Reported Reactions

Reactions

MedDRA preferred term

Urine output decreased: adverse event reports recording this term

8,618 reports to FDA record it, 2004–2026; 0% of the database.

8,618
reports recording the term
0% of all reports
361
reports, 12 months to June 2026
396 in the 12 months before
80.8%
marked serious by the reporter
57.4% across all reports
14.9%
record death among outcomes, as reported
9.1% across all reports

8,618 reports in FDA's adverse event database record the MedDRA term "Urine output decreased": 0% of all reports received between January 2004 and June 2026. Coders pick the term that best matches the reporter's description.

361 reports recorded it in the 12 months to June 2026, close to the 396 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Of reports recording this term, 80.8% are marked serious, 14.9% include death among the outcomes and 50.7% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Furosemide, Tacrolimus and Entresto. That order mostly follows how many reports each drug has overall; the table also gives the term's share within each drug's own reports. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."

Reports by month, five years

02448Jul 2021: 45Aug 2021: 40Sep 2021: 44Oct 2021: 36Nov 2021: 38Dec 2021: 302022Jan 2022: 31Feb 2022: 36Mar 2022: 36Apr 2022: 44May 2022: 28Jun 2022: 23Jul 2022: 33Aug 2022: 34Sep 2022: 21Oct 2022: 32Nov 2022: 27Dec 2022: 432023Jan 2023: 29Feb 2023: 25Mar 2023: 38Apr 2023: 23May 2023: 32Jun 2023: 31Jul 2023: 29Aug 2023: 27Sep 2023: 21Oct 2023: 34Nov 2023: 23Dec 2023: 242024Jan 2024: 18Feb 2024: 31Mar 2024: 24Apr 2024: 48May 2024: 24Jun 2024: 32Jul 2024: 36Aug 2024: 35Sep 2024: 25Oct 2024: 35Nov 2024: 42Dec 2024: 412025Jan 2025: 24Feb 2025: 22Mar 2025: 41Apr 2025: 42May 2025: 30Jun 2025: 23Jul 2025: 31Aug 2025: 31Sep 2025: 32Oct 2025: 20Nov 2025: 28Dec 2025: 262026Jan 2026: 25Feb 2026: 32Mar 2026: 38Apr 2026: 35May 2026: 28Jun 2026: 35

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Drugs listed as suspect products in these reports

DrugClassReports with this termShare of the drug's own reports
FurosemideLoop diuretic2090.4%
TacrolimusCalcineurin inhibitor immunosuppressant1340.1%
EntrestoAngiotensin 2 receptor blocker1130.1%
MethotrexateFolate analog metabolic inhibitor1130.1%
AmlodipineCalcium channel blocker1040.2%
HizentraHuman immunoglobulin G1040.5%
Humira—960%
PrednisoneCorticosteroid890%
RevlimidThalidomide analog880%
CarboplatinPlatinum-based drug860.1%
DexamethasoneCorticosteroid830.1%
Mycophenolate mofetilAntimetabolite immunosuppressant830.1%
CyclophosphamideAlkylating drug810.1%
MetforminBiguanide810.1%
ValtrexHerpes simplex virus nucleoside analog DNA polymerase inhibitor801%
IbuprofenNonsteroidal anti-inflammatory drug760.1%
SolirisComplement inhibitor750.1%
OpsumitEndothelin receptor antagonist730.2%
RamiprilAngiotensin converting enzyme inhibitor710.2%
ExjadeIron chelator690.4%
AfinitorKinase inhibitor650.2%
EtoposideTopoisomerase inhibitor650.1%
CyclosporineCalcineurin inhibitor immunosuppressant640.2%
SimulectInterleukin-2 receptor blocking antibody633.7%
CytarabineNucleoside metabolic inhibitor610.1%

Drugs with a page on this site, ordered by the number of their reports recording this term. The last column is the term's share within that drug's own reports, against 0% across the whole database. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

By pharmacologic class

ClassReports with this termShare of class reportsMedian drug in class
Proton pump inhibitor3290.1%0%
Kinase inhibitor3250%0%
Nonsteroidal anti-inflammatory drug3100.1%0%
Calcineurin inhibitor immunosuppressant3080.1%0%
Corticosteroid3070%0%
Loop diuretic2620.4%0.1%
Angiotensin 2 receptor blocker2530.1%0.1%
Endothelin receptor antagonist1640.1%0.1%
Antimetabolite immunosuppressant1570.1%0.1%
Platinum-based drug1560.1%0.1%

Classes ordered by count. Class shares follow the class's overall report volume as much as anything else.

Patients in these reports

Patient age

Under 21.8%151
2 to 113%259
12 to 171.7%145
18 to 4410.9%940
45 to 6422.2%1,911
65 to 7415.8%1,362
75 and over15.9%1,370
Age not given28.8%2,480

Patient sex

Female51.8%4,462
Male41.2%3,554
Not given7%602

Grey bar: all 20,646,523 reports in the database. 51.7% of these reports give the United States as the country.

Questions about "Urine output decreased"

What does "Urine output decreased" mean in an adverse event report?

It is a MedDRA preferred term, the dictionary FDA uses to code what a reporter described. The report's own description is not published by openFDA and is not shown here.

How many reports record urine output decreased?

8,618 reports through June 2026 (0% of all reports), 361 of them in the latest 12 months.

Which drugs appear most often in these reports?

Furosemide (209), Tacrolimus (134), Entresto (113), Methotrexate (113) and Amlodipine (104). Drugs with many reports overall lead almost every term's list. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Does a drug appearing here mean it was responsible for this reaction?

No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."

I have this symptom. What should I do?

This site cannot assess anyone. A pharmacist or clinician can; for an emergency, call the local emergency number. Nothing on this page is medical advice.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. Terms are pooled across spelling and capitalisation variants of one MedDRA preferred term. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.