MedDRA preferred term

Renal tubular necrosis: adverse event reports recording this term

9,651 reports to FDA record it, 2004–2026; 0.1% of the database.

Read first · FDA's statement on these data

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. openFDA, FDA

FDA adds: "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 "cannot be used to estimate the incidence of these events."

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.

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

9,651
reports recording the term: 0.1% of all reports; 594
reports, 12 months to June 2026: 561 in the 12 months before; 99.1%
marked serious by the reporter: 57.4% across all reports; 13.6%
record death among outcomes, as reported: 9.1% across all reports

"Renal tubular necrosis" is a MedDRA preferred term recorded in 9,651 adverse event reports received by FDA, 0.1% of the database, from January 2004 to June 2026. The term is chosen by whoever codes the report to match what the reporter described.

594 reports recorded it in the 12 months to June 2026, close to the 561 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, 99.1% are marked serious, 13.6% include death among the outcomes and 70.8% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Vancomycin, Tacrolimus and Ibuprofen. 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

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

Drugs listed as suspect products in these reports

Drug	Class	Reports with this term	Share of the drug's own reports
Vancomycin	Glycopeptide antibacterial	665	2.2%
Tacrolimus	Calcineurin inhibitor immunosuppressant	598	0.6%
Ibuprofen	Nonsteroidal anti-inflammatory drug	446	0.6%
Nexium	Proton pump inhibitor	411	0.5%
Mycophenolate mofetil	Antimetabolite immunosuppressant	397	0.5%
Prilosec	Proton pump inhibitor	332	0.8%
Prednisone	Corticosteroid	312	0.2%
Prevacid	Proton pump inhibitor	309	0.8%
Pantoprazole sodium	Proton pump inhibitor	284	0.6%
Omeprazole	Proton pump inhibitor	247	0.4%
Carboplatin	Platinum-based drug	243	0.2%
Metformin	Biguanide	240	0.4%
Pantoprazole	Proton pump inhibitor	234	0.5%
Prilosec OTC	Proton pump inhibitor	213	0.9%
Nexium 24HR	Proton pump inhibitor	195	0.7%
Acetaminophen	Nonsteroidal anti-inflammatory drug	192	0.2%
Pembrolizumab	Programmed death Receptor-1 blocking antibody	181	0.6%
Pemetrexed	Folate analog metabolic inhibitor	180	1%
Cisplatin	Platinum-based drug	170	0.3%
Lisinopril	Angiotensin converting enzyme inhibitor	169	0.4%
Ciprofloxacin	Fluoroquinolone antibacterial	166	0.4%
Gentamicin	Aminoglycoside antibacterial	165	3%
Truvada	Human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor	165	0.4%
Zoledronic acid	Bisphosphonate	161	1%
Methylprednisolone	Corticosteroid	159	0.3%

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 0.1% 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

Class	Reports with this term	Share of class reports	Median drug in class
Proton pump inhibitor	2,607	0.5%	0.4%
Nonsteroidal anti-inflammatory drug	1,043	0.2%	0%
Calcineurin inhibitor immunosuppressant	922	0.4%	0.3%
Glycopeptide antibacterial	739	2.1%	1.8%
Corticosteroid	716	0.1%	0%
Antimetabolite immunosuppressant	584	0.5%	0.6%
Platinum-based drug	473	0.2%	0.2%
Folate analog metabolic inhibitor	434	0.1%	0.1%
Programmed death Receptor-1 blocking antibody	362	0.2%	0.1%
Biguanide	337	0.3%	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 20.6%56

2 to 111.7%163

12 to 172.6%251

18 to 4415.7%1,517

45 to 6432.8%3,162

65 to 7418.5%1,790

75 and over11.2%1,081

Age not given16.9%1,631

Patient sex

Female41.7%4,027

Male49.7%4,799

Not given8.5%825

Grey bar: all 20,646,523 reports in the database. 48.5% of these reports give the United States as the country.

Questions about "Renal tubular necrosis"

What does "Renal tubular necrosis" 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 renal tubular necrosis?

9,651 reports through June 2026 (0.1% of all reports), 594 of them in the latest 12 months.

Which drugs appear most often in these reports?

Vancomycin (665), Tacrolimus (598), Ibuprofen (446), Nexium (411) and Mycophenolate mofetil (397). 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.