MedDRA preferred term

Renal injury: adverse event reports recording this term

29,614 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.

29,614
reports recording the term: 0.1% of all reports; 460
reports, 12 months to June 2026: 530 in the 12 months before; 99.6%
marked serious by the reporter: 57.4% across all reports; 10.2%
record death among outcomes, as reported: 9.1% across all reports

29,614 reports in FDA's adverse event database record the MedDRA term "Renal injury": 0.1% of all reports received between February 2004 and June 2026. Coders pick the term that best matches the reporter's description.

460 reports recorded it in the 12 months to June 2026, down 13% from 530 in 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, 99.6% are marked serious, 10.2% include death among the outcomes and 17.7% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Viread, Prevacid and Nexium. 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
Viread	Hepatitis B virus nucleoside analog reverse transcriptase inhibitor	9,241	41.9%
Prevacid	Proton pump inhibitor	9,026	22.5%
Nexium	Proton pump inhibitor	8,791	10.3%
Prilosec	Proton pump inhibitor	8,112	19.2%
Truvada	Human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor	7,991	20.7%
Nexium 24HR	Proton pump inhibitor	6,060	21.8%
Pantoprazole sodium	Proton pump inhibitor	6,017	13.6%
Prevacid 24 HR	Proton pump inhibitor	5,649	28.1%
Prilosec OTC	Proton pump inhibitor	4,965	20.2%
Atripla	—	4,746	26.4%
Dexilant	Proton pump inhibitor	4,296	18.2%
Stribild	Cytochrome P450 3A inhibitor	3,303	37.7%
Complera	Human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor	2,959	45.3%
Omeprazole	Proton pump inhibitor	2,766	4.5%
Trasylol	—	2,053	58.2%
Pantoprazole	Proton pump inhibitor	1,939	4.3%
Lansoprazole	Proton pump inhibitor	1,105	4.2%
Esomeprazole	Proton pump inhibitor	1,001	5.8%
Vioxx	—	454	1.2%
Omeprazole magnesium	Proton pump inhibitor	385	9.3%
Aciphex	Proton pump inhibitor	337	4.7%
Zegerid	Proton pump inhibitor	211	18.9%
Esomeprazole magnesium	Proton pump inhibitor	207	4.1%
Tacrolimus	Calcineurin inhibitor immunosuppressant	153	0.2%
Humira	—	128	0%

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	60,995	12.6%	6.6%
Human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor	10,977	13.6%	0%
Hepatitis B virus nucleoside analog reverse transcriptase inhibitor	9,351	12.9%	0.2%
Cytochrome P450 3A inhibitor	3,426	7.4%	0.1%
Nonsteroidal anti-inflammatory drug	472	0.1%	0%
Opioid agonist	361	0%	0%
Corticosteroid	339	0%	0%
Calcineurin inhibitor immunosuppressant	228	0.1%	0%
Kinase inhibitor	214	0%	0%
Sodium-Glucose cotransporter 2 inhibitor	190	0.2%	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 20.1%34

2 to 110.3%103

12 to 170.4%125

18 to 4411.1%3,292

45 to 6427.3%8,088

65 to 748.8%2,601

75 and over4.5%1,341

Age not given47.4%14,030

Patient sex

Female37.1%10,995

Male47.3%14,000

Not given15.6%4,619

Grey bar: all 20,646,523 reports in the database. 90.3% of these reports give the United States as the country.

Questions about "Renal injury"

What does "Renal injury" 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 injury?

29,614 reports through June 2026 (0.1% of all reports), 460 of them in the latest 12 months.

Which drugs appear most often in these reports?

Viread (9,241), Prevacid (9,026), Nexium (8,791), Prilosec (8,112) and Truvada (7,991). 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.