Tacrolimus Ointment 0.1% side effects: what 123,785 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Tacrolimus
Who reports
123,785 reports · 90% serious · 19,724 with death outcome · 43% female
Used for
Tacrolimus ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated as second-line therapy for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompro.
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.
Boxed warning
Long-term Safety of Topical Calcineurin Inhibitors Has Not Been Established Although a causal relationship has not been established, rare cases of malignancy (e.g., skin and lymphoma) have been reported in patients treated with topical calcineurin inhibitors, including tacrolimus ointment.
Causality screen of the 40 strongest signals
What the badges mean
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- 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 | 2,791.2 1,132.3–6,880.5ROR 2,793.1 · calibrated p 7e-17 ✓ | 152.3 EB05 126.9 · 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 | 1,465.9 887.8–2,420.7ROR 1,467.7 · calibrated p 2e-17 ✓ | 147.3 EB05 128.6 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious n=150 | not reported in cached trials |
| Malacoplakia | 334 | 1,047.0 783.6–1,398.9ROR 1,049.8 · calibrated p 6e-17 ✓ | 143.1 EB05 130.7 · 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 | 882.6 517.4–1,505.7ROR 883.2 · calibrated p 8e-15 ✓ | 136.4 EB05 113.8 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious n=85 · 100% clinician | not reported in cached trials |
| Smooth muscle cell neoplasm | 325 | 642.8 505.7–817.0ROR 644.5 · calibrated p 9e-15 ✓ | 131.8 EB05 120.2 · 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 | 626.5 455.8–861.2ROR 627.4 · calibrated p 2e-14 ✓ | 130.3 EB05 115.1 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious n=181 | not reported in cached trials |
| Trichodysplasia spinulosa | 294 | 626.2 487.9–803.7ROR 627.7 · calibrated p 1e-14 ✓ | 131.0 EB05 118.9 · 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 | 543.9 437.6–676.0ROR 545.4 · calibrated p 4e-14 ✓ | 127.1 EB05 116.3 · 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 | 495.2 360.6–679.9ROR 495.8 · calibrated p 2e-13 ✓ | 123.2 EB05 107.7 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious n=145 · 93% clinician | not reported in cached trials |
| Polyomavirus-associated nephropathy | 1,692 | 466.2 424.9–511.5ROR 472.6 · calibrated p 1e-13 ✓ | 123.1 EB05 118.2 · IC025 +6.8 3/3 methods agree | Not in label — unassessed | serious n=1,692 · 97% clinician | not reported in cached trials |
| Delayed graft function | 481 | 368.3 313.8–432.2ROR 369.7 · calibrated p 2e-12 ✓ | 114.7 EB05 106.3 · IC025 +6.5 3/3 methods agree | Not in label — unassessed | serious n=481 · 91% clinician | not reported in cached trials |
| Polyomavirus viraemia | 669 | 349.5 305.9–399.4ROR 351.4 · calibrated p 2e-12 ✓ | 112.9 EB05 105.9 · IC025 +6.6 3/3 methods agree | Not in label — unassessed | serious n=664 · 97% clinician | not reported in cached trials |
| Rhodococcus infection | 106 | 298.5 217.1–410.4ROR 298.7 · calibrated p 3e-11 ✓ | 105.4 EB05 89.6 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=106 · 100% clinician | not reported in cached trials |
| Alternaria infection | 227 | 277.3 224.2–343.0ROR 277.8 · calibrated p 3e-11 ✓ | 103.6 EB05 92.8 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious n=220 · 100% clinician | not reported in cached trials |
| Parvovirus b19 infection | 517 | 243.3 212.6–278.6ROR 244.3 · calibrated p 8e-11 ✓ | 99.0 EB05 92.0 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious n=473 · 100% clinician | not reported in cached trials |
| Chronic allograft nephropathy | 462 | 242.9 210.5–280.2ROR 243.8 · calibrated p 8e-11 ✓ | 98.9 EB05 91.5 · 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 | 233.7 220.9–247.2ROR 239.3 · calibrated p 8e-11 ✓ | 97.6 EB05 94.7 · IC025 +6.5 3/3 methods agree | Not in label — unassessed | serious n=2,891 · 98% clinician | not reported in cached trials |
| Donor specific antibody present | 87 | 233.1 168.3–322.9ROR 233.3 · calibrated p 3e-10 ✓ | 95.6 EB05 79.9 · IC025 +5.6 3/3 methods agree | Lab value / disease marker | serious n=87 · ♀ 100% (drug 43%) · 100% clinician | not reported in cached trials |
| Immunosuppressant drug level increased | 1,838 | 216.1 201.7–231.6ROR 219.4 · calibrated p 2e-10 ✓ | 94.4 EB05 90.8 · IC025 +6.4 3/3 methods agree | Lab value / disease marker | serious n=1,750 | not reported in cached trials |
| Human polyomavirus infection | 286 | 209.3 175.9–249.1ROR 209.8 · calibrated p 3e-10 ✓ | 92.6 EB05 84.0 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious n=271 · 93% clinician | not reported in cached trials |
| Cerebral nocardiosis | 116 | 202.9 154.7–266.1ROR 203.1 · calibrated p 7e-10 ✓ | 90.6 EB05 77.5 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=116 · 100% clinician | not reported in cached trials |
| Renal transplant failure | 536 | 202.4 178.4–229.6ROR 203.3 · calibrated p 4e-10 ✓ | 91.5 EB05 85.2 · IC025 +6.3 3/3 methods agree | Labeled (related wording) related wording | serious n=536 | not reported in cached trials |
| Pancreas transplant rejection | 110 | 200.8 152.1–265.1ROR 201.0 · calibrated p 8e-10 ✓ | 90.1 EB05 76.8 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=110 · ♀ 100% (drug 43%) | not reported in cached trials |
| Human herpesvirus 8 infection | 315 | 183.6 156.5–215.5ROR 184.1 · calibrated p 1e-9 ✓ | 87.3 EB05 79.5 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious n=312 · 100% clinician | not reported in cached trials |
| Pulmonary nocardiosis | 418 | 178.5 155.5–204.9ROR 179.1 · calibrated p 1e-9 ✓ | 86.2 EB05 79.5 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious n=417 · 100% clinician | not reported in cached trials |
| Transplant rejection | 4,073 | 176.6 169.1–184.5ROR 182.6 · calibrated p 9e-10 ✓ | 86.1 EB05 83.9 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious PRR 55.1 · 94% clinician | not reported in cached trials |
| Transplant dysfunction | 891 | 174.8 159.1–192.0ROR 176.0 · calibrated p 1e-9 ✓ | 85.5 EB05 80.9 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious n=891 · 91% clinician | not reported in cached trials |
| Cytomegalovirus syndrome | 82 | 170.3 125.2–231.7ROR 170.4 · calibrated p 4e-9 ✓ | 83.0 EB05 69.0 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=82 · 100% clinician | not reported in cached trials |
| Complications of transplanted kidney | 1,074 | 158.2 145.5–171.9ROR 159.6 · calibrated p 3e-9 ✓ | 81.4 EB05 77.4 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious n=1,070 | not reported in cached trials |
| Epidermodysplasia verruciformis | 80 | 156.4 115.2–212.2ROR 156.5 · calibrated p 7e-9 ✓ | 79.6 EB05 66.0 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=79 · 100% clinician | not reported in cached trials |
| Acanthamoeba infection | 90 | 152.6 114.6–203.1ROR 152.7 · calibrated p 8e-9 ✓ | 78.7 EB05 66.0 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=90 · ♀ 0% (drug 43%) · 100% clinician | not reported in cached trials |
| Heart transplant rejection | 494 | 152.6 135.0–172.3ROR 153.2 · calibrated p 4e-9 ✓ | 79.8 EB05 74.0 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious n=492 | not reported in cached trials |
| Disseminated blastomycosis | 79 | 150.9 111.3–204.6ROR 151.0 · calibrated p 9e-9 ✓ | 78.1 EB05 64.7 · 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 | 139.2 116.9–165.7ROR 139.4 · calibrated p 1e-8 ✓ | 75.7 EB05 67.9 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=232 · 100% clinician | not reported in cached trials |
| Disseminated mucormycosis | 171 | 134.0 109.6–163.9ROR 134.2 · calibrated p 2e-8 ✓ | 74.0 EB05 65.2 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=171 · 100% clinician | not reported in cached trials |
| Epstein-barr viraemia | 469 | 129.0 114.4–145.5ROR 129.5 · calibrated p 2e-8 ✓ | 72.8 EB05 67.5 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious n=467 · 100% clinician | not reported in cached trials |
| Immunosuppressant drug level decreased | 513 | 128.7 114.7–144.5ROR 129.3 · calibrated p 2e-8 ✓ | 72.8 EB05 67.6 · IC025 +5.9 3/3 methods agree | Lab value / disease marker | serious n=467 | not reported in cached trials |
| Complications of transplanted lung | 131 | 128.0 101.9–160.8ROR 128.2 · calibrated p 2e-8 ✓ | 72.0 EB05 62.2 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=130 · 91% clinician | not reported in cached trials |
| Human ehrlichiosis | 86 | 127.6 96.3–169.0ROR 127.7 · calibrated p 3e-8 ✓ | 71.5 EB05 59.7 · 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 | 125.7 94.7–166.9ROR 125.8 · calibrated p 3e-8 ✓ | 70.9 EB05 59.0 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | 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 | 7,109 | 9.39.1–9.5 | signal |
| Kidney injury | 12,220 | 4.64.6–4.7 | signal |
| Serious infection | 11,372 | 2.52.5–2.6 | signal |
| Interstitial lung disease | 1,345 | 2.42.3–2.5 | signal |
| Neutropenia / agranulocytosis | 3,382 | 2.32.3–2.4 | signal |
| Anaemia | 3,489 | 2.01.9–2.0 | raised |
| Thrombocytopenia | 2,458 | 1.91.8–2.0 | raised |
| Liver injury | 3,060 | 1.71.7–1.8 | raised |
| Hyponatraemia | 724 | 1.51.4–1.6 | raised |
| Pancreatitis | 667 | 1.41.3–1.5 | raised |
| Rhabdomyolysis / myopathy | 569 | 1.21.1–1.3 | raised |
| Hyperglycaemia / diabetes | 2,341 | 1.11.1–1.2 | raised |
| Seizure | 1,195 | 1.01.0–1.1 | no difference |
| Gi bleeding | 1,089 | 1.01.0–1.1 | no difference |
| Venous thromboembolism | 1,176 | 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 Ointment 0.1% 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 (0 of 40 signal terms matched).
- NCT03152019 — Efficacy and Safety of a 0.1% Tacrolimus Nasal Ointment as a Treatment for Epistaxis in Hemorrhagic Hereditary (N=50, PHASE2; 7 AE terms posted; arms: Protopic® 0.1% (Tacrolimus) Ointment; Placebo Ointment)
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) | 12,642 | 2.5 2.4–2.5ROR 2.7 · calibrated p 0.748 | 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) | 8,812 | 1.1 1.1–1.2ROR 1.1 · calibrated p 0.403 | 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 | 6,056 | 4.3 4.2–4.4ROR 4.4 · calibrated p 0.303 | 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 | 5,549 | 6.1 5.9–6.3ROR 6.3 · calibrated p 0.129 | 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) | 5,393 | 6.2 6.0–6.3ROR 6.4 · calibrated p 0.125 | 6.0 EB05 5.9 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | age-adj. PRR 6.1 · serious PRR 3.8 · 94% clinician | not reported in cached trials |
| Diarrhoea (diarrhea) | 4,493 | 1.2 1.2–1.2ROR 1.2 · calibrated p 0.434 | 1.2 EB05 1.2 · IC025 +0.2 | Labeled adverse reaction exact term | age-adj. PRR 1.2 · serious PRR 1.2 | not reported in cached trials |
| Transplant rejection | 4,073 | 176.6 169.1–184.5ROR 182.6 · calibrated p 9e-10 ✓ | 86.1 EB05 83.9 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious PRR 55.1 · 94% clinician | not reported in cached trials |
| Cytomegalovirus infection | 4,010 | 53.7 51.8–55.6ROR 55.5 · calibrated p 7e-6 ✓ | 40.8 EB05 39.8 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | age-adj. PRR 38.0 · serious PRR 25.9 · 95% clinician | not reported in cached trials |
| Pyrexia (fever) | 3,812 | 1.9 1.8–1.9ROR 1.9 · calibrated p 0.890 | 1.9 EB05 1.8 · IC025 +0.8 | Labeled (related wording) related wording | age-adj. PRR 1.4 · serious PRR 1.4 | not reported in cached trials |
| Covid-19 | 3,720 | 3.6 3.5–3.7ROR 3.7 · calibrated p 0.439 | 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 | 3,615 | 3.7 3.6–3.8ROR 3.8 · calibrated p 0.419 | 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) | 3,535 | 1.9 1.8–1.9ROR 1.9 · calibrated p 0.881 | 1.9 EB05 1.8 · IC025 +0.8 | Labeled — boxed warning synonym match | age-adj. PRR 1.8 · serious PRR 1.2 | not reported in cached trials |
| Death | 3,378 | 0.7 0.6–0.7ROR 0.7 · calibrated p 0.108 | 0.7 EB05 0.6 · IC025 -0.6 PRR-only: not supported by EBGM or IC | Outcome field, not a reaction | age-adj. PRR 0.7 · serious PRR 0.4 | not reported in cached trials |
| Post transplant lymphoproliferative disorder | 2,896 | 233.7 220.9–247.2ROR 239.3 · calibrated p 8e-11 ✓ | 97.6 EB05 94.7 · IC025 +6.5 3/3 methods agree | Not in label — unassessed | serious n=2,891 · 98% clinician | not reported in cached trials |
| Sepsis (blood infection) | 2,856 | 4.4 4.3–4.6ROR 4.5 · calibrated p 0.296 | 4.3 EB05 4.2 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | age-adj. PRR 3.8 · serious PRR 2.8 · 93% clinician | not reported in cached trials |
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.
- New onset diabetes after transplantation — n=150, PRR 1,465.9
- Malacoplakia — n=334, PRR 1,047.0
- Transplantation associated food allergy — n=85, PRR 882.6
- Smooth muscle cell neoplasm — n=325, PRR 642.8
- Renal graft infection — n=181, PRR 626.5
- Trichodysplasia spinulosa — n=294, PRR 626.2
- Phaeohyphomycosis — n=347, PRR 543.9
- Post transplant distal limb syndrome — n=152, PRR 495.2
- Polyomavirus-associated nephropathy — n=1,692, PRR 466.2
- Delayed graft function — n=481, PRR 368.3
✓ 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 Ointment 0.1%?
In FDA FAERS, the most frequently co-reported reaction terms for Tacrolimus Ointment 0.1% 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 Ointment 0.1% have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: Long-term Safety of Topical Calcineurin Inhibitors Has Not Been Established Although a causal relationship has not been established, rare cases of malignancy (e.g., skin and lymphoma) have been reported in patients treated with topical calcineurin inhibitors, including tacrolimus ointment.
Do FAERS signals prove that Tacrolimus Ointment 0.1% 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 43b38551-6c5e-48a4-a453-9286f1c16b34, effective 20251009; matched on
openfda.generic_name.exact:"TACROLIMUS OINTMENT 0.1%" 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, 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 OINTMENT 0.1%, 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.