Sirolimus side effects: what 13,363 FDA adverse event reports show
Drug class
mTOR Inhibitor Immunosuppressant, Kinase Inhibitor
Who reports
13,363 reports · 86% serious · 2,150 with death outcome · 43% female
Used for
• Sirolimus tablet is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants: o Patients at low-to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2-4 months after transplantation ( 1.1 ).
What it is
Sirolimus is an mTOR inhibitor immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus.
Boxed warning
IMMUNOSUPPRESSION,USE IS NOT RECOMMENDED IN LIVER OR LUNG TRANSPLANT PATIENTS • Increased susceptibility to infection and the possible development of lymphoma and other malignancies may result from immunosuppression Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression.
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.
- 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 flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 1,031 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 |
|---|---|---|---|---|---|---|
| Staphylococcal mediastinitis | 10 | 1,286.6 556.0–2,977.4ROR 1,287.6 · χ² 6,323 / p <1e-300 | 299.7 EB05 174.0 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Skin squamous cell carcinoma metastatic | 25 | 551.4 349.4–870.3ROR 552.4 · χ² 9,719 / p <1e-300 | 310.1 EB05 220.9 · IC025 +4.8 3/3 methods agree | Labeled (related wording) related wording | serious n=25 · 100% clinician | no trial data cached |
| Smooth muscle cell neoplasm | 90 | 435.6 344.9–550.1ROR 438.5 · χ² 30,099 / p <1e-300 | 317.0 EB05 265.8 · IC025 +6.5 3/3 methods agree | Not in label — unassessed | serious n=90 · ♀ 74% (drug 43%) · 98% clinician | no trial data cached |
| Avian influenza | 14 | 432.3 239.1–781.7ROR 432.7 · χ² 4,375 / p <1e-300 | 231.5 EB05 146.6 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Focal glomerulosclerosis | 22 | 404.4 253.0–646.4ROR 405.0 · χ² 6,699 / p <1e-300 | 250.9 EB05 174.6 · IC025 +4.6 3/3 methods agree | Labeled (related wording) related wording | serious n=22 | no trial data cached |
| Kaposi sarcoma inflammatory cytokine syndrome | 11 | 361.3 187.5–696.5ROR 361.6 · χ² 2,918 / p <1e-300 | 194.6 EB05 116.0 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Tularaemia | 13 | 299.6 165.4–542.5ROR 299.9 · χ² 2,994 / p <1e-300 | 183.8 EB05 114.3 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Propionibacterium infection | 16 | 271.5 159.6–461.7ROR 271.8 · χ² 3,440 / p <1e-300 | 181.4 EB05 118.4 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Skin squamous cell carcinoma recurrent | 15 | 246.4 142.9–424.8ROR 246.6 · χ² 2,953 / p <1e-300 | 167.6 EB05 107.8 · IC025 +3.9 3/3 methods agree | Labeled (related wording) related wording | serious n=15 | no trial data cached |
| Periorbital infection | 11 | 239.2 126.8–451.3ROR 239.4 · χ² 2,058 / p <1e-300 | 152.9 EB05 91.1 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Bronchiolitis obliterans syndrome | 22 | 234.3 149.6–366.7ROR 234.6 · χ² 4,236 / p <1e-300 | 173.2 EB05 120.5 · IC025 +4.5 3/3 methods agree | Labeled (related wording) related wording | serious n=22 | no trial data cached |
| Chronic graft versus host disease oral | 29 | 215.3 146.0–317.3ROR 215.7 · χ² 5,241 / p <1e-300 | 168.3 EB05 122.9 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=29 | no trial data cached |
| Chronic graft versus host disease in eye | 20 | 176.4 111.1–280.2ROR 176.7 · χ² 2,976 / p <1e-300 | 137.9 EB05 94.2 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=20 · 95% clinician | no trial data cached |
| Diverticulum oesophageal | 12 | 173.2 95.4–314.4ROR 173.3 · χ² 1,695 / p <1e-300 | 125.3 EB05 76.4 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Infected neoplasm | 24 | 169.2 111.0–257.8ROR 169.5 · χ² 3,466 / p <1e-300 | 136.3 EB05 96.4 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=24 · ♀ 100% (drug 43%) · 100% clinician | no trial data cached |
| Epidermodysplasia verruciformis | 16 | 165.8 99.0–277.6ROR 166.0 · χ² 2,220 / p <1e-300 | 127.4 EB05 83.1 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Chronic allograft nephropathy | 73 | 159.9 125.7–203.3ROR 160.7 · χ² 10,300 / p <1e-300 | 139.7 EB05 114.8 · IC025 +5.8 3/3 methods agree | Labeled adverse reaction exact term | serious n=72 · 94% clinician | no trial data cached |
| Renal graft infection | 21 | 155.9 99.5–244.1ROR 156.1 · χ² 2,796 / p <1e-300 | 125.7 EB05 86.8 · IC025 +4.3 3/3 methods agree | Labeled (related wording) related wording | serious n=21 | no trial data cached |
| Human ehrlichiosis | 18 | 154.4 95.1–250.6ROR 154.6 · χ² 2,356 / p <1e-300 | 122.5 EB05 82.0 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
| Adenovirus reactivation | 12 | 148.2 82.0–267.9ROR 148.3 · χ² 1,469 / p <1e-300 | 111.8 EB05 68.1 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Lymphangioma | 12 | 147.0 81.4–265.8ROR 147.2 · χ² 1,459 / p <1e-300 | 111.1 EB05 67.7 · IC025 +3.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=10 | no trial data cached |
| Polyomavirus-associated nephropathy | 199 | 146.6 126.9–169.4ROR 148.8 · χ² 26,149 / p <1e-300 | 132.3 EB05 117.6 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious n=199 · 99% clinician | no trial data cached |
| Melas syndrome | 18 | 143.3 88.4–232.1ROR 143.4 · χ² 2,198 / p <1e-300 | 115.4 EB05 77.2 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
| Alopecia scarring | 14 | 142.2 82.3–245.8ROR 142.4 · χ² 1,670 / p <1e-300 | 111.0 EB05 70.3 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Chronic graft versus host disease in lung | 13 | 130.3 74.0–229.5ROR 130.5 · χ² 1,422 / p <1e-300 | 102.6 EB05 63.8 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Chronic graft versus host disease in skin | 69 | 128.4 100.5–164.0ROR 129.0 · χ² 7,933 / p <1e-300 | 114.9 EB05 93.9 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious n=69 · 91% clinician | no trial data cached |
| Renal-limited thrombotic microangiopathy | 17 | 127.4 77.7–208.9ROR 127.6 · χ² 1,854 / p <1e-300 | 104.3 EB05 69.0 · IC025 +3.9 3/3 methods agree | Labeled (related wording) related wording | serious n=17 | no trial data cached |
| Malignant fibrous histiocytoma | 10 | 124.5 65.4–237.1ROR 124.6 · χ² 1,022 / p 1e-224 | 95.0 EB05 55.1 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Complications of transplanted heart | 15 | 117.0 69.2–197.6ROR 117.1 · χ² 1,497 / p <1e-300 | 95.9 EB05 61.7 · IC025 +3.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=15 | no trial data cached |
| Human herpesvirus 8 infection | 42 | 116.2 85.0–158.9ROR 116.6 · χ² 4,355 / p <1e-300 | 103.2 EB05 79.6 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=41 · 100% clinician | no trial data cached |
| Graft versus host disease in liver | 46 | 108.1 80.2–145.7ROR 108.5 · χ² 4,462 / p <1e-300 | 97.1 EB05 75.8 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=46 · ♀ 17% (drug 43%) · 100% clinician | no trial data cached |
| Lung transplant rejection | 42 | 105.4 77.2–144.1ROR 105.8 · χ² 3,970 / p <1e-300 | 94.6 EB05 73.0 · IC025 +5.0 3/3 methods agree | Labeled (related wording) related wording | serious n=42 · 100% clinician | no trial data cached |
| Gingivitis ulcerative | 13 | 102.4 58.4–179.5ROR 102.5 · χ² 1,131 / p 3e-248 | 84.5 EB05 52.6 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Graft versus host disease in eye | 14 | 101.0 58.8–173.4ROR 101.1 · χ² 1,209 / p 4e-265 | 84.3 EB05 53.4 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Chronic graft versus host disease | 216 | 98.8 86.2–113.2ROR 100.4 · χ² 19,561 / p <1e-300 | 92.2 EB05 82.3 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious n=215 · 92% clinician | no trial data cached |
| Cystitis viral | 21 | 91.3 58.8–141.8ROR 91.5 · χ² 1,687 / p <1e-300 | 80.2 EB05 55.3 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=21 · 95% clinician | no trial data cached |
| Mycobacterium haemophilum infection | 14 | 91.2 53.2–156.3ROR 91.3 · χ² 1,096 / p 1e-240 | 77.4 EB05 49.0 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Alveolar proteinosis | 32 | 90.5 63.4–129.2ROR 90.7 · χ² 2,591 / p <1e-300 | 81.5 EB05 60.4 · IC025 +4.6 3/3 methods agree | Labeled adverse reaction exact term | serious n=32 · 100% clinician | no trial data cached |
| Polyomavirus viraemia | 54 | 89.4 68.0–117.5ROR 89.7 · χ² 4,377 / p <1e-300 | 82.1 EB05 65.3 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=54 · 94% clinician | no trial data cached |
| Lymphocele | 36 | 89.1 63.7–124.6ROR 89.3 · χ² 2,881 / p <1e-300 | 80.8 EB05 61.0 · IC025 +4.7 3/3 methods agree | Labeled adverse reaction exact term | serious n=36 · 91% clinician | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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) | 2,055 | 3.7 3.6–3.9ROR 4.2 · χ² 4,238 / p <1e-300 | 3.7 EB05 3.6 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 3.5 | no trial data cached |
| Drug ineffective (drug did not work) | 1,117 | 1.3 1.3–1.4ROR 1.4 · χ² 96 / p 5e-23 | 1.3 EB05 1.3 · IC025 +0.3 | Reporting / coding artifact | serious PRR 2.3 · 95% clinician | no trial data cached |
| Product use in unapproved indication | 784 | 5.0 4.7–5.4ROR 5.3 · χ² 2,554 / p <1e-300 | 5.0 EB05 4.7 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 6.6 | no trial data cached |
| Pyrexia (fever) | 525 | 2.4 2.2–2.6ROR 2.4 · χ² 423 / p 2e-94 | 2.4 EB05 2.2 · IC025 +1.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 1.9 | no trial data cached |
| Diarrhoea (diarrhea) | 514 | 1.3 1.1–1.4ROR 1.3 · χ² 26 / p 1e-7 | 1.3 EB05 1.2 · IC025 +0.2 | Labeled adverse reaction exact term | serious PRR 1.3 | no trial data cached |
| Pneumonia (lung infection) | 487 | 2.4 2.2–2.6ROR 2.4 · χ² 386 / p 3e-86 | 2.4 EB05 2.2 · IC025 +1.1 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 1.6 | no trial data cached |
| Drug interaction | 448 | 4.4 4.0–4.9ROR 4.5 · χ² 1,192 / p 2e-261 | 4.4 EB05 4.1 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 2.9 · 94% clinician | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 435 | 4.5 4.1–4.9ROR 4.6 · χ² 1,178 / p 2e-258 | 4.5 EB05 4.1 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.0 · 95% clinician | no trial data cached |
| Thrombotic microangiopathy | 376 | 63.2 57.1–70.0ROR 65.0 · χ² 22,066 / p <1e-300 | 60.6 EB05 55.6 · IC025 +5.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 40.8 · 96% clinician | no trial data cached |
| Transplant rejection | 372 | 76.3 68.8–84.5ROR 78.4 · χ² 26,265 / p <1e-300 | 72.5 EB05 66.5 · IC025 +5.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 49.2 · 95% clinician | no trial data cached |
| Cytomegalovirus infection | 348 | 33.4 30.1–37.1ROR 34.3 · χ² 10,695 / p <1e-300 | 32.7 EB05 29.9 · IC025 +4.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 22.3 · 94% clinician | no trial data cached |
| Toxicity to various agents | 314 | 2.9 2.6–3.3ROR 3.0 · χ² 400 / p 2e-89 | 2.9 EB05 2.7 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 1.7 · 95% clinician | no trial data cached |
| Condition aggravated | 313 | 1.6 1.5–1.8ROR 1.6 · χ² 75 / p 2e-18 | 1.6 EB05 1.5 · IC025 +0.5 | Reporting / coding artifact | serious PRR 1.5 · 90% clinician | no trial data cached |
| Death | 308 | 0.6 0.5–0.6ROR 0.5 · χ² 111 / p 3e-26 | 0.6 EB05 0.5 · IC025 -1.0 PRR-only: not supported by EBGM or IC | Outcome field, not a reaction boxed warning mentions mortality | serious PRR 0.4 | no trial data cached |
| Nausea | 306 | 0.6 0.5–0.7ROR 0.6 · χ² 80 / p 2e-19 | 0.6 EB05 0.6 · IC025 -0.9 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 0.6 | no trial data cached |
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.
- Smooth muscle cell neoplasm — n=90, PRR 435.6
- Chronic graft versus host disease oral — n=29, PRR 215.3
- Chronic graft versus host disease in eye — n=20, PRR 176.4
- Infected neoplasm — n=24, PRR 169.2
- Polyomavirus-associated nephropathy — n=199, PRR 146.6
- Chronic graft versus host disease in skin — n=69, PRR 128.4
- Human herpesvirus 8 infection — n=42, PRR 116.2
- Graft versus host disease in liver — n=46, PRR 108.1
- Chronic graft versus host disease — n=216, PRR 98.8
- Cystitis viral — n=21, PRR 91.3
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 Sirolimus?
In FDA FAERS, the most frequently co-reported reaction terms for Sirolimus are pyrexia, diarrhoea, pneumonia, acute kidney injury, thrombotic microangiopathy, transplant rejection. 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 Sirolimus have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: IMMUNOSUPPRESSION,USE IS NOT RECOMMENDED IN LIVER OR LUNG TRANSPLANT PATIENTS • Increased susceptibility to infection and the possible development of lymphoma and other malignancies may result from immunosuppression Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression.
Do FAERS signals prove that Sirolimus 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 1bef7d8f-524b-4218-8fef-6c3f3628d33e, effective 20251110; matched on
openfda.generic_name.exact:"SIROLIMUS") - 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, 1,071 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
Page generated 2026-10-08. 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.