Urosepsis adverse event reports that record this term

Kind of term: MedDRA preferred term

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Reports on file

From January 2004 to June 2026, FDA received 9,081 adverse event reports that record the MedDRA preferred term Urosepsis. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 588 reports in the 12 months to June 2026 and 489 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

By reports in the 12 months to June 2026, this term was number 897 of 1,436 reaction terms with a page. Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 588 (under 0.1%) record this term. Reports for patients 75 and over were 20.1% of the reports that record this term and 9.5% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate.

MedDRA

The Medical Dictionary for Regulatory Activities. The person who codes a report selects the preferred term that agrees best with the description of the reporter. FDA does not publish the description.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Drugs in these reports

The table has the 130 drug pages with 25 or more reports that record this term. The rows are in order of name. A drug page with fewer reports for this term is not in the table. The counts are the counts that the site keeps for each reaction term, and a count can be lower than the count of FDA.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Drugs that the reports with the term Urosepsis name as a suspect product, in order of name
Drug	Class	Reports with this term
Abatacept	Selective T cell costimulation modulator	30
Abiraterone acetate	Cytochrome P450 17A1 inhibitor	34
Acetaminophen		35
Actemra	Interleukin-6 receptor antagonist	75
Adalimumab	Tumor necrosis factor blocker	55
Alemtuzumab	CD52-directed cytolytic antibody	34
Allopurinol	Xanthine oxidase inhibitor	40
Ampyra	Potassium channel blocker	43
Apixaban	Factor Xa inhibitor	46
Aspirin	Nonsteroidal anti-inflammatory drug	64
Atezolizumab	Programmed death Receptor-1 blocking antibody	41
Atorvastatin		30
Avastin	Vascular endothelial growth factor inhibitor	25
Avonex	Interferon beta	159
Azathioprine	Purine antimetabolite	96
Baclofen	gamma-Aminobutyric acid-ergic agonist	53
Basiliximab	Interleukin-2 receptor blocking antibody	33
Bendamustine		41
Bevacizumab	Vascular endothelial growth factor inhibitor	51
Bortezomib	Proteasome inhibitor	48
Capecitabine	Nucleoside metabolic inhibitor	35
Carbidopa levodopa	Aromatic amino acid	49
Carboplatin	Platinum-based drug	211
CellCept	Antimetabolite immunosuppressant	32
Certolizumab pegol	Tumor necrosis factor blocker	34
Cimzia	Tumor necrosis factor blocker	40
Ciprofloxacin	Fluoroquinolone antibacterial	77
Cisplatin	Platinum-based drug	68
Clozapine	Atypical antipsychotic	45
Clozaril	Atypical antipsychotic	97
Cosentyx	Interleukin-17A antagonist	39
Cyclophosphamide	Alkylating drug	197
Cyclosporine	Calcineurin inhibitor immunosuppressant	68
Dapagliflozin	Sodium-Glucose cotransporter 2 inhibitor	113
Daratumumab	CD38-directed cytolytic antibody	31
Darzalex	CD38-directed cytolytic antibody	25
Dexamethasone	Corticosteroid	174
Digoxin	Cardiac glycoside	28
Docetaxel	Microtubule inhibitor	66
Doxorubicin	Anthracycline topoisomerase inhibitor	68
Doxorubicin hydrochloride	Anthracycline topoisomerase inhibitor	39
Duodopa		65
Eliquis	Factor Xa inhibitor	27
Empagliflozin	Sodium-Glucose cotransporter 2 inhibitor	51
Enbrel	Tumor necrosis factor blocker	134
Etanercept	Tumor necrosis factor blocker	38
Etoposide	Topoisomerase inhibitor	73
Everolimus	Kinase inhibitor	42
Farxiga	Sodium-Glucose cotransporter 2 inhibitor	48
Fluorouracil	Nucleoside metabolic inhibitor	48
Forxiga		45
Fosamax	Bisphosphonate	27
Furosemide	Loop diuretic	60
Gabapentin	Anti-epileptic agent	34
Gemcitabine	Nucleoside metabolic inhibitor	90
Gemcitabine hydrochloride	Nucleoside metabolic inhibitor	27
Gilenya	Sphingosine 1-phosphate receptor modulator	27
Human immunoglobulin g	Human immunoglobulin G	30
Humira		295
Hydroxychloroquine	Antimalarial	54
Hydroxychloroquine sulfate	Antimalarial	30
Ifosfamide	Alkylating drug	30
Imbruvica	Kinase inhibitor	42
Indapamide	Thiazide-like diuretic	25
Infliximab	Tumor necrosis factor blocker	65
Invokana	Sodium-Glucose cotransporter 2 inhibitor	130
Ipilimumab	CTLA-4-directed blocking antibody	31
Jardiance	Sodium-Glucose cotransporter 2 inhibitor	193
Keytruda	Programmed death Receptor-1 blocking antibody	28
Leflunomide	Antirheumatic agent	92
Lenalidomide	Thalidomide analog	69
Letrozole	Aromatase inhibitor	42
Mabthera		41
Metformin	Biguanide	131
Metformin hydrochloride	Biguanide	33
Methotrexate	Folate analog metabolic inhibitor	280
Methotrexate sodium	Folate analog metabolic inhibitor	45
Methylprednisolone	Corticosteroid	61
Mycophenolate mofetil	Antimetabolite immunosuppressant	235
Mycophenolic acid	Antimetabolite immunosuppressant	46
Myfortic	Antimetabolite immunosuppressant	46
Nivolumab	Programmed death Receptor-1 blocking antibody	63
Ocrelizumab	CD20-directed cytolytic antibody	46
Ocrevus	CD20-directed cytolytic antibody	113
Omeprazole	Proton pump inhibitor	25
Opsumit	Endothelin receptor antagonist	26
Orencia	Selective T cell costimulation modulator	75
Oxaliplatin	Platinum-based drug	59
Paclitaxel	Microtubule inhibitor	102
Palbociclib	Kinase inhibitor	26
Pantoprazole	Proton pump inhibitor	42
Pertuzumab	HER2/neu receptor antagonist	29
Plegridy	Interferon beta	28
Polatuzumab vedotin		40
Pomalyst	Thalidomide analog	36
Pradaxa	Direct thrombin inhibitor	43
Prednisolone	Corticosteroid	251
Prednisone	Corticosteroid	323
Prograf	Calcineurin inhibitor immunosuppressant	38
Prolia	RANK ligand inhibitor	41
Ramipril	Angiotensin converting enzyme inhibitor	88
Rebif	Interferon beta	33
Remicade	Tumor necrosis factor blocker	117
Revlimid	Thalidomide analog	189
Ribavirin	Nucleoside analog antiviral	27
Rinvoq	Janus kinase inhibitor	88
Risperidone	Atypical antipsychotic	45
Rituxan	CD20-directed cytolytic antibody	28
Rituximab	CD20-directed cytolytic antibody	318
Simponi	Tumor necrosis factor blocker	55
Simvastatin	HMG-CoA reductase inhibitor	51
Skyrizi	Interleukin-23 antagonist	73
Soliris	Complement inhibitor	30
Stelara	Interleukin-12 antagonist	33
Sulfasalazine	Aminosalicylate	63
Tacrolimus	Calcineurin inhibitor immunosuppressant	312
Tecfidera		155
Tocilizumab	Interleukin-6 receptor antagonist	40
Torsemide	Loop diuretic	39
Trastuzumab	HER2/neu receptor antagonist	42
Tysabri	Integrin receptor antagonist	337
Vedolizumab	Integrin receptor antagonist	35
Velcade	Proteasome inhibitor	75
Vincristine		73
Vincristine sulfate	Vinca alkaloid	32
Vioxx		43
Vumerity		25
Xarelto	Factor Xa inhibitor	56
Xeljanz	Janus kinase inhibitor	60
Zometa		28

The page of each drug has the count of each reaction term in its reaction lookup.

Drug classes in these reports

The table has the 47 pharmacologic classes with 50 or more reports that record this term. The rows are in order of name.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Pharmacologic classes of the drugs that the reports with the term Urosepsis name, in order of name
Class	Reports with this term
Alkylating drug	251
Aminosalicylate	63
Angiotensin 2 receptor blocker	52
Angiotensin converting enzyme inhibitor	94
Anthracycline topoisomerase inhibitor	118
Anti-epileptic agent	71
Antimalarial	94
Antimetabolite immunosuppressant	359
Antirheumatic agent	105
Aromatase inhibitor	61
Aromatic amino acid	66
Atypical antipsychotic	244
Biguanide	200
Calcineurin inhibitor immunosuppressant	461
CD20-directed cytolytic antibody	537
CD38-directed cytolytic antibody	65
Corticosteroid	883
Cytochrome P450 17A1 inhibitor	56
Endothelin receptor antagonist	60
Factor Xa inhibitor	146
Fluoroquinolone antibacterial	96
Folate analog metabolic inhibitor	331
gamma-Aminobutyric acid-ergic agonist	69
HER2/neu receptor antagonist	89
HMG-CoA reductase inhibitor	55
Integrin receptor antagonist	377
Interferon beta	225
Interleukin-23 antagonist	73
Interleukin-6 receptor antagonist	123
Janus kinase inhibitor	184
Kinase inhibitor	337
Loop diuretic	101
Microtubule inhibitor	182
Nonsteroidal anti-inflammatory drug	93
Nucleoside metabolic inhibitor	277
Platinum-based drug	338
Potassium channel blocker	51
Programmed death Receptor-1 blocking antibody	155
Proteasome inhibitor	154
Proton pump inhibitor	139
Purine antimetabolite	119
Selective T cell costimulation modulator	105
Sodium-Glucose cotransporter 2 inhibitor	548
Thalidomide analog	316
Topoisomerase inhibitor	106
Tumor necrosis factor blocker	576
Vascular endothelial growth factor inhibitor	89

A class with many reports in all has many reports for almost every term.

Reports by month

Reports that record Urosepsis, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Patients in these reports

Age of the patient in the reports that record Urosepsis
Age	Reports	Share
Under 2	13	0.1%
2 to 11	56	0.6%
12 to 17	42	0.5%
18 to 44	607	6.7%
45 to 64	2,192	24.1%
65 to 74	1,901	20.9%
75 and over	1,823	20.1%
Age not given	2,447	26.9%

Sex of the patient in the reports that record Urosepsis
Sex	Reports	Share
Female	4,756	52.4%
Male	3,632	40%
Unknown or not given	693	7.6%

Age and sex are as the report gives them. 41.1% of these reports give the United States as the country.

Terms near this one

These are the next terms in the A to Z list. The links are for navigation.

Official pages

MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Urosepsis: adverse event reports that record this term. https://reportedreactions.com/reaction/urosepsis/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

The count has the reports with each spelling of one MedDRA preferred term. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

What does Urosepsis mean in an adverse event report?

It is a MedDRA preferred term. FDA codes the description of a reporter with the MedDRA dictionary. The openFDA files do not have the description itself, and this site does not show it.

Does a drug in the table mean that the drug was responsible for this reaction?

No. FDA says:

No individual drug is connected to any individual reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

What does this page tell a person who has this symptom?

This page gives counts of reports. It cannot assess a person. A pharmacist or a clinician can assess a person.

If this is a medical emergency, please call 911.
Source: FDA, MedWatch Online Voluntary Reporting Form. The site read the page on 2 Oct 2026.

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