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Drug · FAERS side-effect profile with label screen

Cyclosporine side effects: what 110,597 FDA adverse event reports show

Cyclosporine · Cyclosporine Modified · 1,288 reaction terms · 429,525 drug–reaction co-reports · data 2026-09-14

Drug class

Calcineurin Inhibitor Immunosuppressant

FDA label (Established Pharmacologic Class) · compare the class

Brand names

Cyclosporine Modified

openFDA label

Who reports

110,597 reports · 68% serious · 14,502 with death outcome · 61% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Kidney, Liver, and Heart Transplantation Cyclosporine capsules, USP MODIFIED are indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Cyclosporine capsules, USP MODIFIED have been used in combination with azathioprine and corticosteroids.

FDA label, Indications and Usage

What it is

Cyclosporin A is a cyclic nonribosomal peptide of eleven amino acids; an immunosuppressant drug widely used in post-allogeneic organ transplant to reduce the activity of the patient's immune system, and therefore the risk of organ rejection.

PubChem CID 5284373 (ChEBI)

Boxed warning

Only physicians experienced in management of systemic immunosuppressive therapy for the indicated disease should prescribe cyclosporine capsules, USP MODIFIED. At doses used in solid organ transplantation, only physi.

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 adverse reaction 1Labeled (related wording) 15Likely indication confounding 1Reporting / coding artifact 1Lab value / disease marker 3Not in label — unassessed 19

What the badges mean

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, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,248 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
Lymphoid tissue hypoplasia	93	320.5 229.2–448.1ROR 320.7 · calibrated p 2e-11 ✓	115.6 EB05 97.2 · IC025 +5.8 3/3 methods agree vs other Calcineurin Inhibitor Immunosuppressants: only this drug	Not in label — unassessed	serious n=93 · ♀ 0% (drug 61%)	no trial arm names this drug
Thymus hypoplasia	92	219.5 162.3–296.7ROR 219.7 · calibrated p 4e-10 ✓	99.2 EB05 83.3 · IC025 +5.7 3/3 methods agree vs other Calcineurin Inhibitor Immunosuppressants: only this drug	Not in label — unassessed	serious n=92 · ♀ 0% (drug 61%)	no trial arm names this drug
Cytomegalovirus antigen positive	84	157.9 118.1–211.1ROR 158.0 · calibrated p 6e-9 ✓	84.3 EB05 70.2 · IC025 +5.5 3/3 methods agree vs other Calcineurin Inhibitor Immunosuppressants: only this drug	Lab value / disease marker	serious n=84 · ♀ 0% (drug 61%) · 100% clinician	no trial arm names this drug
Red blood cell sedimentation rate	107	116.4 91.4–148.2ROR 116.5 · calibrated p 5e-8 ✓	71.1 EB05 60.5 · IC025 +5.4 3/3 methods agree vs other Calcineurin Inhibitor Immunosuppressants: only this drug	Lab value / disease marker	serious n=107 · ♀ 100% (drug 61%) · 100% clinician	no trial arm names this drug
Acute graft versus host disease in skin	1,017	110.9 102.6–119.8ROR 111.9 · calibrated p 5e-8 ✓	69.8 EB05 66.2 · IC025 +6.0 3/3 methods agree vs other Calcineurin Inhibitor Immunosuppressants: only this drug	Labeled (related wording) related wording	serious n=1,010 · ♀ 38% (drug 61%) · 97% clinician	no trial arm names this drug
Acute graft versus host disease in liver	265	110.3 94.8–128.4ROR 110.6 · calibrated p 6e-8 ✓	69.3 EB05 62.6 · IC025 +5.7 3/3 methods agree vs other Calcineurin Inhibitor Immunosuppressants: only this drug	Labeled (related wording) related wording	serious n=264 · ♀ 28% (drug 61%) · 100% clinician	no trial arm names this drug
Chronic graft versus host disease oral	88	109.9 84.4–143.0ROR 110.0 · calibrated p 9e-8 ✓	68.5 EB05 57.3 · IC025 +5.3 3/3 methods agree vs other Calcineurin Inhibitor Immunosuppressants: only this drug	Labeled (related wording) related wording	serious n=88 · ♀ 0% (drug 61%) · 100% clinician	no trial arm names this drug
Acute graft versus host disease in intestine	508	107.8 96.6–120.2ROR 108.3 · calibrated p 7e-8 ✓	68.4 EB05 63.6 · IC025 +5.9 3/3 methods agree vs other Calcineurin Inhibitor Immunosuppressants: only this drug	Not in label — unassessed	serious n=507 · ♀ 32% (drug 61%) · 100% clinician	no trial arm names this drug
Graft dysfunction	99	98.5 77.2–125.7ROR 98.6 · calibrated p 2e-7 ✓	64.0 EB05 54.1 · IC025 +5.3 3/3 methods agree vs other Calcineurin Inhibitor Immunosuppressants: only this drug	Labeled (related wording) related wording	serious n=99 · ♀ 0% (drug 61%) · 100% clinician	no trial arm names this drug
Transplant dysfunction	588	95.1 86.2–105.1ROR 95.6 · calibrated p 2e-7 ✓	63.2 EB05 59.0 · IC025 +5.8 3/3 methods agree vs other Calcineurin Inhibitor Immunosuppressants: only this drug	Labeled (related wording) related wording	serious n=588 · ♀ 88% (drug 61%) · 100% clinician	no trial arm names this drug
Chronic graft versus host disease	1,203	93.7 87.4–100.4ROR 94.7 · calibrated p 2e-7 ✓	62.6 EB05 59.7 · IC025 +5.8 3/3 methods agree vs other Calcineurin Inhibitor Immunosuppressants: only this drug	Labeled (related wording) related wording	serious n=1,199 · 94% clinician	no trial arm names this drug
Chronic graft versus host disease in liver	111	84.6 67.6–105.9ROR 84.7 · calibrated p 5e-7 ✓	57.9 EB05 49.4 · IC025 +5.2 3/3 methods agree vs other Calcineurin Inhibitor Immunosuppressants: only this drug	Labeled (related wording) related wording	serious n=111 · ♀ 0% (drug 61%) · 100% clinician	no trial arm names this drug
Cystitis viral	116	83.0 66.7–103.3ROR 83.1 · calibrated p 6e-7 ✓	57.2 EB05 49.0 · IC025 +5.2 3/3 methods agree vs other Calcineurin Inhibitor Immunosuppressants: only this drug	Not in label — unassessed	serious n=113 · ♀ 0% (drug 61%) · 100% clinician	no trial arm names this drug
Graft versus host disease in gastrointestinal tract	619	77.7 70.8–85.3ROR 78.2 · calibrated p 7e-7 ✓	55.0 EB05 51.5 · IC025 +5.6 3/3 methods agree vs other Calcineurin Inhibitor Immunosuppressants: only this drug	Labeled (related wording) related wording	serious n=619 · 95% clinician	no trial arm names this drug
Viral haemorrhagic cystitis	205	77.5 65.9–91.2ROR 77.7 · calibrated p 8e-7 ✓	54.8 EB05 48.7 · IC025 +5.4 3/3 methods agree vs other Calcineurin Inhibitor Immunosuppressants: only this drug	Not in label — unassessed	serious n=205 · 100% clinician	no trial arm names this drug
Encephalitis cytomegalovirus	125	77.0 62.5–94.9ROR 77.1 · calibrated p 1e-6 ✓	54.3 EB05 46.8 · IC025 +5.2 3/3 methods agree vs other Calcineurin Inhibitor Immunosuppressants: only this drug	Not in label — unassessed	serious n=125 · ♀ 0% (drug 61%) · 100% clinician	no trial arm names this drug
Granuloma skin	234	74.6 64.1–86.8ROR 74.7 · calibrated p 1e-6 ✓	53.3 EB05 47.8 · IC025 +5.4 3/3 methods agree vs other Calcineurin Inhibitor Immunosuppressants: only this drug	Not in label — unassessed	serious n=234 · ♀ 100% (drug 61%)	no trial arm names this drug
Graft versus host disease in liver	200	74.0 62.8–87.1ROR 74.1 · calibrated p 1e-6 ✓	53.0 EB05 47.1 · IC025 +5.3 3/3 methods agree vs other Calcineurin Inhibitor Immunosuppressants: only this drug	Labeled (related wording) related wording	serious n=200 · ♀ 40% (drug 61%) · 100% clinician	no trial arm names this drug
Acute graft versus host disease	1,290	73.5 68.9–78.3ROR 74.3 · calibrated p 1e-6 ✓	52.9 EB05 50.5 · IC025 +5.6 3/3 methods agree vs other Calcineurin Inhibitor Immunosuppressants: only this drug	Labeled (related wording) related wording	serious n=1,288 · ♀ 39% (drug 61%) · 97% clinician	no trial arm names this drug
Epstein-barr virus infection reactivation	347	71.6 63.3–81.0ROR 71.8 · calibrated p 1e-6 ✓	51.8 EB05 47.4 · IC025 +5.4 3/3 methods agree vs other Calcineurin Inhibitor Immunosuppressants: only this drug	Not in label — unassessed	serious n=346 · 100% clinician	no trial arm names this drug
Chronic graft versus host disease in skin	249	71.3 61.6–82.5ROR 71.4 · calibrated p 1e-6 ✓	51.6 EB05 46.5 · IC025 +5.3 3/3 methods agree vs other Calcineurin Inhibitor Immunosuppressants: only this drug	Labeled (related wording) related wording	serious n=249 · 91% clinician	no trial arm names this drug
Graft versus host disease in skin	575	67.0 60.9–73.6ROR 67.3 · calibrated p 2e-6 ✓	49.4 EB05 46.1 · IC025 +5.4 3/3 methods agree vs other Calcineurin Inhibitor Immunosuppressants: only this drug	Labeled (related wording) related wording	serious n=575 · 94% clinician	no trial arm names this drug
Smooth muscle cell neoplasm	105	64.3 51.5–80.2ROR 64.3 · calibrated p 3e-6 ✓	47.6 EB05 40.5 · IC025 +5.0 3/3 methods agree vs other Calcineurin Inhibitor Immunosuppressants: only this drug	Not in label — unassessed	serious n=105 · ♀ 100% (drug 61%) · 100% clinician	no trial arm names this drug
Product dropper issue	202	64.3 54.8–75.4ROR 64.4 · calibrated p 3e-6 ✓	47.8 EB05 42.5 · IC025 +5.2 3/3 methods agree vs other Calcineurin Inhibitor Immunosuppressants: only this drug	Reporting / coding artifact	♀ 84% (drug 61%) · 100% consumer	no trial arm names this drug
Cytomegalovirus infection reactivation	1,074	63.7 59.4–68.2ROR 64.3 · calibrated p 3e-6 ✓	47.7 EB05 45.3 · IC025 +5.4 3/3 methods agree vs other Calcineurin Inhibitor Immunosuppressants: only this drug	Labeled (related wording) related wording	serious n=1,071 · ♀ 36% (drug 61%) · 97% clinician	no trial arm names this drug
Bk virus infection	828	62.2 57.5–67.2ROR 62.6 · calibrated p 3e-6 ✓	46.8 EB05 44.2 · IC025 +5.4 3/3 methods agree vs other Calcineurin Inhibitor Immunosuppressants: only this drug	Labeled adverse reaction exact term	serious n=819 · ♀ 28% (drug 61%) · 97% clinician	no trial arm names this drug
Scleral hyperaemia	168	61.2 51.4–72.8ROR 61.3 · calibrated p 4e-6 ✓	46.1 EB05 40.5 · IC025 +5.1 3/3 methods agree vs other Calcineurin Inhibitor Immunosuppressants: only this drug	Not in label — unassessed	♀ 100% (drug 61%)	no trial arm names this drug
Graft versus host disease	1,726	59.3 56.2–62.6ROR 60.2 · calibrated p 4e-6 ✓	45.2 EB05 43.4 · IC025 +5.4 3/3 methods agree vs other Calcineurin Inhibitor Immunosuppressants: only this drug	Labeled (related wording) related wording	serious PRR 38.1 · 93% clinician	no trial arm names this drug
Epstein-barr virus associated lymphoproliferative disorder	384	52.3 46.8–58.6ROR 52.5 · calibrated p 1e-5 ✓	41.0 EB05 37.7 · IC025 +5.1 3/3 methods agree vs other Calcineurin Inhibitor Immunosuppressants: only this drug	Labeled (related wording) related wording	serious n=383 · ♀ 39% (drug 61%) · 100% clinician	no trial arm names this drug
Kaposi's sarcoma	109	51.5 41.6–63.6ROR 51.5 · calibrated p 1e-5 ✓	40.3 EB05 34.3 · IC025 +4.8 3/3 methods agree vs other Calcineurin Inhibitor Immunosuppressants: only this drug	Not in label — unassessed	serious n=109 · ♀ 0% (drug 61%) · 100% clinician	no trial arm names this drug
Chronic allograft nephropathy	167	50.9 42.9–60.3ROR 50.9 · calibrated p 1e-5 ✓	40.0 EB05 35.2 · IC025 +4.9 3/3 methods agree vs other Calcineurin Inhibitor Immunosuppressants: only this drug	Not in label — unassessed	serious n=165 · ♀ 38% (drug 61%) · 100% clinician	no trial arm names this drug
Lymphocele	140	50.1 41.6–60.4ROR 50.2 · calibrated p 2e-5 ✓	39.5 EB05 34.3 · IC025 +4.8 3/3 methods agree vs other Calcineurin Inhibitor Immunosuppressants: only this drug	Not in label — unassessed	serious n=140 · ♀ 41% (drug 61%) · 100% clinician	no trial arm names this drug
Epstein-barr viraemia	215	46.6 40.2–54.1ROR 46.7 · calibrated p 2e-5 ✓	37.4 EB05 33.4 · IC025 +4.9 3/3 methods agree vs other Calcineurin Inhibitor Immunosuppressants: only this drug	Not in label — unassessed	serious n=214 · ♀ 30% (drug 61%) · 100% clinician	no trial arm names this drug
Disseminated aspergillosis	90	44.9 35.7–56.5ROR 44.9 · calibrated p 3e-5 ✓	36.1 EB05 30.3 · IC025 +4.6 3/3 methods agree vs other Calcineurin Inhibitor Immunosuppressants: only this drug	Not in label — unassessed	serious n=90 · ♀ 0% (drug 61%)	no trial arm names this drug
Blood parathyroid hormone decreased	280	43.7 38.4–49.8ROR 43.8 · calibrated p 3e-5 ✓	35.5 EB05 32.2 · IC025 +4.9 3/3 methods agree vs other Calcineurin Inhibitor Immunosuppressants: only this drug	Lab value / disease marker	serious n=280 · ♀ 100% (drug 61%)	no trial arm names this drug
Adenovirus infection	514	41.3 37.5–45.4ROR 41.5 · calibrated p 4e-5 ✓	33.9 EB05 31.5 · IC025 +4.9 3/3 methods agree vs other Calcineurin Inhibitor Immunosuppressants: only this drug	Not in label — unassessed	serious n=506 · 100% clinician	no trial arm names this drug
Heart transplant rejection	182	39.8 34.0–46.8ROR 39.9 · calibrated p 6e-5 ✓	32.9 EB05 29.1 · IC025 +4.7 3/3 methods agree vs other Calcineurin Inhibitor Immunosuppressants: only this drug	Likely indication confounding term in indications; also in warnings	serious n=182 · ♀ 37% (drug 61%) · 100% clinician	no trial arm names this drug
Aspergillosis	229	39.5 34.2–45.5ROR 39.6 · calibrated p 6e-5 ✓	32.7 EB05 29.3 · IC025 +4.7 3/3 methods agree vs other Calcineurin Inhibitor Immunosuppressants: only this drug	Not in label — unassessed	serious n=229 · ♀ 37% (drug 61%) · 100% clinician	no trial arm names this drug
Foreign body sensation in eyes	1,068	39.0 36.5–41.7ROR 39.4 · calibrated p 6e-5 ✓	32.4 EB05 30.8 · IC025 +4.9 3/3 methods agree vs other Calcineurin Inhibitor Immunosuppressants: only this drug	Not in label — unassessed	♀ 87% (drug 61%) · 81% consumer	no trial arm names this drug
Paroxysmal nocturnal haemoglobinuria	78	38.6 30.2–49.3ROR 38.6 · calibrated p 8e-5 ✓	31.9 EB05 26.4 · IC025 +4.4 3/3 methods agree vs other Calcineurin Inhibitor Immunosuppressants: only this drug	Not in label — unassessed	serious n=78 · ♀ 100% (drug 61%) · 100% clinician	no trial arm names this drug

Clinical concept groups

MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.

Concept	Reports	PRR 95% CI	Reading
Opportunistic infection	4,466	6.46.2–6.6	signal
Kidney injury	7,905	3.33.3–3.4	signal
Rhabdomyolysis / myopathy	1,139	2.72.5–2.8	signal
Thrombocytopenia	2,865	2.52.4–2.6	signal
Interstitial lung disease	1,245	2.52.3–2.6	signal
Serious infection	9,325	2.32.3–2.4	signal
Liver injury	3,628	2.32.2–2.4	signal
Anaemia	3,571	2.32.2–2.3	signal
Neutropenia / agranulocytosis	2,813	2.22.1–2.2	signal
Anaphylaxis / angioedema	1,100	1.71.6–1.8	raised
Tendon disorder	331	1.71.5–1.8	raised
Hyponatraemia	584	1.41.3–1.5	raised
Severe cutaneous reaction	481	1.21.1–1.3	raised
Pancreatitis	511	1.21.1–1.3	raised
Osteonecrosis	331	1.11.0–1.2	no difference
Seizure	1,099	1.11.0–1.1	raised

Trial evidence (ClinicalTrials.gov)

ClinicalTrials.gov returned results-bearing trials mentioning Cyclosporine only as a background or rescue medication (NCT01646385, NCT02618577); no trial listing it as the tested intervention was cached, so no trial cross-check is shown.

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
Drug ineffective (drug did not work)	12,918	1.9 1.8–1.9ROR 2.0 · calibrated p 0.935	1.9 EB05 1.8 · IC025 +0.9 vs other Calcineurin Inhibitor Immunosuppressants: PRR 1,027.1 (866.8–1,217.1)	Reporting / coding artifact	age-adj. PRR 2.2 · serious PRR 3.0	no trial arm names this drug
Off label use (used outside approved label)	9,566	2.1 2.1–2.1ROR 2.2 · calibrated p 0.948	2.1 EB05 2.1 · IC025 +1.0 3/3 methods agree vs other Calcineurin Inhibitor Immunosuppressants: PRR 376.1 (333.6–424.1)	Reporting / coding artifact	age-adj. PRR 2.1 · serious PRR 2.7	no trial arm names this drug
Eye irritation	7,986	31.6 30.9–32.3ROR 34.0 · calibrated p 1e-4 ✓	27.2 EB05 26.7 · IC025 +4.7 3/3 methods agree vs other Calcineurin Inhibitor Immunosuppressants: PRR 1,890.8 (1,411.0–2,533.8)	Not in label — unassessed	age-adj. PRR 22.2 · serious PRR 5.7 · ♀ 84% (drug 61%) · 84% consumer	no trial arm names this drug
Product use in unapproved indication	4,320	3.4 3.3–3.5ROR 3.5 · calibrated p 0.486	3.4 EB05 3.3 · IC025 +1.7 3/3 methods agree vs other Calcineurin Inhibitor Immunosuppressants: PRR 354.1 (297.5–421.3)	Reporting / coding artifact	age-adj. PRR 3.6 · serious PRR 5.6	no trial arm names this drug
Pyrexia (fever)	4,174	2.3 2.2–2.4ROR 2.4 · calibrated p 0.878	2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree vs other Calcineurin Inhibitor Immunosuppressants: PRR 694.9 (543.1–889.1)	Labeled (related wording) related wording	age-adj. PRR 2.2 · serious PRR 2.3	no trial arm names this drug
Eye pain	3,891	14.3 13.9–14.8ROR 14.8 · calibrated p 0.007 ✓	13.4 EB05 13.0 · IC025 +3.7 3/3 methods agree vs other Calcineurin Inhibitor Immunosuppressants: PRR 6,909.5 (3,102.5–15,387.7)	Labeled adverse reaction exact term	age-adj. PRR 10.7 · serious PRR 2.9 · ♀ 84% (drug 61%) · 81% consumer	no trial arm names this drug
Nausea	3,754	0.9 0.9–0.9ROR 0.9 · calibrated p 0.242	0.9 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC vs other Calcineurin Inhibitor Immunosuppressants: PRR 63.2 (58.1–68.7)	Labeled adverse reaction exact term	age-adj. PRR 0.9 · serious PRR 1.1	no trial arm names this drug
Diarrhoea (diarrhea)	3,722	1.1 1.1–1.1ROR 1.1 · calibrated p 0.373	1.1 EB05 1.1 · IC025 +0.1 vs other Calcineurin Inhibitor Immunosuppressants: PRR 74.0 (67.6–80.9)	Labeled adverse reaction exact term	age-adj. PRR 1.2 · serious PRR 1.4	no trial arm names this drug
Headache	3,717	1.1 1.1–1.2ROR 1.1 · calibrated p 0.393	1.1 EB05 1.1 · IC025 +0.1 vs other Calcineurin Inhibitor Immunosuppressants: PRR 57.9 (53.4–62.8)	Labeled adverse reaction exact term	age-adj. PRR 1.1 · serious PRR 1.3	no trial arm names this drug
Fatigue (tiredness)	3,489	0.9 0.8–0.9ROR 0.8 · calibrated p 0.210	0.9 EB05 0.8 · IC025 -0.3 PRR-only: not supported by EBGM or IC vs other Calcineurin Inhibitor Immunosuppressants: PRR 70.8 (64.7–77.5)	Labeled adverse reaction exact term	age-adj. PRR 0.9 · serious PRR 1.0	no trial arm names this drug
Pneumonia (lung infection)	3,394	2.0 1.9–2.1ROR 2.0 · calibrated p 0.962	2.0 EB05 1.9 · IC025 +0.9 vs other Calcineurin Inhibitor Immunosuppressants: PRR 306.5 (255.2–368.0)	Labeled — boxed warning synonym match	age-adj. PRR 2.2 · serious PRR 1.7	no trial arm names this drug
Pain	3,243	1.0 1.0–1.0ROR 1.0 · calibrated p 0.306	1.0 EB05 1.0 · IC025 -0.1 PRR-only: not supported by EBGM or IC vs other Calcineurin Inhibitor Immunosuppressants: PRR 171.1 (148.5–197.1)	Labeled adverse reaction exact term	age-adj. PRR 1.2 · serious PRR 1.0	no trial arm names this drug
Condition aggravated	3,228	2.0 2.0–2.1ROR 2.1 · calibrated p 0.981	2.0 EB05 2.0 · IC025 +1.0 vs other Calcineurin Inhibitor Immunosuppressants: PRR 648.9 (494.8–851.0)	Reporting / coding artifact	age-adj. PRR 2.1 · serious PRR 2.2	no trial arm names this drug
Vision blurred (blurred vision)	2,905	4.1 4.0–4.2ROR 4.2 · calibrated p 0.345	4.0 EB05 3.9 · IC025 +1.9 3/3 methods agree vs other Calcineurin Inhibitor Immunosuppressants: PRR 507.4 (393.9–653.6)	Labeled (related wording) related wording	age-adj. PRR 3.2 · serious PRR 1.2 · 76% consumer	no trial arm names this drug
Rash	2,719	1.2 1.1–1.2ROR 1.2 · calibrated p 0.437	1.2 EB05 1.2 · IC025 +0.2 vs other Calcineurin Inhibitor Immunosuppressants: PRR 157.4 (135.7–182.7)	Labeled adverse reaction exact term	age-adj. PRR 1.3 · serious PRR 1.7	no trial arm names this drug

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.

Lymphoid tissue hypoplasia — n=93, PRR 320.5
Thymus hypoplasia — n=92, PRR 219.5
Acute graft versus host disease in intestine — n=508, PRR 107.8
Cystitis viral — n=116, PRR 83.0
Viral haemorrhagic cystitis — n=205, PRR 77.5
Encephalitis cytomegalovirus — n=125, PRR 77.0
Granuloma skin — n=234, PRR 74.6
Epstein-barr virus infection reactivation — n=347, PRR 71.6
Smooth muscle cell neoplasm — n=105, PRR 64.3
Scleral hyperaemia — n=168, PRR 61.2

✓ A hand-written Bradford Hill causality assessment exists for this drug: Cyclosporine ↔ Nephrotoxicity.

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 Cyclosporine?

In FDA FAERS, the most frequently co-reported reaction terms for Cyclosporine are eye irritation, pyrexia, eye pain, nausea, diarrhoea, headache. 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 Cyclosporine have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: Only physicians experienced in management of systemic immunosuppressive therapy for the indicated disease should prescribe cyclosporine capsules, USP MODIFIED. At doses used in solid organ transplantation, only physi.

Do FAERS signals prove that Cyclosporine 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 2de1e8b1-625f-43ce-a1d5-d543be208b11, effective 20240401; matched on openfda.generic_name.exact:"CYCLOSPORINE" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG")
PubChem CID 5284373 description (ChEBI)
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, 1,288 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
ClinicalTrials.gov API v2 (query CYCLOSPORINE, results-bearing studies sorted by enrollment)

Page generated 2026-10-14. 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.