Ixiaro Adverse Reactions

vaccine, japanese encephalitis




Full Prescribing Info
Adverse Reactions
The safety of Ixiaro was assessed in controlled and uncontrolled clinical studies in 4,248 healthy adults (from non-endemic countries) and 1371 children and adolescents (from endemic countries).
Approximately 40% of treated subjects experienced systemic adverse reactions and approximately 54% experienced injection site reactions. They usually occur within the first three days after vaccination, are usually mild and resolve within a few days. No increase in the number of adverse reactions was noted between first and second doses or following a booster dose.
Most commonly reported adverse reactions included headache and myalgia occurring in approximately 20% and 13% of subjects, respectively.
Adverse reactions are listed according to the following frequencies: Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1000 to <1/100); Rare (≥1/10,000 to <1/1000).
Adult and Elderly Subjects: Blood and lymphatic system disorders: Uncommon: lymphadenopathy. Rare: Thrombocytopenia.
Nervous system disorders: Very Common: headache. Uncommon: migraine, dizziness. Rare: paraesthesia, neuritis.
Ear and labyrinth disorders: Uncommon: Vertigo.
Cardiac disorders: Rare: palpitations, tachycardia.
Respiratory, thoracic and mediastinal disorders: Rare: dyspnoea.
Gastrointestinal disorders: Common: nausea. Uncommon: vomiting, diarrhoea, abdominal pain.
Skin and subcutaneous tissue disorders: Uncommon: rash, pruritus. Rare: urticaria, erythema.
Musculoskeletal and connective tissue disorders: Very Common: myalgia. Uncommon: musculoskeletal stiffness. Rare: pain in extremity, arthralgia.
General disorders and administration site conditions: Very Common: injection site pain, tenderness. Common: fatigue, influenza-like illness, pyrexia; injection site reactions eg, redness, hardening, swelling, itching. Uncommon: chills, malaise, injection site haematoma. Rare: oedema peripheral.
Investigations: Uncommon: hepatic enzymes increased.
Children and adolescents: See table 8.

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