Mineral Oil side effects: what 1,410 FDA adverse event reports show

Mineral Oil · 113 reaction terms · 4,007 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Who reports

1,410 reports · 79% serious · 166 with death outcome · 59% 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 40 strongest signals

Reporting / coding artifact 2No label text to screen 38

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. 73 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
Tubulointerstitial nephritis	85	66.7 54.3–82.1ROR 70.9 · χ² 5,419 / p <1e-300	65.5 EB05 54.6 · IC025 +5.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 49.1 · ♀ 22% (drug 59%) · 91% clinician	no trial data cached
Impaired quality of life	59	60.3 46.9–77.4ROR 62.8 · χ² 3,369 / p <1e-300	58.9 EB05 47.4 · IC025 +4.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 65.7 · ♀ 15% (drug 59%) · 91% clinician	no trial data cached
Impaired work ability	66	45.2 35.7–57.2ROR 47.3 · χ² 2,803 / p <1e-300	44.5 EB05 36.2 · IC025 +4.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 42.5 · ♀ 14% (drug 59%) · 92% clinician	no trial data cached
Frequent bowel movements	70	38.2 30.4–48.0ROR 40.1 · χ² 2,495 / p <1e-300	37.7 EB05 30.9 · IC025 +4.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 43.3 · ♀ 15% (drug 59%) · 90% clinician	no trial data cached
Vitamin d deficiency	22	33.1 21.9–50.2ROR 33.6 · χ² 652 / p 3e-144	32.2 EB05 22.4 · IC025 +3.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 29.4 · ♀ 95% (drug 59%) · 95% clinician	no trial data cached
Subarachnoid haemorrhage	23	33.0 22.0–49.6ROR 33.6 · χ² 682 / p 1e-150	32.2 EB05 22.6 · IC025 +3.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 24.3	no trial data cached
Swollen tongue	69	32.4 25.7–40.8ROR 34.0 · χ² 2,066 / p <1e-300	32.1 EB05 26.2 · IC025 +4.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 32.9 · ♀ 15% (drug 59%) · 91% clinician	no trial data cached
Nightmare	74	31.2 25.0–39.0ROR 32.9 · χ² 2,135 / p <1e-300	30.9 EB05 25.5 · IC025 +4.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 39.0 · ♀ 21% (drug 59%) · 93% clinician	no trial data cached
Systemic lupus erythematosus	73	30.3 24.2–37.9ROR 31.8 · χ² 2,037 / p <1e-300	30.0 EB05 24.7 · IC025 +4.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 22.8 · ♀ 18% (drug 59%) · 92% clinician	no trial data cached
Accidental overdose	75	30.1 24.1–37.5ROR 31.7 · χ² 2,081 / p <1e-300	29.8 EB05 24.6 · IC025 +4.3 3/3 methods agree	Reporting / coding artifact	serious PRR 33.5 · ♀ 20% (drug 59%)	no trial data cached
Tinnitus (ringing in the ears)	94	30.0 24.6–36.4ROR 32.0 · χ² 2,604 / p <1e-300	29.8 EB05 25.0 · IC025 +4.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 33.6 · ♀ 35% (drug 59%)	no trial data cached
Eosinophilia	35	29.4 21.2–40.8ROR 30.1 · χ² 931 / p 1e-204	28.9 EB05 21.7 · IC025 +3.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 22.6 · ♀ 97% (drug 59%) · 94% clinician	no trial data cached
Vasculitis	23	28.9 19.3–43.4ROR 29.4 · χ² 592 / p 5e-131	28.3 EB05 19.8 · IC025 +3.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 22.9	no trial data cached
Iron deficiency anaemia	18	28.7 18.2–45.5ROR 29.1 · χ² 454 / p 5e-101	27.9 EB05 18.7 · IC025 +3.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 22.4	no trial data cached
Hepatic cytolysis	22	26.4 17.4–40.0ROR 26.8 · χ² 512 / p 1e-113	25.8 EB05 18.0 · IC025 +3.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 19.4 · 100% clinician	no trial data cached
Rectal haemorrhage	74	25.2 20.2–31.4ROR 26.5 · χ² 1,694 / p <1e-300	25.0 EB05 20.6 · IC025 +4.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 19.8 · ♀ 18% (drug 59%)	no trial data cached
Anosmia (loss of smell)	24	24.3 16.3–36.1ROR 24.7 · χ² 512 / p 1e-113	23.8 EB05 16.8 · IC025 +3.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=24	no trial data cached
Eczema	80	23.3 18.8–28.9ROR 24.6 · χ² 1,688 / p <1e-300	23.2 EB05 19.2 · IC025 +4.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 49.0 · ♀ 26% (drug 59%)	no trial data cached
Schizophrenia	19	22.9 14.7–35.8ROR 23.2 · χ² 376 / p 4e-84	22.4 EB05 15.1 · IC025 +3.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 17.5	no trial data cached
Colitis ulcerative	69	22.7 18.0–28.6ROR 23.8 · χ² 1,410 / p <1e-300	22.5 EB05 18.4 · IC025 +3.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 17.9 · ♀ 11% (drug 59%) · 91% clinician	no trial data cached
Loss of personal independence in daily activities	73	22.5 18.0–28.2ROR 23.7 · χ² 1,480 / p <1e-300	22.4 EB05 18.4 · IC025 +3.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 21.8 · ♀ 20% (drug 59%) · 92% clinician	no trial data cached
Presyncope (near-fainting)	36	21.8 15.8–30.1ROR 22.4 · χ² 694 / p 3e-153	21.6 EB05 16.3 · IC025 +3.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 20.6 · ♀ 100% (drug 59%) · 94% clinician	no trial data cached
Eye pain	77	20.4 16.4–25.4ROR 21.5 · χ² 1,406 / p <1e-300	20.3 EB05 16.8 · IC025 +3.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 1.4 · ♀ 85% (drug 59%) · 90% consumer	no trial data cached
Ventricular tachycardia	23	20.3 13.6–30.5ROR 20.7 · χ² 404 / p 4e-90	20.0 EB05 13.9 · IC025 +3.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 15.1	no trial data cached
Pericarditis	23	20.2 13.5–30.4ROR 20.5 · χ² 401 / p 1e-89	19.9 EB05 13.8 · IC025 +3.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 15.0	no trial data cached
Vertigo (spinning dizziness)	80	19.2 15.5–23.8ROR 20.3 · χ² 1,367 / p 2e-299	19.1 EB05 15.9 · IC025 +3.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 19.4 · ♀ 27% (drug 59%)	no trial data cached
Haematochezia (blood in stool)	70	18.6 14.8–23.4ROR 19.5 · χ² 1,151 / p 1e-252	18.5 EB05 15.1 · IC025 +3.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 15.1 · ♀ 13% (drug 59%) · 91% clinician	no trial data cached
Medication error	68	18.0 14.2–22.7ROR 18.8 · χ² 1,074 / p 9e-236	17.9 EB05 14.5 · IC025 +3.6 3/3 methods agree	Reporting / coding artifact	serious PRR 21.1 · ♀ 12% (drug 59%) · 91% clinician	no trial data cached
Pulmonary embolism (lung blood clot)	114	17.5 14.7–20.9ROR 18.9 · χ² 1,764 / p <1e-300	17.4 EB05 14.9 · IC025 +3.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 12.8 · 92% clinician	no trial data cached
Skin infection	13	17.1 9.9–29.3ROR 17.2 · χ² 181 / p 2e-41	16.1 EB05 9.3 · IC025 +2.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 17.4	no trial data cached
Deep vein thrombosis (leg blood clot)	74	16.6 13.3–20.7ROR 17.5 · χ² 1,072 / p 2e-235	16.5 EB05 13.6 · IC025 +3.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 12.3 · ♀ 14% (drug 59%)	no trial data cached
Chronic obstructive pulmonary disease	59	16.6 12.9–21.3ROR 17.3 · χ² 850 / p 4e-187	16.5 EB05 13.2 · IC025 +3.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 14.0 · ♀ 97% (drug 59%) · 91% clinician	no trial data cached
Haemorrhoids	22	16.5 10.9–25.0ROR 16.7 · χ² 305 / p 1e-68	16.1 EB05 10.9 · IC025 +2.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 13.7 · ♀ 90% (drug 59%)	no trial data cached
Migraine	106	16.4 13.6–19.7ROR 17.6 · χ² 1,520 / p <1e-300	16.3 EB05 13.8 · IC025 +3.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 22.5	no trial data cached
Diplopia (double vision)	28	15.8 10.9–22.8ROR 16.1 · χ² 374 / p 2e-83	15.5 EB05 11.0 · IC025 +3.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 14.8 · ♀ 90% (drug 59%)	no trial data cached
Ocular discomfort	11	14.8 8.2–26.8ROR 15.0 · χ² 128 / p 4e-30	13.4 EB05 6.9 · IC025 +2.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial data cached
Dysgeusia (altered taste)	75	14.7 11.8–18.3ROR 15.5 · χ² 948 / p 2e-208	14.6 EB05 12.0 · IC025 +3.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 30.3 · ♀ 22% (drug 59%)	no trial data cached
Stress	72	14.7 11.7–18.4ROR 15.4 · χ² 906 / p 3e-199	14.6 EB05 11.9 · IC025 +3.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 17.9 · ♀ 16% (drug 59%) · 90% clinician	no trial data cached
Pain of skin	27	14.7 10.1–21.3ROR 14.9 · χ² 330 / p 5e-74	14.3 EB05 10.0 · IC025 +2.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 38.2	no trial data cached
Muscle twitching	23	14.6 9.7–21.9ROR 14.8 · χ² 278 / p 1e-62	14.1 EB05 9.5 · IC025 +2.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 16.7	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
Pulmonary embolism (lung blood clot)	114	17.5 14.7–20.9ROR 18.9 · χ² 1,764 / p <1e-300	17.4 EB05 14.9 · IC025 +3.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 12.8 · 92% clinician	no trial data cached
Covid-19	107	8.9 7.4–10.6ROR 9.5 · χ² 744 / p 4e-164	8.7 EB05 7.3 · IC025 +2.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 11.4	no trial data cached
Migraine	106	16.4 13.6–19.7ROR 17.6 · χ² 1,520 / p <1e-300	16.3 EB05 13.8 · IC025 +3.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 22.5	no trial data cached
Abdominal discomfort	104	9.1 7.6–11.0ROR 9.8 · χ² 749 / p 4e-165	8.9 EB05 7.5 · IC025 +2.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 14.6	no trial data cached
Somnolence (drowsiness)	95	6.9 5.7–8.4ROR 7.3 · χ² 480 / p 1e-106	6.7 EB05 5.7 · IC025 +2.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 8.4 · ♀ 30% (drug 59%)	no trial data cached
Palpitations (pounding heartbeat)	94	11.8 9.7–14.3ROR 12.5 · χ² 920 / p 2e-202	11.6 EB05 9.7 · IC025 +3.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 13.1 · ♀ 34% (drug 59%)	no trial data cached
Tinnitus (ringing in the ears)	94	30.0 24.6–36.4ROR 32.0 · χ² 2,604 / p <1e-300	29.8 EB05 25.0 · IC025 +4.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 33.6 · ♀ 35% (drug 59%)	no trial data cached
Intentional product use issue	86	14.3 11.7–17.6ROR 15.2 · χ² 1,057 / p 4e-232	14.2 EB05 11.8 · IC025 +3.4 3/3 methods agree	Reporting / coding artifact	serious PRR 15.5 · ♀ 25% (drug 59%)	no trial data cached
Inappropriate schedule of product administration	85	7.0 5.7–8.7ROR 7.4 · χ² 438 / p 1e-97	6.8 EB05 5.7 · IC025 +2.4 3/3 methods agree	Reporting / coding artifact	serious PRR 12.3 · ♀ 26% (drug 59%)	no trial data cached
Tubulointerstitial nephritis	85	66.7 54.3–82.1ROR 70.9 · χ² 5,419 / p <1e-300	65.5 EB05 54.6 · IC025 +5.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 49.1 · ♀ 22% (drug 59%) · 91% clinician	no trial data cached
Vertigo (spinning dizziness)	80	19.2 15.5–23.8ROR 20.3 · χ² 1,367 / p 2e-299	19.1 EB05 15.9 · IC025 +3.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 19.4 · ♀ 27% (drug 59%)	no trial data cached
Eczema	80	23.3 18.8–28.9ROR 24.6 · χ² 1,688 / p <1e-300	23.2 EB05 19.2 · IC025 +4.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 49.0 · ♀ 26% (drug 59%)	no trial data cached
Cerebrovascular accident (stroke)	79	6.8 5.5–8.4ROR 7.1 · χ² 388 / p 9e-87	6.6 EB05 5.4 · IC025 +2.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 5.0 · ♀ 14% (drug 59%)	no trial data cached
Eye pain	77	20.4 16.4–25.4ROR 21.5 · χ² 1,406 / p <1e-300	20.3 EB05 16.8 · IC025 +3.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 1.4 · ♀ 85% (drug 59%) · 90% consumer	no trial data cached
Dysgeusia (altered taste)	75	14.7 11.8–18.3ROR 15.5 · χ² 948 / p 2e-208	14.6 EB05 12.0 · IC025 +3.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 30.3 · ♀ 22% (drug 59%)	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?

In FDA FAERS, the most frequently co-reported reaction terms for Mineral Oil are pulmonary embolism, covid-19, migraine, abdominal discomfort, somnolence, palpitations. 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 have an FDA boxed warning?

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

Do FAERS signals prove that Mineral Oil 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, 113 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.