|The following CIOMS frequency rating is used: (very common (<1/10), common (1/10 – 1/100), uncommon (1/100 – 1/1000), rare (1/1000 – 1/10000).
Blood and Lymphatic System Disorders:Uncommon: Thrombocytosis (usually reversible upon treatment discontinuation).
Rare: Eosinophilia, thrombocytopenia, neutropenia, agranulocytosis, haemolytic anaemia, lymphocytosis, anaemia, leukopenia, leucocytosis.
Ear and Labyrinth Disorders:Uncommon: Tinnitus.
Gastrointestinal Disorders:Common: Diarrhoea, nausea, abdominal pain, vomiting, flatulence.
Rare: Enterocolitis, including pseudomembranous colitis, blood in stools, acute pancreatitis.
Renal and Urinary Disorders:Rare: Acute renal insufficiency .
Changes in renal function have been observed with antibiotics from the same group as cefpodoxime, particularly when co-prescribed with aminoglycosides and/or potent diuretics (See Section 4.4. Special Warnings and Precautions for Use).
General Disorders and Administration Site Conditions:Uncommon: Asthenia, fatigue, malaise.
Hepatobiliary Disorders:Uncommon: Bilirubinemia, livery injury, cholestasis.
Rare: Acute hepatitis .
Immune System Disorders:Rare: Hypersensitivity reactions of all severities – e.g. from angioedema and bronchospasm to life-threatening shock.
Infections and Infestations:Common: Superinfections, overgrowth of non-susceptible organisms.
Superinfection: as with other antibiotics, the use of cefpodoxime proxetil, especially if prolonged, may result in overgrowth of non-susceptible organisms. Repeated evaluation of the patient's condition is essential. If superinfection occurs during therapy, appropriate measures should be taken.
Investigations:Uncommon: Increases in liver enzymes (transaminases, alkaline phosphatases).
Rare: Increase in blood urea and creatinine.
Nervous System Disorders:Uncommon: Dizzy sensations, headache, paraesthesia.
Skin and Subcutaneous Tissue Disorders:Uncommon: Pruritus, rash, urticaria, purpura.
Rare: Stevens-Johnson Syndrome, toxic epidermal necrolysis, erythema multiforme.
Metabolism and Nutrition Disorders:Common: Appetite loss.
Reporting of suspected adverse reactionsReporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via:
IRL - Dublin 2
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