OpenClaim

Urea Side Effects

The most commonly reported side effects of urea include fatigue, diarrhoea, and nausea, based on 3,610 FDA adverse event reports from 2004 to 2025. 3.9% of reports found the drug to be ineffective.

Urea side effects

Percentages show how often each reaction appears relative to total reports for urea.

1
Fatigue6.5%236
2
Diarrhoea6.0%217
3
Nausea5.8%211
4
Off Label Use4.2%150
5
Pain3.9%141
6
Drug Ineffective3.9%141
7
Dyspnoea3.7%133
8
Headache3.7%132
9
Vomiting3.5%125
10
Decreased Appetite3.2%117
11
Pyrexia3.2%116
12
Arthralgia3.2%114
13
Dizziness3.2%114
14
Rash3.0%110
15
Pain In Extremity3.0%108

These are voluntary reports and do not establish that urea caused these reactions.

Report severity

78.9%Serious2,847 reports
41.5%Hospitalizations1,497 reports
9.7%Fatal350 reports

Seriousness is determined by the reporter, not by OpenClaim.

Urea drug interactions

Other drugs that appear in adverse event reports alongside urea. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Lenvatinib-mesylate4.5%162
2
Pembrolizumab3.7%134
3
Cabozantinib3.1%112
4
Capecitabine2.9%104
5
Sodium-oxybate2.7%97
6
Dupilumab2.6%93
7
Nivolumab2.4%86
8
Adalimumab2.1%77
9
Pantoprazole-sodium2.0%74
10
Lenalidomide2.0%71
11
Atezolizumab1.9%70
12
Apremilast1.8%66
13
Deferasirox1.8%65
14
Etanercept1.7%60
15
Hydrocortisone1.7%60

Taken alongside

1
Acetaminophen18.8%678
2
Aspirin13.6%491
3
Levothyroxine-sodium13.3%481
4
Ergocalciferol12.9%466
5
Omeprazole12.7%458
6
Amlodipine12.5%453
7
Metformin12.5%450
8
Atorvastatin-calcium9.9%357
9
Furosemide9.1%330
10
Albuterol9.1%328
11
Ondansetron8.1%292
12
Loperamide-hydrochloride8.0%287
13
Clobetasol-propionate7.9%285
14
Gabapentin7.7%278
15
Fluticasone7.5%272

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports urea side effects

47.4% of urea adverse event reports involve female patients and 45.3% involve male patients. The largest age group is adult at 49%. These figures reflect who reports side effects, not underlying risk.

Sex

Female47.4%
Male45.3%
Unknown7.3%

Age group

< 20.4%
2–111.6%
12–171.2%
18–6448.6%
65+48.2%

What is urea used for

Conditions and purposes for which patients were taking urea when the adverse event was reported.

AcarodermatitisAccidental ExposureAcrokeratosis ParaneoplasticaAcute Lymphocytic LeukaemiaAcute Myeloid LeukaemiaAdverse EventAntidepressant TherapyAnxietyArthralgiaAsthmaAtrial FibrillationAcarodermatitisAdaptive Servo-ventilationAdverse EventAngina Pectoris

Showing 15 of 257 indications

Urea brand names and reporting trend

Urea is sold under the brand name Sterile Urea.

Brand names

Sterile Urea3,743

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking urea with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.