Raniclor Side Effects

Generic Name: cefaclor

Note: This page contains side effects data for the generic drug cefaclor. It is possible that some of the dosage forms included below may not apply to the brand name Raniclor.

It is possible that some side effects of Raniclor may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

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.

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.

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 (the active ingredient contained in Raniclor) and have been characterized by erythema multiforme, rash, arthritis, and/or arthralgia with or without fever.

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.

Hepatic

Hepatic side effects have included slight elevations AST, ALT, and alkaline phosphatase in 2.5% of patients. Extended-release cefaclor (the active ingredient contained in Raniclor) 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.

Renal

One case report of acute interstitial nephritis and nonoliguric renal failure has been reported following cefaclor (the active ingredient contained in Raniclor) therapy. (Reversible fever, azotemia, pyuria, and eosinophiluria are the hallmarks of cephalosporin-induced interstitial nephritis.)

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.

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 (the active ingredient contained in Raniclor) 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.

Genitourinary

Genitourinary side effects have included genital pruritus and vaginitis in less than 1% of patients. Extended-release cefaclor (the active ingredient contained in Raniclor) 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.

Nervous system

Nervous system side effects have rarely included reversible hyperactivity, agitation, nervousness, insomnia, confusion, hypertonia, dizziness, hallucinations, and somnolence. Extended release cefaclor (the active ingredient contained in Raniclor) 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.

Other

Other side effects associated with extended-release cefaclor (the active ingredient contained in Raniclor) 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.

Respiratory

Respiratory side effects associated with extended-release cefaclor (the active ingredient contained in Raniclor) 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.

Dermatologic

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

Musculoskeletal

Musculoskeletal side effects associated with extended-release cefaclor (the active ingredient contained in Raniclor) have included arthralgia and myalgia in 0.1% to 1% of patients.

Cardiovascular

Cardiovascular side effects associated with extended-release cefaclor (the active ingredient contained in Raniclor) 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.

Ocular

Ocular side effects associated with extended-release cefaclor (the active ingredient contained in Raniclor) have included conjunctivitis (0.1% to 1%).

Endocrine

Endocrine side effects associated with extended-release cefaclor (the active ingredient contained in Raniclor) have included sweating (0.1% to 1%).

Metabolic

Metabolic side effects associated with extended-release cefaclor (the active ingredient contained in Raniclor) 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%).

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

Hide
(web4)