PETROLATUM

N/A

Manufactured by Aldermed Inc.

2,672 FDA adverse event reports analyzed

Last updated: 2026-04-15

About PETROLATUM

PETROLATUM is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Aldermed Inc.. The most commonly reported adverse reactions for PETROLATUM include PYREXIA, RASH, DIARRHOEA, NAUSEA, PNEUMONIA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for PETROLATUM.

Top Adverse Reactions

PYREXIA84 reports
RASH81 reports
DIARRHOEA77 reports
NAUSEA72 reports
PNEUMONIA68 reports
OFF LABEL USE56 reports
VOMITING54 reports
DYSPNOEA51 reports
DRUG INEFFECTIVE49 reports
PRURITUS49 reports
ANAEMIA47 reports
DIZZINESS44 reports
FEBRILE NEUTROPENIA44 reports
PAIN44 reports
CELLULITIS42 reports
HEADACHE42 reports
URINARY TRACT INFECTION42 reports
FATIGUE41 reports
CONSTIPATION39 reports
DEATH39 reports
DECREASED APPETITE39 reports
FALL38 reports
SEPSIS38 reports
MALAISE37 reports
ERYTHEMA36 reports
DEHYDRATION34 reports
PLATELET COUNT DECREASED33 reports
INSOMNIA32 reports
CARDIAC FAILURE30 reports
ABDOMINAL PAIN29 reports
ARTHRALGIA29 reports
PLEURAL EFFUSION28 reports
ASTHENIA27 reports
CONDITION AGGRAVATED27 reports
COUGH27 reports
BLOOD BILIRUBIN INCREASED26 reports
WHITE BLOOD CELL COUNT DECREASED25 reports
ACUTE KIDNEY INJURY23 reports
DELIRIUM23 reports
DRY SKIN23 reports
SKIN EXFOLIATION23 reports
CHEST PAIN22 reports
DERMATITIS ATOPIC22 reports
HEPATIC FUNCTION ABNORMAL22 reports
INTERSTITIAL LUNG DISEASE22 reports
WEIGHT DECREASED22 reports
HYPERTENSION20 reports
NASOPHARYNGITIS20 reports
NEUTROPHIL COUNT DECREASED20 reports
OEDEMA PERIPHERAL20 reports
PNEUMONIA ASPIRATION20 reports
RESPIRATORY FAILURE20 reports
BRONCHITIS19 reports
HAEMOGLOBIN DECREASED19 reports
NEUROPATHY PERIPHERAL19 reports
RENAL FAILURE19 reports
RENAL IMPAIRMENT19 reports
SEPTIC SHOCK19 reports
ALOPECIA18 reports
BACK PAIN18 reports
DEPRESSION18 reports
NEUTROPENIA18 reports
PAIN IN EXTREMITY18 reports
STEVENS JOHNSON SYNDROME18 reports
C REACTIVE PROTEIN INCREASED17 reports
DYSPEPSIA17 reports
HYPOKALAEMIA17 reports
HYPONATRAEMIA17 reports
HYPOTENSION17 reports
URINARY RETENTION17 reports
BLISTER16 reports
HYPOAESTHESIA16 reports
MUSCULAR WEAKNESS16 reports
PALMAR PLANTAR ERYTHRODYSAESTHESIA SYNDROME16 reports
PRODUCT USE ISSUE16 reports
SKIN INFECTION16 reports
STOMATITIS16 reports
URTICARIA16 reports
DISSEMINATED INTRAVASCULAR COAGULATION15 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION15 reports
ASPARTATE AMINOTRANSFERASE INCREASED14 reports
COVID 1914 reports
DRUG INTERACTION14 reports
ECZEMA14 reports
MEMORY IMPAIRMENT14 reports
PRODUCT DOSE OMISSION ISSUE14 reports
SCHIZOPHRENIA14 reports
TACHYCARDIA14 reports
ANXIETY13 reports
CHRONIC OBSTRUCTIVE PULMONARY DISEASE13 reports
DRUG ERUPTION13 reports
FEELING ABNORMAL13 reports
HYPERGLYCAEMIA13 reports
HYPOTHYROIDISM13 reports
INFLUENZA13 reports
INFUSION RELATED REACTION13 reports
IRON DEFICIENCY ANAEMIA13 reports
PERIPHERAL SWELLING13 reports
SINUSITIS13 reports
VISION BLURRED13 reports

Report Outcomes

Out of 1,293 classified reports for PETROLATUM:

Serious 79.7%Non-Serious 20.3%

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

Female606 (50.3%)
Male597 (49.5%)
Unknown2 (0.2%)

Reports by Age

Age 6633 reports
Age 7431 reports
Age 5330 reports
Age 5428 reports
Age 6727 reports
Age 7327 reports
Age 5624 reports
Age 7824 reports
Age 6523 reports
Age 7523 reports
Age 6022 reports
Age 7021 reports
Age 5720 reports
Age 7120 reports
Age 7220 reports
Age 6319 reports
Age 7619 reports
Age 4118 reports
Age 5018 reports
Age 5817 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 PETROLATUM?

This profile reflects 2,672 FDA FAERS reports that mention PETROLATUM. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for PETROLATUM?

Frequently reported terms in FAERS include PYREXIA, RASH, DIARRHOEA, NAUSEA, PNEUMONIA, OFF LABEL USE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures PETROLATUM?

Labeling and FAERS entries often list Aldermed Inc. in connection with PETROLATUM. 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.