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What the label lists and what reports show

Iobenguane i 123 side effects

Iobenguane i 123's FDA label: “The most common adverse reactions, dizziness, rash, pruritis, flushing, headache, and injection site hemorrhage occurred in < 1.3% of patients.” FAERS holds 110 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 neutropenia (22 reports).

  • No generic listed

Check it at the source: the iobenguane i 123 FDA label on DailyMed (effective January 10, 2024); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

The most common adverse reactions, dizziness, rash, pruritis, flushing, headache, and injection site hemorrhage occurred in < 1.3% of patients.

From the label: adverse reactions, continued

Serious hypersensitivity reactions have been reported following AdreView administration. The most common adverse reactions, dizziness, rash, pruritis, flushing, headache, and injection site hemorrhage occurred in < 1.3% of patients. ( 6.1 , 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact GE Healthcare at 1-800-654-0118 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Study Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. During clinical development 1346 patients were exposed to AdreView, 251 patients with known or suspected pheochromocytoma or neuroblastoma, 985 patients with heart failure, and 110 control patients. All patients were monitored for adverse reactions over a 24 hour period following AdreView administration. Pheochromocytoma and Neuroblastoma Serious adverse reactions were not observed in the AdreView clinical study. Adverse reactions were all mild to moderate in severity and were predominantly isolated occurrences (≤ 2 patients) of one of the following reactions: dizziness, rash, pruritus, flushing or injection site hemorrhage. …

Source: FDA drug label, Medi-Physics Inc., effective January 10, 2024 (SPL set c89d3ecc-4f4c-4566-8808-79152344194d), via openFDA; the full label on DailyMed

What do FAERS reports show?

110 reports list iobenguane i 123 among the medicines taken, each a report of something that happened, not proof the medicine caused it; 6 are coded as a death and 13 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 21 reactions below, 2 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.

The 25 most reported reactions

  • No Adverse Event (a use or a product term, not a reaction)41
  • Neutropenia22
  • Drug Ineffective (a use or a product term, not a reaction)21
  • Radioisotope Scan Abnormal20
  • Mucosal Inflammation14
  • Fatigue5
  • Febrile Neutropenia5
  • Neuroblastoma Recurrent5
  • Pyrexia4
  • Vomiting4
  • False Positive Investigation Result3
  • Myelodysplastic Syndrome3
  • Therapy Non-Responder3
  • Antibody Test Positive2
  • Burning Sensation2
  • Clostridium Difficile Colitis2
  • Dizziness (named in the label)2
  • Dyspnoea2
  • Headache (named in the label)2
  • Human Anti-Mouse Antibody Positive2
  • Hydronephrosis2
  • Nausea2
  • Off Label Use (a use or a product term, not a reaction)2
  • Posterior Reversible Encephalopathy Syndrome2
  • Product Quality Issue (a use or a product term, not a reaction)2

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

What next?

Iobenguane i 123: the full record
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Side effects hub
the most reported medicines and reactions