UREA

N/A

Manufactured by AvPAK

4,508 FDA adverse event reports analyzed

Last updated: 2026-04-15

About UREA

UREA is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by AvPAK. The most commonly reported adverse reactions for UREA include DIARRHOEA, FATIGUE, NAUSEA, OFF LABEL USE, DRUG INEFFECTIVE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for UREA.

Top Adverse Reactions

DIARRHOEA177 reports
FATIGUE170 reports
NAUSEA149 reports
OFF LABEL USE128 reports
DRUG INEFFECTIVE107 reports
DECREASED APPETITE102 reports
VOMITING99 reports
DYSPNOEA97 reports
RASH90 reports
PAIN89 reports
HEADACHE86 reports
DIZZINESS80 reports
PALMAR PLANTAR ERYTHRODYSAESTHESIA SYNDROME78 reports
ARTHRALGIA76 reports
PYREXIA75 reports
HYPERTENSION73 reports
PAIN IN EXTREMITY73 reports
PRURITUS71 reports
ASTHENIA70 reports
CONDITION AGGRAVATED69 reports
WEIGHT DECREASED59 reports
ABDOMINAL PAIN57 reports
ACUTE KIDNEY INJURY56 reports
PNEUMONIA56 reports
MALAISE53 reports
PERIPHERAL SWELLING51 reports
ANAEMIA50 reports
DEATH49 reports
ABDOMINAL PAIN UPPER45 reports
COUGH45 reports
PSORIASIS45 reports
ABDOMINAL DISCOMFORT44 reports
ALOPECIA44 reports
FALL43 reports
SKIN EXFOLIATION42 reports
ANXIETY40 reports
HYPOTENSION40 reports
PRODUCT USE IN UNAPPROVED INDICATION40 reports
WEIGHT INCREASED40 reports
CONSTIPATION38 reports
OEDEMA PERIPHERAL38 reports
ERYTHEMA37 reports
GAIT DISTURBANCE37 reports
CONFUSIONAL STATE36 reports
FEBRILE NEUTROPENIA36 reports
URINARY TRACT INFECTION35 reports
DRY SKIN34 reports
BACK PAIN33 reports
CHEST PAIN33 reports
PLATELET COUNT DECREASED33 reports
STOMATITIS33 reports
BLOOD PRESSURE INCREASED32 reports
HYPONATRAEMIA31 reports
INSOMNIA31 reports
RENAL FAILURE31 reports
CHRONIC KIDNEY DISEASE30 reports
DEHYDRATION29 reports
HYPERSENSITIVITY29 reports
HYPOAESTHESIA29 reports
PRODUCT DOSE OMISSION ISSUE29 reports
C REACTIVE PROTEIN INCREASED28 reports
DISEASE PROGRESSION28 reports
DRUG INTOLERANCE28 reports
DYSPHAGIA28 reports
SWELLING28 reports
DRUG HYPERSENSITIVITY27 reports
GAIT INABILITY27 reports
MYALGIA27 reports
SINUSITIS27 reports
SOMNOLENCE27 reports
GENERAL PHYSICAL HEALTH DETERIORATION26 reports
INTENTIONAL PRODUCT USE ISSUE26 reports
JOINT SWELLING26 reports
NASOPHARYNGITIS26 reports
OEDEMA25 reports
BLOOD CHOLESTEROL INCREASED24 reports
DEPRESSION24 reports
HEPATIC ENZYME INCREASED24 reports
INJECTION SITE PAIN24 reports
MALIGNANT NEOPLASM PROGRESSION24 reports
SEPSIS24 reports
ADVERSE DRUG REACTION23 reports
CELLULITIS23 reports
CONTUSION23 reports
MUSCLE SPASMS23 reports
PRODUCT USE ISSUE23 reports
DRY MOUTH22 reports
FEELING ABNORMAL22 reports
INFECTION22 reports
MEMORY IMPAIRMENT22 reports
NEUROPATHY PERIPHERAL22 reports
HAEMOGLOBIN DECREASED21 reports
MUSCULAR WEAKNESS21 reports
OSTEOARTHRITIS21 reports
ABDOMINAL DISTENSION20 reports
ADVERSE EVENT20 reports
ALANINE AMINOTRANSFERASE INCREASED20 reports
HYPOKALAEMIA20 reports
MOBILITY DECREASED20 reports
PSORIATIC ARTHROPATHY20 reports

Report Outcomes

Out of 2,051 classified reports for UREA:

Serious 79.3%Non-Serious 20.7%

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

Male957 (50.3%)
Female944 (49.7%)

Reports by Age

Age 7359 reports
Age 6953 reports
Age 6551 reports
Age 7446 reports
Age 6045 reports
Age 7244 reports
Age 6343 reports
Age 7543 reports
Age 6442 reports
Age 6642 reports
Age 7041 reports
Age 5437 reports
Age 5637 reports
Age 6137 reports
Age 6237 reports
Age 6737 reports
Age 7134 reports
Age 5733 reports
Age 7932 reports
Age 8232 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 UREA?

This profile reflects 4,508 FDA FAERS reports that mention UREA. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for UREA?

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

Who manufactures UREA?

Labeling and FAERS entries often list AvPAK in connection with UREA. 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.