Drug · FAERS side-effect profile with label screen
Fluoride F-18 side effects: what 1,077 FDA adverse event reports show
Drug class
Radioactive diagnostic agent
FDA label, Indications wording of the closest related product
Label matched
Sodium Fluoride F-18 (Sodium Fluoride F 18)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
1,077 reports · 82% serious · 348 with death outcome · 65% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Sodium Fluoride F 18 Injection, USP is indicated for diagnostic positron emission tomography (PET) imaging of bone to define areas of altered osteogenic activity. Sodium Fluoride F 18 Injection, USP is a radioactive diagnostic agent for positron emission tomography (PET) indicated for imaging of bone to define areas of altered osteogenic activity (1) .
FDA label, Indications and Usage
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Reporting / coding artifact 1Lab value / disease marker 2Not in label — unassessed 37
What the badges mean
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 86 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Wound infection | 139 | 252.0 215.5–294.6ROR 289.1 · χ² 34,069 / p <1e-300 | 240.5 EB05 208.8 · IC025 +6.8 3/3 methods agree | Not in label — unassessed | serious PRR 188.6 · ♀ 100% (drug 65%) · 96% clinician | no trial data cached |
| Helicobacter infection | 112 | 216.1 181.1–257.7ROR 241.0 · χ² 23,507 / p <1e-300 | 206.2 EB05 176.1 · IC025 +6.5 3/3 methods agree | Not in label — unassessed | serious PRR 159.6 · ♀ 100% (drug 65%) · 95% clinician | no trial data cached |
| Hypercholesterolaemia | 93 | 190.9 157.0–232.1ROR 208.8 · χ² 17,217 / p <1e-300 | 182.0 EB05 153.0 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious PRR 142.0 · ♀ 99% (drug 65%) · 96% clinician | no trial data cached |
| Pemphigus | 119 | 188.0 158.5–222.9ROR 211.2 · χ² 21,746 / p <1e-300 | 180.8 EB05 155.1 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious PRR 132.0 · ♀ 99% (drug 65%) · 95% clinician | no trial data cached |
| Folliculitis | 95 | 180.5 148.9–219.0ROR 197.9 · χ² 16,635 / p <1e-300 | 172.7 EB05 145.5 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious PRR 148.6 · ♀ 99% (drug 65%) · 96% clinician | no trial data cached |
| Joint dislocation | 96 | 179.0 147.7–216.8ROR 196.4 · χ² 16,665 / p <1e-300 | 171.3 EB05 144.4 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious PRR 141.1 · ♀ 100% (drug 65%) · 98% clinician | no trial data cached |
| Autoimmune disorder | 79 | 161.9 130.8–200.3ROR 174.6 · χ² 12,371 / p <1e-300 | 154.6 EB05 128.0 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious PRR 121.4 · ♀ 100% (drug 65%) · 97% clinician | no trial data cached |
| Laryngitis | 86 | 155.3 126.7–190.4ROR 168.7 · χ² 12,933 / p <1e-300 | 149.0 EB05 124.4 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious n=86 · ♀ 100% (drug 65%) · 98% clinician | no trial data cached |
| Foot deformity | 82 | 144.8 117.5–178.4ROR 156.6 · χ² 11,485 / p <1e-300 | 139.1 EB05 115.6 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious PRR 118.1 · ♀ 100% (drug 65%) · 95% clinician | no trial data cached |
| Red blood cell sedimentation rate increased | 81 | 143.1 116.0–176.6ROR 154.6 · χ² 11,210 / p <1e-300 | 137.5 EB05 114.2 · IC025 +5.9 3/3 methods agree | Lab value / disease marker | serious PRR 113.9 · ♀ 100% (drug 65%) · 96% clinician | no trial data cached |
| Pericarditis | 121 | 142.3 120.2–168.4ROR 160.1 · χ² 16,721 / p <1e-300 | 138.2 EB05 118.7 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious PRR 100.6 · ♀ 100% (drug 65%) · 95% clinician | no trial data cached |
| Joint range of motion decreased | 96 | 140.7 116.2–170.4ROR 154.4 · χ² 13,089 / p <1e-300 | 136.0 EB05 114.6 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious PRR 125.9 · ♀ 100% (drug 65%) · 98% clinician | no trial data cached |
| Hand deformity | 88 | 131.7 107.7–161.0ROR 143.3 · χ² 11,214 / p <1e-300 | 127.3 EB05 106.5 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious PRR 100.6 · ♀ 100% (drug 65%) · 98% clinician | no trial data cached |
| Prescribed underdose | 134 | 131.6 112.2–154.2ROR 150.1 · χ² 17,130 / p <1e-300 | 128.3 EB05 111.1 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious PRR 157.9 · ♀ 100% (drug 65%) · 97% clinician | no trial data cached |
| Sciatica | 98 | 120.9 100.1–146.2ROR 132.9 · χ² 11,473 / p <1e-300 | 117.5 EB05 99.2 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious PRR 114.2 · ♀ 98% (drug 65%) · 95% clinician | no trial data cached |
| Prescribed overdose | 96 | 97.0 80.1–117.4ROR 106.3 · χ² 8,985 / p <1e-300 | 94.7 EB05 79.9 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious PRR 116.4 · ♀ 99% (drug 65%) · 94% clinician | no trial data cached |
| Hip arthroplasty | 75 | 96.5 77.6–120.2ROR 103.7 · χ² 6,966 / p <1e-300 | 93.8 EB05 77.3 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious PRR 70.0 · ♀ 100% (drug 65%) · 97% clinician | no trial data cached |
| Wound | 135 | 94.9 81.0–111.2ROR 108.3 · χ² 12,405 / p <1e-300 | 93.2 EB05 80.8 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious PRR 79.5 · ♀ 100% (drug 65%) · 99% clinician | no trial data cached |
| Irritable bowel syndrome | 102 | 93.3 77.5–112.3ROR 102.9 · χ² 9,186 / p <1e-300 | 91.3 EB05 77.4 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious PRR 83.3 · ♀ 100% (drug 65%) · 97% clinician | no trial data cached |
| Synovitis | 86 | 93.1 76.0–114.1ROR 101.1 · χ² 7,715 / p <1e-300 | 90.9 EB05 75.9 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious PRR 68.6 · ♀ 100% (drug 65%) · 98% clinician | no trial data cached |
| Fibromyalgia | 115 | 92.5 77.8–110.0ROR 103.5 · χ² 10,284 / p <1e-300 | 90.7 EB05 77.7 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious PRR 85.6 · ♀ 100% (drug 65%) · 96% clinician | no trial data cached |
| Pulmonary fibrosis | 89 | 91.0 74.5–111.1ROR 99.1 · χ² 7,802 / p <1e-300 | 88.9 EB05 74.4 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious PRR 64.7 · ♀ 100% (drug 65%) · 96% clinician | no trial data cached |
| Lower limb fracture | 88 | 90.0 73.7–110.1ROR 98.0 · χ² 7,632 / p <1e-300 | 88.0 EB05 73.6 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious PRR 68.8 · ♀ 100% (drug 65%) · 92% clinician | no trial data cached |
| Hepatic cirrhosis | 85 | 88.9 72.4–109.0ROR 96.4 · χ² 7,270 / p <1e-300 | 86.8 EB05 72.4 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious PRR 63.3 · ♀ 100% (drug 65%) · 95% clinician | no trial data cached |
| Type 2 diabetes mellitus | 149 | 86.2 74.2–100.1ROR 99.9 · χ² 12,425 / p <1e-300 | 84.9 EB05 74.1 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious PRR 63.9 · ♀ 99% (drug 65%) · 95% clinician | no trial data cached |
| Liver function test increased | 88 | 80.6 65.9–98.5ROR 87.7 · χ² 6,816 / p <1e-300 | 78.9 EB05 66.0 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious PRR 88.6 · ♀ 100% (drug 65%) · 98% clinician | no trial data cached |
| Glossodynia (burning tongue/mouth pain) | 92 | 80.4 66.1–97.8ROR 87.8 · χ² 7,110 / p <1e-300 | 78.8 EB05 66.2 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious PRR 81.9 · ♀ 100% (drug 65%) · 96% clinician | no trial data cached |
| Liver injury | 98 | 79.1 65.5–95.6ROR 87.0 · χ² 7,461 / p <1e-300 | 77.7 EB05 65.6 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious PRR 57.8 · ♀ 99% (drug 65%) · 95% clinician | no trial data cached |
| Joint stiffness | 97 | 72.2 59.7–87.3ROR 79.2 · χ² 6,720 / p <1e-300 | 70.9 EB05 59.9 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious PRR 92.5 · ♀ 100% (drug 65%) · 98% clinician | no trial data cached |
| Disability | 67 | 66.1 52.4–83.4ROR 70.4 · χ² 4,219 / p <1e-300 | 64.7 EB05 52.7 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 47.9 · ♀ 98% (drug 65%) · 95% clinician | no trial data cached |
| C-reactive protein increased | 120 | 64.4 54.4–76.2ROR 72.3 · χ² 7,414 / p <1e-300 | 63.6 EB05 54.6 · IC025 +5.4 3/3 methods agree | Lab value / disease marker | serious PRR 47.2 · 97% clinician | no trial data cached |
| Osteoarthritis | 135 | 62.0 53.0–72.6ROR 70.8 · χ² 8,034 / p <1e-300 | 61.3 EB05 53.1 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious PRR 49.0 · ♀ 98% (drug 65%) · 93% clinician | no trial data cached |
| Knee arthroplasty | 65 | 60.8 48.0–77.0ROR 64.7 · χ² 3,757 / p <1e-300 | 59.6 EB05 48.4 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 44.6 · ♀ 100% (drug 65%) · 98% clinician | no trial data cached |
| Ear infection | 78 | 57.3 46.3–71.0ROR 61.7 · χ² 4,253 / p <1e-300 | 56.4 EB05 46.7 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 72.8 · ♀ 99% (drug 65%) · 96% clinician | no trial data cached |
| Impaired healing | 95 | 56.4 46.6–68.4ROR 61.8 · χ² 5,111 / p <1e-300 | 55.7 EB05 46.9 · IC025 +5.1 3/3 methods agree | Reporting / coding artifact | serious PRR 48.1 · ♀ 99% (drug 65%) · 96% clinician | no trial data cached |
| Upper respiratory tract infection (cold/sinus infection) | 133 | 56.2 47.9–65.9ROR 64.0 · χ² 7,153 / p <1e-300 | 55.6 EB05 48.1 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 67.5 · ♀ 98% (drug 65%) · 95% clinician | no trial data cached |
| Gait inability | 94 | 55.4 45.6–67.2ROR 60.6 · χ² 4,960 / p <1e-300 | 54.7 EB05 46.0 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 48.6 · ♀ 100% (drug 65%) · 97% clinician | no trial data cached |
| Osteoporosis | 113 | 53.5 44.9–63.7ROR 59.7 · χ² 5,766 / p <1e-300 | 52.9 EB05 45.2 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 43.6 · ♀ 100% (drug 65%) · 96% clinician | no trial data cached |
| Systemic lupus erythematosus | 96 | 52.9 43.7–64.1ROR 58.0 · χ² 4,834 / p <1e-300 | 52.3 EB05 44.1 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 38.3 · ♀ 100% (drug 65%) · 94% clinician | no trial data cached |
| Delirium | 89 | 50.2 41.1–61.3ROR 54.6 · χ² 4,238 / p <1e-300 | 49.6 EB05 41.5 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 36.1 · ♀ 97% (drug 65%) · 92% clinician | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Weight increased (weight gain) | 162 | 14.2 12.3–16.3ROR 16.5 · χ² 1,987 / p <1e-300 | 14.1 EB05 12.4 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 18.4 · ♀ 99% (drug 65%) · 96% clinician | no trial data cached |
| Nasopharyngitis (common cold) | 155 | 16.3 14.1–18.9ROR 18.9 · χ² 2,234 / p <1e-300 | 16.3 EB05 14.2 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 25.8 · ♀ 97% (drug 65%) | no trial data cached |
| Type 2 diabetes mellitus | 149 | 86.2 74.2–100.1ROR 99.9 · χ² 12,425 / p <1e-300 | 84.9 EB05 74.1 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious PRR 63.9 · ♀ 99% (drug 65%) · 95% clinician | no trial data cached |
| Urticaria (hives) | 146 | 17.1 14.7–19.9ROR 19.6 · χ² 2,210 / p <1e-300 | 17.0 EB05 14.8 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 23.8 · ♀ 98% (drug 65%) · 96% clinician | no trial data cached |
| Peripheral swelling | 146 | 18.5 15.9–21.5ROR 21.3 · χ² 2,418 / p <1e-300 | 18.5 EB05 16.1 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 21.8 · ♀ 96% (drug 65%) | no trial data cached |
| Wound infection | 139 | 252.0 215.5–294.6ROR 289.1 · χ² 34,069 / p <1e-300 | 240.5 EB05 208.8 · IC025 +6.8 3/3 methods agree | Not in label — unassessed | serious PRR 188.6 · ♀ 100% (drug 65%) · 96% clinician | no trial data cached |
| Osteoarthritis | 135 | 62.0 53.0–72.6ROR 70.8 · χ² 8,034 / p <1e-300 | 61.3 EB05 53.1 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious PRR 49.0 · ♀ 98% (drug 65%) · 93% clinician | no trial data cached |
| Wound | 135 | 94.9 81.0–111.2ROR 108.3 · χ² 12,405 / p <1e-300 | 93.2 EB05 80.8 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious PRR 79.5 · ♀ 100% (drug 65%) · 99% clinician | no trial data cached |
| Wheezing | 134 | 44.2 37.7–51.7ROR 50.3 · χ² 5,612 / p <1e-300 | 43.8 EB05 37.9 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 43.0 · ♀ 100% (drug 65%) · 98% clinician | no trial data cached |
| Prescribed underdose | 134 | 131.6 112.2–154.2ROR 150.1 · χ² 17,130 / p <1e-300 | 128.3 EB05 111.1 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious PRR 157.9 · ♀ 100% (drug 65%) · 97% clinician | no trial data cached |
| Upper respiratory tract infection (cold/sinus infection) | 133 | 56.2 47.9–65.9ROR 64.0 · χ² 7,153 / p <1e-300 | 55.6 EB05 48.1 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 67.5 · ♀ 98% (drug 65%) · 95% clinician | no trial data cached |
| Pain in extremity | 129 | 8.5 7.2–10.0ROR 9.5 · χ² 858 / p 5e-189 | 8.3 EB05 7.2 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 10.4 · ♀ 96% (drug 65%) · 95% clinician | no trial data cached |
| Oedema peripheral (swelling of legs/feet) | 126 | 20.1 17.0–23.6ROR 22.6 · χ² 2,273 / p <1e-300 | 20.0 EB05 17.2 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 19.0 · ♀ 97% (drug 65%) | no trial data cached |
| Musculoskeletal stiffness | 125 | 27.8 23.5–32.8ROR 31.3 · χ² 3,208 / p <1e-300 | 27.6 EB05 23.8 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 32.1 · ♀ 100% (drug 65%) | no trial data cached |
| Visual impairment | 124 | 19.6 16.6–23.2ROR 22.0 · χ² 2,184 / p <1e-300 | 19.6 EB05 16.8 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 23.6 · ♀ 100% (drug 65%) · 97% clinician | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Wound infection — n=139, PRR 252.0
- Helicobacter infection — n=112, PRR 216.1
- Hypercholesterolaemia — n=93, PRR 190.9
- Pemphigus — n=119, PRR 188.0
- Folliculitis — n=95, PRR 180.5
- Joint dislocation — n=96, PRR 179.0
- Autoimmune disorder — n=79, PRR 161.9
- Laryngitis — n=86, PRR 155.3
- Foot deformity — n=82, PRR 144.8
- Pericarditis — n=121, PRR 142.3
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Fluoride F-18?
In FDA FAERS, the most frequently co-reported reaction terms for Fluoride F-18 are weight increased, nasopharyngitis, type 2 diabetes mellitus, urticaria, peripheral swelling, wound infection. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Fluoride F-18 have an FDA boxed warning?
No. The FDA label retrieved for Fluoride F-18 has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Fluoride F-18 causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 4c45fe05-e3b7-4383-966c-4e218ff6f94a, effective 20260610; matched on
openfda.generic_name.exact:"SODIUM FLUORIDE F-18") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 126 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.