Tacrolimus side effects: what 155,699 FDA adverse event reports show

Tacrolimus · 1,396 reaction terms · 497,968 drug–reaction co-reports · data 2026-09-14

Drug class

Calcineurin-inhibitor immunosuppressant

FDA label, Indications wording

Who reports

155,699 reports · 90% serious · 25,744 with death outcome · 44% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Tacrolimus capsule is a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients receiving allogeneic liver, kidney, or heart transplants, and pediatric patients receiving allogeneic liver transplants in combination with other immunosuppressants.

FDA label, Indications and Usage

What it is

Tacrolimus (anhydrous) is a macrolide lactam containing a 23-membered lactone ring, originally isolated from the fermentation broth of a Japanese soil sample that contained the bacteria Streptomyces tsukubaensis.

PubChem CID 445643 (ChEBI)

Boxed warning

MALIGNANCIES AND SERIOUS INFECTIONS • Increased risk for developing serious infections and malignancies with tacrolimus or other immunosuppressants that may lead to hospitalization or death. ( 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 adverse reaction 5Labeled (related wording) 8Likely indication confounding 10Lab value / disease marker 1Not in label — unassessed 16

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.
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). 1,356 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
New onset diabetes after transplantation	163	5,374.4 1,993.1–14,491.9ROR 5,380.0 · calibrated p 8e-19 ✓	127.8 EB05 112.2 · IC025 +6.3 3/3 methods agree	Labeled adverse reaction exact term	serious n=163	no trial arm names this drug
Transplantation associated food allergy	96	2,532.2 1,030.5–6,222.5ROR 2,533.8 · calibrated p 2e-16 ✓	123.3 EB05 103.9 · IC025 +5.9 3/3 methods agree	Labeled (related wording) related wording	serious n=95 · 100% clinician	no trial arm names this drug
Malacoplakia	341	977.7 718.6–1,330.1ROR 979.8 · calibrated p 2e-16 ✓	116.3 EB05 106.3 · IC025 +6.5 3/3 methods agree	Not in label — unassessed	serious n=337 · 100% clinician	no trial arm names this drug
Renal graft infection	195	756.4 525.5–1,088.8ROR 757.4 · calibrated p 5e-15 ✓	111.9 EB05 99.4 · IC025 +6.2 3/3 methods agree	Labeled (related wording) related wording	serious n=195	no trial arm names this drug
Post transplant distal limb syndrome	167	611.8 426.8–877.0ROR 612.5 · calibrated p 4e-14 ✓	108.0 EB05 94.9 · IC025 +6.1 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=159 · 100% clinician	no trial arm names this drug
Trichodysplasia spinulosa	301	559.1 431.7–724.1ROR 560.2 · calibrated p 4e-14 ✓	106.8 EB05 97.1 · IC025 +6.3 3/3 methods agree	Not in label — unassessed	serious n=267 · 100% clinician	no trial arm names this drug
Smooth muscle cell neoplasm	330	550.9 431.0–704.2ROR 552.1 · calibrated p 5e-14 ✓	106.6 EB05 97.3 · IC025 +6.3 3/3 methods agree	Not in label — unassessed	serious n=327 · ♀ 79% (drug 44%) · 100% clinician	no trial arm names this drug
Polyomavirus-associated nephropathy	1,817	501.3 453.3–554.4ROR 507.2 · calibrated p 5e-14 ✓	105.1 EB05 101.1 · IC025 +6.6 3/3 methods agree	Labeled adverse reaction exact term	serious n=1,817 · 97% clinician	no trial arm names this drug
Phaeohyphomycosis	351	453.8 364.1–565.8ROR 454.9 · calibrated p 3e-13 ✓	102.4 EB05 93.7 · IC025 +6.3 3/3 methods agree	Not in label — unassessed	serious n=351 · 100% clinician	no trial arm names this drug
Delayed graft function	540	450.8 377.6–538.1ROR 452.3 · calibrated p 2e-13 ✓	102.4 EB05 95.4 · IC025 +6.4 3/3 methods agree	Not in label — unassessed	serious n=540 · 92% clinician	no trial arm names this drug
Pancreas transplant rejection	149	377.9 275.6–518.2ROR 378.3 · calibrated p 3e-12 ✓	97.3 EB05 84.9 · IC025 +5.9 3/3 methods agree	Labeled (related wording) related wording	serious n=149	no trial arm names this drug
Immunosuppressant drug level increased	2,394	368.4 340.8–398.3ROR 374.2 · calibrated p 1e-12 ✓	97.8 EB05 94.5 · IC025 +6.5 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious n=2,255	no trial arm names this drug
Transplant dysfunction	1,248	335.9 302.6–372.9ROR 338.6 · calibrated p 3e-12 ✓	95.3 EB05 90.9 · IC025 +6.4 3/3 methods agree	Labeled (related wording) related wording	serious n=1,248 · 93% clinician	no trial arm names this drug
Polyomavirus viraemia	689	304.9 266.2–349.3ROR 306.3 · calibrated p 9e-12 ✓	92.5 EB05 86.9 · IC025 +6.3 3/3 methods agree	Not in label — unassessed	serious n=684 · 97% clinician	no trial arm names this drug
Chronic allograft nephropathy	540	299.2 256.9–348.5ROR 300.3 · calibrated p 1e-11 ✓	91.9 EB05 85.6 · IC025 +6.3 3/3 methods agree	Not in label — unassessed	serious n=540 · 90% clinician	no trial arm names this drug
Donor specific antibody present	101	277.5 196.8–391.3ROR 277.7 · calibrated p 7e-11 ✓	88.6 EB05 75.0 · IC025 +5.6 3/3 methods agree	Lab value / disease marker	serious n=101 · ♀ 100% (drug 44%) · 100% clinician	no trial arm names this drug
Immunosuppressant drug level decreased	780	260.4 230.8–293.9ROR 261.7 · calibrated p 4e-11 ✓	88.0 EB05 83.0 · IC025 +6.3 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious n=691	no trial arm names this drug
Rhodococcus infection	108	249.9 181.3–344.4ROR 250.1 · calibrated p 1e-10 ✓	85.7 EB05 73.0 · IC025 +5.6 3/3 methods agree	Not in label — unassessed	serious n=108 · ♀ 0% (drug 44%) · 100% clinician	no trial arm names this drug
Alternaria infection	236	245.1 197.5–304.1ROR 245.5 · calibrated p 1e-10 ✓	85.8 EB05 77.0 · IC025 +6.0 3/3 methods agree	Not in label — unassessed	serious n=229 · 100% clinician	no trial arm names this drug
Transplant rejection	5,029	230.7 220.4–241.5ROR 238.4 · calibrated p 8e-11 ✓	84.5 EB05 82.6 · IC025 +6.3 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 54.4 · 92% clinician	no trial arm names this drug
Liver transplant rejection	1,100	211.2 192.0–232.3ROR 212.7 · calibrated p 2e-10 ✓	81.7 EB05 77.7 · IC025 +6.2 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious n=1,094	no trial arm names this drug
Renal transplant failure	600	210.5 185.0–239.4ROR 211.3 · calibrated p 3e-10 ✓	81.5 EB05 76.2 · IC025 +6.1 3/3 methods agree	Labeled (related wording) related wording	serious n=600	no trial arm names this drug
Post transplant lymphoproliferative disorder	3,045	210.3 198.6–222.6ROR 214.4 · calibrated p 2e-10 ✓	81.6 EB05 79.2 · IC025 +6.3 3/3 methods agree	Labeled (related wording) related wording	serious n=3,040 · 97% clinician	no trial arm names this drug
Parvovirus b19 infection	531	206.6 180.3–236.7ROR 207.3 · calibrated p 3e-10 ✓	80.9 EB05 75.3 · IC025 +6.1 3/3 methods agree	Labeled adverse reaction exact term	serious n=487 · 100% clinician	no trial arm names this drug
Heart transplant rejection	619	197.7 174.5–223.9ROR 198.5 · calibrated p 5e-10 ✓	79.5 EB05 74.4 · IC025 +6.1 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious n=617	no trial arm names this drug
Complications of transplanted kidney	1,319	197.0 180.9–214.5ROR 198.7 · calibrated p 4e-10 ✓	79.5 EB05 76.0 · IC025 +6.2 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=1,314	no trial arm names this drug
Human polyomavirus infection	295	178.5 149.8–212.6ROR 178.8 · calibrated p 1e-9 ✓	76.1 EB05 69.0 · IC025 +5.9 3/3 methods agree	Labeled (related wording) related wording	serious n=280 · 93% clinician	no trial arm names this drug
Cerebral nocardiosis	121	177.3 135.0–232.9ROR 177.5 · calibrated p 2e-9 ✓	75.3 EB05 64.7 · IC025 +5.6 3/3 methods agree	Not in label — unassessed	serious n=121 · 100% clinician	no trial arm names this drug
Lung transplant rejection	366	165.9 142.2–193.5ROR 166.3 · calibrated p 2e-9 ✓	73.8 EB05 67.6 · IC025 +5.9 3/3 methods agree	Labeled (related wording) related wording	serious n=366	no trial arm names this drug
Human herpesvirus 8 infection	323	153.8 131.0–180.6ROR 154.1 · calibrated p 4e-9 ✓	71.2 EB05 65.0 · IC025 +5.8 3/3 methods agree	Not in label — unassessed	serious n=320 · 100% clinician	no trial arm names this drug
Pulmonary nocardiosis	429	149.7 130.4–171.9ROR 150.1 · calibrated p 5e-9 ✓	70.4 EB05 65.0 · IC025 +5.9 3/3 methods agree	Not in label — unassessed	serious n=428 · 100% clinician	no trial arm names this drug
Acanthamoeba infection	96	137.6 103.4–183.2ROR 137.7 · calibrated p 2e-8 ✓	67.0 EB05 56.5 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	serious n=96 · ♀ 0% (drug 44%) · 100% clinician	no trial arm names this drug
Graft loss	357	128.3 110.9–148.4ROR 128.6 · calibrated p 2e-8 ✓	65.3 EB05 59.8 · IC025 +5.7 3/3 methods agree	Labeled adverse reaction exact term	serious n=355 · 94% clinician	no trial arm names this drug
Complications of transplanted lung	147	125.9 100.4–157.8ROR 126.0 · calibrated p 3e-8 ✓	64.4 EB05 56.1 · IC025 +5.5 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=146	no trial arm names this drug
Kidney transplant rejection	2,312	124.7 117.8–131.9ROR 126.5 · calibrated p 2e-8 ✓	64.5 EB05 62.4 · IC025 +5.9 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious n=2,306	no trial arm names this drug
Complications of transplanted heart	100	116.7 89.2–152.7ROR 116.8 · calibrated p 6e-8 ✓	61.7 EB05 52.2 · IC025 +5.2 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=100 · ♀ 0% (drug 44%)	no trial arm names this drug
Bk virus infection	1,551	116.6 108.9–124.8ROR 117.7 · calibrated p 3e-8 ✓	62.3 EB05 59.7 · IC025 +5.9 3/3 methods agree	Labeled adverse reaction exact term	serious n=1,523 · 94% clinician	no trial arm names this drug
Pulmonary mucormycosis	235	113.1 95.0–134.6ROR 113.3 · calibrated p 5e-8 ✓	61.1 EB05 54.8 · IC025 +5.5 3/3 methods agree	Not in label — unassessed	serious n=235 · 100% clinician	no trial arm names this drug
Disseminated mucormycosis	176	112.1 91.7–137.1ROR 112.3 · calibrated p 6e-8 ✓	60.7 EB05 53.5 · IC025 +5.5 3/3 methods agree	Not in label — unassessed	serious n=176 · 100% clinician	no trial arm names this drug
Epstein-barr viraemia	491	111.3 98.7–125.5ROR 111.6 · calibrated p 5e-8 ✓	60.7 EB05 56.3 · IC025 +5.7 3/3 methods agree	Not in label — unassessed	serious n=489 · 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	8,200	8.68.4–8.8	signal
Kidney injury	15,704	4.84.7–4.8	signal
Interstitial lung disease	1,815	2.62.5–2.7	signal
Serious infection	14,170	2.52.5–2.5	signal
Neutropenia / agranulocytosis	4,247	2.32.3–2.4	signal
Anaemia	4,627	2.12.0–2.2	signal
Thrombocytopenia	3,188	2.01.9–2.0	raised
Liver injury	3,956	1.81.7–1.8	raised
Hyponatraemia	980	1.61.5–1.8	raised
Pancreatitis	926	1.61.5–1.7	raised
Hyperglycaemia / diabetes	3,347	1.31.3–1.4	raised
Rhabdomyolysis / myopathy	734	1.21.1–1.3	raised
Seizure	1,655	1.11.1–1.2	raised
Gi bleeding	1,453	1.11.0–1.1	raised
Venous thromboembolism	1,603	1.00.9–1.0	no difference
Heart failure	1,323	1.00.9–1.1	no difference

Trial evidence (ClinicalTrials.gov)

ClinicalTrials.gov returned results-bearing trials mentioning Tacrolimus only as a background or rescue medication (NCT01139450, NCT01950819); 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
Off label use (used outside approved label)	15,200	2.4 2.3–2.4ROR 2.5 · calibrated p 0.799	2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 2.0 · serious PRR 2.5	no trial arm names this drug
Drug ineffective (drug did not work)	10,335	1.1 1.0–1.1ROR 1.1 · calibrated p 0.347	1.1 EB05 1.0 · IC025 +0.0	Reporting / coding artifact	age-adj. PRR 1.3 · serious PRR 1.7	no trial arm names this drug
Drug interaction	6,428	5.6 5.5–5.8ROR 5.8 · calibrated p 0.160	5.5 EB05 5.3 · IC025 +2.4 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 5.0 · serious PRR 3.7 · 93% clinician	no trial arm names this drug
Product use in unapproved indication	6,364	3.6 3.5–3.7ROR 3.7 · calibrated p 0.441	3.5 EB05 3.4 · IC025 +1.8 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 3.2 · serious PRR 4.4 · 91% clinician	no trial arm names this drug
Acute kidney injury (sudden kidney damage)	6,153	5.6 5.5–5.8ROR 5.8 · calibrated p 0.162	5.4 EB05 5.3 · IC025 +2.4 3/3 methods agree	Labeled (related wording) related wording	age-adj. PRR 5.6 · serious PRR 3.5 · 93% clinician	no trial arm names this drug
Diarrhoea (diarrhea)	5,952	1.2 1.2–1.3ROR 1.3 · calibrated p 0.480	1.2 EB05 1.2 · IC025 +0.3	Labeled adverse reaction exact term	age-adj. PRR 1.2 · serious PRR 1.3	no trial arm names this drug
Death	5,037	0.8 0.8–0.8ROR 0.8 · calibrated p 0.172	0.8 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC	Outcome field, not a reaction boxed warning mentions mortality	age-adj. PRR 0.9 · serious PRR 0.5	no trial arm names this drug
Transplant rejection	5,029	230.7 220.4–241.5ROR 238.4 · calibrated p 8e-11 ✓	84.5 EB05 82.6 · IC025 +6.3 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 54.4 · 92% clinician	no trial arm names this drug
Pyrexia (fever)	4,878	1.9 1.9–2.0ROR 1.9 · calibrated p 0.911	1.9 EB05 1.9 · IC025 +0.9	Labeled (related wording) related wording	age-adj. PRR 1.5 · serious PRR 1.5	no trial arm names this drug
Cytomegalovirus infection	4,655	52.2 50.5–54.0ROR 53.8 · calibrated p 8e-6 ✓	37.7 EB05 36.8 · IC025 +5.2 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 38.5 · serious PRR 24.1 · 94% clinician	no trial arm names this drug
Pneumonia (lung infection)	4,564	1.9 1.9–2.0ROR 1.9 · calibrated p 0.912	1.9 EB05 1.9 · IC025 +0.9	Labeled — boxed warning synonym match	age-adj. PRR 1.8 · serious PRR 1.3	no trial arm names this drug
Covid-19	3,967	3.1 3.0–3.2ROR 3.1 · calibrated p 0.588	3.0 EB05 2.9 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	age-adj. PRR 2.8 · serious PRR 3.2 · 90% clinician	no trial arm names this drug
Toxicity to various agents	3,879	3.2 3.1–3.3ROR 3.2 · calibrated p 0.560	3.1 EB05 3.0 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	age-adj. PRR 2.4 · serious PRR 2.0 · 92% clinician	no trial arm names this drug
Renal impairment	3,703	6.2 6.0–6.4ROR 6.3 · calibrated p 0.131	6.0 EB05 5.8 · IC025 +2.5 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 6.5 · serious PRR 3.9	no trial arm names this drug
Sepsis (blood infection)	3,540	4.4 4.2–4.5ROR 4.5 · calibrated p 0.302	4.3 EB05 4.2 · IC025 +2.0 3/3 methods agree	Labeled — boxed warning synonym match	age-adj. PRR 3.9 · serious PRR 2.7 · 91% clinician	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.

Malacoplakia — n=341, PRR 977.7
Trichodysplasia spinulosa — n=301, PRR 559.1
Smooth muscle cell neoplasm — n=330, PRR 550.9
Phaeohyphomycosis — n=351, PRR 453.8
Delayed graft function — n=540, PRR 450.8
Polyomavirus viraemia — n=689, PRR 304.9
Chronic allograft nephropathy — n=540, PRR 299.2
Rhodococcus infection — n=108, PRR 249.9
Alternaria infection — n=236, PRR 245.1
Cerebral nocardiosis — n=121, PRR 177.3

✓ A hand-written Bradford Hill causality assessment exists for this drug: Tacrolimus ↔ 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 Tacrolimus?

In FDA FAERS, the most frequently co-reported reaction terms for Tacrolimus are acute kidney injury, diarrhoea, transplant rejection, pyrexia, cytomegalovirus infection, pneumonia. 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 Tacrolimus have an FDA boxed warning?

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

Do FAERS signals prove that Tacrolimus 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 0addf3f5-9bd5-4ef3-8c7f-52be20c16cf9, effective 20260521; matched on openfda.generic_name.exact:"TACROLIMUS" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG")
PubChem CID 445643 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, 1,396 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 TACROLIMUS, 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.