Spectracef Side Effects
Generic Name: cefditoren
Note: This document contains side effect information about cefditoren. Some of the dosage forms listed on this page may not apply to the brand name Spectracef.
Some side effects of Spectracef may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to cefditoren: oral tablet
Along with its needed effects, cefditoren (the active ingredient contained in Spectracef) 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 cefditoren:Rare
- Allergic reaction, such as, itching, pain, redness, or swelling of eye or eyelid, watering of eyes, troubled breathing or wheezing, severe skin rash or hives, flushing, headache, fever, chills, runny nose, increased sensitivity to sunlight, joint pain, swollen glands
- leukopenia, such as, black, tarry stools, chest pain, chills, cough, fever, painful or difficult urination, shortness of breath, sore throat, sores, ulcers, or white spots on lips or in mouth, swollen glands, unusual bleeding or bruising, unusual tiredness, or weakness
- pseudomembranous colitis, such as, abdominal or stomach cramps, pain, bloating, abdominal tenderness, diarrhea, watery and severe, which may also be bloody, fever, increased thirst, nausea or vomiting, unusual tiredness or weakness, or unusual weight loss
- or thrombocythemia, such as, pain, warmth or burning in fingers, toes, and legs, dizziness, problems with vision or hearing
Some side effects of cefditoren 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:More Common
- or vaginal moniliasis, such as, thick whitish discharge from the vagina or cervical canal
- Abdominal pain
- Dyspepsia, such as, acid or sour stomach, belching, heartburn, indigestion, or stomach discomfort, upset or pain
- or headache
- Abnormal dreams
- anorexia, such as, loss of appetite
- asthenia, such as, lack or loss of strength
- dry mouth
- dysgeusia, such as, taste perversion
- eructation, such as, belching, bloated full feeling, excess air or gas in stomach
- flatulence, such as, passing of gas
- fungal infection
- gastritis, such as, burning feeling in chest or stomach, tenderness in stomach area, stomach upset, or indigestion
- hyperglycemia, such as, blurred vision, dry mouth, fatigue, flushed, dry skin, fruit-like breath odor, increased hunger, increased thirst, increased urination, loss of consciousness, nausea, stomachache, sweating, troubled breathing, unexplained weight loss, vomiting
- increased appetite
- insomnia, such as, sleeplessness
- leukorrhea, such as, increase in amount of clear vaginal discharge, white vaginal discharge
- mouth ulceration
- myalgia, such as, muscle pain
- oral moniliasis, such as, sore mouth or tongue, white patches in mouth, tongue, or throat
- peripheral edema, such as, bloating or swelling of face, arms, hands, lower legs, or feet, rapid weight gain, tingling of hands or feet, unusual weight gain or loss
- pharyngitis, such as, body aches or pain, congestion, cough, dryness or soreness of throat, fever, hoarseness, runny nose, tender, swollen glands in neck, trouble in swallowing, or voice changes
- pruritus, such as, itching skin
- rhinitis, such as, stuffy nose, runny nose, or sneezing
- sinusitis, such as, pain or tenderness around eyes and cheekbones, fever, stuffy or runny nose, headache, cough, shortness of breath or troubled breathing, tightness of chest or wheezing
- somnolence, such as, sleepiness or unusual drowsiness
- stomatitis, such as, swelling or inflammation of the mouth
- urinary frequency
- urticaria, such as, hives or welts, itching, redness of skin, or rash
- or weight loss
For Healthcare Professionals
Applies to cefditoren: oral tablet
In clinical trials, cefditoren (the active ingredient contained in Spectracef) has been well tolerated. Most adverse effects were mild and self-limiting, and the overall incidence was higher with increased dosage.
Onset of pseudomembranous colitis symptoms has been reported during or after antibacterial therapy.
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.
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.
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 (the active ingredient contained in Spectracef)
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.
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.
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.
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.
Thirty percent and 46% decreases in serum carnitine levels were reported in patients after cefditoren (the active ingredient contained in Spectracef) 200 mg twice daily for 14 days and 400 mg twice daily for 14 days, respectively. Carnitine levels normalized within 7 days after discontinuation.
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.
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.
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.
Psychiatric side effects have included abnormal dreams, insomnia, and nervousness in less than 1% of patients.
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.
Musculoskeletal side effects have included myalgia (less than 1%). Arthralgia has been reported during postmarketing experience.
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