Cefaclor Generic Name: cefaclor Brand Name: Cefaclor Oral Suspension Drug Class: Cephalosporins, 2nd Generation Cefaclor Oral Suspension (Cefaclor) side effects drug center Related Drugs Azactam Injection Ceftin Cefuroxime Duricef Keflex Lorabid Omnicef Solosec Suprax Health Resources Middle Ear Infection (Otitis Media) Sinus Infection (Sinusitis) Sore Throat Urinary Tract Infection (UTI) Related Supplements Alpha-Linolenic Acid Cowslip Cranberry Elderflower Gentian Melatonin Papain Slippery Elm Sorrel Verbena Xylitol PROFESSIONAL CONSUMER SIDE EFFECTS Overview Consumer Information Professional Information Cefaclor Side Effects Center What Is Cefaclor? Cefaclor is a cephalosporin-type antibiotic used to treat a wide variety of bacterial infections (e.g., middle ear, skin, urine, and respiratory tract infections). What Are Side Effects of Cefaclor? Side effects of Cefaclor include: diarrhea, stomach upset, headache, nausea, vomiting, vaginal itching or discharge, or hypersensitivity reactions. Dosage for Cefaclor? The usual adult dosage of Cefaclor is 250 mg every 8 hours. What Drugs, Substances, or Supplements Interact with Cefaclor? Cefaclor may interact with oral anticoagulants, hormonal birth control, and other drugs. Tell your doctor all medications and supplements you use. Cefaclor During Pregnancy and Breastfeeding During pregnancy Cefaclor should only be used if prescribed. Tell your doctor if you are pregnant or plan to become pregnant before taking Cefaclor. Cefaclor passes into breast milk. Consult your doctor before breastfeeding. Additional Information Our Cefaclor Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication. Cefaclor Consumer Information SIDE EFFECTS: Stomach upset, headache, nausea, vomiting, or diarrhea may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes or skin, dark urine, new signs of infection (e.g., persistent sore throat or fever), easy bruising/bleeding, change in the amount of urine, mental/mood changes (such confusion). This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have any of the following symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool. Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection (oral or vaginal fungal infection). Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge or other new symptoms. A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), unusual joint pain, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345. Read the entire patient information overview for Cefaclor (Cefaclor) Cefaclor Professional Information SIDE EFFECTS Adverse effects considered to be related to therapy with cefaclor are listed below: Hypersensitivity reactions have been reported in about 1.5% of patients and include morbilliform eruptions (1 in 100). Pruritus, urticaria, and positive Coombs' tests each occur in less than 1 in 200 patients. Cases of serum-sickness-like reactions have been reported with the use of cefaclor. These are characterized by findings of erythema multiforme, rashes, and other skin manifestations accompanied by arthritis/arthralgia, with or without fever, and differ from classic serum sickness in that there is infrequently associated lymphadenopathy and proteinuria, no circulating immune complexes, and no evidence to date of sequelae of the reaction. Occasionally, solitary symptoms may occur, but do not represent a serum-sickness-like reaction. While further investigation is ongoing, serum-sickness-like reactions appear to be due to hypersensitivity and more often occur during or following a second (or subsequent) course of therapy with cefaclor. Such reactions have been reported more frequently in pediatric patients than in adults with an overall occurrence ranging from 1 in 200 (0.5%) in one focused trial to 2 in 8,346 (0.024%) in overall clinical trials (with an incidence in pediatric patients in clinical trials of 0.055%) to 1 in 38,000 (0.003%) in spontaneous event reports. Signs and symptoms usually occur a few days after initiation of therapy and subside within a few days after cessation of therapy; occasionally these reactions have resulted in hospitalization, usually of short duration (median hospitalization = 2 to 3 days, based on postmarketing surveillance studies). In those requiring hospitalization, the symptoms have ranged from mild to severe at the time of admission with more of the severe reactions occurring in pediatric patients. Antihistamines and glucocorticoids appear to enhance resolution of the signs and symptoms. No serious sequelae have been reported. More severe hypersensitivity reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and anaphylaxis have been reported rarely. Anaphylactoid events may be manifested by solitary symptoms, including angioedema, asthenia, edema (including face and limbs), dyspnea, paresthesias, syncope, hypotension, or vasodilatation. Anaphylaxis may be more common in patients with a history of penicillin allergy. Rarely, hypersensitivity symptoms may persist for several months. Gastrointestinal symptoms occur in about 2.5% of patients and include diarrhea (1 in 70). Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment (see WARNINGS). Nausea and vomiting have been reported rarely. As with some penicillins and some other cephalosporins, transient hepatitis and cholestatic jaundice have been reported rarely. Other effects considered related to therapy included eosinophilia (1 in 50 patients), genital pruritus, moniliasis or vaginitis (about 1 in 50 patients), and, rarely, thrombocytopenia or reversible interstitial nephritis. Causal Relationship Uncertain CNS -- Rarely, reversible hyperactivity, agitation, nervousness, insomnia, confusion, hypertonia, dizziness, hallucinations, and somnolence have been reported. Transitory abnormalities in clinical laboratory test results have been reported. Although they were of uncertain etiology, they are listed below to serve as alerting information for the physician. Hepatic -- Slight elevations of AST, ALT, or alkaline phosphatase values (1 in 40). Hematopoietic -- As has also been reported with other β-lactam antibiotics, transient lymphocytosis, leukopenia, and, rarely, hemolytic anemia, aplastic anemia, agranulocytosis, and reversible neutropenia of possible clinical significance. There have been rare reports of increased prothrombin time with or without clinical bleeding in patients receiving cefaclor and Coumadin® concomitantly. Renal -- Slight elevations in BUN or serum creatinine (less than 1 in 500) or abnormal urinalysis (less than 1 in 200). Cephalosporin-class Adverse Reactions In addition to the adverse reactions listed above that have been observed in patients treated with cefaclor, the following adverse reactions and altered laboratory tests have been reported for cephalosporin-class antibiotics: fever, abdominal pain, superinfection, renal dysfunction, toxic nephropathy, hemorrhage, false-positive test for urinary glucose, elevated bilirubin, elevated LDH, and pancytopenia. Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced. If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated (see DOSAGE AND ADMINISTRATION and OVERDOSAGE sections). To report SUSPECTED ADVERSE REACTIONS, contact FSC Laboratories, Inc. at 1-866-764-7822 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Read the entire FDA prescribing information for Cefaclor (Cefaclor) &Copy; Cefaclor Patient Information is supplied by Cerner Multum, Inc. and Cefaclor Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.