Reported Reactions

Adverse event reports that FDA received

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Renal injury 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 . 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 February 2004 to June 2026, FDA received 29,614 adverse event reports that record the MedDRA preferred term Renal injury. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 460 reports in the 12 months to June 2026 and 530 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 1,028 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, 460 (under 0.1%) record this term. Reports for female patients were 37.1% 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.

Data version

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

Drugs in these reports

The table has the 100 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 .

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 Renal injury name as a suspect product, in order of name
DrugClassReports with this term
Acetaminophen40
AciphexProton pump inhibitor337
AcyclovirHerpes simplex virus nucleoside analog DNA polymerase inhibitor30
AdvilNonsteroidal anti-inflammatory drug32
AleveNonsteroidal anti-inflammatory drug124
AllopurinolXanthine oxidase inhibitor30
Amiodarone hydrochlorideAntiarrhythmic27
AmlodipineCalcium channel blocker32
AmoxicillinPenicillin-class antibacterial25
AspirinNonsteroidal anti-inflammatory drug47
Atorvastatin31
Atripla4,746
Avandia87
BasiliximabInterleukin-2 receptor blocking antibody29
BevacizumabVascular endothelial growth factor inhibitor52
BortezomibProteasome inhibitor26
ByettaGLP-1 receptor agonist62
CapecitabineNucleoside metabolic inhibitor36
CarboplatinPlatinum-based drug29
CelebrexNonsteroidal anti-inflammatory drug39
Ciclosporin27
CiprofloxacinFluoroquinolone antibacterial59
CisplatinPlatinum-based drug78
CompleraHuman immunodeficiency virus nucleoside analog reverse transcriptase inhibitor2,959
CyclophosphamideAlkylating drug92
CyclosporineCalcineurin inhibitor immunosuppressant44
CytarabineNucleoside metabolic inhibitor51
DexamethasoneCorticosteroid96
DexilantProton pump inhibitor4,296
DexlansoprazoleProton pump inhibitor53
DiclofenacNonsteroidal anti-inflammatory drug53
Diclofenac sodiumNonsteroidal anti-inflammatory drug41
DoxorubicinAnthracycline topoisomerase inhibitor35
EliquisFactor Xa inhibitor26
EntrestoAngiotensin 2 receptor blocker42
EsomeprazoleProton pump inhibitor1,001
Esomeprazole magnesiumProton pump inhibitor207
EtoposideTopoisomerase inhibitor35
FarxigaSodium-Glucose cotransporter 2 inhibitor42
FurosemideLoop diuretic64
Humira128
Hydrocodone bitartrate and acetaminophenOpioid agonist29
IbuprofenNonsteroidal anti-inflammatory drug76
ImbruvicaKinase inhibitor25
InvokanaSodium-Glucose cotransporter 2 inhibitor94
JardianceSodium-Glucose cotransporter 2 inhibitor27
KaletraCytochrome P450 3A inhibitor105
KeytrudaProgrammed death Receptor-1 blocking antibody28
LamivudineHepatitis B virus nucleoside analog reverse transcriptase inhibitor32
LansoprazoleProton pump inhibitor1,105
LisinoprilAngiotensin converting enzyme inhibitor35
MeropenemPenem antibacterial35
MetforminBiguanide104
Metformin hydrochlorideBiguanide43
MethotrexateFolate analog metabolic inhibitor118
Methotrexate sodiumFolate analog metabolic inhibitor43
MethylprednisoloneCorticosteroid46
Morphine sulfateOpioid agonist35
Mycophenolate mofetilAntimetabolite immunosuppressant88
NexiumProton pump inhibitor8,791
Nexium 24HRProton pump inhibitor6,060
Nexium I V100
OmeprazoleProton pump inhibitor2,766
Omeprazole magnesiumProton pump inhibitor385
Omeprazole Sodium53
OxaliplatinPlatinum-based drug48
Oxycodone and acetaminophenOpioid agonist31
Oxycodone hydrochlorideOpioid agonist81
OxyContinOpioid agonist67
PaclitaxelMicrotubule inhibitor30
PantoprazoleProton pump inhibitor1,939
Pantoprazole sodiumProton pump inhibitor6,017
Phosphosoda Flavor Not Specified36
PrednisoloneCorticosteroid63
PrednisoneCorticosteroid123
PrevacidProton pump inhibitor9,026
Prevacid 24 HRProton pump inhibitor5,649
PrilosecProton pump inhibitor8,112
Prilosec OTCProton pump inhibitor4,965
RanitidineHistamine-2 receptor antagonist32
RevlimidThalidomide analog47
RituximabCD20-directed cytolytic antibody82
RosuvastatinHMG-CoA reductase inhibitor27
SpironolactoneAldosterone antagonist41
StribildCytochrome P450 3A inhibitor3,303
TacrolimusCalcineurin inhibitor immunosuppressant153
Tenofovir disoproxil fumarateHepatitis B virus nucleoside analog reverse transcriptase inhibitor26
Trasylol2,053
TruvadaHuman immunodeficiency virus nucleoside analog reverse transcriptase inhibitor7,991
TylenolExpectorant27
ValsartanAngiotensin 2 receptor blocker29
VancomycinGlycopeptide antibacterial104
Vimovo119
Vincristine38
Vioxx454
VireadHepatitis B virus nucleoside analog reverse transcriptase inhibitor9,241
XareltoFactor Xa inhibitor101
Zantac50
ZegeridProton pump inhibitor211
Zegerid OTCProton pump inhibitor70

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 53 pharmacologic classes with 25 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 Renal injury name, in order of name
ClassReports with this term
Aldosterone antagonist41
Alkylating drug140
Aminoglycoside antibacterial39
Angiotensin 2 receptor blocker124
Angiotensin converting enzyme inhibitor94
Anthracycline topoisomerase inhibitor39
Antiarrhythmic38
Antimetabolite immunosuppressant111
Atypical antipsychotic77
Azole antifungal25
beta-Adrenergic blocker25
Biguanide177
Calcineurin inhibitor immunosuppressant228
Calcium channel blocker32
CD20-directed cytolytic antibody100
Cephalosporin antibacterial54
Corticosteroid339
Cytochrome P450 3A inhibitor3,426
Dihydrofolate reductase inhibitor antibacterial30
Expectorant27
Factor Xa inhibitor143
Fluoroquinolone antibacterial75
Folate analog metabolic inhibitor178
GLP-1 receptor agonist136
Glycopeptide antibacterial117
Hepatitis B virus nucleoside analog reverse transcriptase inhibitor9,351
Herpes simplex virus nucleoside analog DNA polymerase inhibitor30
Histamine-2 receptor antagonist64
HMG-CoA reductase inhibitor75
Human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor10,977
Insulin analog43
Interleukin-2 receptor blocking antibody41
Janus kinase inhibitor34
Kinase inhibitor214
Loop diuretic77
Macrolide antimicrobial32
Microtubule inhibitor38
Nonsteroidal anti-inflammatory drug432
Nucleoside metabolic inhibitor145
Opioid agonist361
Penem antibacterial37
Penicillin-class antibacterial41
Platinum-based drug155
Programmed death Receptor-1 blocking antibody88
Proteasome inhibitor74
Proton pump inhibitor60,995
Sodium-Glucose cotransporter 2 inhibitor190
Thalidomide analog66
Thiazide diuretic26
Topoisomerase inhibitor35
Tumor necrosis factor blocker75
Vascular endothelial growth factor inhibitor75
Xanthine oxidase inhibitor34

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

Reports by month

Reports that record Renal injury, by month, five years to June 2026
010020020222023202420252026

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 Renal injury
AgeReportsShareShare as a bar
Under 2340.1%
2 to 111030.3%
12 to 171250.4%
18 to 443,29211.1%
45 to 648,08827.3%
65 to 742,6018.8%
75 and over1,3414.5%
Age not given14,03047.4%
Sex of the patient in the reports that record Renal injury
SexReportsShareShare as a bar
Female10,99537.1%
Male14,00047.3%
Unknown or not given4,61915.6%

Age and sex are as the report gives them. 90.3% of these reports give the United States as the country.

Terms near this one

Official pages

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Reported Reactions. Renal injury: adverse event reports that record this term. https://reportedreactions.com/reaction/renal-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 Renal injury 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 .

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 .