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What the label lists and what reports show

Indium in -111 pentetreotide side effects

Indium in -111 pentetreotide's FDA label lists its adverse reactions in its own words. FAERS holds 128 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 intentional drug misuse (31 reports).

  • No generic listed

Check it at the source: the indium in -111 pentetreotide FDA label on DailyMed (effective February 21, 2022); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

The following adverse effects were observed in clinical trials at a frequency of less than 1% of 538 patients: dizziness, fever, flush, headache, hypotension, changes in liver enzymes, joint pain, nausea, sweating, and weakness. These adverse effects were transient. Also in clinical trials, there was one reported case of bradycardia and one case of decreased hematocrit and hemoglobin. Pentetreotide is derived from octreotide which is used as a therapeutic agent to control symptoms from certain tumors. The usual dose for Indium In 111 Pentetreotide Injection is approximately 5 to 20 times less than for octreotide and is subtherapeutic. The following adverse reactions have been associated with octreotide in 3% to 10% of patients: nausea, injection site pain, diarrhea, abdominal pain/discomfort, loose stools, and vomiting. …

Source: FDA drug label, Curium US LLC, effective February 21, 2022 (SPL set 93d8f3b2-1216-41dc-a63d-0e812b33891d), via openFDA; the full label on DailyMed

What do FAERS reports show?

128 reports list indium in -111 pentetreotide among the medicines taken, each a report of something that happened, not proof the medicine caused it; 42 are coded as a death and 23 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.

The 25 most reported reactions

  • Intentional Drug Misuse31
  • Death (an outcome recorded in the report)21
  • Haemoglobin Abnormal16
  • Nausea (named in the label)15
  • Drug Ineffective (a use or a product term, not a reaction)14
  • Platelet Disorder10
  • Product Use Issue (a use or a product term, not a reaction)10
  • Disease Progression (a use or a product term, not a reaction)8
  • Product Use In Unapproved Indication (a use or a product term, not a reaction)8
  • Blood Bilirubin Abnormal7
  • Haematotoxicity7
  • Pyrexia7
  • Diarrhoea (named in the label)6
  • Flushing6
  • Malignant Neoplasm Progression6
  • Myelodysplastic Syndrome6
  • Neoplasm Progression6
  • Vomiting (named in the label)6
  • White Blood Cell Disorder6
  • Abdominal Pain (named in the label)5
  • Fatigue5
  • Lymphopenia5
  • Platelet Toxicity5
  • Acute Myeloid Leukaemia4
  • Asthenia4

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

What next?

Indium in -111 pentetreotide: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions