Voclosporin side effects: what 8,634 FDA adverse event reports show

Voclosporin · Lupkynis · 685 reaction terms · 22,529 drug–reaction co-reports · data 2026-09-14

Drug class

Calcineurin Inhibitor Immunosuppressant

FDA label (Established Pharmacologic Class) · compare the class

Brand names

Lupkynis

openFDA label

Who reports

8,634 reports · 21% serious · 49 with death outcome · 84% female

openFDA FAERS counts, all years, deduplication not applied

Used for

LUPKYNIS is indicated in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active lupus nephritis (LN). Limitations of Use: Safety and efficacy of LUPKYNIS have not been established in combination with cyclophosphamide. Use of LUPKYNIS is not recommended in this situation.

FDA label, Indications and Usage

What it is

LUPKYNIS (voclosporin) capsules, a calcineurin-inhibitor immunosuppressant, is available for administration as soft gelatin capsules containing 7.9 mg voclosporin per capsule. Inactive ingredi.

FDA label, Description section

Boxed warning

MALIGNANCIES AND SERIOUS INFECTIONS Increased risk for developing malignancies and serious infections with LUPKYNIS or other immunosuppressants that may lead to hospitalization or death [see Warnings and Precautions ( 5.1 , 5.2 )]. WARNING: MALIGNANCIES AND SERIOUS INFECTIONS See full prescribing information for complete boxed warning.

FDA label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 40 strongest signals

Labeled — boxed warning 2Labeled adverse reaction 4Labeled (related wording) 2Likely indication confounding 1Reporting / coding artifact 6Lab value / disease marker 13Not in label — unassessed 12

What the badges mean

Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 645 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Absence of immediate treatment response	90	1,891.3 1,435.8–2,491.4ROR 1,911.2 · χ² 93,968 / p <1e-300	862.0 EB05 722.6 · IC025 +6.9 3/3 methods agree	Labeled (related wording) related wording	serious n=16 · 79% consumer	no trial data cached
Herpes simplex colitis	12	1,306.7 646.9–2,639.5ROR 1,308.5 · χ² 9,303 / p <1e-300	359.8 EB05 219.3 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious n=12	no trial data cached
Urine protein/creatinine ratio increased	221	804.6 691.9–935.7ROR 825.7 · χ² 132,186 / p <1e-300	572.5 EB05 511.9 · IC025 +7.8 3/3 methods agree	Lab value / disease marker	serious n=167	no trial data cached
Disseminated herpes simplex	10	435.6 222.1–854.2ROR 436.1 · χ² 3,310 / p <1e-300	216.7 EB05 125.8 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=10	no trial data cached
Urine protein/creatinine ratio abnormal	14	264.1 152.1–458.4ROR 264.5 · χ² 3,072 / p <1e-300	180.0 EB05 113.9 · IC025 +3.8 3/3 methods agree	Lab value / disease marker	serious n=13	no trial data cached
Complement factor c3 decreased	21	232.9 148.9–364.4ROR 233.5 · χ² 4,211 / p <1e-300	178.2 EB05 123.0 · IC025 +4.4 3/3 methods agree	Lab value / disease marker	serious n=15	no trial data cached
Double stranded dna antibody positive	27	225.4 152.0–334.2ROR 226.1 · χ² 5,309 / p <1e-300	180.0 EB05 129.9 · IC025 +4.8 3/3 methods agree	Lab value / disease marker	serious n=19	no trial data cached
Complement factor c4 decreased	15	216.5 127.7–367.0ROR 216.8 · χ² 2,756 / p <1e-300	158.9 EB05 102.2 · IC025 +3.9 3/3 methods agree	Lab value / disease marker	serious n=8	no trial data cached
Complement factor decreased	14	212.3 122.9–366.5ROR 212.6 · χ² 2,514 / p <1e-300	154.4 EB05 97.8 · IC025 +3.8 3/3 methods agree	Lab value / disease marker	serious n=10	no trial data cached
Product packaging difficult to open	153	160.3 136.3–188.6ROR 163.2 · χ² 22,561 / p <1e-300	147.6 EB05 129.0 · IC025 +6.4 3/3 methods agree	Reporting / coding artifact	serious n=19 · 96% consumer	no trial data cached
Urine albumin/creatinine ratio increased	25	120.3 80.5–179.6ROR 120.6 · χ² 2,703 / p <1e-300	105.5 EB05 75.2 · IC025 +4.5 3/3 methods agree	Lab value / disease marker	serious n=19	no trial data cached
Biopsy kidney	13	117.5 67.4–205.0ROR 117.7 · χ² 1,323 / p 7e-290	96.6 EB05 60.1 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=4	no trial data cached
Lupus nephritis	57	77.7 59.7–101.1ROR 78.2 · χ² 4,107 / p <1e-300	73.5 EB05 58.9 · IC025 +5.1 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious n=53	no trial data cached
Glomerular filtration rate decreased	329	67.8 60.9–75.5ROR 70.4 · χ² 21,001 / p <1e-300	65.7 EB05 60.0 · IC025 +5.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 153.7	no trial data cached
Proteinuria	497	65.7 60.3–71.7ROR 69.7 · χ² 30,805 / p <1e-300	63.9 EB05 59.3 · IC025 +5.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 91.6	no trial data cached
Therapy interrupted	964	34.4 32.4–36.5ROR 38.6 · χ² 30,895 / p <1e-300	33.9 EB05 32.2 · IC025 +5.0 3/3 methods agree	Reporting / coding artifact	serious PRR 22.4 · 91% consumer	no trial data cached
Glomerular filtration rate abnormal	19	33.2 21.2–52.3ROR 33.3 · χ² 555 / p 6e-123	31.9 EB05 21.6 · IC025 +3.4 3/3 methods agree	Lab value / disease marker	serious n=10	no trial data cached
Urine abnormality	60	32.9 25.5–42.4ROR 33.1 · χ² 1,801 / p <1e-300	32.2 EB05 25.9 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious n=28	no trial data cached
Protein urine present	63	31.2 24.3–40.0ROR 31.4 · χ² 1,788 / p <1e-300	30.5 EB05 24.7 · IC025 +4.2 3/3 methods agree	Lab value / disease marker	serious n=25	no trial data cached
Protein total increased	30	27.8 19.4–39.8ROR 27.9 · χ² 739 / p 5e-163	27.0 EB05 19.9 · IC025 +3.7 3/3 methods agree	Lab value / disease marker	serious n=7 · 90% consumer	no trial data cached
Protein urine	10	27.1 14.6–50.6ROR 27.2 · χ² 224 / p 7e-51	25.5 EB05 14.5 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious n=5	no trial data cached
Butterfly rash	10	24.5 13.1–45.6ROR 24.5 · χ² 200 / p 9e-46	23.0 EB05 12.9 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious n=3	no trial data cached
Intentional underdose	66	22.2 17.4–28.2ROR 22.4 · χ² 1,303 / p 1e-285	21.9 EB05 17.8 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious n=9 · 95% consumer	no trial data cached
Insurance issue	133	21.9 18.5–26.0ROR 22.3 · χ² 2,614 / p <1e-300	21.7 EB05 18.8 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious PRR 21.2 · 86% consumer	no trial data cached
Product odour abnormal	92	21.7 17.7–26.6ROR 21.9 · χ² 1,781 / p <1e-300	21.4 EB05 18.0 · IC025 +3.9 3/3 methods agree	Reporting / coding artifact	serious n=13 · 97% consumer	no trial data cached
Protein total abnormal	10	18.7 10.0–34.9ROR 18.7 · χ² 149 / p 1e-34	17.3 EB05 9.0 · IC025 +2.3 3/3 methods agree	Lab value / disease marker	serious n=2	no trial data cached
Gingival hypertrophy	10	16.3 8.7–30.3ROR 16.3 · χ² 128 / p 7e-30	14.6 EB05 7.3 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious n=4	no trial data cached
Product dose omission in error	173	15.7 13.6–18.3ROR 16.0 · χ² 2,361 / p <1e-300	15.6 EB05 13.7 · IC025 +3.7 3/3 methods agree	Reporting / coding artifact	serious PRR 13.6 · 95% consumer	no trial data cached
Systemic lupus erythematosus	199	13.7 12.0–15.8ROR 14.0 · χ² 2,327 / p <1e-300	13.6 EB05 12.1 · IC025 +3.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 31.5	no trial data cached
Blood creatinine abnormal	18	12.8 8.1–20.3ROR 12.8 · χ² 183 / p 5e-42	11.8 EB05 7.4 · IC025 +2.5 3/3 methods agree	Lab value / disease marker	serious n=6	no trial data cached
Laboratory test abnormal	133	11.0 9.3–13.0ROR 11.2 · χ² 1,196 / p 3e-262	10.8 EB05 9.3 · IC025 +3.1 3/3 methods agree	Reporting / coding artifact	serious PRR 10.7 · 80% consumer	no trial data cached
Blood creatinine increased	279	10.4 9.3–11.7ROR 10.7 · χ² 2,358 / p <1e-300	10.3 EB05 9.3 · IC025 +3.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 20.2	no trial data cached
Blood potassium abnormal	10	9.2 4.9–17.0ROR 9.2 · χ² 65 / p 5e-16	7.2 EB05 3.9 · IC025 +1.6 3/3 methods agree	Lab value / disease marker	serious n=8	no trial data cached
Hair growth abnormal	26	9.1 6.2–13.4ROR 9.2 · χ² 180 / p 2e-41	8.3 EB05 5.8 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious n=1 · 85% consumer	no trial data cached
Hypertension (high blood pressure)	719	8.3 7.7–8.9ROR 8.9 · χ² 4,612 / p <1e-300	8.2 EB05 7.7 · IC025 +2.9 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 12.1 · 73% consumer	no trial data cached
Hypervolaemia	16	8.1 5.0–13.3ROR 8.1 · χ² 93 / p 3e-22	6.9 EB05 4.4 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious n=11	no trial data cached
Blood potassium increased	53	8.0 6.1–10.4ROR 8.0 · χ² 315 / p 1e-70	7.5 EB05 5.9 · IC025 +2.4 3/3 methods agree	Labeled — boxed warning synonym match	serious PRR 17.5	no trial data cached
Product distribution issue	28	7.7 5.3–11.1ROR 7.7 · χ² 156 / p 4e-36	7.0 EB05 5.0 · IC025 +2.1 3/3 methods agree	Reporting / coding artifact	serious n=5 · 100% consumer	no trial data cached
Renal impairment	256	7.5 6.6–8.4ROR 7.6 · χ² 1,424 / p <1e-300	7.4 EB05 6.6 · IC025 +2.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 18.3	no trial data cached
Autoimmune haemolytic anaemia	10	7.1 3.8–13.3ROR 7.1 · χ² 47 / p 4e-12	5.6 EB05 3.2 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious n=10	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Therapy interrupted	964	34.4 32.4–36.5ROR 38.6 · χ² 30,895 / p <1e-300	33.9 EB05 32.2 · IC025 +5.0 3/3 methods agree	Reporting / coding artifact	serious PRR 22.4 · 91% consumer	no trial data cached
Product dose omission issue	793	6.8 6.3–7.2ROR 7.4 · χ² 3,945 / p <1e-300	6.7 EB05 6.4 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	serious PRR 7.1 · 96% consumer	no trial data cached
Hypertension (high blood pressure)	719	8.3 7.7–8.9ROR 8.9 · χ² 4,612 / p <1e-300	8.2 EB05 7.7 · IC025 +2.9 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 12.1 · 73% consumer	no trial data cached
Headache	684	2.7 2.5–2.9ROR 2.8 · χ² 725 / p 6e-160	2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 3.3 · 84% consumer	no trial data cached
Nausea	633	1.9 1.8–2.1ROR 2.0 · χ² 303 / p 4e-68	1.9 EB05 1.8 · IC025 +0.8	Labeled adverse reaction exact term	serious PRR 2.6 · 80% consumer	no trial data cached
Diarrhoea (diarrhea)	536	2.0 1.9–2.2ROR 2.1 · χ² 285 / p 2e-64	2.0 EB05 1.9 · IC025 +0.9	Labeled adverse reaction exact term	serious PRR 2.8 · 82% consumer	no trial data cached
Fatigue (tiredness)	525	1.6 1.5–1.8ROR 1.7 · χ² 136 / p 1e-31	1.6 EB05 1.5 · IC025 +0.6	Labeled adverse reaction exact term	serious PRR 2.5 · 81% consumer	no trial data cached
Proteinuria	497	65.7 60.3–71.7ROR 69.7 · χ² 30,805 / p <1e-300	63.9 EB05 59.3 · IC025 +5.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 91.6	no trial data cached
Blood pressure increased	371	5.9 5.3–6.5ROR 6.1 · χ² 1,510 / p <1e-300	5.8 EB05 5.4 · IC025 +2.4 3/3 methods agree	Labeled — boxed warning synonym match	serious PRR 7.4	no trial data cached
Vomiting	332	1.7 1.5–1.9ROR 1.7 · χ² 102 / p 3e-24	1.7 EB05 1.6 · IC025 +0.6	Labeled adverse reaction exact term	serious PRR 2.6 · 80% consumer	no trial data cached
Glomerular filtration rate decreased	329	67.8 60.9–75.5ROR 70.4 · χ² 21,001 / p <1e-300	65.7 EB05 60.0 · IC025 +5.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 153.7	no trial data cached
Abdominal discomfort	324	4.7 4.2–5.2ROR 4.9 · χ² 950 / p 6e-209	4.7 EB05 4.3 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 4.5 · 90% consumer	no trial data cached
Product use issue	313	4.1 3.7–4.5ROR 4.2 · χ² 727 / p 2e-160	4.0 EB05 3.7 · IC025 +1.8 3/3 methods agree	Reporting / coding artifact	serious PRR 2.2 · 89% consumer	no trial data cached
Arthralgia (joint pain)	280	1.6 1.5–1.8ROR 1.7 · χ² 71 / p 2e-17	1.6 EB05 1.5 · IC025 +0.5	Not in label — unassessed	serious PRR 2.8	no trial data cached
Blood creatinine increased	279	10.4 9.3–11.7ROR 10.7 · χ² 2,358 / p <1e-300	10.3 EB05 9.3 · IC025 +3.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 20.2	no trial data cached

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

Urine abnormality — n=60, PRR 32.9
Intentional underdose — n=66, PRR 22.2
Insurance issue — n=133, PRR 21.9
Hair growth abnormal — n=26, PRR 9.1

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Voclosporin?

In FDA FAERS, the most frequently co-reported reaction terms for Voclosporin are hypertension, headache, nausea, diarrhoea, fatigue, proteinuria. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Voclosporin have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: MALIGNANCIES AND SERIOUS INFECTIONS Increased risk for developing malignancies and serious infections with LUPKYNIS or other immunosuppressants that may lead to hospitalization or death [see Warnings and Precautions ( 5.1 , 5.2 )]. WARNING: MALIGNANCIES AND SERIOUS INFECTIONS See full prescribing information for complete boxed warning.

Do FAERS signals prove that Voclosporin causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID 9f489295-1156-52c7-5fd0-5c4c52f9b813, effective 20260825; matched on openfda.generic_name.exact:"VOCLOSPORIN")
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 685 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.