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Undesirable Effects

Most of the adverse reactions reported were transient and of mild intensity. Those most commonly reported were: feeling of warmth/flushing, headache and nausea. In clinical trials with Teslascan (mangafodipir) , adverse reactions have been reported with the following frequencies given in the table below (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, not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

System Organ Class Adverse Reactions Frequency
Immune system disorders Hypersensitivity reactions (such as skin reactions, rhinitis, pharyngitis)
Anaphylactic/anaphylactoid reactions
Uncommon
Not known
Nervous system disorders Headache
Dizziness, paraesthesia, transient perverted sensation of taste
Common
Uncommon
Eye disorders Visual disturbance Very rare
Cardiac disorders Palpitation Uncommon
Vascular disorders Hypertension Rare
Gastrointestinal disorders Nausea
Abdominal pain, diarrhoea, vomiting
Flatulence
Common
Uncommon
Very rare
General disorders and administration site conditions Flushing, feeling hot
Fever, injection site pain
Chest pain
Common
Uncommon
Very rare

Mangafodipir can cause transient increases of bilirubin and liver transaminases and transient decreases in plasma zinc.

The frequency of mild and moderate, non-serious adverse reactions, mainly transient warmth and flushing, is likely to increase when TESLASCAN (mangafodipir) is administered at the faster rate advised (4–6 ml/min).