Cefprozil Side Effects

Brand Names: Cefzil

Please note - some side effects for Cefprozil 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 Cefprozil - for the Consumer

Cefprozil

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 Cefprozil:

Dizziness; headache; itching in the genital area; mild diarrhea; nausea; stomach pain; tiredness; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools or diarrhea; severe diarrhea; severe stomach pain or cramps; vaginal irritation or discharge; yellowing of the skin or eyes.

Cefprozil Suspension

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 Cefprozil Suspension:

Dizziness; headache; itching in the genital area; mild diarrhea; nausea; stomach pain; tiredness; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; severe diarrhea; severe stomach pain or cramps; vaginal irritation or discharge; yellowing of the skin or eyes.

Cefprozil Side Effects - for the Professional

Cefprozil

The adverse reactions to Cefprozil are similar to those observed with other orally administered cephalosporins. Cefprozil was usually well tolerated in controlled clinical trials. Approximately 2% of patients discontinued Cefprozil therapy due to adverse events.

The most common adverse effects observed in patients treated with Cefprozil are:

Gastrointestinal

Diarrhea (2.9%), nausea (3.5%), vomiting (1%), and abdominal pain (1%).

Hepatobiliary

Elevations of AST (SGOT) (2%), ALT (SGPT) (2%), alkaline phosphatase (0.2%), and bilirubin values (<0.1%). As with some penicillins and some other cephalosporin antibiotics, cholestatic jaundice has been reported rarely.

Hypersensitivity

Rash (0.9%), urticaria (0.1%). Such reactions have been reported more frequently in children than in adults. Signs and symptoms usually occur a few days after initiation of therapy and subside within a few days after cessation of therapy.

CNS

Dizziness (1%). Hyperactivity, headache, nervousness, insomnia, confusion, and somnolence have been reported rarely (<1%). All were reversible.

Hematopoietic

Decreased leukocyte count (0.2%), eosinophilia (2.3%).

Renal

Elevated BUN (0.1%), serum creatinine (0.1%).

Other

Diaper rash and superinfection (1.5%), genital pruritus and vaginitis (1.6%).

The following adverse events, regardless of established causal relationship to Cefprozil, have been rarely reported during postmarketing surveillance: anaphylaxis, angioedema, colitis (including pseudomembranous colitis), erythema multiforme, fever, serum-sickness like reactions, Stevens-Johnson syndrome, and thrombocytopenia.

Cephalosporin Class Paragraph

In addition to the adverse reactions listed above which have been observed in patients treated with Cefprozil, the following adverse reactions and altered laboratory tests have been reported for cephalosporin-class antibiotics:

Aplastic anemia, hemolytic anemia, hemorrhage, renal dysfunction, toxic epidermal necrolysis, toxic nephropathy, prolonged prothrombin time, positive Coombs’ test, elevated LDH, pancytopenia, neutropenia, agranulocytosis.

Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment, when the dosage was not reduced. If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.

Side Effects by Body System

General

Cefprozil is generally well-tolerated.

Hypersensitivity

Up to 20% of patients with penicillin allergy may demonstrate allergy to cefprozil.

Hypersensitivity reactions have included rash (0.9%), urticaria (0.1%), anaphylaxis, angioedema, bronchospasm, eosinophilia, erythema multiforme, fever, serum-sickness-like reactions, and Stevens-Johnson syndrome.

Gastrointestinal

Pseudomembranous colitis has been reported in patients treated with cephalosporin antibiotics. If diarrhea occurs and is unresponsive to discontinuation of the drug and/or standard therapy, pseudomembranous colitis should be considered.

Gastrointestinal side effects have included nausea (3.5%), diarrhea (2.9%), vomiting (1%), and abdominal pain (1%). Rare cases of Clostridium difficile colitis have been reported with some cephalosporins.

Hematologic

Hematologic side effects have included eosinophilia (2.3%), decreased leukocyte count (0.2%), and thrombocytopenia. Cephalosporins as a class have been associated with aplastic anemia, hemolytic anemia, hemorrhage, prolonged prothrombin time, positive Coombs' test, pancytopenia, neutropenia, and agranulocytosis.

Renal

Renal side effects have included elevated serum creatinine (0.1%) and BUN (0.1%). Some other cephalosporins have included interstitial nephritis. (Reversible fever, azotemia, pyuria, and eosinophiluria are the hallmarks of cephalosporin-induced interstitial nephritis.) Cephalosporins as a class have been associated with toxic nephropathy and renal dysfunction.

Genitourinary

Genitourinary side effects have included vaginitis and genital pruritus in 1.6% of patients.

Hepatic

Hepatic side effects have included increased AST (2%), ALT (2%), alkaline phosphatase (0.2%), and bilirubin (<0.1%). Some cephalosporins have been associated with rare cases of cholestatic jaundice. Cephalosporins as a class have been associated with elevated LDH.

Nervous system

Nervous system side effects have included dizziness in 1% of patients, and hyperactivity, headache, nervousness, insomnia, confusion, and somnolence in <1%. Some cephalosporins have been associated with seizures, primarily when dosages were not reduced in renally impaired patients.

Other

Other side effects have included superinfection and diaper rash in 1.5% of patients.

Dermatologic

Dermatologic side effects have included rash (0.9%), urticaria (0.1%), and erythema multiforme. Cefprozil has been associated with rash in a patients with infectious mononucleosis.

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