9%). 2% (1/516). Tabulated list of adverse reactions The following adverse reactions have been reported with cefepime alone during clinical studies or post marketing surveillance and/or identified during Phase 2 or/and Phase 3 studies with cefepime-enmetazobactam.
Adverse reactions are classified according to System Organ Class, frequency, preferred term using MedDRA terminology. Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1 000 to <1/100), rare (≥1/10 000 to <1/1 000), very rare (< 1/10 000) and not known (frequency cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Table 2. Frequency of adverse reactions by system organ class System organ class Frequency MedDRA preferred term (PT) Uncommon Clostridioides difficile associated diarrhoea (CDAD), oral candidiasisa, vaginal infection Infections and infestations Rare Candida infectiona Very common Coombs test positivea Common Prothrombin time prolongeda, partial thromboplastin time prolongeda, anaemiaa, eosinophiliaa Blood and lymphatic system disorders Uncommon Thrombocytopenia, leukopeniaa, neutropeniaa Not known Aplastic anaemiab, haemolytic anaemiab, agranulocytosisa Rare Anaphylactic reactiona, angioedemaa, dermatitis allergic Immune system disorders Not known Anaphylactic shocka Metabolism and nutrition disorders Not known Urine glucose false positivea Psychiatric disorders Not known Confusional statea, hallucinationa Nervous system disorders Common Headache Uncommon Dizziness Rare Convulsiona, paraesthesiaa, dysgeusia Not known Comaa, stupora, encephalopathya, altered state of consciousnessa, myoclonusa Common Infusion site phlebitisVascular disorders Rare Vasodilationa Not known Haemorrhageb, System organ class Frequency MedDRA preferred term (PT) Respiratory, thoracic and mediastinal disorders Rare Dyspnoeaa Gastrointestinal disorders Common Diarrhoea Uncommon Pseudomembranous colitis, colitis, vomiting, nausea, Rare Abdominal pain, constipation Hepatobiliary disorders Common Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood bilirubin increased, Alkaline phosphatase increased Common Rash Uncommon Erythema, urticaria, pruritus Skin and subcutaneous tissue disorders Not known Toxic epidermal necrolysisb, Stevens- Johnson syndromeb, erythema multiformeb Uncommon Blood urea increased, blood creatinine increased Renal and urinary disorders Not known Renal failurea, toxic nephropathyb Reproductive system and breast disorders Rare Vulvovaginal pruritus Common Infusion site reaction, injection site pain, injection site inflammation Uncommon Pyrexiaa, infusion site inflammation General disorders and administration site condition Rare Chillsa Investigations Common Amylase increased, lipase increased, lactate dehydrogenase increased a: Adverse reactions reported only with cefepime alone.
b: Adverse reactions that are generally accepted as being attributable to other compounds in the class (class effects). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
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