What the label lists and what reports show
Flutemetamol f 18 side effects
Flutemetamol f 18's FDA label: “Most common adverse reactions (incidence ≥ 1%) were flushing, increased blood pressure, headache, nausea, and dizziness.” FAERS holds 463 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 flushing (242 reports).
- No generic listed
Check it at the source: the flutemetamol f 18 FDA label on DailyMed (effective April 6, 2026, GE Healthcare Inc. (Medi-Physics, Inc. dba GE Healthcare)); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence ≥ 1%) were flushing, increased blood pressure, headache, nausea, and dizziness.
Table 2: Adverse Reactions Reported in ≥ 1% of Adult Subjects Who Received VIZAMYL in Clinical Trials
| Adverse Reaction | VIZAMYL N=761 % |
|---|---|
| Flushing | 2 |
| Increased blood pressure | 2 |
| Headache | 1 |
| Nausea | 1 |
| Dizziness | 1 |
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 reaction is described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Most common adverse reactions (incidence ≥ 1%) were flushing, increased blood pressure, headache, nausea, and dizziness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact GE HealthCare at 1-800-654-0118 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 clinical practice. The safety of VIZAMYL was evaluated in 761 adult subjects who received VIZAMYL by intravenous injection in clinical trials. Most subjects (70%) received a dose of 185 MBq (5 mCi). The subjects had a mean age of 62 years (range 18 years to 93 years); 45% of the subjects were male and 91% were White. A serious hypersensitivity reaction characterized by flushing, dyspnea, and chest pressure was reported within minutes following VIZAMYL administration in one subject who recovered with treatment. Adverse reactions reported in ≥ 1% of subjects from the clinical trials are shown in Table 2.
Source: FDA drug label, GE Healthcare Inc. (Medi-Physics, Inc. dba GE Healthcare), effective April 6, 2026 (SPL set b3558f16-8f9a-4e55-8d9c-836427ebaa57), via openFDA; the full label on DailyMed
What do FAERS reports show?
463 reports list flutemetamol f 18 among the medicines taken, each a report of something that happened, not proof the medicine caused it; 2 are coded as a death and 29 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 25 reactions below, 5 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?
- Flutemetamol 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