Gold side effects: what 5,753 FDA adverse event reports show

Gold · Aurum Metallicum · 385 reaction terms · 110,139 drug–reaction co-reports · data 2026-09-14

Drug class

Standardized Chemical Allergen

FDA label (Established Pharmacologic Class) · compare the class

Brand names

Aurum Metallicum

openFDA label

Who reports

5,753 reports · 98% serious · 1,231 with death outcome · 87% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Irritability with intolerance to noise

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 5Lab value / disease marker 2No label text to screen 33

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, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 345 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Hand deformity	915	274.2 257.7–291.8ROR 325.9 · calibrated p 4e-12 ✓	253.5 EB05 240.0 · IC025 +7.7 3/3 methods agree vs other Standardized Chemical Allergens: PRR 166.1 (94.0–293.5)	No label text to screen label has no adverse-reaction text	serious PRR 163.2	no trial arm names this drug
Synovitis	1,015	217.3 205.1–230.2ROR 263.6 · calibrated p 3e-11 ✓	204.2 EB05 193.9 · IC025 +7.4 3/3 methods agree vs other Standardized Chemical Allergens: PRR 184.2 (104.3–325.5)	No label text to screen label has no adverse-reaction text	serious PRR 126.4	no trial arm names this drug
Red blood cell sedimentation rate increased	599	208.2 192.5–225.1ROR 232.2 · calibrated p 1e-10 ✓	195.6 EB05 182.8 · IC025 +7.3 3/3 methods agree vs other Standardized Chemical Allergens: only this drug	Lab value / disease marker	serious PRR 131.6	no trial arm names this drug
Helicobacter infection	530	199.9 183.9–217.4ROR 220.1 · calibrated p 2e-10 ✓	188.2 EB05 175.1 · IC025 +7.2 3/3 methods agree vs other Standardized Chemical Allergens: PRR 96.2 (54.3–170.5)	No label text to screen label has no adverse-reaction text	serious PRR 118.0 · 97% clinician	no trial arm names this drug
Contraindicated product administered	1,495	190.1 181.7–198.9ROR 256.5 · calibrated p 4e-11 ✓	180.2 EB05 172.7 · IC025 +7.3 3/3 methods agree vs other Standardized Chemical Allergens: only this drug	Reporting / coding artifact	serious PRR 132.5	no trial arm names this drug
Folliculitis	511	189.7 174.3–206.6ROR 208.1 · calibrated p 3e-10 ✓	179.1 EB05 166.4 · IC025 +7.1 3/3 methods agree vs other Standardized Chemical Allergens: PRR 92.7 (52.3–164.4)	No label text to screen label has no adverse-reaction text	serious PRR 124.9 · 97% clinician	no trial arm names this drug
Hypercholesterolaemia	450	179.9 164.3–197.1ROR 195.1 · calibrated p 5e-10 ✓	170.2 EB05 157.4 · IC025 +7.0 3/3 methods agree vs other Standardized Chemical Allergens: only this drug	No label text to screen label has no adverse-reaction text	serious PRR 107.4 · 96% clinician	no trial arm names this drug
Pemphigus	565	173.6 160.2–188.1ROR 192.4 · calibrated p 6e-10 ✓	164.7 EB05 153.6 · IC025 +7.0 3/3 methods agree vs other Standardized Chemical Allergens: PRR 87.9 (51.7–149.4)	No label text to screen label has no adverse-reaction text	serious PRR 97.9 · 96% clinician	no trial arm names this drug
Joint range of motion decreased	603	172.2 159.4–186.1ROR 192.3 · calibrated p 6e-10 ✓	163.6 EB05 152.9 · IC025 +7.0 3/3 methods agree vs other Standardized Chemical Allergens: PRR 218.9 (98.0–489.2)	No label text to screen label has no adverse-reaction text	serious PRR 123.6 · 91% clinician	no trial arm names this drug
Bursitis	505	159.2 146.2–173.4ROR 174.5 · calibrated p 1e-9 ✓	151.7 EB05 140.9 · IC025 +6.9 3/3 methods agree vs other Standardized Chemical Allergens: PRR 22.4 (16.7–30.1)	No label text to screen label has no adverse-reaction text	serious PRR 105.9 · 97% clinician	no trial arm names this drug
Coeliac disease	373	144.0 130.3–159.2ROR 153.9 · calibrated p 4e-9 ✓	137.5 EB05 126.2 · IC025 +6.7 3/3 methods agree vs other Standardized Chemical Allergens: PRR 270.8 (86.9–843.5)	No label text to screen label has no adverse-reaction text	serious PRR 101.7 · 94% clinician	no trial arm names this drug
Wound infection	344	119.1 107.3–132.2ROR 126.6 · calibrated p 2e-8 ✓	114.6 EB05 104.8 · IC025 +6.5 3/3 methods agree vs other Standardized Chemical Allergens: PRR 53.5 (31.4–91.3)	No label text to screen label has no adverse-reaction text	serious PRR 72.9 · 97% clinician	no trial arm names this drug
Arthropathy	1,756	118.5 113.8–123.3ROR 170.1 · calibrated p 2e-9 ✓	114.6 EB05 110.2 · IC025 +6.7 3/3 methods agree vs other Standardized Chemical Allergens: PRR 81.4 (60.9–108.7)	No label text to screen label has no adverse-reaction text	serious PRR 82.5	no trial arm names this drug
Back injury	340	118.2 106.4–131.2ROR 125.5 · calibrated p 2e-8 ✓	113.7 EB05 103.9 · IC025 +6.4 3/3 methods agree vs other Standardized Chemical Allergens: only this drug	No label text to screen label has no adverse-reaction text	serious PRR 89.3 · 96% clinician	no trial arm names this drug
Adverse reaction	411	116.5 106.0–128.1ROR 125.4 · calibrated p 2e-8 ✓	112.3 EB05 103.5 · IC025 +6.5 3/3 methods agree vs other Standardized Chemical Allergens: only this drug	Reporting / coding artifact	serious n=410 · 90% clinician	no trial arm names this drug
Obesity	468	110.1 100.8–120.3ROR 119.8 · calibrated p 3e-8 ✓	106.4 EB05 98.6 · IC025 +6.4 3/3 methods agree vs other Standardized Chemical Allergens: only this drug	No label text to screen label has no adverse-reaction text	serious PRR 73.2 · 98% clinician	no trial arm names this drug
Glossodynia (burning tongue/mouth pain)	645	108.3 100.6–116.6ROR 121.8 · calibrated p 3e-8 ✓	104.8 EB05 98.2 · IC025 +6.5 3/3 methods agree vs other Standardized Chemical Allergens: PRR 82.6 (51.1–133.8)	No label text to screen label has no adverse-reaction text	serious PRR 89.8 · 96% clinician	no trial arm names this drug
Pericarditis	478	107.6 98.6–117.4ROR 117.3 · calibrated p 3e-8 ✓	104.1 EB05 96.5 · IC025 +6.4 3/3 methods agree vs other Standardized Chemical Allergens: PRR 208.2 (86.3–502.5)	No label text to screen label has no adverse-reaction text	serious PRR 62.1 · 94% clinician	no trial arm names this drug
Fibromyalgia	695	107.4 100.0–115.3ROR 122.0 · calibrated p 3e-8 ✓	104.0 EB05 97.7 · IC025 +6.5 3/3 methods agree vs other Standardized Chemical Allergens: only this drug	No label text to screen label has no adverse-reaction text	serious PRR 80.9	no trial arm names this drug
Therapeutic product effect decreased	1,206	101.8 96.7–107.1ROR 128.6 · calibrated p 2e-8 ✓	98.9 EB05 94.3 · IC025 +6.5 3/3 methods agree vs other Standardized Chemical Allergens: only this drug	Reporting / coding artifact	serious PRR 115.2	no trial arm names this drug
C-reactive protein increased	944	97.1 91.5–103.1ROR 116.0 · calibrated p 4e-8 ✓	94.4 EB05 89.5 · IC025 +6.4 3/3 methods agree vs other Standardized Chemical Allergens: only this drug	Lab value / disease marker	serious PRR 58.1	no trial arm names this drug
Rheumatoid arthritis	2,784	92.0 89.5–94.6ROR 177.4 · calibrated p 1e-9 ✓	89.7 EB05 86.9 · IC025 +6.4 3/3 methods agree vs other Standardized Chemical Allergens: only this drug	No label text to screen label has no adverse-reaction text	serious PRR 64.6	no trial arm names this drug
Pulmonary fibrosis	414	80.7 73.5–88.6ROR 86.9 · calibrated p 3e-7 ✓	78.7 EB05 72.5 · IC025 +6.0 3/3 methods agree vs other Standardized Chemical Allergens: only this drug	No label text to screen label has no adverse-reaction text	serious PRR 47.0	no trial arm names this drug
Irritable bowel syndrome	454	79.1 72.4–86.5ROR 85.8 · calibrated p 4e-7 ✓	77.2 EB05 71.4 · IC025 +6.0 3/3 methods agree vs other Standardized Chemical Allergens: only this drug	No label text to screen label has no adverse-reaction text	serious PRR 58.0 · 97% clinician	no trial arm names this drug
Drug intolerance	2,035	78.7 76.0–81.6ROR 121.3 · calibrated p 3e-8 ✓	77.0 EB05 74.2 · IC025 +6.2 3/3 methods agree vs other Standardized Chemical Allergens: only this drug	Reporting / coding artifact	serious PRR 73.9	no trial arm names this drug
Liver function test increased	447	78.0 71.3–85.4ROR 84.5 · calibrated p 4e-7 ✓	76.1 EB05 70.4 · IC025 +6.0 3/3 methods agree vs other Standardized Chemical Allergens: only this drug	No label text to screen label has no adverse-reaction text	serious PRR 70.0 · 90% clinician	no trial arm names this drug
Psoriatic arthropathy	781	72.2 67.6–77.1ROR 83.4 · calibrated p 4e-7 ✓	70.7 EB05 66.6 · IC025 +6.0 3/3 methods agree vs other Standardized Chemical Allergens: only this drug	No label text to screen label has no adverse-reaction text	serious PRR 52.5 · 91% clinician	no trial arm names this drug
Foot deformity	215	72.0 63.1–82.2ROR 74.8 · calibrated p 1e-6 ✓	70.2 EB05 62.7 · IC025 +5.7 3/3 methods agree vs other Standardized Chemical Allergens: only this drug	No label text to screen label has no adverse-reaction text	serious PRR 48.4	no trial arm names this drug
Treatment failure	1,539	69.6 66.7–72.7ROR 94.7 · calibrated p 2e-7 ✓	68.3 EB05 65.5 · IC025 +6.0 3/3 methods agree vs other Standardized Chemical Allergens: only this drug	Reporting / coding artifact	serious PRR 76.7	no trial arm names this drug
Liver injury	432	66.3 60.5–72.6ROR 71.6 · calibrated p 1e-6 ✓	64.9 EB05 60.0 · IC025 +5.8 3/3 methods agree vs other Standardized Chemical Allergens: only this drug	No label text to screen label has no adverse-reaction text	serious PRR 39.7 · 98% clinician	no trial arm names this drug
Sciatica	279	65.3 58.1–73.2ROR 68.5 · calibrated p 2e-6 ✓	63.8 EB05 57.8 · IC025 +5.7 3/3 methods agree vs other Standardized Chemical Allergens: only this drug	No label text to screen label has no adverse-reaction text	serious PRR 50.8 · 90% clinician	no trial arm names this drug
Inflammation	899	65.0 61.1–69.0ROR 76.8 · calibrated p 8e-7 ✓	63.7 EB05 60.3 · IC025 +5.8 3/3 methods agree vs other Standardized Chemical Allergens: only this drug	No label text to screen label has no adverse-reaction text	serious PRR 50.3 · 91% clinician	no trial arm names this drug
Taste disorder	350	64.8 58.5–71.8ROR 68.9 · calibrated p 2e-6 ✓	63.4 EB05 58.1 · IC025 +5.7 3/3 methods agree vs other Standardized Chemical Allergens: only this drug	No label text to screen label has no adverse-reaction text	serious PRR 75.4 · 98% clinician	no trial arm names this drug
Joint swelling	1,983	61.0 58.8–63.2ROR 92.6 · calibrated p 2e-7 ✓	60.0 EB05 57.8 · IC025 +5.8 3/3 methods agree vs other Standardized Chemical Allergens: only this drug	No label text to screen label has no adverse-reaction text	serious PRR 60.9	no trial arm names this drug
Tenderness	170	60.3 51.9–70.0ROR 62.1 · calibrated p 4e-6 ✓	59.0 EB05 51.9 · IC025 +5.4 3/3 methods agree vs other Standardized Chemical Allergens: only this drug	No label text to screen label has no adverse-reaction text	serious n=169	no trial arm names this drug
Systemic lupus erythematosus	566	59.3 54.8–64.1ROR 65.6 · calibrated p 2e-6 ✓	58.2 EB05 54.3 · IC025 +5.7 3/3 methods agree vs other Standardized Chemical Allergens: only this drug	No label text to screen label has no adverse-reaction text	serious PRR 35.3 · 94% clinician	no trial arm names this drug
Hepatitis (liver inflammation)	399	57.7 52.5–63.5ROR 61.9 · calibrated p 4e-6 ✓	56.7 EB05 52.2 · IC025 +5.6 3/3 methods agree vs other Standardized Chemical Allergens: only this drug	No label text to screen label has no adverse-reaction text	serious PRR 34.1 · 93% clinician	no trial arm names this drug
Wound	422	56.2 51.2–61.6ROR 60.5 · calibrated p 4e-6 ✓	55.2 EB05 50.9 · IC025 +5.5 3/3 methods agree vs other Standardized Chemical Allergens: only this drug	No label text to screen label has no adverse-reaction text	serious PRR 38.8 · 94% clinician	no trial arm names this drug
Pharyngitis	184	54.6 47.3–63.0ROR 56.4 · calibrated p 7e-6 ✓	53.5 EB05 47.4 · IC025 +5.3 3/3 methods agree vs other Standardized Chemical Allergens: only this drug	No label text to screen label has no adverse-reaction text	serious PRR 41.1	no trial arm names this drug
Osteoarthritis	623	54.3 50.3–58.5ROR 60.7 · calibrated p 4e-6 ✓	53.4 EB05 50.0 · IC025 +5.5 3/3 methods agree vs other Standardized Chemical Allergens: only this drug	No label text to screen label has no adverse-reaction text	serious PRR 35.3 · 90% clinician	no trial arm names this drug

Trial evidence (ClinicalTrials.gov)

ClinicalTrials.gov returned results-bearing trials mentioning Gold only as a background or rescue medication (NCT00720798); no trial listing it as the tested intervention was cached, so no trial cross-check is shown.

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
Drug ineffective (drug did not work)	3,478	9.7 9.5–9.9ROR 22.9 · calibrated p 0.001 ✓	9.6 EB05 9.4 · IC025 +3.2 3/3 methods agree vs other Standardized Chemical Allergens: only this drug	Reporting / coding artifact	serious PRR 15.8	no trial arm names this drug
Rheumatoid arthritis	2,784	92.0 89.5–94.6ROR 177.4 · calibrated p 1e-9 ✓	89.7 EB05 86.9 · IC025 +6.4 3/3 methods agree vs other Standardized Chemical Allergens: only this drug	No label text to screen label has no adverse-reaction text	serious PRR 64.6	no trial arm names this drug
Drug intolerance	2,035	78.7 76.0–81.6ROR 121.3 · calibrated p 3e-8 ✓	77.0 EB05 74.2 · IC025 +6.2 3/3 methods agree vs other Standardized Chemical Allergens: only this drug	Reporting / coding artifact	serious PRR 73.9	no trial arm names this drug
Joint swelling	1,983	61.0 58.8–63.2ROR 92.6 · calibrated p 2e-7 ✓	60.0 EB05 57.8 · IC025 +5.8 3/3 methods agree vs other Standardized Chemical Allergens: only this drug	No label text to screen label has no adverse-reaction text	serious PRR 60.9	no trial arm names this drug
Off label use (used outside approved label)	1,959	8.2 8.0–8.5ROR 12.0 · calibrated p 0.017 ✓	8.2 EB05 7.9 · IC025 +3.0 3/3 methods agree vs other Standardized Chemical Allergens: only this drug	Reporting / coding artifact	serious PRR 9.1	no trial arm names this drug
Arthralgia (joint pain)	1,849	16.3 15.7–17.0ROR 23.6 · calibrated p 9e-4 ✓	16.3 EB05 15.6 · IC025 +3.9 3/3 methods agree vs other Standardized Chemical Allergens: only this drug	No label text to screen label has no adverse-reaction text	serious PRR 17.5	no trial arm names this drug
Drug hypersensitivity	1,843	34.9 33.6–36.3ROR 50.9 · calibrated p 1e-5 ✓	34.6 EB05 33.3 · IC025 +5.0 3/3 methods agree vs other Standardized Chemical Allergens: PRR 49.6 (39.7–61.9)	No label text to screen label has no adverse-reaction text	serious PRR 56.3	no trial arm names this drug
Arthropathy	1,756	118.5 113.8–123.3ROR 170.1 · calibrated p 2e-9 ✓	114.6 EB05 110.2 · IC025 +6.7 3/3 methods agree vs other Standardized Chemical Allergens: PRR 81.4 (60.9–108.7)	No label text to screen label has no adverse-reaction text	serious PRR 82.5	no trial arm names this drug
Pain	1,643	9.8 9.4–10.2ROR 13.3 · calibrated p 0.011 ✓	9.7 EB05 9.3 · IC025 +3.2 3/3 methods agree vs other Standardized Chemical Allergens: only this drug	No label text to screen label has no adverse-reaction text	serious PRR 9.1	no trial arm names this drug
Condition aggravated	1,553	18.8 18.1–19.7ROR 25.4 · calibrated p 6e-4 ✓	18.7 EB05 18.0 · IC025 +4.1 3/3 methods agree vs other Standardized Chemical Allergens: only this drug	Reporting / coding artifact	serious PRR 16.8	no trial arm names this drug
Treatment failure	1,539	69.6 66.7–72.7ROR 94.7 · calibrated p 2e-7 ✓	68.3 EB05 65.5 · IC025 +6.0 3/3 methods agree vs other Standardized Chemical Allergens: only this drug	Reporting / coding artifact	serious PRR 76.7	no trial arm names this drug
Contraindicated product administered	1,495	190.1 181.7–198.9ROR 256.5 · calibrated p 4e-11 ✓	180.2 EB05 172.7 · IC025 +7.3 3/3 methods agree vs other Standardized Chemical Allergens: only this drug	Reporting / coding artifact	serious PRR 132.5	no trial arm names this drug
Nausea	1,311	6.1 5.8–6.4ROR 7.6 · calibrated p 0.079	6.0 EB05 5.8 · IC025 +2.5 3/3 methods agree vs other Standardized Chemical Allergens: only this drug	No label text to screen label has no adverse-reaction text	serious PRR 6.9	no trial arm names this drug
Rash	1,297	10.9 10.4–11.5ROR 13.8 · calibrated p 0.010 ✓	10.9 EB05 10.4 · IC025 +3.3 3/3 methods agree vs other Standardized Chemical Allergens: only this drug	No label text to screen label has no adverse-reaction text	serious PRR 14.3	no trial arm names this drug
Therapeutic product effect decreased	1,206	101.8 96.7–107.1ROR 128.6 · calibrated p 2e-8 ✓	98.9 EB05 94.3 · IC025 +6.5 3/3 methods agree vs other Standardized Chemical Allergens: only this drug	Reporting / coding artifact	serious PRR 115.2	no trial arm names this drug

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 Gold?

In FDA FAERS, the most frequently co-reported reaction terms for Gold are rheumatoid arthritis, joint swelling, arthralgia, drug hypersensitivity, arthropathy, pain. 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 Gold have an FDA boxed warning?

No. The FDA label retrieved for Gold has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Gold 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 6b413d60-29d5-11e7-8208-424c58303031, effective 20231108; matched on openfda.generic_name.exact:"GOLD")
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, field patient.drug.openfda.generic_name.exact, 385 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
ClinicalTrials.gov API v2 (query GOLD, results-bearing studies sorted by enrollment)

Page generated 2026-10-14. 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.