Raniclor Side Effects

Generic Name: cefaclor

Please note - some side effects for Raniclor may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Raniclor - for the Consumer

Raniclor

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Raniclor:

Headache; mild diarrhea; nausea; sinus infection; tiredness; vomiting.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; itching); bloody stools; fever; seizures; severe diarrhea; stomach cramps/pain; urge to have a bowel movement; vaginal irritation or discharge.

Side Effects by Body System

Gastrointestinal

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.

If diarrhea occurs and it is unresponsive to discontinuation of the drug and/or standard therapy, pseudomembranous colitis should be considered.

Hypersensitivity

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.

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.

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.

Renal

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.

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.)

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.

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.

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.

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.

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.

Dermatologic

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

Musculoskeletal

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

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.

Ocular

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

Endocrine

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

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%).

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