MINERAL OIL

N/A

Manufactured by OCuSOFT LLC

6,758 FDA adverse event reports analyzed

Last updated: 2026-04-15

About MINERAL OIL

MINERAL OIL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by OCuSOFT LLC. The most commonly reported adverse reactions for MINERAL OIL include OFF LABEL USE, FATIGUE, DRUG INEFFECTIVE, HEADACHE, PYREXIA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for MINERAL OIL.

Top Adverse Reactions

OFF LABEL USE159 reports
FATIGUE153 reports
DRUG INEFFECTIVE150 reports
HEADACHE145 reports
PYREXIA145 reports
NAUSEA137 reports
PAIN132 reports
RASH121 reports
VOMITING112 reports
PULMONARY EMBOLISM110 reports
DYSPNOEA108 reports
CARDIAC MURMUR105 reports
COVID 19102 reports
ABDOMINAL DISCOMFORT101 reports
MIGRAINE100 reports
CONDITION AGGRAVATED98 reports
WEIGHT DECREASED96 reports
DIARRHOEA94 reports
TINNITUS92 reports
PALPITATIONS91 reports
SOMNOLENCE85 reports
DEPRESSION84 reports
INTENTIONAL PRODUCT USE ISSUE81 reports
CONFUSIONAL STATE80 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION79 reports
EYE PAIN76 reports
VERTIGO76 reports
CEREBROVASCULAR ACCIDENT75 reports
TUBULOINTERSTITIAL NEPHRITIS75 reports
ECZEMA74 reports
PAIN IN EXTREMITY74 reports
DYSGEUSIA73 reports
PRODUCT USE IN UNAPPROVED INDICATION72 reports
NIGHTMARE71 reports
ACCIDENTAL OVERDOSE70 reports
CONSTIPATION70 reports
DEEP VEIN THROMBOSIS70 reports
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES69 reports
RECTAL HAEMORRHAGE69 reports
STRESS68 reports
SYSTEMIC LUPUS ERYTHEMATOSUS68 reports
BRONCHIECTASIS67 reports
DIZZINESS67 reports
PAROSMIA67 reports
FREQUENT BOWEL MOVEMENTS66 reports
HAEMATOCHEZIA66 reports
RHINITIS66 reports
SWOLLEN TONGUE66 reports
ARTHRITIS65 reports
COLITIS ULCERATIVE65 reports
ADVERSE DRUG REACTION64 reports
BURNS SECOND DEGREE64 reports
CATARRH64 reports
GINGIVAL PAIN64 reports
HYPOPNOEA64 reports
STEROID DEPENDENCE64 reports
IMPAIRED WORK ABILITY63 reports
MEDICATION ERROR63 reports
CHRONIC OBSTRUCTIVE PULMONARY DISEASE59 reports
ARTHRALGIA58 reports
PRURITUS57 reports
BACK PAIN56 reports
IMPAIRED QUALITY OF LIFE55 reports
ASTHENIA54 reports
ALCOHOL POISONING52 reports
OEDEMA PERIPHERAL52 reports
INSOMNIA50 reports
URINARY TRACT INFECTION50 reports
FEBRILE NEUTROPENIA48 reports
PNEUMONIA48 reports
CHEST PAIN46 reports
ANXIETY44 reports
MALAISE44 reports
ABDOMINAL PAIN UPPER42 reports
ABDOMINAL PAIN41 reports
DEATH41 reports
DEHYDRATION41 reports
WHEEZING40 reports
UPPER RESPIRATORY TRACT INFECTION39 reports
NASAL CONGESTION38 reports
ALOPECIA37 reports
ASTHMA37 reports
FALL37 reports
LOWER RESPIRATORY TRACT INFECTION37 reports
PRODUCTIVE COUGH37 reports
VISUAL IMPAIRMENT37 reports
PERIPHERAL SWELLING36 reports
PRESYNCOPE36 reports
BREATH SOUNDS ABNORMAL35 reports
EOSINOPHILIA35 reports
FEELING ABNORMAL35 reports
MUSCULAR WEAKNESS34 reports
PNEUMONIA VIRAL34 reports
DRY SKIN33 reports
AMNESIA32 reports
PRODUCT DOSE OMISSION ISSUE32 reports
ANAEMIA31 reports
BLOOD GLUCOSE INCREASED31 reports
HYPERHIDROSIS31 reports
INTENTIONAL PRODUCT MISUSE31 reports

Report Outcomes

Out of 1,356 classified reports for MINERAL OIL:

Serious 78.5%Non-Serious 21.5%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female749 (59.5%)
Male509 (40.4%)
Unknown1 (0.1%)

Reports by Age

Age 5361 reports
Age 8940 reports
Age 7735 reports
Age 7630 reports
Age 6627 reports
Age 5226 reports
Age 7526 reports
Age 7926 reports
Age 8026 reports
Age 4825 reports
Age 6525 reports
Age 7425 reports
Age 7224 reports
Age 8424 reports
Age 5723 reports
Age 6223 reports
Age 6323 reports
Age 7023 reports
Age 6922 reports
Age 5820 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with MINERAL OIL?

This profile reflects 6,758 FDA FAERS reports that mention MINERAL OIL. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for MINERAL OIL?

Frequently reported terms in FAERS include OFF LABEL USE, FATIGUE, DRUG INEFFECTIVE, HEADACHE, PYREXIA, NAUSEA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures MINERAL OIL?

Labeling and FAERS entries often list OCuSOFT LLC in connection with MINERAL OIL. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.