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What the label lists and what reports show

Fluciclovine f 18 side effects

Fluciclovine f 18's FDA label: “Most commonly reported adverse reactions are injection site pain, erythema, and dysgeusia ( 6.1 ).” FAERS holds 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 positron emission tomogram abnormal (22 reports).

  • No generic listed

Check it at the source: the fluciclovine f 18 FDA label on DailyMed (effective March 5, 2025, Blue Earth Diagnostics); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Most commonly reported adverse reactions are injection site pain, erythema, and dysgeusia ( 6.1 ).

From the label: adverse reactions, continued

Most commonly reported adverse reactions are injection site pain, erythema, and dysgeusia ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Blue Earth Diagnostics, Ltd at 1-855-AXUMIN1 (1-855-298-6461) 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 clinical trial database for Axumin includes data from 877 subjects including 797 males diagnosed with prostate cancer. Most patients received a single administration of Axumin, a small number of subjects (n = 50) received up to five administrations of the drug. The mean administered activity was 370 MBq (range, 163 MBq to 485 MBq). Adverse reactions were reported in ≤1% of subjects during clinical studies with Axumin. The most common adverse reactions were injection site pain, injection site erythema and dysgeusia.

Source: FDA drug label, Blue Earth Diagnostics, effective March 5, 2025 (SPL set 389a502e-a7d5-43dd-b6bf-f022ff23f3b9), via openFDA; the full label on DailyMed

What do FAERS reports show?

100 reports list fluciclovine f 18 among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1 are coded as a death and 2 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 19 reactions below, none 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

  • Positron Emission Tomogram Abnormal22
  • No Adverse Event (a use or a product term, not a reaction)18
  • Therapeutic Response Unexpected18
  • Scan Abnormal11
  • False Negative Investigation Result7
  • Drug Ineffective (a use or a product term, not a reaction)6
  • Off Label Use (a use or a product term, not a reaction)6
  • Injection Site Extravasation5
  • False Positive Investigation Result4
  • Therapeutic Product Effect Decreased (a use or a product term, not a reaction)4
  • Diarrhoea3
  • Extravasation2
  • Malaise2
  • Manufacturing Product Shipping Issue2
  • Product Dose Omission (a use or a product term, not a reaction)2
  • Underdose (a use or a product term, not a reaction)2
  • Vomiting2
  • Wrong Product Administered2
  • Abdominal Discomfort1
  • Agitation1
  • Anxiety1
  • Bacterial Test Positive1
  • Blood Creatinine Increased1
  • Bone Lesion1
  • Claustrophobia1

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Fluciclovine f 18: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions