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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

MINERAL OIL: 231 Adverse Event Reports & Safety Profile

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231
Total FAERS Reports
33 (14.3%)
Deaths Reported
115
Hospitalizations
231
As Primary/Secondary Suspect
11
Life-Threatening
4
Disabilities
Safeway
Manufacturer

Route: RECTAL · Manufacturer: Safeway · HUMAN OTC DRUG · FDA Label: Available

First Report: 19980418 · Latest Report: 20250505

What Are the Most Common MINERAL OIL Side Effects?

#1 Most Reported
Chronic obstructive pulmonary disease
55 reports (23.8%)
#2 Most Reported
Drug ineffective
52 reports (22.5%)
#3 Most Reported
Vomiting
49 reports (21.2%)

All MINERAL OIL Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Chronic obstructive pulmonary disease 55 23.8% 0 55
Drug ineffective 52 22.5% 0 44
Vomiting 49 21.2% 10 49
Pyrexia 45 19.5% 0 44
Dyspnoea 44 19.1% 0 43
Cardiac murmur 40 17.3% 0 39
Eosinophilia 40 17.3% 0 40
Nausea 40 17.3% 0 39
Productive cough 40 17.3% 0 40
Asthma 39 16.9% 0 39
Breath sounds abnormal 39 16.9% 0 39
Lower respiratory tract infection 39 16.9% 0 39
Nasal congestion 39 16.9% 0 39
Oedema peripheral 39 16.9% 0 39
Pneumonia viral 39 16.9% 0 39
Presyncope 39 16.9% 0 39
Upper respiratory tract infection 39 16.9% 0 39
Wheezing 39 16.9% 0 39
Pulmonary embolism 38 16.5% 0 37
Therapeutic product effect incomplete 29 12.6% 0 29

Who Reports MINERAL OIL Side Effects? Age & Gender Data

Gender: 61.5% female, 38.5% male. Average age: 67.1 years. Most reports from: CA. View detailed demographics →

Is MINERAL OIL Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 1 0 1
2004 1 0 1
2009 1 0 1
2013 2 1 1
2014 6 0 3
2015 21 2 20
2016 6 0 3
2017 15 1 8
2018 18 9 4
2019 5 0 3
2020 15 0 9
2021 10 0 0
2023 2 0 1
2024 9 9 9
2025 12 10 1

View full timeline →

What Is MINERAL OIL Used For?

IndicationReports
Product used for unknown indication 86
Constipation 61
Eczema 16
Enema administration 11
Medication error 7
Ill-defined disorder 5

MINERAL OIL vs Alternatives: Which Is Safer?

MINERAL OIL vs MINERAL OIL\PETROLATUM MINERAL OIL vs MINERALS MINERAL OIL vs MINERALS\VITAMINS MINERAL OIL vs MINIVELLE MINERAL OIL vs MINOCYCLINE MINERAL OIL vs MINOCYCLINE\MINOCYCLINE MINERAL OIL vs MINODRONIC ACID MINERAL OIL vs MINOXIDIL MINERAL OIL vs MIPOMERSEN MINERAL OIL vs MIRABEGRON

Official FDA Label for MINERAL OIL

Official prescribing information from the FDA-approved drug label.

FDA Approved Uses (Indications)

Directions adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before applying ointment. when first opening the tube, puncture foil seal with top end of cap apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement interacetal use: remove cover from applicator, attach applicator to tube, lubricate applicator well and gently insert applicator into thoroughly cleanse applicator after each use and replace cover also apply ointment to external area regular use provides continual therapy for relief of symptoms children under 12 years of age: ask a doctor

Dosage & Administration

Directions (or as directed by a doctor) Rectal enema dosage is 120 mL in a single daily dosage (per 24 hours) adults & children 13 years and over 1 bottle children under 13 years of age DO NOT USE Caution: Remove green protective shield before inserting: hold bottle upright, grasping bottle cap with fingers. Grasp protective shield with other hand and pull gently to remove Positioning: Left-side position: Lie on left side with knee bent and arms at rest. Knee-chest position: Kneel, then lower head and chest forward until left side of face is resting on surface. Position arms comfortably. Administering enema: With steady pressure, gently insert enema tip into rectum with a slight side-to-side movement, with tip pointing toward navel. Insertion may be easier if person receiving enema bears down, as if having a bowel movement. This helps relax the muscles around the anus. Do not force the enema tip into rectum as this can cause injury. Squeeze bottle until nearly all liquid is gone. It is not necessary to empty the bottle completely, as it contains more liquid than needed. Remove enema tip from rectum. This product generally produces a bowel movement in 2 to 15 minutes. Do not retain enema solution in body for longer than 15 minutes. Remove protective shield illustration Left Side position illustration Knee-chest position illustration

Known Adverse Reactions

ADVERSE REACTION DISTRIBUTED BY: FOODHOLD U.S.A., LLC, LANDOVER, MD 20785 For product questions or concerns, contact us at 1-877-846-9949 ©2018 Ahold Delhaize Licensing Sari Quality guaranteed or your money back.

Warnings

Warnings Do not use Do not use if you have difficulty swallowing in children under 6 years of age if you are pregnant for a period longer than 1 week if you are bedridden or aged Ask a doctor before use Ask a doctor before use if you have abdominal pain, nausea, or vomiting noticed a sudden change in bowel habits that persists over a period of 2 weeks Ask a doctor or pharmacist before use Ask a doctor or pharmacist before use if you are presently taking a stool softener laxative taking any other drug. Take this product 2 or more hours before or after other drugs. Laxatives may affect how other drugs work. When using When using this product do not take with meals take only at bedtime Stop use and ask a doctor Stop use and ask a doctor if you have rectal bleeding or failure to have a bowel movement after use. These could be signs of a serious condition. If pregnant or breastfeeding If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Active Ingredient

Drug Facts Active ingredients Purposes Mineral oil 14.0%.....................................................................Skin protectant Petrolatum 74.9%....................................................................Skin protectant Phenylephrine HCI 0.25%........................................................Vasoconstrictor

Inactive Ingredients

Inactive ingredients benzoic acid, butylated hydroxyanisole, corn oil, glycerin, lanolin, lanolin alcohols, methylparaben, mineral oil, paraffin, propylparaben, purified water, thymus vulgaris (thyme) oil, tocopheryl acetate, white wax Questions or comments? Call 833-358-6431 Monday to Friday 9:00am to 7:00pm EST