Adverse reactions : תופעות לוואי

4.8.   Undesirable Effects

Evaluation of adverse effects has been based on the following frequency categories:
Very common (≥1/10)
Common (≥1/100, <1/10)
Uncommon (≥1/1,000, <1/100)
Rare (≥1/10,000, <1/1,000)
Very rare (≤1/10,000)
Not known (cannot be estimated from the available data)

Within each frequency grouping adverse effects are listed in the sequence of decreasing severity.

Immune System Disorders
Rare: hypersensitivity
Very rare: anaphylactic reactions frequently accompanied by blood pressure drop, dizziness, nausea and possibly dyspnea.

Endocrine Disorders
Very rare: iodine-induced hyperthyroidism in predisposed persons (sometimes with symptoms of tachycardia or restlessness; see sections 4.3 and 4.9)1) Not known: hypothyroidism2)

Metabolism and Nutrition Disorders
Not known: electrolyte imbalance3), metabolic acidosis3)
Skin and Subcutaneous Tissue disorders
Rare: contact dermatitis (with symptoms like erythema, blistering and itching) Very rare: angioedema

Renal and Urinary Disorders
Not known: acute renal failure3), abnormal osmolarity of blood3) 
1)   In patients with a history of thyroid dysfunction upon absorption of larger volumes of iodine e.g., in the course of large-scale use of povidone-iodine in the treatment of wounds and burns for a prolonged period
2)   Hypothyroidism upon prolonged or excessive use of povidone-iodine
3)   May occur upon absorption of larger volumes of povidone-iodine (e.g., treatment of burns).

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form.
 https://sideeffects.health.gov.il/