Spectracef Side Effects

Generic name: cefditoren

Medically reviewed by Drugs.com. Last updated on Apr 21, 2024.

Note: This document provides detailed information about Spectracef Side Effects associated with cefditoren. Some dosage forms listed on this page may not apply specifically to the brand name Spectracef.

Applies to cefditoren: oral tablet.

Serious side effects of Spectracef

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Any unexplained bruising or bleeding.
• Fever or chills.
• Sore throat.
• Feeling very tired or weak.
• Not able to pass urine or change in how much urine is passed.
• Seizures.
• Vaginal itching or discharge.
• Diarrhea is common with antibiotics. Rarely, a severe form called C diff–associated diarrhea (CDAD) may happen. Sometimes, this has led to a deadly bowel problem (colitis). CDAD may happen during or a few months after taking antibiotics. Call your doctor right away if you have stomach pain, cramps, or very loose, watery, or bloody stools. Check with your doctor before treating diarrhea.

Other side effects of Spectracef

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Upset stomach.
• Diarrhea.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

For healthcare professionals

Applies to cefditoren: oral tablet.

General adverse events

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.^[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 (the active ingredient contained in Spectracef) ^[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 (the active ingredient contained in Spectracef) 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]

Further information

Spectracef side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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