What the label lists and what reports show
Gallium ga 68 gozetotide side effects
Gallium ga 68 gozetotide's FDA label: “The most commonly reported adverse reactions include nausea, diarrhea, and dizziness.” FAERS holds 382 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 injection site pain (128 reports).
- Generic listed
Check it at the source: the gallium ga 68 gozetotide FDA label on DailyMed (effective November 14, 2025, UCSF Radiopharmaceutical Facility); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most commonly reported adverse reactions include nausea, diarrhea, and dizziness.
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
This table is printed in the ILLUCCIX label published by Telix Pharmaceuticals (US) Inc. of June 15, 2026; the label quoted above does not print one.
| Adverse Reaction | Gallium Ga 68 Gozetotide Injection N = 1,003 n (%) General disorders |
|---|---|
| Fatigue | 12 (1.2) |
| Nausea | 8 (0.8) |
| Constipation | 5 (0.5) |
| Vomiting | 5 (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 most commonly reported adverse reactions include nausea, diarrhea, and dizziness. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact UCSF Nuclear Medicine at 1-888-919-0740 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. . 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 safety of Gallium Ga 68 Gozetotide Injection was evaluated in 960 patients, each receiving one dose of Gallium Ga 68 Gozetotide Injection. The average injected activity was 188.7 ± 40.7 MBq (5.1 ± 1.1 mCi). The most commonly reported adverse reactions were nausea, diarrhea, and dizziness, occurring at a rate of <1%
Source: FDA drug label, NDA212643 (Univ Of Ca San Fran), as published by UCSF Radiopharmaceutical Facility, effective November 14, 2025 (SPL set b6253a7b-0f73-36be-e053-2a95a90a9015), via openFDA; the full label on DailyMed
What do FAERS reports show?
382 reports list gallium ga 68 gozetotide among the medicines taken, each a report of something that happened, not proof the medicine caused it; 20 are coded as a death and 67 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 22 reactions below, 1 is 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
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Gallium ga 68 gozetotide: 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