosporins have been associated with seizures in renally impaired patients.

Metabolic

Metabolic side effects have included hyperglycemia and thirst 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 of cefditoren pivoxil has not been associated with clinical effects of decreased carnitine levels.

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.

Renal

Renal side effects have included acute renal failure. Cephalosporins as a class have been associated with renal dysfunction and toxic nephropathy.

Respiratory

Respiratory side effects have rarely included asthma, pharyngitis, rhinitis, sinusitis, interstitial pneumonia, and acute eosinophilic pneumonia.

Musculoskeletal

Musculoskeletal side effects have included arthralgia and myalgia (less than 1%).

Psychiatric

Psychiatric side effects have included abnormal dreams.

Endocrine

Endocrine side effects have included sweating (less than 1%).

Other

Other side effects have included face edema, fungal infection, peripheral edema, and pain in less than 1% of patients.

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