What the label lists and what reports show
Piflufolastat f 18 side effects
Piflufolastat f 18's FDA label: “Most common adverse reactions (incidence > 0.5%) are headache, dysgeusia, and fatigue.” FAERS holds 197 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 radioisotope scan abnormal (76 reports).
- No generic listed
Check it at the source: the piflufolastat f 18 FDA label on DailyMed (effective July 1, 2026, Aphelion LLC); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence > 0.5%) are headache, dysgeusia, and fatigue.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.2) ] Most common adverse reactions (incidence > 0.5%) are headache, dysgeusia, and fatigue. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Aphelion LLC at 1-800-362-2668 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 safety of PYLARIFY TRUVU has been established based on data from clinical studies of another formulation of piflufolastat F 18 in patients with prostate cancer [see Clinical Studies (14) ]. The results of these two studies are presented below. The safety population included 593 patients, each receiving one dose of piflufolastat F 18. The average injected activity was 340 ± 26 MBq (9.2 ± 0.7 mCi). The adverse reactions reported in >0.5% of patients within the studies are shown in Table 2. In addition, a hypersensitivity reaction was reported in one patient (0.2%) with a history of allergic reaction. Table 2. …
Source: FDA drug label, Aphelion LLC, effective July 1, 2026 (SPL set 121c1cb8-6f60-4644-a775-b81c6f21d812), via openFDA; the full label on DailyMed
What do FAERS reports show?
197 reports list piflufolastat f 18 among the medicines taken, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 4 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, 2 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?
- Piflufolastat f 18: 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