Drug · FAERS side-effect profile with label screen

Mineral Oil and White Petrolatum side effects: what 511 FDA adverse event reports show

Mineral Oil And White Petrolatum · 14 reaction terms · 919 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Label matched

Mineral Oil (Mineral Oil)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

511 reports · 11% serious · 2 with death outcome · 77% female

openFDA FAERS counts, all years, deduplication not applied

Used for

relieves occasional constipation (irregularity) generally produces bowel movement in 6 to 8 hours

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 12 strongest signals

Reporting / coding artifact 1No label text to screen 11

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.
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
Eye discharge	54	218.0 169.3–280.8ROR 243.7 · χ² 11,394 / p <1e-300	201.5 EB05 160.3 · IC025 +5.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=1 · ♀ 46% (drug 77%) · 100% consumer	no trial data cached
Eye irritation	173	127.7 113.1–144.2ROR 192.6 · χ² 21,616 / p <1e-300	125.6 EB05 110.7 · IC025 +6.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 120.0 · 98% consumer	no trial data cached
Ocular hyperaemia	129	113.6 97.8–131.9ROR 151.6 · χ² 14,279 / p <1e-300	111.5 EB05 96.2 · IC025 +6.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 42.2 · 97% consumer	no trial data cached
Eye pruritus	83	103.6 85.0–126.1ROR 123.5 · χ² 8,320 / p <1e-300	101.0 EB05 84.0 · IC025 +5.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	99% consumer	no trial data cached
Dry eye	121	102.7 87.9–120.1ROR 134.3 · χ² 12,086 / p <1e-300	100.9 EB05 86.7 · IC025 +5.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 100.7 · 97% consumer	no trial data cached
Lacrimation increased	58	79.8 62.6–101.7ROR 89.9 · χ² 4,433 / p <1e-300	77.7 EB05 62.3 · IC025 +5.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 38.9 · 98% consumer	no trial data cached
Eye pain	103	76.7 64.5–91.1ROR 95.8 · χ² 7,623 / p <1e-300	75.5 EB05 64.0 · IC025 +5.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 28.1 · 98% consumer	no trial data cached
Ocular discomfort	15	56.8 34.5–93.5ROR 58.4 · χ² 766 / p 7e-169	53.1 EB05 34.1 · IC025 +3.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial data cached
Vision blurred (blurred vision)	125	37.6 32.3–43.8ROR 49.4 · χ² 4,439 / p <1e-300	37.4 EB05 32.2 · IC025 +4.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 15.7 · 98% consumer	no trial data cached
Eyelid oedema	7	24.6 11.8–51.3ROR 24.9 · χ² 135 / p 1e-31	22.3 EB05 10.3 · IC025 +2.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial data cached
Eye swelling	17	18.9 11.8–30.1ROR 19.5 · χ² 271 / p 4e-61	18.3 EB05 11.8 · IC025 +2.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial data cached
Product quality issue	28	8.5 5.9–12.2ROR 9.0 · χ² 180 / p 3e-41	7.8 EB05 5.5 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	serious PRR 13.9 · 100% consumer	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
Eye irritation	173	127.7 113.1–144.2ROR 192.6 · χ² 21,616 / p <1e-300	125.6 EB05 110.7 · IC025 +6.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 120.0 · 98% consumer	no trial data cached
Ocular hyperaemia	129	113.6 97.8–131.9ROR 151.6 · χ² 14,279 / p <1e-300	111.5 EB05 96.2 · IC025 +6.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 42.2 · 97% consumer	no trial data cached
Vision blurred (blurred vision)	125	37.6 32.3–43.8ROR 49.4 · χ² 4,439 / p <1e-300	37.4 EB05 32.2 · IC025 +4.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 15.7 · 98% consumer	no trial data cached
Dry eye	121	102.7 87.9–120.1ROR 134.3 · χ² 12,086 / p <1e-300	100.9 EB05 86.7 · IC025 +5.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 100.7 · 97% consumer	no trial data cached
Eye pain	103	76.7 64.5–91.1ROR 95.8 · χ² 7,623 / p <1e-300	75.5 EB05 64.0 · IC025 +5.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 28.1 · 98% consumer	no trial data cached
Eye pruritus	83	103.6 85.0–126.1ROR 123.5 · χ² 8,320 / p <1e-300	101.0 EB05 84.0 · IC025 +5.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	99% consumer	no trial data cached
Lacrimation increased	58	79.8 62.6–101.7ROR 89.9 · χ² 4,433 / p <1e-300	77.7 EB05 62.3 · IC025 +5.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 38.9 · 98% consumer	no trial data cached
Eye discharge	54	218.0 169.3–280.8ROR 243.7 · χ² 11,394 / p <1e-300	201.5 EB05 160.3 · IC025 +5.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=1 · ♀ 46% (drug 77%) · 100% consumer	no trial data cached
Product quality issue	28	8.5 5.9–12.2ROR 9.0 · χ² 180 / p 3e-41	7.8 EB05 5.5 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	serious PRR 13.9 · 100% consumer	no trial data cached
Eye swelling	17	18.9 11.8–30.1ROR 19.5 · χ² 271 / p 4e-61	18.3 EB05 11.8 · IC025 +2.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial data cached
Ocular discomfort	15	56.8 34.5–93.5ROR 58.4 · χ² 766 / p 7e-169	53.1 EB05 34.1 · IC025 +3.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial data cached
Eyelid oedema	7	24.6 11.8–51.3ROR 24.9 · χ² 135 / p 1e-31	22.3 EB05 10.3 · IC025 +2.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial data cached
Eye inflammation	3	13.1 4.2–40.3ROR 13.1 · χ² 22 / p 1e-6	6.6 EB05 2.0 · IC025 +0.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=1	no trial data cached
Product packaging issue	3	13.3 4.3–41.0ROR 13.3 · χ² 23 / p 9e-7	6.7 EB05 2.1 · IC025 +0.2 3/3 methods agree	Reporting / coding artifact	–	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 Mineral Oil and White Petrolatum?

In FDA FAERS, the most frequently co-reported reaction terms for Mineral Oil and White Petrolatum are eye irritation, ocular hyperaemia, vision blurred, dry eye, eye pain, eye pruritus. 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 Mineral Oil and White Petrolatum have an FDA boxed warning?

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

Do FAERS signals prove that Mineral Oil and White Petrolatum 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 0dd5380e-9671-4a2b-a2ce-6477503d06d2, effective 20250424; matched on openfda.generic_name.exact:"MINERAL OIL")
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, 14 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.