OATMEAL

N/A

Manufactured by Kenvue Brands LLC

160 FDA adverse event reports analyzed

Last updated: 2026-04-15

About OATMEAL

OATMEAL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Kenvue Brands LLC. The most commonly reported adverse reactions for OATMEAL include RASH, DRUG INEFFECTIVE, DRY SKIN, PRURITUS, DERMATITIS ATOPIC. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for OATMEAL.

Top Adverse Reactions

RASH9 reports
DRUG INEFFECTIVE6 reports
DRY SKIN5 reports
PRURITUS5 reports
DERMATITIS ATOPIC4 reports
DIARRHOEA3 reports
ERYTHEMA3 reports
SCRATCH3 reports
SKIN HAEMORRHAGE3 reports
WEIGHT DECREASED3 reports
ABDOMINAL DISCOMFORT2 reports
ABDOMINAL PAIN2 reports
ANAEMIA2 reports
ANAL INCONTINENCE2 reports
APPLICATION SITE BURN2 reports
APPLICATION SITE HYPERSENSITIVITY2 reports
APPLICATION SITE RASH2 reports
APPLICATION SITE VESICLES2 reports
ARTHRALGIA2 reports
BACK PAIN2 reports
BLISTER2 reports
CONTUSION2 reports
DIALYSIS2 reports
ECZEMA2 reports
EYE IRRITATION2 reports
EYE PAIN2 reports
HYPERSENSITIVITY2 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION2 reports
INJECTION SITE ERYTHEMA2 reports
INJECTION SITE RASH2 reports
INTENTIONAL DOSE OMISSION2 reports
MALAISE2 reports
RASH MACULAR2 reports
SKIN IRRITATION2 reports
SOMNOLENCE2 reports
URTICARIA2 reports
ABDOMINAL DISTENSION1 reports
ABNORMAL FAECES1 reports
ADVERSE REACTION1 reports
AGEUSIA1 reports
ALANINE AMINOTRANSFERASE INCREASED1 reports
ALOPECIA1 reports
ANAPHYLACTIC REACTION1 reports
ANGIOEDEMA1 reports
ANKYLOSING SPONDYLITIS1 reports
ANXIETY1 reports
APNOEA1 reports
APPETITE DISORDER1 reports
APPLICATION SITE DRYNESS1 reports
APPLICATION SITE REACTION1 reports
ARTERIAL DISORDER1 reports
ARTHROPATHY1 reports
ASPARTATE AMINOTRANSFERASE INCREASED1 reports
ASTHENIA1 reports
ASTHMA1 reports
BEDRIDDEN1 reports
BLOOD POTASSIUM DECREASED1 reports
BLOOD PRESSURE DECREASED1 reports
BONE PAIN1 reports
BURNS FIRST DEGREE1 reports
CARDIAC ARREST1 reports
CATHETER SITE RELATED REACTION1 reports
CHEST PAIN1 reports
CHILLS1 reports
COAGULOPATHY1 reports
COLITIS1 reports
COMA1 reports
CONDITION AGGRAVATED1 reports
COUGH1 reports
COVID 191 reports
CRYING1 reports
DECREASED APPETITE1 reports
DEPRESSED MOOD1 reports
DEVICE BREAKAGE1 reports
DEVICE ISSUE1 reports
DISEASE PROGRESSION1 reports
DYSGEUSIA1 reports
DYSPEPSIA1 reports
DYSPHAGIA1 reports
EATING DISORDER1 reports
EYE DISCHARGE1 reports
EYE PRURITUS1 reports
EYE SWELLING1 reports
EYELID RASH1 reports
FAECES DISCOLOURED1 reports
FATIGUE1 reports
FEELING ABNORMAL1 reports
FLATULENCE1 reports
FOOD ALLERGY1 reports
FOOD INTERACTION1 reports
FOOD INTOLERANCE1 reports
FOREIGN BODY SENSATION IN EYES1 reports
FREQUENT BOWEL MOVEMENTS1 reports
GAIT DISTURBANCE1 reports
GINGIVAL PAIN1 reports
GLOSSODYNIA1 reports
GRANULOMA1 reports
HAEMOLYTIC ANAEMIA1 reports
HAEMORRHAGE1 reports
HEADACHE1 reports

Report Outcomes

Out of 48 classified reports for OATMEAL:

Serious 50.0%Non-Serious 50.0%

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

Female31 (70.5%)
Male13 (29.5%)

Reports by Age

Age 673 reports
Age 773 reports
Age 32 reports
Age 42 reports
Age 562 reports
Age 71 reports
Age 81 reports
Age 131 reports
Age 151 reports
Age 161 reports
Age 211 reports
Age 261 reports
Age 281 reports
Age 301 reports
Age 351 reports
Age 361 reports
Age 401 reports
Age 411 reports
Age 421 reports
Age 461 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 OATMEAL?

This profile reflects 160 FDA FAERS reports that mention OATMEAL. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for OATMEAL?

Frequently reported terms in FAERS include RASH, DRUG INEFFECTIVE, DRY SKIN, PRURITUS, DERMATITIS ATOPIC, DIARRHOEA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures OATMEAL?

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