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).