Drug · FAERS side-effect profile with label screen
Titanium side effects: what 79 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Titanium Metallicum
openFDA label
Who reports
79 reports · 96% serious · 67 with death outcome · 27% female
openFDA FAERS counts, all years, deduplication not applied
Used for
See symptoms on front panel. Relieves skin irritation
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 26 strongest signals
Reporting / coding artifact 3Lab value / disease marker 1No label text to screen 22
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.
- No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.
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. 5 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 |
|---|---|---|---|---|---|---|
| Appendicitis | 49 | 1,406.5 1,182.2–1,673.5ROR 3,702.2 · χ² 67,094 / p <1e-300 | 902.0 EB05 709.3 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 849.1 · 94% clinician | no trial data cached |
| Ventricular fibrillation | 49 | 1,172.9 986.0–1,395.2ROR 3,086.9 · χ² 55,986 / p <1e-300 | 800.0 EB05 629.0 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 700.0 · 94% clinician | no trial data cached |
| Cardiogenic shock | 46 | 858.4 711.6–1,035.4ROR 2,053.5 · χ² 38,440 / p <1e-300 | 629.9 EB05 491.4 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 511.4 · 93% clinician | no trial data cached |
| Incorrect route of product administration | 40 | 633.3 509.1–787.7ROR 1,281.7 · χ² 24,582 / p <1e-300 | 484.6 EB05 371.2 · IC025 +5.6 3/3 methods agree | Reporting / coding artifact | serious PRR 755.3 · 98% clinician | no trial data cached |
| Bacterial infection | 41 | 587.2 474.7–726.5ROR 1,219.7 · χ² 23,380 / p <1e-300 | 459.7 EB05 353.3 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 405.0 · 95% clinician | no trial data cached |
| Hyperlipidaemia | 25 | 554.8 401.0–767.5ROR 811.1 · χ² 13,250 / p <1e-300 | 388.5 EB05 276.7 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 364.8 · 92% clinician | no trial data cached |
| Neuralgia | 46 | 504.4 418.3–608.2ROR 1,206.0 · χ² 22,591 / p <1e-300 | 416.0 EB05 324.5 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 447.2 · 96% clinician | no trial data cached |
| Ulcer | 27 | 450.5 331.6–612.1ROR 684.0 · χ² 11,654 / p <1e-300 | 340.9 EB05 246.1 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 339.5 · 93% clinician | no trial data cached |
| Ascites | 49 | 442.9 372.5–526.5ROR 1,164.6 · χ² 21,157 / p <1e-300 | 376.9 EB05 296.4 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 268.3 · 94% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 46 | 438.3 363.5–528.4ROR 1,047.8 · χ² 19,626 / p <1e-300 | 370.0 EB05 288.7 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 261.5 · 93% clinician | no trial data cached |
| Blood test abnormal | 23 | 435.5 308.6–614.6ROR 614.0 · χ² 9,532 / p <1e-300 | 319.3 EB05 224.1 · IC025 +4.7 3/3 methods agree | Reporting / coding artifact | serious PRR 398.3 · 96% clinician | no trial data cached |
| End stage renal disease | 27 | 389.6 286.8–529.3ROR 591.4 · χ² 10,075 / p <1e-300 | 305.0 EB05 220.1 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 232.6 · 93% clinician | no trial data cached |
| Gout | 26 | 384.7 280.7–527.2ROR 572.9 · χ² 9,564 / p <1e-300 | 299.5 EB05 214.8 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 347.4 · 96% clinician | no trial data cached |
| Blood cholesterol increased | 42 | 239.2 194.5–294.3ROR 509.7 · χ² 9,740 / p <1e-300 | 215.7 EB05 166.3 · IC025 +5.5 3/3 methods agree | Lab value / disease marker | serious PRR 217.0 · 95% clinician | no trial data cached |
| Chronic obstructive pulmonary disease | 44 | 224.2 184.1–273.0ROR 504.8 · χ² 9,570 / p <1e-300 | 204.2 EB05 158.4 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 156.4 · 95% clinician | no trial data cached |
| Hyponatraemia (low sodium) | 45 | 212.7 175.5–257.6ROR 492.8 · χ² 9,287 / p <1e-300 | 195.0 EB05 151.7 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 130.4 · 93% clinician | no trial data cached |
| Liver function test increased | 15 | 186.8 118.4–294.6ROR 230.3 · χ² 2,590 / p <1e-300 | 151.2 EB05 97.2 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 174.4 | no trial data cached |
| Stress | 45 | 166.2 137.2–201.3ROR 384.8 · χ² 7,244 / p <1e-300 | 155.2 EB05 120.8 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 164.8 · 93% clinician | no trial data cached |
| Sleep disorder | 43 | 163.2 133.4–199.7ROR 357.0 · χ² 6,790 / p <1e-300 | 152.2 EB05 117.7 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 161.0 · 95% clinician | no trial data cached |
| Diabetes mellitus | 47 | 163.0 135.9–195.6ROR 401.0 · χ² 7,429 / p <1e-300 | 152.9 EB05 119.6 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 105.9 · 94% clinician | no trial data cached |
| Dry mouth | 48 | 157.4 131.8–187.9ROR 399.6 · χ² 7,328 / p <1e-300 | 148.1 EB05 116.2 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 186.8 · 94% clinician | no trial data cached |
| Thrombosis | 46 | 151.4 125.6–182.5ROR 361.1 · χ² 6,746 / p <1e-300 | 142.5 EB05 111.2 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 93.9 · 96% clinician | no trial data cached |
| Intentional product misuse | 46 | 140.6 116.7–169.5ROR 335.3 · χ² 6,262 / p <1e-300 | 132.9 EB05 103.7 · IC025 +5.3 3/3 methods agree | Reporting / coding artifact | serious PRR 191.0 · 93% clinician | no trial data cached |
| Lower respiratory tract infection | 24 | 140.6 100.7–196.4ROR 201.6 · χ² 3,195 / p <1e-300 | 126.6 EB05 89.6 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 89.0 · 92% clinician | no trial data cached |
| Swelling | 47 | 133.7 111.4–160.3ROR 328.5 · χ² 6,080 / p <1e-300 | 126.8 EB05 99.2 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 129.7 · 96% clinician | no trial data cached |
| Pulmonary embolism (lung blood clot) | 45 | 125.2 103.3–151.6ROR 289.5 · χ² 5,442 / p <1e-300 | 118.9 EB05 92.5 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 75.2 · 96% 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 |
|---|---|---|---|---|---|---|
| Ascites | 49 | 442.9 372.5–526.5ROR 1,164.6 · χ² 21,157 / p <1e-300 | 376.9 EB05 296.4 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 268.3 · 94% clinician | no trial data cached |
| Ventricular fibrillation | 49 | 1,172.9 986.0–1,395.2ROR 3,086.9 · χ² 55,986 / p <1e-300 | 800.0 EB05 629.0 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 700.0 · 94% clinician | no trial data cached |
| Appendicitis | 49 | 1,406.5 1,182.2–1,673.5ROR 3,702.2 · χ² 67,094 / p <1e-300 | 902.0 EB05 709.3 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 849.1 · 94% clinician | no trial data cached |
| Dry mouth | 48 | 157.4 131.8–187.9ROR 399.6 · χ² 7,328 / p <1e-300 | 148.1 EB05 116.2 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 186.8 · 94% clinician | no trial data cached |
| Swelling | 47 | 133.7 111.4–160.3ROR 328.5 · χ² 6,080 / p <1e-300 | 126.8 EB05 99.2 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 129.7 · 96% clinician | no trial data cached |
| Diabetes mellitus | 47 | 163.0 135.9–195.6ROR 401.0 · χ² 7,429 / p <1e-300 | 152.9 EB05 119.6 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 105.9 · 94% clinician | no trial data cached |
| Intentional product misuse | 46 | 140.6 116.7–169.5ROR 335.3 · χ² 6,262 / p <1e-300 | 132.9 EB05 103.7 · IC025 +5.3 3/3 methods agree | Reporting / coding artifact | serious PRR 191.0 · 93% clinician | no trial data cached |
| Thrombosis | 46 | 151.4 125.6–182.5ROR 361.1 · χ² 6,746 / p <1e-300 | 142.5 EB05 111.2 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 93.9 · 96% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 46 | 438.3 363.5–528.4ROR 1,047.8 · χ² 19,626 / p <1e-300 | 370.0 EB05 288.7 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 261.5 · 93% clinician | no trial data cached |
| Neuralgia | 46 | 504.4 418.3–608.2ROR 1,206.0 · χ² 22,591 / p <1e-300 | 416.0 EB05 324.5 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 447.2 · 96% clinician | no trial data cached |
| Cardiogenic shock | 46 | 858.4 711.6–1,035.4ROR 2,053.5 · χ² 38,440 / p <1e-300 | 629.9 EB05 491.4 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 511.4 · 93% clinician | no trial data cached |
| Pulmonary embolism (lung blood clot) | 45 | 125.2 103.3–151.6ROR 289.5 · χ² 5,442 / p <1e-300 | 118.9 EB05 92.5 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 75.2 · 96% clinician | no trial data cached |
| Stress | 45 | 166.2 137.2–201.3ROR 384.8 · χ² 7,244 / p <1e-300 | 155.2 EB05 120.8 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 164.8 · 93% clinician | no trial data cached |
| Hyponatraemia (low sodium) | 45 | 212.7 175.5–257.6ROR 492.8 · χ² 9,287 / p <1e-300 | 195.0 EB05 151.7 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 130.4 · 93% clinician | no trial data cached |
| Chronic obstructive pulmonary disease | 44 | 224.2 184.1–273.0ROR 504.8 · χ² 9,570 / p <1e-300 | 204.2 EB05 158.4 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 156.4 · 95% clinician | no trial data cached |
Unlabeled candidate signals
Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.
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 Titanium?
In FDA FAERS, the most frequently co-reported reaction terms for Titanium are ascites, ventricular fibrillation, appendicitis, dry mouth, swelling, diabetes mellitus. 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 Titanium have an FDA boxed warning?
No. The FDA label retrieved for Titanium has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Titanium 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 21b504bc-e12d-3a8e-e063-6294a90a7708, effective 20240909; matched on
openfda.generic_name.exact:"TITANIUM") - 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, 31 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.