Side Effects of Raniclor (cefaclor)

Raniclor (cefaclor) is a semi-synthetic cephalosporin antibiotic prescribed for staph, E. coli, middle ear, and urinary tract infections (UTIs), and for tonsilitis, bronchitis, and laryngitis.

Cefaclor stops bacteria from multiplying by preventing them from forming walls. These walls protect bacteria from the environment and keep the bacterial cell intact.

Cefaclor is effective against many different bacterial organisms such as Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, E. coli, and many others.

Common side effects of cefaclor:

• rash,
• fever,
• joint pain,
• arthritis,
• abnormal liver tests,
• yellowing skin and eyes (jaundice),
• vaginitis,
• itching,
• nervousness,
• insomnia,
• hallucinations.

Serious side effects of cefaclor include overgrowth of C. difficile, bacteria responsible for pseudomembranous colitis (diarrhea, abdominal pain, fever, and sometimes shock).

Drug interactions of cefaclor include aluminum or magnesium-containing antacids, which reduce cefaclor absorption. Administering cefaclor and these antacids one hour apart prevents this interaction.

There are no adequate studies of cefaclor in pregnant women.

Small amounts of cefaclor are secreted in breast milk. Consult your doctor before breastfeeding.

The important side effects of Raniclor (cefaclor)

Cefaclor is generally well tolerated, and side effects usually are transient. Reported side effects include:

Avoid cefaclor if you are allergic to cephalosporin antibiotics. Cefaclor can cause an allergic reaction in patients allergic to penicillin.

Treatment with cefaclor and other antibiotics can alter normal bacteria flora of the colon and cause overgrowth of C. difficile, bacteria responsible for pseudomembranous colitis. Symptoms include diarrhea, abdominal pain, fever, and sometimes shock.

Raniclor (cefaclor) side effects list for healthcare professionals

Adverse effects considered related to therapy with cefaclor:

• 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 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.
• Occasionally, solitary symptoms may occur, but do not represent a serum-sickness-like reaction.

• Such reactions have been reported more frequently in pediatric patients than in adults (overall occurrence ranging from 1 in 200 to 1 in 38,000).
• 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.
• Stevens-Johnson syndrome,
• toxic epidermal necrolysis, and
• anaphylaxis have been reported rarely.
• angioedema,
• asthenia,
• edema,
• dyspnea,
• paresthesias,
• syncope,
• hypotension,
• vasodilatation.
• eosinophilia,
• genital pruritus,
• moniliasis or vaginitis,
• 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.
• Hepatic—Slight elevations of AST, ALT, or alkaline phosphatase values.
• Hematopoietic—Transient lymphocytosis, leukopenia, and, rarely, hemolytic anemia, aplastic anemia, agranulocytosis, and reversible neutropenia.
• 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 or abnormal urinalysis.

Cephalosporin-class Adverse Reactions

In addition to the adverse reactions listed above, 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. Discontinue the drug if seizures occur.

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.

What drugs interact with Raniclor (cefaclor)?

Drug/Laboratory Test Interactions

• Patients receiving cefaclor may show a false-positive reaction for glucose in the urine with tests that use Benedict’s and Fehling’s solutions and Clinitest tablets.
• Reports of increased anticoagulant effect when cefaclor and oral anticoagulants were administered concomitantly.

Summary

Raniclor (cefaclor) is a semi-synthetic cephalosporin antibiotic prescribed for staph, E. coli, middle ear, and urinary tract infections (UTIs), and for tonsilitis, bronchitis, and laryngitis. Common side effects of cefaclor include rash, fever, joint pain, arthritis, abnormal liver tests, yellowing skin and eyes (jaundice), vaginitis, itching, nervousness, insomnia, and hallucinations. There are no adequate studies of cefaclor in pregnant women. Small amounts of cefaclor are secreted in breast milk.