Reported Reactions

Adverse event reports that FDA received

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Acute kidney injury adverse event reports that record this term

Kind of term
MedDRA preferred term
Plain meaning
sudden loss of kidney function

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 . The data have the reports that FDA received through .

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 .

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 .

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 March 2004 to June 2026, FDA received 150,297 adverse event reports that record the MedDRA preferred term Acute kidney injury. In plain words, the term means: sudden loss of kidney function. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 11,000 reports in the 12 months to June 2026 and 10,472 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 48 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, 11,000 (0.8%) record this term. Reports for female patients were 38.5% of the reports that record this term and 52.7% 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.

Plain meaning

Sudden loss of kidney function. The words are from the fixed dictionary of this site. They add nothing to a report.

Data version

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

Drugs in these reports

The table has the 126 drug pages with 500 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 .

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 . The site read the page on .

Drugs that the reports with the term Acute kidney injury name as a suspect product, in order of name
DrugClassReports with this term
Acetaminophen2,159
Acetylsalicylic Acid801
AciphexProton pump inhibitor2,424
AcyclovirHerpes simplex virus nucleoside analog DNA polymerase inhibitor876
AldactoneAldosterone antagonist857
AllopurinolXanthine oxidase inhibitor1,541
AlprazolamBenzodiazepine504
Amiodarone565
AmlodipineCalcium channel blocker2,358
AmoxicillinPenicillin-class antibacterial1,154
ApixabanFactor Xa inhibitor632
AspirinNonsteroidal anti-inflammatory drug1,726
AtezolizumabProgrammed death Receptor-1 blocking antibody536
Atorvastatin1,681
Atripla1,279
BactrimDihydrofolate reductase inhibitor antibacterial1,054
BenicarAngiotensin 2 receptor blocker1,284
Benicar HCTThiazide diuretic925
BevacizumabVascular endothelial growth factor inhibitor746
Bisoprololbeta-Adrenergic blocker1,473
CandesartanAngiotensin 2 receptor blocker794
Candesartan cilexetilAngiotensin 2 receptor blocker506
CarboplatinPlatinum-based drug2,371
CarfilzomibProteasome inhibitor568
CefepimeCephalosporin antibacterial611
CeftriaxoneCephalosporin antibacterial610
CiprofloxacinFluoroquinolone antibacterial1,292
CisplatinPlatinum-based drug1,701
ClarithromycinMacrolide antimicrobial649
ColchicineAlkaloid573
CyclophosphamideAlkylating drug2,048
CyclosporineCalcineurin inhibitor immunosuppressant1,026
CytarabineNucleoside metabolic inhibitor978
DapagliflozinSodium-Glucose cotransporter 2 inhibitor1,065
DexamethasoneCorticosteroid2,578
DexilantProton pump inhibitor7,537
DiclofenacNonsteroidal anti-inflammatory drug771
DigoxinCardiac glycoside628
DocetaxelMicrotubule inhibitor593
DoxorubicinAnthracycline topoisomerase inhibitor838
EliquisFactor Xa inhibitor931
EnalaprilAngiotensin converting enzyme inhibitor865
EntrestoAngiotensin 2 receptor blocker1,361
EplerenoneAldosterone antagonist504
EsomeprazoleProton pump inhibitor2,835
Esomeprazole magnesiumProton pump inhibitor620
EtoposideTopoisomerase inhibitor1,085
FluorouracilNucleoside metabolic inhibitor963
FurosemideLoop diuretic7,287
GabapentinAnti-epileptic agent722
GemcitabineNucleoside metabolic inhibitor673
GentamicinAminoglycoside antibacterial622
Humira824
HydrochlorothiazideThiazide diuretic1,704
IbuprofenNonsteroidal anti-inflammatory drug3,486
IndapamideThiazide-like diuretic579
InvokanaSodium-Glucose cotransporter 2 inhibitor1,749
IpilimumabCTLA-4-directed blocking antibody587
IrbesartanAngiotensin 2 receptor blocker1,268
JardianceSodium-Glucose cotransporter 2 inhibitor709
Kardegic735
KeytrudaProgrammed death Receptor-1 blocking antibody1,191
LansoprazoleProton pump inhibitor2,600
Lasilix664
LenalidomideThalidomide analog811
Levetiracetam591
LevofloxacinFluoroquinolone antibacterial714
LinezolidOxazolidinone antibacterial606
LisinoprilAngiotensin converting enzyme inhibitor1,995
LosartanAngiotensin 2 receptor blocker910
MeropenemPenem antibacterial507
MetforminBiguanide8,344
Metformin hydrochlorideBiguanide2,542
Metformine501
MethotrexateFolate analog metabolic inhibitor3,109
Methotrexate sodiumFolate analog metabolic inhibitor562
MethylprednisoloneCorticosteroid1,196
Mycophenolate mofetilAntimetabolite immunosuppressant2,221
Mycophenolic acidAntimetabolite immunosuppressant559
NaproxenNonsteroidal anti-inflammatory drug774
NexiumProton pump inhibitor16,652
Nexium 24HRProton pump inhibitor9,510
NivolumabProgrammed death Receptor-1 blocking antibody1,265
OlanzapineAtypical antipsychotic595
OmeprazoleProton pump inhibitor7,982
Omeprazole magnesiumProton pump inhibitor919
OpdivoProgrammed death Receptor-1 blocking antibody550
OxaliplatinPlatinum-based drug1,180
PaclitaxelMicrotubule inhibitor965
PantoprazoleProton pump inhibitor6,411
Pantoprazole sodiumProton pump inhibitor12,488
Paracetamol822
PembrolizumabProgrammed death Receptor-1 blocking antibody1,110
PemetrexedFolate analog metabolic inhibitor751
Perindopril998
Piperacillin and tazobactamPenicillin-class antibacterial836
Piperacillin sodium,tazobactam sodium645
PlavixP2Y12 platelet inhibitor503
PradaxaDirect thrombin inhibitor736
PrednisoloneCorticosteroid1,402
PrednisoneCorticosteroid2,945
PrevacidProton pump inhibitor14,895
Prevacid 24 HRProton pump inhibitor7,839
PrilosecProton pump inhibitor14,622
Prilosec OTCProton pump inhibitor8,495
QuetiapineAtypical antipsychotic747
RamiprilAngiotensin converting enzyme inhibitor3,262
RemdesivirSARS-CoV-2 nucleotide analog RNA polymerase inhibitor528
RevlimidThalidomide analog1,397
RituximabCD20-directed cytolytic antibody2,205
RosuvastatinHMG-CoA reductase inhibitor1,302
SimvastatinHMG-CoA reductase inhibitor1,039
SpironolactoneAldosterone antagonist2,873
StribildCytochrome P450 3A inhibitor605
TacrolimusCalcineurin inhibitor immunosuppressant4,420
TorsemideLoop diuretic666
Tramadol561
TruvadaHuman immunodeficiency virus nucleoside analog reverse transcriptase inhibitor2,172
ValsartanAngiotensin 2 receptor blocker1,289
VancomycinGlycopeptide antibacterial3,273
VenlafaxineSerotonin and norepinephrine reuptake inhibitor513
Vimovo1,119
Vincristine825
VireadHepatitis B virus nucleoside analog reverse transcriptase inhibitor1,017
XareltoFactor Xa inhibitor3,572
Zoledronic acidBisphosphonate506

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 52 pharmacologic classes with 1,000 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 .

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 . The site read the page on .

Pharmacologic classes of the drugs that the reports with the term Acute kidney injury name, in order of name
ClassReports with this term
Aldosterone antagonist4,360
Alkylating drug3,791
Aminoglycoside antibacterial1,524
Angiotensin 2 receptor blocker8,768
Angiotensin converting enzyme inhibitor6,570
Anthracycline topoisomerase inhibitor1,335
Anti-epileptic agent1,742
Antimetabolite immunosuppressant3,475
Atypical antipsychotic3,459
Azole antifungal1,281
Benzodiazepine2,166
beta-Adrenergic blocker3,535
Biguanide11,628
Calcineurin inhibitor immunosuppressant6,372
Calcium channel blocker2,529
CD20-directed cytolytic antibody2,570
Cephalosporin antibacterial2,142
Corticosteroid9,101
Cytochrome P450 3A inhibitor1,340
Dihydrofolate reductase inhibitor antibacterial2,196
Factor Xa inhibitor5,555
Fluoroquinolone antibacterial2,226
Folate analog metabolic inhibitor4,888
GLP-1 receptor agonist2,095
Glycopeptide antibacterial3,736
Hepatitis B virus nucleoside analog reverse transcriptase inhibitor1,459
Herpes simplex virus nucleoside analog DNA polymerase inhibitor1,684
HMG-CoA reductase inhibitor3,624
Human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor2,915
Insulin analog1,006
Janus kinase inhibitor1,052
Kinase inhibitor6,055
Loop diuretic8,933
Microtubule inhibitor1,761
Nonsteroidal anti-inflammatory drug9,008
Nucleoside metabolic inhibitor4,671
Opioid agonist2,830
P2Y12 platelet inhibitor1,450
Penicillin-class antibacterial2,601
Platinum-based drug5,252
Programmed death Receptor-1 blocking antibody4,825
Proteasome inhibitor2,032
Proton pump inhibitor116,683
Serotonin and norepinephrine reuptake inhibitor1,185
Serotonin reuptake inhibitor2,201
Sodium-Glucose cotransporter 2 inhibitor4,364
Thalidomide analog2,853
Thiazide diuretic2,786
Topoisomerase inhibitor1,350
Tumor necrosis factor blocker1,404
Vascular endothelial growth factor inhibitor1,138
Xanthine oxidase inhibitor1,695

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

Reports by month

Reports that record Acute kidney injury, by month, five years to June 2026
01,0002,00020222023202420252026

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 Acute kidney injury
AgeReportsShareShare as a bar
Under 24900.3%
2 to 111,3830.9%
12 to 172,4621.6%
18 to 4414,6559.8%
45 to 6438,31325.5%
65 to 7428,82619.2%
75 and over28,99819.3%
Age not given35,17023.4%
Sex of the patient in the reports that record Acute kidney injury
SexReportsShareShare as a bar
Female57,90438.5%
Male67,45444.9%
Unknown or not given24,93916.6%

Age and sex are as the report gives them. 46.7% of these reports give the United States as the country.

Terms near this one

Official pages

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Reported Reactions. Acute kidney injury: adverse event reports that record this term. https://reportedreactions.com/reaction/acute-kidney-injury/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of . Reports received through .

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 Acute kidney injury mean in an adverse event report?

In plain words: sudden loss of kidney function. 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 .

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 .

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 .