What the label lists and what reports show
Voclosporin side effects
Voclosporin's FDA label: “The most commonly reported adverse reactions (≥3%) were: glomerular filtration rate decreased, hypertension, diarrhea, headache, anemia, cough, urinary tract infection, abdominal pain upper, dyspepsia, alopecia, renal impairment, abdominal pain, mouth …” FAERS holds 8,634 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is hypertension (719 reports).
- No generic listed
- Boxed warning
Check it at the source: the voclosporin FDA label on DailyMed (effective August 25, 2026, Aurinia Pharma U.S., Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of LUPKYNIS?LUPKYNIS may cause serious side effects, including: See “ What is the most important information I should know about LUPKYNIS? ” kidney problems. Kidney problems are common side effects of LUPKYNIS and may be serious. Your healthcare provider may do certain tests to check your kidney function while you take LUPKYNIS. high blood pressure. High blood pressure is a common side effect of LUPKYNIS and may be serious. Your healthcare provider will monitor your blood pressure while you take LUPKYNIS and may ask you to check your blood pressure at home. nervous system problems. Nervous system problems are a common side effect of LUPKYNIS and may be serious. Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these symptoms while taking LUPKYNIS. […]
Source: FDA drug label, Aurinia Pharma U.S., Inc., effective August 25, 2026 (SPL set 9f489295-1156-52c7-5fd0-5c4c52f9b813), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most commonly reported adverse reactions (≥3%) were: glomerular filtration rate decreased, hypertension, diarrhea, headache, anemia, cough, urinary tract infection, abdominal pain upper, dyspepsia, alopecia, renal impairment, abdominal pain, mouth ulceration, fatigue, tremor, acute kidney injury, and decreased appetite.
Table 1: Adverse Reactions in ≥3% of Patients Treated with LUPKYNIS 23.7 mg Twice a Day and ≥2% Higher than Placebo in Studies 1 and 2
| Adverse Reaction | LUPKYNIS 23.7 mg twice a day (n=267) | Placebo (n=266) |
|---|---|---|
| Glomerular filtration rate decreased See Specific Adverse Reactions below (Nephrotoxicity) | 26% | 9% |
| Hypertension | 19% | 9% |
| Diarrhea | 19% | 13% |
| Headache | 15% | 8% |
| Anemia | 12% | 6% |
| Cough | 11% | 2% |
| Urinary tract infection | 10% | 6% |
| Abdominal pain upper | 7% | 2% |
| Dyspepsia | 6% | 3% |
| Alopecia | 6% | 3% |
| Renal Impairment | 6% | 3% |
| Abdominal pain | 5% | 2% |
| Mouth ulceration | 4% | 1% |
| Fatigue | 4% | 1% |
| Tremor | 3% | 1% |
| Acute kidney injury | 3% | 1% |
| Decreased appetite | 3% | 1% |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are described elsewhere in the labeling: Lymphoma and Other Malignancies [see Warnings and Precautions ( 5.1 )] Serious Infections [see Warnings and Precautions ( 5.2 )] Nephrotoxicity due to LUPKYNIS and Drug Interactions [see Warnings and Precautions ( 5.3 )] Hypertension [see Warnings and Precautions ( 5.4 )] Neurotoxicity [see Warnings and Precautions ( 5.5 )] Hyperkalemia [see Warnings and Precautions ( 5.6 )] QTc Prolongation [see Warnings and Precautions ( 5.7 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.8 )] Immunizations [see Warnings and Precautions ( 5.9 ) ] Pure Red Cell Aplasia [see Warnings and Precautions ( 5.10 )] The most commonly reported adverse reactions (≥3%) were: glomerular filtration rate decreased, hypertension, diarrhea, headache, anemia, cough, urinary tract infection, abdominal pain upper, dyspepsia, alopecia, renal impairment, abdominal pain, mouth ulceration, fatigue, tremor, acute kidney injury, and decreased appetite. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Aurinia Pharmaceuticals at 1-833-672-0028 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …
Source: FDA drug label, Aurinia Pharma U.S., Inc., effective August 25, 2026 (SPL set 9f489295-1156-52c7-5fd0-5c4c52f9b813), via openFDA; the full label on DailyMed
What do FAERS reports show?
8,634 reports list voclosporin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 49 are coded as a death and 786 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2025 (2,316, against a median of 1 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 21 reactions below, 13 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Voclosporin: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions