Lupkynis: adverse event reports filed with FDA

8,467

reports as suspect product

0% of all reports · about 1,614 a year

2,444

reports, 12 months to June 2026

2,178 in the 12 months before

20.3%

marked serious by the reporter

79.1% across the class

0.6%

record death among outcomes, as reported

47 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Lupkynis reports recording the termmedian drug in calcineurin inhibitor immunosuppressant

1. Therapy interrupted11.4%964
2. Product dose omission issuea dose was missed9.3%786
3. Hypertensionhigh blood pressure8.4%711
4. Headachehead pain8%674
5. Nauseafeeling sick7.2%612
6. Diarrhoealoose or frequent stools6.2%521
7. Fatiguetiredness6.1%514
8. Proteinuriaprotein in the urine5.7%482
9. Blood pressure increaseda raised blood pressure reading4.3%368
10. Glomerular filtration rate decreasedreduced kidney filtering3.8%325
11. Abdominal discomfortstomach discomfort3.8%322
12. Vomitingbeing sick3.8%320
13. Product use issuea problem in how the product was used3.7%312
14. Arthralgiajoint pain3.3%276
15. Blood creatinine increasedraised creatinine, a kidney test3.2%275
16. Dizzinesslight-headedness or unsteadiness3.2%270
17. Abdominal pain upperupper stomach pain3.1%261
18. Renal impairmentreduced kidney function3%251
19. Covid-19COVID-19 infection2.9%242
20. Alopeciahair loss2.8%237
21. Off label useused for a purpose or in a way not on the label2.7%231
22. Urine protein/creatinine ratio increased2.5%215
23. Peripheral swellingswelling of the arms or legs2.4%205
24. Painpain, site not specified2.3%198
25. Systemic lupus erythematosuslupus, an autoimmune disease2.3%193
26. Rashskin rash2.1%180
27. Illness2.1%178
28. Malaisegeneral feeling of being unwell2.1%178
29. Urinary tract infectionbladder or urinary infection2.1%174
30. Product dose omission in error2%170

Top 30 of 673 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 11 drugs in the calcineurin inhibitor immunosuppressant class; it describes the reports, not the patients. 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."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 206,378 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 98.9% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 8,467 reports.

Drugs most often listed in the same reports

Other products listed in reports where Lupkynis is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. 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."

Other drugs in the calcineurin inhibitor immunosuppressant class

Ordered by report count for navigation only. 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." A brand and its generic are separate rows because reporters name them separately.

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. A report counts here when it lists Lupkynis as a suspect or interacting product; reports listing it only as a concomitant medication (58) are excluded. 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.