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FAERS disproportionality dashboard
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Calcineurin Inhibitor Immunosuppressant side effects compared: 3 drugs, 120,934 FDA adverse event reports

Class as assigned in the FDA label (Established Pharmacologic Class) · data 2026-09-14
How to read this page. Report counts are not incidence rates: a drug with more reports is usually older, more widely used or more publicised, not more dangerous. Signals are screened against each product's FDA label on its own page; a term flagged across most of a class usually reflects the shared mechanism or the shared patient population.

Members

DrugFAERS reportsSeriousDeath outcomeBoxed warningTop labeled signalsUnlabeled (unassessed)
Cyclosporine (Cyclosporine Modified)110,59768%14,502boxedGraft versus host disease; Acute graft versus host disease; Chronic graft versus host diseaseForeign body sensation in eyes; Adenovirus infection
Voclosporin (Lupkynis)8,63421%49boxedHypertension; Proteinuria; Glomerular filtration rate decreasedInsurance issue; Intentional underdose
Pimecrolimus1,70332%22boxedPruritus; Dry skin; EczemaSkin exfoliation; Sleep disorder due to a general medical condition

Class-wide signals (flagged in at least 2 of 3 members)

No term is flagged in at least half the members.

Member-specific signals (flagged in exactly one drug)

No strong single-member signals (n ≥ 50) in this class.

Common questions

Which calcineurin inhibitor immunosuppressant has the most FDA adverse event reports?

Cyclosporine has the most FAERS co-reports in this class (110,597), followed by Voclosporin (8,634). Report volume tracks how widely and how long a drug has been used, and how much attention it has had, far more than its risk.

Which side effects are shared across calcineurin inhibitor immunosuppressant drugs?

No reaction term is flagged in at least half of the members; the signals in this class are largely product-specific or population-specific.

Does a FAERS signal mean the drug causes the reaction?

No. These are disproportionality signals from voluntary reports with no denominator. Each is screened against the FDA label (known vs unlabeled) on the drug pages; causality needs temporality, dose-response, plausibility and trial or cohort evidence.

Sources: openFDA FAERS pair statistics (OpenPV build 2026-09-14), FDA labels via openFDA, seriousness and death counts from openFDA count queries. Generated 2026-10-08. Not medical advice.