Adverse reactions are listed below by system organ class and frequency. Frequencies are defined as:
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) or
unknown (can not to be estimated from available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Immune system disorders
Rare: Hypersensitivity
Very rare: Anaphylactic reaction
Endocrine disorders
Very rare: Hyperthyroidism
Metabolism and nutrition disorders
Unknown: Metabolic acidosis, hypernatraemia
Skin and subcutaneous tissue disorders
Rare: Skin reaction localised
Renal and urinary disorders
Unknown: Renal impairment
Povidone-iodine may produce local skin reactions although it is considered to be less irritant than iodine.
The application of povidone-iodine to large wounds or severe burns may produce systemic adverse effects such as metabolic acidosis, hypernatraemia and impairment of renal function.