DIMETHICONE

N/A

Manufactured by Kenvue Brands LLC

1,584 FDA adverse event reports analyzed

Last updated: 2026-04-15

About DIMETHICONE

DIMETHICONE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Kenvue Brands LLC. The most commonly reported adverse reactions for DIMETHICONE include DIARRHOEA, VOMITING, PYREXIA, ABDOMINAL PAIN, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DIMETHICONE.

Top Adverse Reactions

DIARRHOEA53 reports
VOMITING49 reports
PYREXIA46 reports
ABDOMINAL PAIN44 reports
NAUSEA42 reports
PNEUMONIA42 reports
OFF LABEL USE41 reports
DRUG INEFFECTIVE33 reports
MALAISE32 reports
DECREASED APPETITE31 reports
ABDOMINAL DISTENSION30 reports
FATIGUE29 reports
CONSTIPATION28 reports
URINARY TRACT INFECTION26 reports
DIZZINESS25 reports
DYSPNOEA25 reports
PAIN25 reports
WEIGHT DECREASED25 reports
RASH22 reports
ANAEMIA21 reports
ASTHENIA20 reports
HEADACHE19 reports
RESPIRATORY FAILURE19 reports
INSOMNIA18 reports
PRURITUS18 reports
ABDOMINAL PAIN UPPER17 reports
ARTHRALGIA17 reports
COVID 1917 reports
ACUTE KIDNEY INJURY16 reports
FLATULENCE16 reports
GASTRITIS16 reports
SEPSIS16 reports
DEATH15 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION15 reports
FALL14 reports
HYPERTENSION14 reports
SEPTIC SHOCK14 reports
WEIGHT INCREASED14 reports
ALANINE AMINOTRANSFERASE INCREASED13 reports
ANXIETY13 reports
BACK PAIN13 reports
DEHYDRATION13 reports
FEBRILE NEUTROPENIA13 reports
GASTROOESOPHAGEAL REFLUX DISEASE13 reports
GENERAL PHYSICAL HEALTH DETERIORATION13 reports
OEDEMA PERIPHERAL13 reports
ABDOMINAL DISCOMFORT12 reports
COUGH12 reports
DYSPEPSIA12 reports
ERYTHEMA12 reports
HEPATIC FAILURE12 reports
HYPERSENSITIVITY12 reports
URTICARIA12 reports
ASCITES11 reports
ASPARTATE AMINOTRANSFERASE INCREASED11 reports
CARDIAC ARREST11 reports
CONDITION AGGRAVATED11 reports
PLATELET COUNT DECREASED11 reports
TREMOR11 reports
WHITE BLOOD CELL COUNT DECREASED11 reports
CONFUSIONAL STATE10 reports
DRUG HYPERSENSITIVITY10 reports
HYPERKALAEMIA10 reports
MALIGNANT NEOPLASM PROGRESSION10 reports
NEUTROPENIA10 reports
PAIN IN EXTREMITY10 reports
PNEUMONIA ASPIRATION10 reports
PRODUCT USE ISSUE10 reports
THROMBOCYTOPENIA10 reports
APPLICATION SITE RASH9 reports
CHEST PAIN9 reports
CHILLS9 reports
DYSPHAGIA9 reports
FEELING ABNORMAL9 reports
GAIT DISTURBANCE9 reports
HAEMATOCHEZIA9 reports
HYPOKALAEMIA9 reports
ILEUS9 reports
INFLAMMATION9 reports
INFLUENZA9 reports
INTERSTITIAL LUNG DISEASE9 reports
INTESTINAL OBSTRUCTION9 reports
MUSCULAR WEAKNESS9 reports
MYALGIA9 reports
PLEURAL EFFUSION9 reports
RENAL FAILURE9 reports
BLOOD GLUCOSE INCREASED8 reports
BLOOD PRESSURE DECREASED8 reports
DEVICE RELATED INFECTION8 reports
DIABETES MELLITUS8 reports
DRUG INTERACTION8 reports
DRY SKIN8 reports
GAMMA GLUTAMYLTRANSFERASE INCREASED8 reports
INFECTION8 reports
INJECTION SITE PAIN8 reports
NEUTROPHIL COUNT DECREASED8 reports
OEDEMA8 reports
SEIZURE8 reports
SOMNOLENCE8 reports
SPEECH DISORDER8 reports

Report Outcomes

Out of 725 classified reports for DIMETHICONE:

Serious 89.8%Non-Serious 10.2%

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

Female348 (52.2%)
Male318 (47.7%)
Unknown1 (0.1%)

Reports by Age

Age 7222 reports
Age 5721 reports
Age 5921 reports
Age 5818 reports
Age 7016 reports
Age 6215 reports
Age 7614 reports
Age 6113 reports
Age 7313 reports
Age 4712 reports
Age 5412 reports
Age 6412 reports
Age 6512 reports
Age 7912 reports
Age 8012 reports
Age 8212 reports
Age 6911 reports
Age 7111 reports
Age 7511 reports
Age 7410 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 DIMETHICONE?

This profile reflects 1,584 FDA FAERS reports that mention DIMETHICONE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for DIMETHICONE?

Frequently reported terms in FAERS include DIARRHOEA, VOMITING, PYREXIA, ABDOMINAL PAIN, NAUSEA, PNEUMONIA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures DIMETHICONE?

Labeling and FAERS entries often list Kenvue Brands LLC in connection with DIMETHICONE. 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.