Fortaz Side Effects

Generic Name: ceftazidime

Please note - some side effects for Fortaz may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Fortaz - for the Consumer

Fortaz

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 Fortaz:

Diarrhea; headache; nausea; numbness or tingling of skin; stomach pain; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal muscle movements; bloody stools; decreased urination; fever; hoarseness; pain, redness, or swelling at the injection site; red, swollen, or blistered skin; seizures; severe diarrhea; severe nausea or vomiting; severe stomach pain/cramps; unusual bruising or bleeding; unusual tiredness; vaginal irritation or discharge; vein inflammation; white patches in the mouth; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Fortaz Side Effects - for the Professional

Fortaz

Ceftazidime is generally well tolerated. The incidence of adverse reactions associated with the administration of ceftazidime was low in clinical trials. The most common were local reactions following IV injection and allergic and gastrointestinal reactions. Other adverse reactions were encountered infrequently. No disulfiram-like reactions were reported.

The following adverse effects from clinical trials were considered to be either related to ceftazidime therapy or were of uncertain etiology:

Local Effects, reported in fewer than 2% of patients, were phlebitis and inflammation at the site of injection (1 in 69 patients).

Hypersensitivity Reactions, reported in 2% of patients, were pruritus, rash, and fever. Immediate reactions, generally manifested by rash and/or pruritus, occurred in 1 in 285 patients. Toxic epidermal necrolysis, Stevens-Johnson syndrome, and erythema multiforme have also been reported with cephalosporin antibiotics, including ceftazidime. Angioedema and anaphylaxis (bronchospasm and/or hypotension) have been reported very rarely.

Gastrointestinal Symptoms, reported in fewer than 2% of patients, were diarrhea (1 in 78), nausea (1 in 156), vomiting (1 in 500), and abdominal pain (1 in 416). The onset of pseudomembranous colitis symptoms may occur during or after treatment.

Central Nervous System Reactions (fewer than 1%) included headache, dizziness, and paresthesia. Seizures have been reported with several cephalosporins, including ceftazidime. In addition, encephalopathy, coma, asterixis, neuromuscular excitability, and myoclonia have been reported in renally impaired patients treated with unadjusted dosing regimens of ceftazidime.

Less Frequent Adverse Events (fewer than 1%) were candidiasis (including oral thrush) and vaginitis.

Hematologic: Rare cases of hemolytic anemia have been reported.

Laboratory Test Changes noted during clinical trials with Fortaz were transient and included: eosinophilia (1 in 13), positive Coombs test without hemolysis (1 in 23), thrombocytosis (1 in 45), and slight elevations in one or more of the hepatic enzymes, aspartate aminotransferase (AST, SGOT) (1 in 16), alanine aminotransferase (ALT, SGPT) (1 in 15), LDH (1 in 18), GGT (1 in 19), and alkaline phosphatase (1 in 23). As with some other cephalosporins, transient elevations of blood urea, blood urea nitrogen, and/or serum creatinine were observed occasionally. Transient leukopenia, neutropenia, agranulocytosis, thrombocytopenia, and lymphocytosis were seen very rarely.

Side Effects by Body System - for Healthcare Professionals

Gastrointestinal

Gastrointestinal side effects reported in less than 2% of patients have included diarrhea, nausea, vomiting, abdominal pain, and pseudomembranous colitis. Oral candidiasis has been reported in less than 1% of patients. Clostridium difficile associated diarrhea has also been reported.

Discontinuation of ceftazidime may be necessary in severe, prolonged cases of diarrhea. Pseudomembranous colitis has been reported and should be considered if the patient does not respond to discontinuation of ceftazidime.

Hypersensitivity

Mild hypersensitivity reactions, such as rash, pruritus, and fever, have been reported and may necessitate discontinuation of ceftazidime. A case of asthma induced by occupational exposure to ceftazidime has been reported.

A case of occupational contact dermatitis due to cephalosporin allergy has been reported in a nurse who prepared cephalosporin solutions for administration to patients. The dermatitis resolved after the nurse stopped preparing the solutions.

A patient with sensitization to aztreonam showed cross-reactivity to ceftazidime. Ceftazidime and aztreonam contain the same side chain, which may explain the cross-sensitivity.

Hypersensitivity reactions including rash, pruritus, and fever have been reported (2%). Cross reactions may occur in penicillin-allergic or aztreonam-allergic patients. Rarely, angioedema and anaphylactic reactions have occurred. Allergic reactions including cardiopulmonary arrest have been reported during postmarketing experience. Cephalosporin class antibiotics have been associated with Stevens-Johnson syndrome, erythema multiforme, and toxic epidermal necrolysis.

Renal

Although increases in serum creatinine do not necessarily indicate renal toxicity, urinary alanine aminopeptidase (AAP) has been found to be significantly increased in some patients and may indicate renal tubular cell damage.

Renal side effects have included transient increases in serum creatinine and BUN. Renal impairment has been reported during postmarketing experience. Cephalosporins as a class have been associated with renal dysfunction and toxic nephropathy.

Nervous system

Ceftazidime-induced encephalopathy has been reported in an 80-year-old man with underlying renal dysfunction. This patient became incoherent and tremulous and had severe myoclonic jerking in all extremities. Therapy was discontinued and symptoms abated, but reappeared on rechallenge with a smaller dose. Symptoms again resolved with discontinuation of ceftazidime therapy. Several other cases of ceftazidime-induced encephalopathy, and hallucinations have been reported. In most cases the patients had underlying renal dysfunction. Symptoms were similar and resolved with dose reduction or drug discontinuation.

Neurologic reactions may be more likely to occur in patients with underlying renal dysfunction. Close monitoring of neurologic status is recommended.

Nervous system side effects reported in less than 1% of patients have included headache, dizziness, paresthesia, and seizures. Encephalopathy, coma, asterixis, neuromuscular excitability, and myoclonia have occurred in patients with renal dysfunction who received unadjusted doses of ceftazidime.

Dermatologic

Dermatologic side effects have included pemphigus erythematosus and urticaria.

Local

Local side effects have included phlebitis and inflammation at the injection site.

Hematologic

Hematologic side effects have included transient eosinophilia, positive Coombs test without hemolysis, thrombocytosis, leukopenia, neutropenia, agranulocytosis, thrombocytopenia, and lymphocytosis. Cephalosporins as a class have been associated with aplastic anemia, hemolytic anemia, prolonged prothrombin time, hemorrhage, neutropenia, pancytopenia, and agranulocytosis.

Other transient hematologic effects, such as thrombocytopenia, thrombocytosis, and leukopenia, have been observed less frequently.

Hepatic

Hepatic side effects have included transient increases in AST, ALT, GGT, and alkaline phosphatase. These elevations generally resolve after discontinuation of therapy. Hyperbilirubinemia and jaundice have been reported during postmarketing experience. Cephalosporins as a class have been associated with hepatic dysfunction, including cholestasis.

Genitourinary

Genitourinary side effects have included vaginitis and candidiasis. Cephalosporins as a class have been associated with false-positive tests for urine glucose.

Other

Other side effects have included superinfection.

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 information does not endorse drugs, diagnose patients, or recommend therapy. This drug 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 drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information 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 drugs you are taking, check with your doctor, nurse, or pharmacist.