MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL

N/A

Manufactured by Haleon US Holdings LLC

436 FDA adverse event reports analyzed

Last updated: 2026-04-15

About MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL

MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Haleon US Holdings LLC. The most commonly reported adverse reactions for MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL include HAEMORRHAGE, FATIGUE, RECTAL HAEMORRHAGE, DIARRHOEA, HAEMORRHOIDS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL.

Top Adverse Reactions

HAEMORRHAGE18 reports
FATIGUE14 reports
RECTAL HAEMORRHAGE14 reports
DIARRHOEA12 reports
HAEMORRHOIDS12 reports
DRUG INEFFECTIVE10 reports
DYSPNOEA10 reports
NAUSEA10 reports
PAIN10 reports
CONSTIPATION9 reports
COUGH8 reports
HEADACHE8 reports
ANAEMIA7 reports
BACK PAIN7 reports
DECREASED APPETITE7 reports
HAEMATOCHEZIA7 reports
ASTHENIA6 reports
CONDITION AGGRAVATED6 reports
INSOMNIA6 reports
RASH6 reports
URINARY TRACT INFECTION6 reports
ANXIETY5 reports
BURNING SENSATION5 reports
CHILLS5 reports
DEATH5 reports
DIZZINESS5 reports
FALL5 reports
HAEMORRHOIDAL HAEMORRHAGE5 reports
HYPERTENSION5 reports
PRURITUS5 reports
RENAL FAILURE ACUTE5 reports
THERAPEUTIC RESPONSE UNEXPECTED5 reports
TREMOR5 reports
VOMITING5 reports
DEHYDRATION4 reports
DEPRESSION4 reports
DRY MOUTH4 reports
GASTROINTESTINAL HAEMORRHAGE4 reports
INJECTION SITE BRUISING4 reports
INJECTION SITE PAIN4 reports
INTENTIONAL DRUG MISUSE4 reports
MALAISE4 reports
NASOPHARYNGITIS4 reports
PNEUMONIA4 reports
PYREXIA4 reports
WEIGHT DECREASED4 reports
ABDOMINAL DISTENSION3 reports
ABDOMINAL PAIN3 reports
ACUTE KIDNEY INJURY3 reports
ANORECTAL DISCOMFORT3 reports
ARTHRALGIA3 reports
CEREBROVASCULAR ACCIDENT3 reports
CHEST PAIN3 reports
DRUG INTERACTION3 reports
DRY SKIN3 reports
DYSGEUSIA3 reports
ERYTHEMA3 reports
FEELING ABNORMAL3 reports
HAEMATURIA3 reports
HYPOTENSION3 reports
INJURY3 reports
NEPHROPATHY3 reports
OFF LABEL USE3 reports
OROPHARYNGEAL PAIN3 reports
PAIN IN EXTREMITY3 reports
PSORIASIS3 reports
RENAL FAILURE3 reports
RENAL IMPAIRMENT3 reports
ABDOMINAL DISCOMFORT2 reports
ABDOMINAL PAIN UPPER2 reports
ABORTION SPONTANEOUS2 reports
ANAL HAEMORRHAGE2 reports
ANAL PRURITUS2 reports
BACTERIAL TEST POSITIVE2 reports
BALANCE DISORDER2 reports
BLOOD PRESSURE INCREASED2 reports
BRONCHITIS2 reports
CATARACT2 reports
CHRONIC KIDNEY DISEASE2 reports
COLITIS2 reports
CORONARY ARTERY DISEASE2 reports
CROHN^S DISEASE2 reports
CYSTITIS2 reports
DEEP VEIN THROMBOSIS2 reports
DEVICE OCCLUSION2 reports
DRUG DEPENDENCE2 reports
DRUG EFFECT DECREASED2 reports
DRUG WITHDRAWAL SYNDROME2 reports
DYSPEPSIA2 reports
DYSPHONIA2 reports
DYSSTASIA2 reports
ECONOMIC PROBLEM2 reports
EMOTIONAL DISTRESS2 reports
END STAGE RENAL DISEASE2 reports
FEELING HOT2 reports
GALLBLADDER DISORDER2 reports
GASTRIC ULCER2 reports
GASTROINTESTINAL DISORDER2 reports
GASTROINTESTINAL MOTILITY DISORDER2 reports
GASTROINTESTINAL PAIN2 reports

Report Outcomes

Out of 165 classified reports for MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL:

Serious 77.0%Non-Serious 23.0%

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

Female94 (58.8%)
Male65 (40.6%)
Unknown1 (0.6%)

Reports by Age

Age 646 reports
Age 544 reports
Age 704 reports
Age 724 reports
Age 764 reports
Age 393 reports
Age 573 reports
Age 593 reports
Age 603 reports
Age 633 reports
Age 663 reports
Age 352 reports
Age 382 reports
Age 402 reports
Age 452 reports
Age 492 reports
Age 502 reports
Age 552 reports
Age 622 reports
Age 652 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, PETROLATUM, PHENYLEPHRINE HCL?

This profile reflects 436 FDA FAERS reports that mention MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL?

Frequently reported terms in FAERS include HAEMORRHAGE, FATIGUE, RECTAL HAEMORRHAGE, DIARRHOEA, HAEMORRHOIDS, DRUG INEFFECTIVE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL?

Labeling and FAERS entries often list Haleon US Holdings LLC in connection with MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL. 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.