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What the label lists and what reports show

Ioflupane i 123 side effects

Ioflupane i 123's FDA label lists its adverse reactions in its own words. FAERS holds 532 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 radioisotope scan abnormal (145 reports).

  • Generic listed

Check it at the source: the ioflupane i 123 FDA label on DailyMed (effective April 24, 2026, Medi-Physics Inc. dba GE Healthcare.); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

The following clinically significant adverse reaction is described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] The following adverse reactions were reported at ≤1%: headache, nausea, vertigo, dry mouth and dizziness. ( 6.1 ) 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 Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of DATSCAN cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data from clinical trials reflect exposure to DATSCAN in 942 subjects with a mean age of 66 years (range 25 years to 90 years). Among these subjects, 42% were female and 99% White. …

Source: FDA drug label, NDA022454 (Ge Hlthcare Inc), as published by Medi-Physics Inc. dba GE Healthcare., effective April 24, 2026 (SPL set ef7804d7-c691-495b-8aaf-5bc54fd5d9f6), via openFDA; the full label on DailyMed

What do FAERS reports show?

532 reports list ioflupane i 123 among the medicines taken, each a report of something that happened, not proof the medicine caused it; 7 are coded as a death and 17 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, 5 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

  • No Adverse Event (a use or a product term, not a reaction)258
  • Radioisotope Scan Abnormal145
  • Drug Ineffective (a use or a product term, not a reaction)127
  • Injection Site Pain (named in the label)59
  • Drug Interaction (a use or a product term, not a reaction)46
  • Burning Sensation24
  • Parkinsonism24
  • False Positive Radioisotope Investigation Result16
  • Dopamine Transporter Scintigraphy Abnormal12
  • Nausea (named in the label)12
  • Product Quality Issue (a use or a product term, not a reaction)11
  • Dizziness (named in the label)10
  • Headache (named in the label)10
  • Malaise9
  • Pain9
  • False Positive Investigation Result7
  • Labelled Drug-Drug Interaction Medication Error (a use or a product term, not a reaction)7
  • Vomiting7
  • Fatigue6
  • Abdominal Discomfort5
  • Erythema (named in the label)5
  • False Negative Investigation Result5
  • Feeling Cold5
  • Seizure5
  • Brain Scan Abnormal4

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

What next?

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