Platinum side effects: what 527 FDA adverse event reports show

Platinum · Platinum Metallicum · 23 reaction terms · 324 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Brand names

Platinum Metallicum

openFDA label

Who reports

527 reports · 96% serious · 102 with death outcome · 47% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Constipation while traveling

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 21 strongest signals

Reporting / coding artifact 4Lab value / disease marker 2No label text to screen 15

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. 2 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
Ovarian cancer	12	51.6 29.5–90.3ROR 52.8 · χ² 546 / p 6e-121	47.9 EB05 29.2 · IC025 +3.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 31.0	no trial data cached
Blood lactate dehydrogenase increased	20	50.0 32.5–76.8ROR 51.9 · χ² 911 / p 2e-200	47.8 EB05 32.7 · IC025 +3.8 3/3 methods agree	Lab value / disease marker	serious PRR 31.8 · 90% clinician	no trial data cached
Myocarditis	13	45.7 26.7–78.2ROR 46.9 · χ² 525 / p 2e-116	43.0 EB05 26.7 · IC025 +3.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 27.4	no trial data cached
Pneumonitis	25	36.8 25.1–54.0ROR 38.6 · χ² 836 / p 4e-184	35.9 EB05 25.6 · IC025 +3.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 22.9 · 92% clinician	no trial data cached
Therapy partial responder	13	34.4 20.1–58.8ROR 35.2 · χ² 388 / p 9e-87	32.8 EB05 20.4 · IC025 +3.0 3/3 methods agree	Reporting / coding artifact	serious PRR 23.0	no trial data cached
Blood calcium decreased	9	31.8 16.6–60.7ROR 32.3 · χ² 238 / p 5e-54	29.8 EB05 16.6 · IC025 +2.5 3/3 methods agree	Lab value / disease marker	serious PRR 23.8	no trial data cached
Myelodysplastic syndrome	10	27.5 14.9–50.8ROR 28.0 · χ² 230 / p 4e-52	26.1 EB05 14.9 · IC025 +2.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 16.6	no trial data cached
Drug resistance	17	26.4 16.5–42.1ROR 27.2 · χ² 390 / p 4e-87	25.6 EB05 16.9 · IC025 +3.1 3/3 methods agree	Reporting / coding artifact	serious PRR 16.7	no trial data cached
Renal tubular necrosis	6	24.3 11.0–53.8ROR 24.6 · χ² 112 / p 2e-26	21.4 EB05 8.5 · IC025 +1.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 14.6	no trial data cached
Hepatotoxicity (liver damage)	13	23.3 13.6–39.9ROR 23.9 · χ² 256 / p 6e-58	22.5 EB05 13.8 · IC025 +2.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 14.3	no trial data cached
Haematotoxicity	5	21.5 9.0–51.4ROR 21.7 · χ² 78 / p 5e-19	17.3 EB05 5.5 · IC025 +1.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 13.2	no trial data cached
Mucosal inflammation	14	21.4 12.8–35.9ROR 21.9 · χ² 252 / p 4e-57	20.7 EB05 12.8 · IC025 +2.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 13.6	no trial data cached
Disease progression	62	20.9 16.6–26.4ROR 23.6 · χ² 1,163 / p 4e-255	20.8 EB05 16.8 · IC025 +3.8 3/3 methods agree	Reporting / coding artifact	serious PRR 14.5 · ♀ 79% (drug 47%) · 95% clinician	no trial data cached
Metastases to lung	6	20.7 9.3–45.9ROR 20.9 · χ² 94 / p 2e-22	17.6 EB05 6.5 · IC025 +1.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 12.5	no trial data cached
Proteinuria	9	19.0 9.9–36.3ROR 19.3 · χ² 136 / p 1e-31	17.5 EB05 8.6 · IC025 +2.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 12.7	no trial data cached
Malignant neoplasm progression	43	16.8 12.6–22.4ROR 18.2 · χ² 626 / p 2e-138	16.6 EB05 12.8 · IC025 +3.3 3/3 methods agree	Reporting / coding artifact	serious PRR 10.3	no trial data cached
Bone marrow failure	7	13.6 6.5–28.4ROR 13.8 · χ² 70 / p 3e-17	10.6 EB05 4.5 · IC025 +1.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 8.2	no trial data cached
Metastases to bone	5	12.2 5.1–29.1ROR 12.3 · χ² 41 / p 9e-11	8.0 EB05 3.1 · IC025 +1.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 7.4	no trial data cached
Palmar-plantar erythrodysaesthesia syndrome	7	11.9 5.7–24.9ROR 12.1 · χ² 60 / p 6e-15	8.9 EB05 3.9 · IC025 +1.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 9.5	no trial data cached
Myelosuppression	10	11.7 6.3–21.6ROR 11.9 · χ² 88 / p 4e-21	9.6 EB05 4.9 · IC025 +1.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 7.0	no trial data cached
Plasma cell myeloma	10	10.2 5.5–18.8ROR 10.4 · χ² 74 / p 4e-18	8.1 EB05 4.3 · IC025 +1.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 6.6	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
Disease progression	62	20.9 16.6–26.4ROR 23.6 · χ² 1,163 / p 4e-255	20.8 EB05 16.8 · IC025 +3.8 3/3 methods agree	Reporting / coding artifact	serious PRR 14.5 · ♀ 79% (drug 47%) · 95% clinician	no trial data cached
Malignant neoplasm progression	43	16.8 12.6–22.4ROR 18.2 · χ² 626 / p 2e-138	16.6 EB05 12.8 · IC025 +3.3 3/3 methods agree	Reporting / coding artifact	serious PRR 10.3	no trial data cached
Pneumonitis	25	36.8 25.1–54.0ROR 38.6 · χ² 836 / p 4e-184	35.9 EB05 25.6 · IC025 +3.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 22.9 · 92% clinician	no trial data cached
Blood lactate dehydrogenase increased	20	50.0 32.5–76.8ROR 51.9 · χ² 911 / p 2e-200	47.8 EB05 32.7 · IC025 +3.8 3/3 methods agree	Lab value / disease marker	serious PRR 31.8 · 90% clinician	no trial data cached
Drug resistance	17	26.4 16.5–42.1ROR 27.2 · χ² 390 / p 4e-87	25.6 EB05 16.9 · IC025 +3.1 3/3 methods agree	Reporting / coding artifact	serious PRR 16.7	no trial data cached
Mucosal inflammation	14	21.4 12.8–35.9ROR 21.9 · χ² 252 / p 4e-57	20.7 EB05 12.8 · IC025 +2.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 13.6	no trial data cached
Hepatotoxicity (liver damage)	13	23.3 13.6–39.9ROR 23.9 · χ² 256 / p 6e-58	22.5 EB05 13.8 · IC025 +2.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 14.3	no trial data cached
Therapy partial responder	13	34.4 20.1–58.8ROR 35.2 · χ² 388 / p 9e-87	32.8 EB05 20.4 · IC025 +3.0 3/3 methods agree	Reporting / coding artifact	serious PRR 23.0	no trial data cached
Myocarditis	13	45.7 26.7–78.2ROR 46.9 · χ² 525 / p 2e-116	43.0 EB05 26.7 · IC025 +3.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 27.4	no trial data cached
Ovarian cancer	12	51.6 29.5–90.3ROR 52.8 · χ² 546 / p 6e-121	47.9 EB05 29.2 · IC025 +3.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 31.0	no trial data cached
Plasma cell myeloma	10	10.2 5.5–18.8ROR 10.4 · χ² 74 / p 4e-18	8.1 EB05 4.3 · IC025 +1.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 6.6	no trial data cached
Myelosuppression	10	11.7 6.3–21.6ROR 11.9 · χ² 88 / p 4e-21	9.6 EB05 4.9 · IC025 +1.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 7.0	no trial data cached
Myelodysplastic syndrome	10	27.5 14.9–50.8ROR 28.0 · χ² 230 / p 4e-52	26.1 EB05 14.9 · IC025 +2.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 16.6	no trial data cached
Proteinuria	9	19.0 9.9–36.3ROR 19.3 · χ² 136 / p 1e-31	17.5 EB05 8.6 · IC025 +2.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 12.7	no trial data cached
Blood calcium decreased	9	31.8 16.6–60.7ROR 32.3 · χ² 238 / p 5e-54	29.8 EB05 16.6 · IC025 +2.5 3/3 methods agree	Lab value / disease marker	serious PRR 23.8	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 Platinum?

In FDA FAERS, the most frequently co-reported reaction terms for Platinum are pneumonitis, blood lactate dehydrogenase increased, mucosal inflammation, hepatotoxicity, myocarditis, ovarian cancer. 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 Platinum have an FDA boxed warning?

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

Do FAERS signals prove that Platinum 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 6908d9bd-fc21-39ff-e053-2a91aa0a4ca7, effective 20231114; matched on openfda.generic_name.exact:"PLATINUM")
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, 23 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.