What the label lists and what reports show
68ga-dotatate side effects
68ga-dotatate's FDA label lists its adverse reactions in its own words. FAERS holds 189 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 nausea (77 reports).
- No generic listed
Check it at the source: the 68ga-dotatate FDA label on DailyMed (effective July 6, 2026); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity reactions [see Warnings and Precautions ( 5.2 )] Nausea, vomiting, and injection site pain and burning sensation were all reported during post-approval use. ( 6 ) 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 The safety of gallium Ga 68 dotatate was evaluated in three single center studies [see Clinical Studies ( 14 )] and in a survey of the scientific literature. No serious adverse reactions were identified. 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of NETSPOT or other somatostatin receptor imaging agents. …
Source: FDA drug label, Advanced Accelerator Applications USA, Inc, effective July 6, 2026 (SPL set b2b3be70-17d8-4093-896c-f1c54a2cf242), via openFDA; the full label on DailyMed
What do FAERS reports show?
189 reports list 68ga-dotatate among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1 are coded as a death and 6 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 24 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.
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?
- 68ga-dotatate: 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