Gastrointestinal - - Vomiting Abdominal discomfort, abdominal disorders distension, abdominal pain, abdominal pain lower, abdominal pain upper, diarrhoea, nausea Skin and - - Pruritus Dermatitis contact, erythema, rash, subcutaneous tissue urticaria disorders Musculoskeletal - - - Arthralgia, back pain, muscle and connective spasms, muscular weakness, tissue disorders musculoskeletal pain, myalgia, neck pain, pain in extremity Renal and urinary - - - Haematuria disorders General disorders Injection/ - Fatigue, pain Chest pain, chills, feeling cold, and administration hypothermia, influenza like illness, infusion site site conditions malaise, pyrexia reactions Investigations - - - Aldolase increased, blood creatine phosphokinase increased, blood lactate dehydrogenase increased, blood pressure increased, body temperature increased, weight decreased Injury, poisoning - - - Contusion and procedural complications Postmarketing Experience In addition to the ADRs listed in Table 2, the following adverse reactions have been observed during post-approval use of Hizentra®:
Gastrointestinal disorders - - Vomiting Abdominal discomfort, abdominal distension, abdominal pain, abdominal pain lower, abdominal pain upper, diarrhoea, nausea Skin and subcutaneous tissue disorders - - Pruritus Dermatitis contact, erythema, rash, urticaria Musculoskeletal and connective tissue disorders - - - Arthralgia, back pain, muscle spasms, muscular weakness, musculoskeletal pain, myalgia, neck pain, pain in extremity Renal and urinary disorders - - - Haematuria General disorders and administration site conditions Injection/ infusion site reactions - Fatigue, pain Chest pain, chills, feeling cold, hypothermia, influenza like illness, malaise, pyrexia Investigations - - - Aldolase increased, blood creatine phosphokinase increased, blood lactate dehydrogenase increased, blood pressure increased, body temperature increased, weight decreased Injury, poisoning and procedural complications - - - Contusion Postmarketing Experience In addition to the ADRs listed in Table 2, the following adverse reactions have been observed during post-approval use of Hizentra®: