Cefaclor Side Effects

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.

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

Gastrointestinal

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]

Hypersensitivity

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

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]

Renal

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

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

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

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

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

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

Dermatologic side effects have included pruritus, maculopapular rash, rash, and urticaria.[Ref]

Musculoskeletal

Musculoskeletal side effects associated with extended-release cefaclor have included arthralgia and myalgia in 0.1% to 1% of patients.[Ref]

Cardiovascular

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

Ocular side effects associated with extended-release cefaclor have included conjunctivitis (0.1% to 1%).[Ref]

Endocrine

Endocrine side effects associated with extended-release cefaclor have included sweating (0.1% to 1%).[Ref]

Metabolic

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]

References

1. Quenzer RW, Davis RL, Neidhart MM "Prospective randomized study comparing the efficacy and safety of ciprofloxacin with cefaclor in the treatment of patients with purulent bronchitis." Diagn Microbiol Infect Dis 13 (1990): 143-8

2. "Product Information. Ceclor CD (cefaclor)." Dura Pharmaceuticals, San Diego, CA.

3. Hyslop DL "Cefaclor safety profile: a ten-year review." Clin Ther 11 Suppl A (1988): 83-94

4. Goumas P, Naxakis S, Bassaris C, Skoutelis A "Comparative efficacy and tolerability of clarithromycin and cefaclor in the treatment of outpatients with acute maxillary sinusitis." Clin Drug Invest 13 (1997): 128-33

5. "Product Information. Ceclor (cefaclor)." Lilly, Eli and Company, Indianapolis, IN.

6. Reynolds RD "Cefaclor and serum sickness-like reaction." JAMA 276 (1996): 950

7. Beghetti M, Wilson GJ, Bohn D, Benson L "Hypersensitivity myocarditis caused by an allergic reaction to cefaclor." J Pediatr 132 (1998): 172-3

8. Boyd LW "Cefaclor-associated serum sickness." Med J Aust 169 (1998): 443-4

9. Ackley AM, Felsher J "Adverse reactions to cefaclor." South Med J 74 (1981): 1550

10. Filipe P, Almeida RSLS, Rodrigo FG "Occupational allergic contact dermatitis from cephalosporins." Contact Dermatitis 34 (1996): 226

11. Hama R, Mori K "High incidence of anaphylactic reactions to cefaclor." Lancet 06/11/88 (1988): 1331

12. Grouhi M, Hummel D, Roifman CM "Anaphylactic reaction to oral cefaclor in a child." Pediatrics 103 (1999): e50

13. Christensen JC, Swenson E, Gooch WM, Herrod JN "Comparative efficacy and safety of cefprozil (BMY-28100) and cefaclor in the treatment of acute group A beta-hemolytic streptococcal pharyngitis." Antimicrob Agents Chemother 35 (1991): 1127-30

14. Pommer W, Krause PH, Berg PA, et al "Acute interstitial nephritis and non-oliguric renal failure after cefaclor treatment." Klin Wochenschr 64 (1986): 290-3

15. "Multum Information Services, Inc. Expert Review Panel"

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