Cefaclor Side Effects
For the Consumer
Applies to cefaclor: oral capsules, oral extended-release tablets, oral for suspension
Side effects include:
Diarrhea, genital pruritus or vaginitis, headache, nausea, vomiting, rash.
For Healthcare Professionals
Applies to cefaclor: oral capsule, oral powder for reconstitution, oral tablet chewable, oral tablet extended release
If diarrhea occurs and it is unresponsive to discontinuation of the drug and/or standard therapy, pseudomembranous colitis should be considered.[Ref]
Gastrointestinal side effects have included diarrhea, nausea, vomiting, and abdominal pain. Extended-release cefaclor has been associated with diarrhea (3.8%), nausea (3.4%), and anorexia, constipation, dyspepsia, flatulence, gastritis, nausea and vomiting, and vomiting in 0.1% to 1% of patients. Pseudomembranous colitis has been reported in patients treated with cephalosporins.[Ref]
Anaphylactic reactions are rare, but may occur, especially in patients with a history of penicillin allergy.
Serum-sickness-like reactions are more frequent in pediatric patients and following a second or subsequent course of cefaclor and have been characterized by erythema multiforme, rash, arthritis, and/or arthralgia with or without fever.[Ref]
Hypersensitivity reactions have included rash, morbilliform eruptions (1%), pruritus, serum-sickness-like reactions, urticaria, anaphylactic reaction, Stevens-Johnson syndrome, toxic epidermal necrolysis, anaphylactoid reaction, and angioedema.[Ref]
Hepatic side effects have included slight elevations AST, ALT, and alkaline phosphatase in 2.5% of patients. Extended-release cefaclor has been associated with increased ALT (0.3%), increased alkaline phosphatase (0.3%), increased bilirubin (0.3%), increased creatine phosphokinase (0.7%), and increased GGT (0.2%). Cephalosporins as a class have been associated with elevated LDH, hepatic dysfunction, and cholestasis.[Ref]
One case report of acute interstitial nephritis and nonoliguric renal failure has been reported following cefaclor therapy. (Reversible fever, azotemia, pyuria, and eosinophiluria are the hallmarks of cephalosporin-induced interstitial nephritis.)[Ref]
Renal side effects have included transient elevations in blood urea nitrogen (BUN) and serum creatinine in 0.2% of patients, reversible interstitial nephritis (rare), and abnormal urinalysis (0.5%). Extended-release cefaclor has been associated with increased BUN (0.2%), and increased creatinine (0.5%). Cephalosporins as a class have been associated with toxic nephropathy, reversible interstitial nephritis, and renal dysfunction.[Ref]
Hematologic side effects have included eosinophilia (2%), positive Coombs' test (less than 0.5%), leukopenia, thrombocytosis, transient thrombocytopenia (rare), transient lymphocytosis, hemolytic anemia, aplastic anemia, agranulocytosis, and reversible neutropenia. Extended-release cefaclor has been associated with increased eosinophils (0.3%), decreased erythrocyte count (0.3%), decreased hemoglobin (0.2%), decreased lymphocytes (0.3%), increased mean cell volume (0.7%), decreased segmented neutrophils (0.3%), and decreased platelet count (0.4%). Cephalosporins as a class have been associated with hemorrhage and pancytopenia.[Ref]
Genitourinary side effects have included genital pruritus and vaginitis in less than 1% of patients. Extended-release cefaclor has been associated with vaginitis (2.4%) and vaginal moniliasis (2.2%), and dysmenorrhea, dysuria, leukorrhea, menstrual disorder, and nocturia in 0.1% to 1% of patients. Cephalosporins as a class have been associated with false-positive tests for urine glucose.[Ref]
Nervous system side effects have rarely included reversible hyperactivity, agitation, nervousness, insomnia, confusion, hypertonia, dizziness, hallucinations, and somnolence. Extended release cefaclor has been associated with headache in 4.9% of patients, and dizziness, insomnia, nervousness, somnolence, and tremor in 0.1% to 1% of patients, and paresthesia and vertigo. Some cephalosporins have been associated with seizures, primarily when dosages were not reduced in renally impaired patients.[Ref]
Other side effects associated with extended-release cefaclor have included abdominal pain (1.6%), back pain (1%), and accidental injury, chest pain, chills, ear pain, fever, flu syndrome, infection, malaise, neck pain, otitis media, pain, and surgical procedure in 0.1% to 1% of patients. Cephalosporins as a class have been associated with abdominal pain, fever, and superinfection.[Ref]
Respiratory side effects associated with extended-release cefaclor have included rhinitis (3.9%), increased cough (1.5%), pharyngitis (1.4%), and asthma, bronchitis, lung disorder, respiratory disorder, and sinusitis in 0.1% to 1% of patients.[Ref]
Dermatologic side effects have included pruritus, maculopapular rash, rash, and urticaria.[Ref]
Musculoskeletal side effects associated with extended-release cefaclor have included arthralgia and myalgia in 0.1% to 1% of patients.[Ref]
Cardiovascular side effects associated with extended-release cefaclor have included congestive heart failure (0.1% to 1%), edema (0.1% to 1%), palpitation (0.1% to 1%), peripheral edema (0.1% to 1%), hypotension, face edema, vasodilatation, and syncope.[Ref]
Ocular side effects associated with extended-release cefaclor have included conjunctivitis (0.1% to 1%).[Ref]
Endocrine side effects associated with extended-release cefaclor have included sweating (0.1% to 1%).[Ref]
Metabolic side effects associated with extended-release cefaclor have included decreased albumin (0.3%), decreased calcium (0.7%), increased creatine phosphokinase (0.7%), increased phosphorus (0.7%), increased potassium (0.4%), decreased sodium (0.3%), and increased sodium (0.4%).[Ref]
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Not all side effects for cefaclor may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
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