Reported Reactions

Reactions

MedDRA preferred term

Renal pain: adverse event reports recording this term

10,397 reports to FDA record it, 2004–2026; 0.1% of the database.

10,397
reports recording the term
0.1% of all reports
587
reports, 12 months to June 2026
543 in the 12 months before
67.7%
marked serious by the reporter
57.4% across all reports
1.7%
record death among outcomes, as reported
9.1% across all reports

"Renal pain" is a MedDRA preferred term recorded in 10,397 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.

587 reports recorded it in the 12 months to June 2026, close to the 543 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, 67.7% are marked serious, 1.7% include death among the outcomes and 23.7% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Humira, Enbrel and Omeprazole. 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

04998Jul 2021: 66Aug 2021: 69Sep 2021: 49Oct 2021: 41Nov 2021: 60Dec 2021: 712022Jan 2022: 55Feb 2022: 49Mar 2022: 75Apr 2022: 51May 2022: 77Jun 2022: 62Jul 2022: 54Aug 2022: 70Sep 2022: 69Oct 2022: 68Nov 2022: 69Dec 2022: 592023Jan 2023: 64Feb 2023: 36Mar 2023: 56Apr 2023: 50May 2023: 69Jun 2023: 35Jul 2023: 54Aug 2023: 45Sep 2023: 42Oct 2023: 48Nov 2023: 62Dec 2023: 402024Jan 2024: 58Feb 2024: 57Mar 2024: 28Apr 2024: 36May 2024: 53Jun 2024: 59Jul 2024: 59Aug 2024: 34Sep 2024: 39Oct 2024: 64Nov 2024: 39Dec 2024: 332025Jan 2025: 34Feb 2025: 48Mar 2025: 49Apr 2025: 47May 2025: 38Jun 2025: 59Jul 2025: 98Aug 2025: 45Sep 2025: 42Oct 2025: 60Nov 2025: 62Dec 2025: 342026Jan 2026: 32Feb 2026: 52Mar 2026: 39Apr 2026: 46May 2026: 36Jun 2026: 41

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
Humira—3090%
EnbrelTumor necrosis factor blocker1400%
OmeprazoleProton pump inhibitor1230.2%
EntrestoAngiotensin 2 receptor blocker1210.1%
PrevacidProton pump inhibitor990.2%
CosentyxInterleukin-17A antagonist980.1%
ForteoParathyroid hormone analog970.1%
RevlimidThalidomide analog930%
CrestorHMG-CoA reductase inhibitor900.2%
XeljanzJanus kinase inhibitor890.1%
ChantixPartial cholinergic nicotinic agonist880.1%
MethotrexateFolate analog metabolic inhibitor860%
TruvadaHuman immunodeficiency virus nucleoside analog reverse transcriptase inhibitor830.2%
CiprofloxacinFluoroquinolone antibacterial790.2%
NexiumProton pump inhibitor770.1%
OzempicGLP-1 receptor agonist740.1%
PantoprazoleProton pump inhibitor710.2%
RemicadeTumor necrosis factor blocker680%
Sandostatin LAR Depot—680.4%
JardianceSodium-Glucose cotransporter 2 inhibitor670.2%
MounjaroGLP-1 receptor agonist660.1%
SolirisComplement inhibitor650.1%
Lyrica—640.1%
Atorvastatin—620.1%
Paxlovid—620.1%

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 0.1% 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

ClassReports with this termShare of class reportsMedian drug in class
Proton pump inhibitor6890.1%0.1%
Kinase inhibitor4330.1%0%
Tumor necrosis factor blocker3760%0%
GLP-1 receptor agonist3010.1%0.1%
Angiotensin 2 receptor blocker2880.1%0.1%
Nonsteroidal anti-inflammatory drug2640%0%
Sodium-Glucose cotransporter 2 inhibitor2240.2%0.2%
Corticosteroid2170%0%
HMG-CoA reductase inhibitor2170.1%0%
Janus kinase inhibitor1780.1%0%

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%3
2 to 110.2%20
12 to 170.5%52
18 to 4415.3%1,594
45 to 6430.3%3,154
65 to 7411.3%1,174
75 and over6.1%639
Age not given36.2%3,761

Patient sex

Female55.6%5,776
Male36.5%3,800
Not given7.9%821

Grey bar: all 20,646,523 reports in the database. 58.6% of these reports give the United States as the country.

Questions about "Renal pain"

What does "Renal pain" 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 pain?

10,397 reports through June 2026 (0.1% of all reports), 587 of them in the latest 12 months.

Which drugs appear most often in these reports?

Humira (309), Enbrel (140), Omeprazole (123), Entresto (121) and Prevacid (99). 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.