What the label lists and what reports show
Lutetium oxodotreotide lu 177 side effects
Lutetium oxodotreotide lu 177's FDA label: “Most common Grade 3-4 adverse reactions (≥ 4% with a higher incidence in LUTATHERA arm) are lymphopenia, increased GGT, vomiting, nausea, increased AST, increased ALT, hyperglycemia and hypokalemia.” FAERS holds 5,683 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 ill-defined disorder (1,541 reports).
- No generic listed
Check it at the source: the lutetium oxodotreotide lu 177 FDA label on DailyMed (effective January 15, 2026); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsMost common Grade 3-4 adverse reactions (≥ 4% with a higher incidence in LUTATHERA arm) are lymphopenia, increased GGT, vomiting, nausea, increased AST, increased ALT, hyperglycemia and hypokalemia.
Table 5. Adverse Reactions Occurring at Higher Incidence in Patients Receiving LUTATHERA with Long-Acting Octreotide Compared to High-Dose Long-Acting Octreotide (Between Arm Difference of ≥ 5% All Grades or ≥ 2% Grades…
| Reaction | All Grades % | Grades 3-4 % | All Grades % | Grades 3-4 % |
|---|---|---|---|---|
| Nausea | 65 | 5 | 12 | 2 |
| Vomiting | 53 | 7 | 10 | 0 |
| Abdominal pain | 26 | 3 | 19 | 3 |
| Diarrhea | 26 | 3 | 18 | 1 |
| Constipation | 10 | 0 | 5 | 0 |
| Fatigue | 38 | 1 | 26 | 2 |
| Peripheral edema | 16 | 0 | 9 | 1 |
| Pyrexia | 8 | 0 | 3 | 0 |
| Decreased appetite | 21 | 0 | 11 | 3 |
| Headache | 17 | 0 | 5 | 0 |
| Dizziness | 17 | 0 | 8 | 0 |
| Dysgeusia | 8 | 0 | 2 | 0 |
| Flushing | 14 | 1 | 9 | 0 |
| Hypertension | 12 | 2 | 7 | 2 |
| Back pain | 13 | 2 | 10 | 0 |
| Pain in extremity | 11 | 0 | 5 | 0 |
| Myalgia | 5 | 0 | 0 | 0 |
| Neck pain | 5 | 0 | 0 | 0 |
| Renal failure b | 13 | 3 | 4 | 1 |
| Radiation-related urinary tract adverse reactions c | 8 | 0 | 3 | 0 |
| Anxiety | 12 | 1 | 5 | 0 |
| Alopecia | 12 | 0 | 2 | 0 |
| Cough | 11 | 1 | 6 | 0 |
| Atrial fibrillation | 5 | 1 | 0 | 0 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are described elsewhere in the labeling: Myelosuppression [see Warnings and Precautions ( 5.2 )] Secondary Myelodysplastic Syndrome and Leukemia [see Warnings and Precautions ( 5.3 )] Renal Toxicity [see Warnings and Precautions ( 5.4 )] Hepatotoxicity [see Warnings and Precautions ( 5.5 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.6 )] Neuroendocrine Hormonal Crisis [see Warnings and Precautions ( 5.7 )] Most common Grade 3-4 adverse reactions (≥ 4% with a higher incidence in LUTATHERA arm) are lymphopenia, increased GGT, vomiting, nausea, increased AST, increased ALT, hyperglycemia and hypokalemia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 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 a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data in WARNINGS AND PRECAUTIONS reflect exposure to LUTATHERA in 111 patients with advanced, progressive midgut neuroendocrine tumors (NETTER-1). …
Source: FDA drug label, Advanced Accelerator Applications USA, Inc, effective January 15, 2026 (SPL set 72d1a024-00b7-418a-b36e-b2cb48f2ab55), via openFDA; the full label on DailyMed
What do FAERS reports show?
5,683 reports list lutetium oxodotreotide lu 177 among the medicines taken, each a report of something that happened, not proof the medicine caused it; 704 are coded as a death and 694 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. Reports rose sharply in 2021 (1,352, against a median of 162 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 22 reactions below, 8 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
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Lutetium oxodotreotide lu 177: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions