Relenza Adverse Reactions

There have been rare reports of patients with previous history of respiratory disease (asthma, COPD) and very rare reports of patients without previous history of respiratory disease, who have experienced acute bronchospasm and/or serious decline in respiratory function after use of RELENZA (see Precautions).
The adverse events considered at least possibly related to the treatment are listed as follows by body system, organ class and absolute frequency. Frequencies are defined as very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10,000, <1/1000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Immune system disorders: Uncommon: Allergic-type reactions including oropharyngeal oedema.
Rare: Anaphylactic/Anaphylactoid reactions, facial oedema.
Nervous systems disorders: Uncommon: Vasovagal-like reactions have been reported in patients with influenza symptoms, such as fever and dehydration, shortly following inhalation of zanamivir.
Respiratory, thoracic and mediastinal disorders: Uncommon: Bronchospasm, dyspnea, throat tightness or constriction.
Skin and subcutaneous tissue disorders: Common: Rash.
Uncommon: Urticaria.
Rare: Severe skin reactions including Erythema Multiforme, Stevens-Johnson syndrome and Toxic epidermal necrolysis.
Psychiatric and nervous system disorders: Convulsions and psychiatric events such as depressed level of consciousness, abnormal behaviour, hallucinations and delirium have been reported during RELENZA administration in patients with influenza. The symptoms were mainly reported in children and adolescents. Convulsions and psychiatric symptoms have also been reported in patients with influenza not taking RELENZA.