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SODIUM IODIDE I

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Sodium Iodide I Adverse Events Reported to the FDA Over Time

How are Sodium Iodide I adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Sodium Iodide I, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Sodium Iodide I is flagged as the suspect drug causing the adverse event.

Most Common Sodium Iodide I Adverse Events Reported to the FDA

What are the most common Sodium Iodide I adverse events reported to the FDA?

Hypothyroidism
319 (28.87%)
Treatment Failure
37 (3.35%)
Acute Myeloid Leukaemia
27 (2.44%)
Abortion Spontaneous
21 (1.9%)
Hyperparathyroidism
21 (1.9%)
Myelodysplastic Syndrome
21 (1.9%)
Thyroid Cancer
21 (1.9%)
Hyperthyroidism
18 (1.63%)
Parathyroid Tumour Benign
18 (1.63%)
Breast Cancer
16 (1.45%)
Metastases To Lymph Nodes
14 (1.27%)
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Sialoadenitis
14 (1.27%)
Hypocalcaemia
13 (1.18%)
Neoplasm Malignant
13 (1.18%)
Drug Exposure During Pregnancy
12 (1.09%)
Colon Cancer
10 (.9%)
Drug Exposure Before Pregnancy
10 (.9%)
Dyspnoea
10 (.9%)
Local Swelling
8 (.72%)
Pulmonary Fibrosis
8 (.72%)
Congenital Hypothyroidism
7 (.63%)
Dacryostenosis Acquired
7 (.63%)
Drug Ineffective
7 (.63%)
Endocrine Ophthalmopathy
7 (.63%)
Gastric Cancer
7 (.63%)
Gingival Bleeding
7 (.63%)
Malignant Urinary Tract Neoplasm
7 (.63%)
Acute Promyelocytic Leukaemia
6 (.54%)
Premature Baby
6 (.54%)
Tongue Discolouration
6 (.54%)
Chronic Myeloid Leukaemia
5 (.45%)
Cyanosis
5 (.45%)
Intra-uterine Death
5 (.45%)
Musculoskeletal Discomfort
5 (.45%)
Parathyroid Gland Enlargement
5 (.45%)
Parathyroid Tumour
5 (.45%)
Parotid Gland Enlargement
5 (.45%)
Radiation Pneumonitis
5 (.45%)
Anaemia
4 (.36%)
Cerebellar Tumour
4 (.36%)
Diarrhoea
4 (.36%)
Fatigue
4 (.36%)
Hyperparathyroidism Primary
4 (.36%)
Hypoaesthesia
4 (.36%)
Hypoparathyroidism
4 (.36%)
Metastases To Lung
4 (.36%)
Psychotic Disorder
4 (.36%)
Stillbirth
4 (.36%)
Thrombocytopenia
4 (.36%)
Abdominal Pain
3 (.27%)
Acute Respiratory Distress Syndrome
3 (.27%)
Ageusia
3 (.27%)
Arthralgia
3 (.27%)
Autoimmune Thyroiditis
3 (.27%)
Blood Thyroid Stimulating Hormone I...
3 (.27%)
Disease Progression
3 (.27%)
Dizziness
3 (.27%)
Drug Toxicity
3 (.27%)
Dysphonia
3 (.27%)
Eye Swelling
3 (.27%)
Headache
3 (.27%)
Hypertension
3 (.27%)
Hyponatraemia
3 (.27%)
Nausea
3 (.27%)
Prothrombin Time Prolonged
3 (.27%)
Rectal Cancer
3 (.27%)
Refractory Anaemia With An Excess O...
3 (.27%)
Refractory Cytopenia With Multiline...
3 (.27%)
Refusal Of Treatment By Patient
3 (.27%)
Sensory Disturbance
3 (.27%)
Sinus Headache
3 (.27%)
Stress Cardiomyopathy
3 (.27%)
Thyroid Neoplasm
3 (.27%)
Thyrotoxic Periodic Paralysis
3 (.27%)
Vomiting
3 (.27%)
Weight Decreased
3 (.27%)
Abortion Induced
2 (.18%)
Apallic Syndrome
2 (.18%)
Astrocytoma
2 (.18%)
Atrial Fibrillation
2 (.18%)
Biopsy Thyroid Gland Abnormal
2 (.18%)
Bone Lesion
2 (.18%)
Bone Marrow Failure
2 (.18%)
Bradycardia
2 (.18%)
Brain Oedema
2 (.18%)
Brain Stem Syndrome
2 (.18%)
Cerebrovascular Accident
2 (.18%)
Chest Pain
2 (.18%)
Cough
2 (.18%)
Decubitus Ulcer
2 (.18%)
Drug Dispensing Error
2 (.18%)
Drug Interaction
2 (.18%)
Dysphagia
2 (.18%)
Ecchymosis
2 (.18%)
Erythema
2 (.18%)
Hepatomegaly
2 (.18%)
Hydrocephalus
2 (.18%)
Hypersensitivity
2 (.18%)
Hypokalaemia
2 (.18%)
Hypophosphataemia
2 (.18%)
Hypoventilation
2 (.18%)

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This graph shows the top adverse events submitted to the FDA for Sodium Iodide I, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Sodium Iodide I is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Sodium Iodide I

What are the most common Sodium Iodide I adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Sodium Iodide I, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Sodium Iodide I is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Sodium Iodide I According to Those Reporting Adverse Events

Why are people taking Sodium Iodide I, according to those reporting adverse events to the FDA?

Basedows Disease
271
Hyperthyroidism
74
Radioactive Iodine Therapy
67
Thyroid Cancer
62
Isotope Therapy To Thyroid
30
Goitre
27
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Toxic Nodular Goitre
17
Thyroid Cancer Metastatic
12
Adjuvant Therapy
9
Scan Thyroid Gland
8
Metastases To Lung
6
Thyroid Neoplasm
5
Radioisotope Scan
4
Radiotherapy
3
Scintigraphy
3
Papillary Thyroid Cancer
3
Thyroid Therapy
2
Thyroid Adenoma
2
Lymphadenopathy
1
Iodine Uptake
1
Neoplasm Malignant
1
Drug Use For Unknown Indication
1
Whole Body Scan
1
Ultrasound Thyroid
1
Product Used For Unknown Indication
1
Thyroid Haemorrhage
1
Thyroid Gland Cancer
1
Angina Pectoris
1
Metastases To The Mediastinum
1
Thyroid Disorder
1
Wrist Fracture
1
Metastases To Bone
1
Neoplasm
1

Drug Labels

LabelLabelerEffective
Hicon Jubilant DraxImage Inc.01-AUG-11
Sodium Iodide I 131 Diagnostic Jubilant DraxImage Inc.11-OCT-11
Iodopen Sodium IodideAPP Pharmaceuticals, LLC20-JAN-12
Sodium Iodide I 123Mallinckrodt Inc.21-MAR-12
Sodium Iodide I 131Mallinckrodt Inc.01-APR-12
Sodium Iodide I-131therapeuticMallinckrodt Inc.30-APR-12

Sodium Iodide I Case Reports

What Sodium Iodide I safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Sodium Iodide I. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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