What the label lists and what reports show
Lutetium lu 177 vipivotide tetraxetan side effects
Lutetium lu 177 vipivotide tetraxetan's FDA label: “Most common (≥ 20%) adverse reactions, including laboratory abnormalities, were decreased lymphocytes, decreased hemoglobin, fatigue, dry mouth, decreased neutrophils, nausea, decreased platelets, decreased estimated glomerular filtration rate, increased …” FAERS holds 13,100 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 general physical health deterioration (6,138 reports).
- No generic listed
Check it at the source: the lutetium lu 177 vipivotide tetraxetan FDA label on DailyMed (effective August 12, 2026, Novartis Pharmaceuticals Corporation); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsMost common (≥ 20%) adverse reactions, including laboratory abnormalities, were decreased lymphocytes, decreased hemoglobin, fatigue, dry mouth, decreased neutrophils, nausea, decreased platelets, decreased estimated glomerular filtration rate, increased aspartate aminotransferase, decreased sodium, increased magnesium, increased potassium, decreased calcium, and increased alkaline phosphatase.
Table 7: Adverse Reactions (≥ 10%) in Patients With PSMA-Positive mAPMR Prostate Cancer Who Received PLUVICTO Plus BSoC or BSoC in VISION
| Reaction | All Grades (%) | Grades 3 or 4 (%) | All Grades (%) | Grades 3 or 4 (%) |
|---|---|---|---|---|
| Fatigue a | 48 | 7 | 29 | 2.4 |
| Decreased appetite | 21 | 1.9 | 15 | 0.5 |
| Weight decreased | 11 | 0.4 | 10 | 0.5 |
| Peripheral edema a | 10 | 0.4 | 7 | 1 |
| Dry mouth a | 39 | 0 | 1 | 0 |
| Nausea | 36 | 1.3 | 17 | 0.5 |
| Constipation | 20 | 1.1 | 11 | 0.5 |
| Vomiting a | 19 | 0.9 | 6 | 0.5 |
| Diarrhea | 19 | 0.8 | 2.9 | 0.5 |
| Abdominal pain a | 12 | 1.3 | 6 | 0.5 |
| Back pain | 24 | 3.6 | 15 | 3.9 |
| Arthralgia | 22 | 1.1 | 13 | 0.5 |
| Bone pain | 11 | 2.5 | 8 | 2.4 |
| Urinary tract infection a | 12 | 3.8 | 1 | 0.5 |
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)] Renal Toxicity [see Warnings and Precautions (5.3)] Most common (≥ 20%) adverse reactions, including laboratory abnormalities, were decreased lymphocytes, decreased hemoglobin, fatigue, dry mouth, decreased neutrophils, nausea, decreased platelets, decreased estimated glomerular filtration rate, increased aspartate aminotransferase, decreased sodium, increased magnesium, increased potassium, decreased calcium, and increased alkaline phosphatase. ( 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.
Source: FDA drug label, Novartis Pharmaceuticals Corporation, effective August 12, 2026 (SPL set 14908037-2892-4d98-a053-253ce35afb1a), via openFDA; the full label on DailyMed
What do FAERS reports show?
13,100 reports list lutetium lu 177 vipivotide tetraxetan among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,631 are coded as a death and 665 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 2024 (3,984, against a median of 0 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 21 reactions below, 7 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 lu 177 vipivotide tetraxetan: the full record
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