COLLOIDAL OATMEAL

N/A

Manufactured by Crown Laboratories, Inc.

621 FDA adverse event reports analyzed

Last updated: 2026-04-15

About COLLOIDAL OATMEAL

COLLOIDAL OATMEAL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Crown Laboratories, Inc.. The most commonly reported adverse reactions for COLLOIDAL OATMEAL include PRURITUS, RASH, DRUG INEFFECTIVE, FATIGUE, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for COLLOIDAL OATMEAL.

Top Adverse Reactions

PRURITUS32 reports
RASH30 reports
DRUG INEFFECTIVE16 reports
FATIGUE16 reports
NAUSEA14 reports
OFF LABEL USE14 reports
HAEMOGLOBIN DECREASED13 reports
PAIN13 reports
PYREXIA13 reports
ARTHRALGIA12 reports
DIZZINESS12 reports
ASTHENIA11 reports
DIARRHOEA10 reports
DYSPNOEA10 reports
ANXIETY9 reports
HEADACHE9 reports
PNEUMONIA9 reports
DEATH8 reports
NO ADVERSE EVENT8 reports
OEDEMA PERIPHERAL8 reports
ABDOMINAL PAIN7 reports
ACUTE KIDNEY INJURY7 reports
ANAEMIA7 reports
COUGH7 reports
DEEP VEIN THROMBOSIS7 reports
DEPRESSION7 reports
FALL7 reports
GAIT DISTURBANCE7 reports
HYPOAESTHESIA7 reports
HYPOTENSION7 reports
VISION BLURRED7 reports
APPLICATION SITE PAIN6 reports
BACK PAIN6 reports
CONSTIPATION6 reports
DEHYDRATION6 reports
DYSPHAGIA6 reports
INSOMNIA6 reports
PANCYTOPENIA6 reports
URINARY TRACT INFECTION6 reports
VOMITING6 reports
APPLICATION SITE ERYTHEMA5 reports
BLOOD BILIRUBIN INCREASED5 reports
MUSCLE SPASMS5 reports
NEUTROPENIA5 reports
PALPITATIONS5 reports
PULMONARY EMBOLISM5 reports
RASH ERYTHEMATOUS5 reports
URTICARIA5 reports
WEIGHT DECREASED5 reports
ABDOMINAL DISCOMFORT4 reports
BLOOD ALKALINE PHOSPHATASE INCREASED4 reports
BLOOD CREATININE INCREASED4 reports
CHEST PAIN4 reports
CONDITION AGGRAVATED4 reports
DECREASED APPETITE4 reports
DISEASE PROGRESSION4 reports
DRUG HYPERSENSITIVITY4 reports
HYPERTENSION4 reports
HYPONATRAEMIA4 reports
HYPOTHYROIDISM4 reports
ILLNESS4 reports
INJURY4 reports
MALAISE4 reports
MUSCULAR WEAKNESS4 reports
NASOPHARYNGITIS4 reports
PAIN IN EXTREMITY4 reports
PLATELET COUNT DECREASED4 reports
RASH PRURITIC4 reports
RED BLOOD CELL COUNT DECREASED4 reports
RHINORRHOEA4 reports
SEPSIS4 reports
SYSTEMIC LUPUS ERYTHEMATOSUS4 reports
TACHYCARDIA4 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS4 reports
ACUTE RESPIRATORY DISTRESS SYNDROME3 reports
ASPARTATE AMINOTRANSFERASE INCREASED3 reports
BACTERAEMIA3 reports
BLOOD ALBUMIN DECREASED3 reports
BRONCHITIS3 reports
CATARACT3 reports
CELLULITIS3 reports
CHILLS3 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION3 reports
ECZEMA3 reports
EYE PAIN3 reports
FEBRILE NEUTROPENIA3 reports
HAEMATOCRIT DECREASED3 reports
HERPES ZOSTER3 reports
HOSPITALISATION3 reports
HYPERGLYCAEMIA3 reports
HYPERSENSITIVITY3 reports
HYPOKALAEMIA3 reports
HYPOMAGNESAEMIA3 reports
IMMUNODEFICIENCY3 reports
LETHARGY3 reports
LEUKOPENIA3 reports
LOWER LIMB FRACTURE3 reports
MALIGNANT NEOPLASM PROGRESSION3 reports
MEMORY IMPAIRMENT3 reports
NEPHROGENIC FIBROSING DERMOPATHY3 reports

Report Outcomes

Out of 229 classified reports for COLLOIDAL OATMEAL:

Serious 64.6%Non-Serious 35.4%

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

Female122 (57.5%)
Male90 (42.5%)

Reports by Age

Age 736 reports
Age 776 reports
Age 525 reports
Age 625 reports
Age 675 reports
Age 685 reports
Age 725 reports
Age 404 reports
Age 564 reports
Age 614 reports
Age 634 reports
Age 644 reports
Age 654 reports
Age 664 reports
Age 694 reports
Age 794 reports
Age 834 reports
Age 203 reports
Age 503 reports
Age 513 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 COLLOIDAL OATMEAL?

This profile reflects 621 FDA FAERS reports that mention COLLOIDAL OATMEAL. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for COLLOIDAL OATMEAL?

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

Who manufactures COLLOIDAL OATMEAL?

Labeling and FAERS entries often list Crown Laboratories, Inc. in connection with COLLOIDAL 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.