Summary of the safety profile The frequencies of reported adverse reactions were derived from the medical literature. e. treatment of benign or malignant disease). Moreover, the safety profile depends on the cumulative doses administered and the dosing intervals which are used.
Therefore, the reported adverse reactions were grouped by their occurrence in treatment of benign or malignant disease. Frequently occurring adverse reactions are: hypothyroidism, transient hyperthyroidism, salivary and lacrimal gland disorders, and local radiation effects.
In cancer treatment additionally gastro-intestinal adverse reactions and bone marrow suppression may frequently occur. Tabulated list of adverse reactions The following tables include reported adverse reactions sorted by system organ classes.
g. sicca syndrome) are subsumed in parenthesis behind the respective syndrome.
The following table presents how the frequencies are reflected in this section:
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) and not known (frequency cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Adverse reactions after treatment of benign disease System Organ Class Adverse Reaction Frequency Immune system disorders Anaphylactoid reaction Not known Permanent hypothyroidism, hypothyroidism Very common Transient hyperthyroidism CommonEndocrine disorders Thyrotoxic crisis, thyroiditis, hypoparathyroidism (blood calcium decreased, tetany) Not known Endocrine ophthalmopathy (in Graves’ disease) Very common Eye disorders Sicca syndrome Not known Respiratory thoracic and mediastinal disorders Vocal cord paralysis Very rare Gastrointestinal disorders Sialoadenitis Common Hepatobiliary disorders Hepatic function abnormal Frequency not know Skin and subcutaneous tissue disorders Iodo acne Not known Congenital, familial and genetic disorders Congenital hypothyroidism Not known General disorders and administration site conditions Local swelling Not known Adverse reactions after treatment of malignant disease System Organ Class Adverse Reaction Frequency Leukaemia UncommonNeoplasms benign, malignant and unspecified (including cysts and polyps) Solid cancers, Bladder cancer, colon cancer, gastric cancer, breast cancer Not known System Organ Class Adverse Reaction Frequency Erythropenia, bone marrow failure Very common Leukopenia, thrombocytopenia Common Blood and lymphatic system disorders Aplastic anemia, permanent or severe bone marrow suppression Not known Immune system disorders Anaphylactoid reaction Not known Thyrotoxic crisis, transient hyperthyroidism Rare Endocrine disorders Thyroiditis (transient leucocytosis), hypoparathyroidism (blood calcium decreased, tetany), hypothyroidism, hyperparathyroidism Not known Parosmia, anosmia Very common Nervous system disorders Brain oedema Not known Sicca syndrome (conjunctivitis, dry eyes, nasal dryness) Very common Eye disorders Nasolacrimal duct obstruction (lacrimation increased) Common Dyspnoea Common Respiratory thoracic and mediastinal disorders Throat constriction*, pulmonary fibrosis, respiratory distress, obstructive airways disorder, pneumonia, tracheitis, vocal cord dysfunction (vocal cord paralysis, dysphonia, hoarseness), oropharyngeal pain, stridor Not known System Organ Class Adverse Reaction Frequency Sialoadenitis (dry mouth, salivary gland pain, salivary gland enlargement, dental caries, tooth loss), radiation sickness syndrome, nausea, ageusia, dysgeusia, decreased appetite Very common Vomiting Common Gastrointestinal disorders Gastritis, dysphagia Not known Hepatobiliary disorders Hepatic function abnormal Not known Renal and urinary disorders Radiation cystitis Not known Ovarian failure, menstrual disorder Very commonReproductive system and breast disorders Azoospermia, oligospermia, decreased fertility male Not known Congenital, familial and genetic disorders Congenital hypothyroidism Not known Flu-like illness, headache, fatigue, neck pain Very common General disorders and administration site conditions Local swelling Common * especially in existing tracheal stenosis Description of selected adverse reactions General advice Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects.
The radiation dose resulting from therapeutic exposure may result in higher incidence of cancer and mutations. In all cases it is necessary to ensure that the risks of the radiation are less than those of the disease itself. The effective dose after therapeutic doses of sodium iodide (131I) is 3,108 mSv when the maximal recommended activity of 11,100 MBq is administered (with thyroid uptake 0%).
Thyroid and parathyroid glands disorders Hypothyroidism may occur, depending on the dose, as a delayed result of treatment for hyperthyroidism with radioiodine. In the treatment of malignant disease, hypothyroidism is often reported as an adverse reaction; however, the treatment of malignant diseases with radioiodine generally follows thyroidectomy.
The destruction of thyroid follicles caused by the radiation exposure of sodium iodide (131I) may lead to exacerbation of an already existing hyperthyroidism within 2 – 10 days or may cause a thyrotoxic crisis. Occasionally, an immune hyperthyroidism may appear after initial normalisation (latency period is 2 – 10 months).
After 1-3 days of administration of high dose radioiodine , the patient may experience transient inflammatory thyroiditis and tracheitis 1-3 days after administration, with a possibility of severe tracheal constriction, especially where there is existing tracheal stenosis.
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