Drug · FAERS side-effect profile with label screen

Mineral Oil and Petrolatum side effects: what 648 FDA adverse event reports show

Mineral Oil, Petrolatum · 31 reaction terms · 795 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

648 reports · 37% serious · 12 with death outcome · 79% 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 18 strongest signals

Reporting / coding artifact 1No label text to screen 17

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. 13 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	34	107.9 77.7–149.7ROR 113.8 · χ² 3,484 / p <1e-300	101.5 EB05 76.0 · IC025 +4.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=15 · 85% consumer	no trial data cached
Eye pain	142	83.3 72.0–96.3ROR 106.3 · χ² 11,463 / p <1e-300	82.2 EB05 71.4 · IC025 +5.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 35.5 · 91% consumer	no trial data cached
Ocular discomfort	23	68.6 45.9–102.5ROR 71.0 · χ² 1,462 / p <1e-300	64.9 EB05 45.5 · IC025 +4.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=2 · 78% consumer	no trial data cached
Eye irritation	116	67.4 57.1–79.5ROR 81.8 · χ² 7,522 / p <1e-300	66.5 EB05 57.0 · IC025 +5.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 49.1 · 86% consumer	no trial data cached
Photophobia (light sensitivity)	29	50.3 35.2–71.8ROR 52.6 · χ² 1,350 / p 7e-296	48.7 EB05 35.5 · IC025 +4.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 26.0 · 79% consumer	no trial data cached
Ocular hyperaemia	61	42.2 33.3–53.6ROR 46.5 · χ² 2,417 / p <1e-300	41.7 EB05 33.6 · IC025 +4.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 28.2 · 86% consumer	no trial data cached
Eye inflammation	12	41.1 23.5–72.1ROR 41.9 · χ² 430 / p 7e-96	38.8 EB05 23.6 · IC025 +3.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=3	no trial data cached
Dry eye	58	38.7 30.3–49.5ROR 42.4 · χ² 2,096 / p <1e-300	38.2 EB05 30.7 · IC025 +4.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 64.6 · 91% consumer	no trial data cached
Lacrimation increased	31	33.6 23.8–47.3ROR 35.2 · χ² 947 / p 3e-208	32.9 EB05 24.3 · IC025 +3.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 21.7 · 86% consumer	no trial data cached
Eye infection	10	28.8 15.6–53.3ROR 29.3 · χ² 241 / p 9e-55	27.4 EB05 15.7 · IC025 +2.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=5	no trial data cached
Eye swelling	22	19.2 12.8–29.0ROR 19.9 · χ² 363 / p 4e-81	18.9 EB05 13.0 · IC025 +3.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 8.6 · 100% consumer	no trial data cached
Vision blurred (blurred vision)	77	18.2 14.8–22.5ROR 20.5 · χ² 1,244 / p 1e-272	18.1 EB05 15.0 · IC025 +3.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 21.0 · 81% consumer	no trial data cached
Product administration error	11	17.8 9.9–32.0ROR 18.1 · χ² 158 / p 1e-36	16.7 EB05 9.0 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	serious PRR 12.2	no trial data cached
Eye pruritus	18	17.6 11.2–27.8ROR 18.1 · χ² 267 / p 3e-60	17.1 EB05 11.1 · IC025 +2.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 16.9	no trial data cached
Eye disorder	17	16.8 10.5–26.8ROR 17.2 · χ² 237 / p 1e-53	16.2 EB05 10.2 · IC025 +2.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 33.7	no trial data cached
Visual acuity reduced	17	16.4 10.3–26.2ROR 16.8 · χ² 231 / p 2e-52	15.8 EB05 10.0 · IC025 +2.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 16.1	no trial data cached
Cataract	28	15.3 10.6–21.9ROR 15.9 · χ² 360 / p 2e-80	14.9 EB05 10.6 · IC025 +3.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 23.6 · 79% consumer	no trial data cached
Blindness	12	9.5 5.4–16.7ROR 9.7 · χ² 83 / p 3e-20	7.8 EB05 4.5 · IC025 +1.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 15.1	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 pain	142	83.3 72.0–96.3ROR 106.3 · χ² 11,463 / p <1e-300	82.2 EB05 71.4 · IC025 +5.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 35.5 · 91% consumer	no trial data cached
Eye irritation	116	67.4 57.1–79.5ROR 81.8 · χ² 7,522 / p <1e-300	66.5 EB05 57.0 · IC025 +5.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 49.1 · 86% consumer	no trial data cached
Vision blurred (blurred vision)	77	18.2 14.8–22.5ROR 20.5 · χ² 1,244 / p 1e-272	18.1 EB05 15.0 · IC025 +3.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 21.0 · 81% consumer	no trial data cached
Ocular hyperaemia	61	42.2 33.3–53.6ROR 46.5 · χ² 2,417 / p <1e-300	41.7 EB05 33.6 · IC025 +4.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 28.2 · 86% consumer	no trial data cached
Dry eye	58	38.7 30.3–49.5ROR 42.4 · χ² 2,096 / p <1e-300	38.2 EB05 30.7 · IC025 +4.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 64.6 · 91% consumer	no trial data cached
Eye discharge	34	107.9 77.7–149.7ROR 113.8 · χ² 3,484 / p <1e-300	101.5 EB05 76.0 · IC025 +4.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=15 · 85% consumer	no trial data cached
Lacrimation increased	31	33.6 23.8–47.3ROR 35.2 · χ² 947 / p 3e-208	32.9 EB05 24.3 · IC025 +3.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 21.7 · 86% consumer	no trial data cached
Photophobia (light sensitivity)	29	50.3 35.2–71.8ROR 52.6 · χ² 1,350 / p 7e-296	48.7 EB05 35.5 · IC025 +4.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 26.0 · 79% consumer	no trial data cached
Cataract	28	15.3 10.6–21.9ROR 15.9 · χ² 360 / p 2e-80	14.9 EB05 10.6 · IC025 +3.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 23.6 · 79% consumer	no trial data cached
Ocular discomfort	23	68.6 45.9–102.5ROR 71.0 · χ² 1,462 / p <1e-300	64.9 EB05 45.5 · IC025 +4.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=2 · 78% consumer	no trial data cached
Eye swelling	22	19.2 12.8–29.0ROR 19.9 · χ² 363 / p 4e-81	18.9 EB05 13.0 · IC025 +3.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 8.6 · 100% consumer	no trial data cached
Eye pruritus	18	17.6 11.2–27.8ROR 18.1 · χ² 267 / p 3e-60	17.1 EB05 11.1 · IC025 +2.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 16.9	no trial data cached
Visual acuity reduced	17	16.4 10.3–26.2ROR 16.8 · χ² 231 / p 2e-52	15.8 EB05 10.0 · IC025 +2.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 16.1	no trial data cached
Eye disorder	17	16.8 10.5–26.8ROR 17.2 · χ² 237 / p 1e-53	16.2 EB05 10.2 · IC025 +2.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 33.7	no trial data cached
Blindness	12	9.5 5.4–16.7ROR 9.7 · χ² 83 / p 3e-20	7.8 EB05 4.5 · IC025 +1.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 15.1	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 Petrolatum?

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

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

Do FAERS signals prove that Mineral Oil and 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, 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.