Tacrolimus Extended-Release side effects: what 124,118 FDA adverse event reports show
Drug class
Calcineurin-inhibitor immunosuppressant
Label matched
Tacrolimus Extended-Release Capsules (Tacrolimus)
Who reports
124,118 reports · 90% serious · 19,764 with death outcome · 43% female
Used for
Tacrolimus extended-release capsules is indicated for the prophylaxis of organ rejection in kidney transplant patients in combination with other immunosuppressants in adult patients who can swallow capsules intact . Pediatric use information is approved for Astellas Pharma US, Inc.'s ASTAGRAF XL (tacrolimus extended-release capsules).
What it is
Tacrolimus is the active ingredient in tacrolimus extended-release capsules. Tacrolimus is a calcineurin-inhibitor immunosuppressant produced by Streptomyces tsukubaensis .
Boxed warning
MALIGNANCIES AND SERIOUS INFECTIONS IN TRANSPLANT PATIENTS; AND INCREASED MORTALITY IN FEMALE LIVER TRANSPLANT PATIENTS Increased risk for developing serious infections and malignancies with tacrolimus extended-release capsulest or other immunosuppressants that may lead to hospitalization or death.
Causality screen of the 40 strongest signals
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). 1,372 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Calcineurin inhibitor induced pain syndrome | 84 | 2,783.6 1,129.2–6,861.9ROR 2,785.5 · calibrated p 7e-17 ✓ | 151.9 EB05 126.6 · IC025 +6.0 3/3 methods agree | Labeled (related wording) related wording | serious n=84 · 100% clinician | not reported in cached trials |
| New onset diabetes after transplantation | 150 | 1,462.0 885.4–2,414.2ROR 1,463.8 · calibrated p 2e-17 ✓ | 147.0 EB05 128.3 · IC025 +6.4 3/3 methods agree | Labeled adverse reaction exact term | serious n=150 | not reported in cached trials |
| Malacoplakia | 334 | 1,044.2 781.5–1,395.1ROR 1,047.0 · calibrated p 6e-17 ✓ | 142.7 EB05 130.3 · IC025 +6.7 3/3 methods agree | Not in label — unassessed | serious n=330 · 100% clinician | not reported in cached trials |
| Transplantation associated food allergy | 85 | 880.2 516.0–1,501.6ROR 880.8 · calibrated p 8e-15 ✓ | 136.1 EB05 113.5 · IC025 +5.9 3/3 methods agree | Labeled (related wording) related wording | serious n=85 · 100% clinician | not reported in cached trials |
| Smooth muscle cell neoplasm | 325 | 641.1 504.4–814.8ROR 642.8 · calibrated p 9e-15 ✓ | 131.4 EB05 119.9 · IC025 +6.6 3/3 methods agree | Not in label — unassessed | serious n=322 · ♀ 80% (drug 43%) · 100% clinician | not reported in cached trials |
| Renal graft infection | 181 | 624.8 454.5–858.8ROR 625.7 · calibrated p 2e-14 ✓ | 130.0 EB05 114.8 · IC025 +6.4 3/3 methods agree | Labeled (related wording) related wording | serious n=181 | not reported in cached trials |
| Trichodysplasia spinulosa | 294 | 624.5 486.6–801.6ROR 626.0 · calibrated p 1e-14 ✓ | 130.6 EB05 118.6 · IC025 +6.6 3/3 methods agree | Not in label — unassessed | serious n=260 · ♀ 63% (drug 43%) · 96% clinician | not reported in cached trials |
| Phaeohyphomycosis | 347 | 542.4 436.4–674.2ROR 543.9 · calibrated p 4e-14 ✓ | 126.8 EB05 116.0 · IC025 +6.6 3/3 methods agree | Not in label — unassessed | serious n=347 · 100% clinician | not reported in cached trials |
| Post transplant distal limb syndrome | 152 | 493.8 359.6–678.1ROR 494.4 · calibrated p 2e-13 ✓ | 122.9 EB05 107.4 · IC025 +6.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=145 · 93% clinician | not reported in cached trials |
| Polyomavirus-associated nephropathy | 1,692 | 464.9 423.7–510.1ROR 471.3 · calibrated p 1e-13 ✓ | 122.7 EB05 117.9 · IC025 +6.8 3/3 methods agree | Labeled adverse reaction exact term | serious n=1,692 · 97% clinician | NCT02723591: 1/287 (0.3%) on Tacrolimus Extended-Release (serious AE) |
| Delayed graft function | 481 | 367.3 312.9–431.1ROR 368.7 · calibrated p 2e-12 ✓ | 114.4 EB05 106.0 · IC025 +6.5 3/3 methods agree | Not in label — unassessed | serious n=481 · 91% clinician | NCT02723591: 4/287 (1.4%) on Tacrolimus Extended-Release (serious AE) |
| Polyomavirus viraemia | 669 | 348.6 305.1–398.3ROR 350.5 · calibrated p 3e-12 ✓ | 112.6 EB05 105.6 · IC025 +6.6 3/3 methods agree | Not in label — unassessed | serious n=664 · 97% clinician | not reported in cached trials |
| Rhodococcus infection | 106 | 297.7 216.5–409.3ROR 297.9 · calibrated p 3e-11 ✓ | 105.1 EB05 89.4 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=106 · 100% clinician | not reported in cached trials |
| Alternaria infection | 227 | 276.6 223.6–342.0ROR 277.1 · calibrated p 3e-11 ✓ | 103.4 EB05 92.6 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious n=220 · 100% clinician | not reported in cached trials |
| Donor specific antibody present | 89 | 245.8 177.2–341.0ROR 246.0 · calibrated p 2e-10 ✓ | 97.5 EB05 81.7 · IC025 +5.7 3/3 methods agree | Lab value / disease marker | serious n=88 · ♀ 100% (drug 43%) · 100% clinician | not reported in cached trials |
| Parvovirus b19 infection | 519 | 245.0 214.0–280.5ROR 246.0 · calibrated p 7e-11 ✓ | 99.1 EB05 92.1 · IC025 +6.4 3/3 methods agree | Labeled adverse reaction exact term | serious n=475 · 100% clinician | not reported in cached trials |
| Chronic allograft nephropathy | 462 | 242.2 210.0–279.5ROR 243.1 · calibrated p 8e-11 ✓ | 98.6 EB05 91.3 · IC025 +6.3 3/3 methods agree | Not in label — unassessed | serious n=462 · 92% clinician | not reported in cached trials |
| Post transplant lymphoproliferative disorder | 2,896 | 233.0 220.3–246.5ROR 238.6 · calibrated p 8e-11 ✓ | 97.4 EB05 94.4 · IC025 +6.5 3/3 methods agree | Labeled (related wording) related wording | serious n=2,891 · 98% clinician | NCT02723591: 1/288 (0.3%) on Tacrolimus Extended-Release (serious AE) |
| Immunosuppressant drug level increased | 1,839 | 215.8 201.4–231.2ROR 219.0 · calibrated p 2e-10 ✓ | 94.2 EB05 90.6 · IC025 +6.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=1,751 | NCT02723591: 1/287 (0.3%) on Tacrolimus Extended-Release (serious AE) |
| Human polyomavirus infection | 286 | 208.8 175.4–248.5ROR 209.2 · calibrated p 3e-10 ✓ | 92.4 EB05 83.7 · IC025 +6.1 3/3 methods agree | Labeled (related wording) related wording | serious n=271 · 93% clinician | not reported in cached trials |
| Pancreas transplant rejection | 111 | 204.4 154.8–269.8ROR 204.5 · calibrated p 7e-10 ✓ | 90.7 EB05 77.4 · IC025 +5.7 3/3 methods agree | Labeled (related wording) related wording | serious n=111 · ♀ 100% (drug 43%) | not reported in cached trials |
| Renal transplant failure | 538 | 203.5 179.4–230.9ROR 204.4 · calibrated p 4e-10 ✓ | 91.6 EB05 85.3 · IC025 +6.3 3/3 methods agree | Labeled (related wording) related wording | serious n=538 | NCT02723591: 1/287 (0.3%) on Tacrolimus Extended-Release (serious AE) |
| Cerebral nocardiosis | 116 | 202.3 154.3–265.3ROR 202.5 · calibrated p 7e-10 ✓ | 90.3 EB05 77.3 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=116 · 100% clinician | not reported in cached trials |
| Human herpesvirus 8 infection | 315 | 183.1 156.0–214.9ROR 183.6 · calibrated p 1e-9 ✓ | 87.1 EB05 79.3 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious n=312 · 100% clinician | not reported in cached trials |
| Pulmonary nocardiosis | 418 | 178.0 155.1–204.4ROR 178.6 · calibrated p 1e-9 ✓ | 86.0 EB05 79.3 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious n=417 · 100% clinician | not reported in cached trials |
| Transplant rejection | 4,078 | 176.6 169.0–184.5ROR 182.6 · calibrated p 9e-10 ✓ | 86.0 EB05 83.8 · IC025 +6.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 55.0 · 94% clinician | NCT02723591: 14/287 (4.9%) on Tacrolimus Extended-Release (serious AE) |
| Transplant dysfunction | 891 | 174.3 158.7–191.5ROR 175.6 · calibrated p 1e-9 ✓ | 85.3 EB05 80.7 · IC025 +6.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=891 · 91% clinician | NCT02723591: 1/287 (0.3%) on Tacrolimus Extended-Release (serious AE) |
| Cytomegalovirus syndrome | 82 | 169.8 124.8–231.1ROR 169.9 · calibrated p 4e-9 ✓ | 82.8 EB05 68.8 · IC025 +5.4 3/3 methods agree | Labeled (related wording) related wording | serious n=82 · 100% clinician | NCT02723591: 1/287 (0.3%) on Tacrolimus Extended-Release (serious AE) |
| Complications of transplanted kidney | 1,075 | 158.0 145.4–171.8ROR 159.4 · calibrated p 3e-9 ✓ | 81.3 EB05 77.3 · IC025 +6.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=1,071 | NCT02723591: 2/287 (0.7%) on Tacrolimus Extended-Release (serious AE) |
| Epidermodysplasia verruciformis | 80 | 155.9 114.9–211.6ROR 156.0 · calibrated p 7e-9 ✓ | 79.3 EB05 65.8 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=79 · 100% clinician | not reported in cached trials |
| Heart transplant rejection | 495 | 152.7 135.2–172.6ROR 153.3 · calibrated p 4e-9 ✓ | 79.7 EB05 74.0 · IC025 +6.1 3/3 methods agree | Labeled (related wording) related wording | serious n=493 | not reported in cached trials |
| Acanthamoeba infection | 90 | 152.2 114.3–202.6ROR 152.3 · calibrated p 8e-9 ✓ | 78.5 EB05 65.8 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=90 · ♀ 0% (drug 43%) · 100% clinician | not reported in cached trials |
| Disseminated blastomycosis | 79 | 150.5 111.0–204.0ROR 150.6 · calibrated p 9e-9 ✓ | 77.9 EB05 64.5 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=79 · ♀ 0% (drug 43%) · 100% clinician | not reported in cached trials |
| Pulmonary mucormycosis | 232 | 138.8 116.6–165.2ROR 139.0 · calibrated p 1e-8 ✓ | 75.5 EB05 67.7 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=232 · 100% clinician | not reported in cached trials |
| Disseminated mucormycosis | 171 | 133.6 109.3–163.5ROR 133.8 · calibrated p 2e-8 ✓ | 73.8 EB05 65.0 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=171 · 100% clinician | not reported in cached trials |
| Immunosuppressant drug level decreased | 522 | 132.5 118.1–148.6ROR 133.0 · calibrated p 1e-8 ✓ | 73.9 EB05 68.7 · IC025 +6.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=469 | NCT02723591: 1/287 (0.3%) on Tacrolimus Extended-Release (serious AE) |
| Epstein-barr viraemia | 469 | 128.7 114.1–145.1ROR 129.1 · calibrated p 2e-8 ✓ | 72.7 EB05 67.3 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious n=467 · 100% clinician | not reported in cached trials |
| Complications of transplanted lung | 131 | 127.7 101.7–160.3ROR 127.8 · calibrated p 2e-8 ✓ | 71.8 EB05 62.1 · IC025 +5.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=130 · 91% clinician | not reported in cached trials |
| Human ehrlichiosis | 86 | 127.2 96.1–168.5ROR 127.3 · calibrated p 3e-8 ✓ | 71.3 EB05 59.5 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=85 · 100% clinician | not reported in cached trials |
| Chronic graft versus host disease in eye | 84 | 125.4 94.4–166.5ROR 125.5 · calibrated p 4e-8 ✓ | 70.7 EB05 58.9 · IC025 +5.3 3/3 methods agree | Labeled (related wording) related wording | serious n=84 · ♀ 0% (drug 43%) | not reported in cached trials |
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 | 7,114 | 9.39.0–9.5 | signal |
| Kidney injury | 12,231 | 4.64.5–4.7 | signal |
| Serious infection | 11,392 | 2.52.5–2.6 | signal |
| Interstitial lung disease | 1,345 | 2.42.3–2.5 | signal |
| Neutropenia / agranulocytosis | 3,382 | 2.32.2–2.4 | signal |
| Anaemia | 3,491 | 2.01.9–2.0 | raised |
| Thrombocytopenia | 2,458 | 1.91.8–2.0 | raised |
| Liver injury | 3,061 | 1.71.7–1.8 | raised |
| Hyponatraemia | 724 | 1.51.4–1.6 | raised |
| Pancreatitis | 668 | 1.41.3–1.5 | raised |
| Rhabdomyolysis / myopathy | 569 | 1.21.1–1.3 | raised |
| Hyperglycaemia / diabetes | 2,346 | 1.11.1–1.2 | raised |
| Seizure | 1,196 | 1.01.0–1.1 | no difference |
| Gi bleeding | 1,089 | 1.00.9–1.1 | no difference |
| Venous thromboembolism | 1,177 | 0.90.9–1.0 | lower than other drugs |
| Arrhythmia / qt | 999 | 0.90.8–0.9 | lower than other drugs |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Tacrolimus Extended-Release as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (10 of 40 signal terms matched).
- NCT02723591 — To Compare the Effects of Immediate-release Tacrolimus and Astagraf XL on Donor-Specific Antibody (DSA) Format (N=599, PHASE4; 363 AE terms posted; arms: Tacrolimus, Extended Release (Astagraf X; Tacrolimus, Immediate Release BID)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
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) | 12,655 | 2.5 2.4–2.5ROR 2.7 · calibrated p 0.750 | 2.5 EB05 2.4 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | age-adj. PRR 2.1 · serious PRR 2.6 | not reported in cached trials |
| Drug ineffective (drug did not work) | 8,817 | 1.1 1.1–1.2ROR 1.1 · calibrated p 0.401 | 1.1 EB05 1.1 · IC025 +0.1 | Reporting / coding artifact | age-adj. PRR 1.3 · serious PRR 1.8 · 91% clinician | not reported in cached trials |
| Product use in unapproved indication | 6,059 | 4.3 4.2–4.4ROR 4.4 · calibrated p 0.305 | 4.2 EB05 4.1 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | age-adj. PRR 3.7 · serious PRR 5.2 · 92% clinician | not reported in cached trials |
| Drug interaction | 5,554 | 6.1 5.9–6.3ROR 6.3 · calibrated p 0.130 | 5.9 EB05 5.8 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | age-adj. PRR 5.3 · serious PRR 4.0 · 95% clinician | not reported in cached trials |
| Acute kidney injury (sudden kidney damage) | 5,395 | 6.2 6.0–6.3ROR 6.4 · calibrated p 0.126 | 6.0 EB05 5.8 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | age-adj. PRR 6.1 · serious PRR 3.8 · 94% clinician | NCT02723591: 31/287 (10.8%) on Tacrolimus Extended-Release (serious AE) |
| Diarrhoea (diarrhea) | 4,508 | 1.2 1.2–1.2ROR 1.2 · calibrated p 0.435 | 1.2 EB05 1.2 · IC025 +0.2 | Labeled adverse reaction exact term | age-adj. PRR 1.2 · serious PRR 1.2 | NCT02723591: 11/287 (3.8%) on Tacrolimus Extended-Release (serious AE) |
| Transplant rejection | 4,078 | 176.6 169.0–184.5ROR 182.6 · calibrated p 9e-10 ✓ | 86.0 EB05 83.8 · IC025 +6.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 55.0 · 94% clinician | NCT02723591: 14/287 (4.9%) on Tacrolimus Extended-Release (serious AE) |
| Cytomegalovirus infection | 4,011 | 53.6 51.7–55.5ROR 55.3 · calibrated p 7e-6 ✓ | 40.7 EB05 39.7 · IC025 +5.3 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 38.0 · serious PRR 25.9 · 95% clinician | NCT02723591: 2/287 (0.7%) on Tacrolimus Extended-Release (serious AE) |
| Pyrexia (fever) | 3,821 | 1.9 1.8–1.9ROR 1.9 · calibrated p 0.889 | 1.9 EB05 1.8 · IC025 +0.8 | Labeled adverse reaction exact term | age-adj. PRR 1.4 · serious PRR 1.4 | NCT02723591: 8/287 (2.8%) on Tacrolimus Extended-Release (serious AE) |
| Covid-19 | 3,721 | 3.6 3.5–3.7ROR 3.7 · calibrated p 0.441 | 3.6 EB05 3.5 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | age-adj. PRR 3.3 · serious PRR 3.8 · 91% clinician | not reported in cached trials |
| Toxicity to various agents | 3,618 | 3.7 3.6–3.8ROR 3.8 · calibrated p 0.421 | 3.6 EB05 3.5 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | age-adj. PRR 2.8 · serious PRR 2.4 · 94% clinician | not reported in cached trials |
| Pneumonia (lung infection) | 3,548 | 1.9 1.8–1.9ROR 1.9 · calibrated p 0.882 | 1.9 EB05 1.8 · IC025 +0.8 | Labeled — boxed warning synonym match | age-adj. PRR 1.8 · serious PRR 1.2 | NCT02723591: 7/287 (2.4%) on Tacrolimus Extended-Release (serious AE) |
| Death | 3,405 | 0.7 0.6–0.7ROR 0.7 · calibrated p 0.110 | 0.7 EB05 0.6 · IC025 -0.6 PRR-only: not supported by EBGM or IC | Outcome field, not a reaction boxed warning mentions mortality | age-adj. PRR 0.7 · serious PRR 0.4 | NCT02723591: 1/287 (0.3%) on Tacrolimus Extended-Release (serious AE) |
| Post transplant lymphoproliferative disorder | 2,896 | 233.0 220.3–246.5ROR 238.6 · calibrated p 8e-11 ✓ | 97.4 EB05 94.4 · IC025 +6.5 3/3 methods agree | Labeled (related wording) related wording | serious n=2,891 · 98% clinician | NCT02723591: 1/288 (0.3%) on Tacrolimus Extended-Release (serious AE) |
| Sepsis (blood infection) | 2,858 | 4.4 4.3–4.6ROR 4.5 · calibrated p 0.297 | 4.3 EB05 4.2 · IC025 +2.1 3/3 methods agree | Labeled — boxed warning synonym match | age-adj. PRR 3.8 · serious PRR 2.8 · 93% clinician | NCT02723591: 1/287 (0.3%) on Tacrolimus Extended-Release (serious AE) |
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=334, PRR 1,044.2
- Smooth muscle cell neoplasm — n=325, PRR 641.1
- Trichodysplasia spinulosa — n=294, PRR 624.5
- Phaeohyphomycosis — n=347, PRR 542.4
- Delayed graft function — n=481, PRR 367.3 (also seen in trial arm)
- Polyomavirus viraemia — n=669, PRR 348.6
- Rhodococcus infection — n=106, PRR 297.7
- Alternaria infection — n=227, PRR 276.6
- Chronic allograft nephropathy — n=462, PRR 242.2
- Cerebral nocardiosis — n=116, PRR 202.3
✓ 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 Extended-Release?
In FDA FAERS, the most frequently co-reported reaction terms for Tacrolimus Extended-Release are acute kidney injury, diarrhoea, transplant rejection, cytomegalovirus infection, pyrexia, covid-19. 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 Extended-Release have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: MALIGNANCIES AND SERIOUS INFECTIONS IN TRANSPLANT PATIENTS; AND INCREASED MORTALITY IN FEMALE LIVER TRANSPLANT PATIENTS Increased risk for developing serious infections and malignancies with tacrolimus extended-release capsulest or other immunosuppressants that may lead to hospitalization or death.
Do FAERS signals prove that Tacrolimus Extended-Release 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 08cf2861-2483-405d-a872-a88a5c235f9a, effective 20240207; matched on
openfda.generic_name.exact:"TACROLIMUS EXTENDED-RELEASE CAPSULES") - 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, fieldpatient.drug.openfda.generic_name.exact, 1,412 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 EXTENDED-RELEASE, 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.