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What the label lists and what reports show

Sodium iodide i 131 side effects

Sodium iodide i 131's FDA label lists its adverse reactions in its own words. FAERS holds 1,122 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is hypothyroidism (402 reports).

  • Generic listed

Check it at the source: the sodium iodide i 131 FDA label on DailyMed (effective January 21, 2025, Jubilant DraxImage Inc., dba Jubilant Radiopharma); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

The following clinically significant adverse reactions are described below and elsewhere in labeling: Radiation-induced Thyroiditis [see Warnings and Precautions ( 5.1 )]. Radiation-induced Toxicities [see Warnings and Precautions ( 5.2 )]. Hypersensitivity Reactions [see Warnings and Precautions ( 5.3 )]. Embryo-Fetal Toxicity [see Warnings and Precautions ( 5.4 ), Use in Specific Populations ( 8.1 )]. Increased Radiation Exposure to Breast Tissue with Lactation [see Warnings and Precautions ( 5.5 ), Use in Specific Populations ( 8.2 )]. Transient Infertility [see Warnings and Precautions ( 5.6 ), Use in Specific Populations ( 8.3 )]. Radiation Exposure to Other Individuals [see Warnings and Precautions ( 5.7 )]. Risk of Decreased Effectiveness of Therapy [see Warnings and Precautions ( 5.8 )]. …

Source: FDA drug label, Jubilant DraxImage Inc., dba Jubilant Radiopharma, effective January 21, 2025 (SPL set 524a0dac-6e2b-2c0c-04b4-76d85dba63c5), via openFDA; the full label on DailyMed

What do FAERS reports show?

1,122 reports list sodium iodide i 131 among the medicines taken, each a report of something that happened, not proof the medicine caused it; 59 are coded as a death and 95 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 4 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

  • Hypothyroidism (named in the label)402
  • Endocrine Ophthalmopathy45
  • Hyperthyroidism (a use or a product term, not a reaction)31
  • Treatment Failure (a use or a product term, not a reaction)30
  • Abortion Spontaneous26
  • Nausea (named in the label)26
  • Drug Ineffective (a use or a product term, not a reaction)25
  • Acute Myeloid Leukaemia24
  • Dacryostenosis Acquired24
  • Maternal Exposure Before Pregnancy (a use or a product term, not a reaction)22
  • Parathyroid Tumour Benign22
  • Lacrimation Increased21
  • Vomiting (named in the label)20
  • Hyperparathyroidism19
  • Sialoadenitis18
  • Thyroid Cancer18
  • Breast Cancer17
  • Dyspnoea17
  • Maternal Exposure During Pregnancy (a use or a product term, not a reaction)17
  • Acute Leukaemia (named in the label)15
  • Basedow^S Disease15
  • Contraindicated Product Administered15
  • Fatigue15
  • Hypocalcaemia15
  • Hyponatraemia15

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Sodium iodide i 131: the full record
label, generics, price, shortages, recalls
Side effects hub
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