What the label lists and what reports show
Mineral oil side effects
Mineral oil's FDA label lists its adverse reactions in its own words. FAERS holds 1,463 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is fatigue (162 reports).
- No generic listed
- Over the counter
Check it at the source: the mineral oil FDA label on DailyMed (effective September 2, 2026); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsAdverse reaction Distributed by: Atlantic Biologicals Corp. Miami, FL 33179
Source: FDA drug label, Atlantic Biologicals Corp., effective September 2, 2026 (SPL set 5a82197b-281d-76c0-e063-6294a90a5746), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,463 reports list mineral oil among the medicines taken, each a report of something that happened, not proof the medicine caused it; 170 are coded as a death and 620 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, none is named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Mineral oil: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions