Basiliximab side effects: what 11,693 FDA adverse event reports show
Drug class
Interleukin-2 Receptor Blocking Antibody
Brand names
Simulect
Who reports
11,693 reports · 98% serious · 2,503 with death outcome · 37% female
Used for
Simulect ® (basiliximab) is indicated for the prophylaxis of acute organ rejection in patients receiving renal transplantation when used as part of an immunosuppressive regimen that includes cyclosporine, USP (MODIFIED), and corticosteroids. The efficacy of Simulect for the prophylaxis of acute rejection in recipients of other solid organ allografts has not been demonstrated.
What it is
DESCRIPTION Basiliximab is a chimeric (murine/human) monoclonal antibody (IgG 1 к ), produced by recombinant DNA technology, that functions as an immunosuppressive agent, specifically binding .
Boxed warning
Only physicians experienced in immunosuppression therapy and management of organ transplantation patients should prescribe Simulect ® (basiliximab). The physician responsible for Simulect administration should have complete information requisite for the follow-up of the patient.
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.
- 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 flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 1,017 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 |
|---|---|---|---|---|---|---|
| Diabetic macroangiopathy | 15 | 1,560.7 779.6–3,124.4ROR 1,562.7 · χ² 11,606 / p <1e-300 | 402.5 EB05 258.9 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Ventricular remodelling | 28 | 1,125.6 701.1–1,807.2ROR 1,128.3 · χ² 18,545 / p <1e-300 | 467.4 EB05 339.4 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=28 · 100% clinician | no trial data cached |
| Passenger lymphocyte syndrome | 19 | 819.7 475.9–1,411.8ROR 821.0 · χ² 10,064 / p <1e-300 | 358.0 EB05 242.2 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=19 | no trial data cached |
| Intestine transplant rejection | 28 | 728.3 469.2–1,130.6ROR 730.1 · χ² 13,895 / p <1e-300 | 381.3 EB05 276.9 · IC025 +5.1 3/3 methods agree | Labeled (related wording) related wording | serious n=28 · 100% clinician | no trial data cached |
| Delayed graft function | 192 | 671.2 569.0–791.7ROR 682.4 · χ² 92,657 / p <1e-300 | 464.2 EB05 411.7 · IC025 +7.5 3/3 methods agree | Not in label — unassessed | serious n=192 | no trial data cached |
| Renal graft loss | 20 | 579.9 350.1–960.7ROR 580.9 · χ² 8,274 / p <1e-300 | 308.2 EB05 210.6 · IC025 +4.5 3/3 methods agree | Labeled (related wording) related wording | serious n=20 · 100% clinician | no trial data cached |
| Encephalitis protozoal | 13 | 534.8 287.6–994.2ROR 535.4 · χ² 4,916 / p <1e-300 | 256.3 EB05 159.4 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Renal lymphocele | 10 | 491.3 243.9–989.8ROR 491.8 · χ² 3,455 / p <1e-300 | 222.1 EB05 128.9 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Intracranial infection | 26 | 484.1 313.8–746.7ROR 485.2 · χ² 9,465 / p <1e-300 | 297.2 EB05 213.1 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=26 · ♀ 100% (drug 37%) · 96% clinician | no trial data cached |
| Arteritis infective | 13 | 479.1 259.6–883.9ROR 479.6 · χ² 4,511 / p <1e-300 | 242.8 EB05 151.0 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Renal graft infection | 43 | 408.9 293.6–569.5ROR 410.4 · χ² 13,883 / p <1e-300 | 289.5 EB05 223.9 · IC025 +5.6 3/3 methods agree | Labeled (related wording) related wording | serious n=43 · ♀ 68% (drug 37%) · 93% clinician | no trial data cached |
| Ureteral necrosis | 11 | 389.1 202.6–747.3ROR 389.5 · χ² 3,180 / p <1e-300 | 205.7 EB05 122.6 · IC025 +3.4 3/3 methods agree | Labeled (related wording) related wording | serious n=11 | no trial data cached |
| Complications of transplanted lung | 53 | 378.0 281.1–508.3ROR 379.7 · χ² 16,111 / p <1e-300 | 280.1 EB05 222.4 · IC025 +5.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=52 · 92% clinician | no trial data cached |
| Polyomavirus-associated nephropathy | 390 | 362.1 325.2–403.2ROR 374.6 · χ² 116,294 / p <1e-300 | 296.4 EB05 272.5 · IC025 +7.6 3/3 methods agree | Not in label — unassessed | serious n=390 · 96% clinician | no trial data cached |
| Kidney transplant rejection | 775 | 344.2 319.4–370.9ROR 368.5 · χ² 221,754 / p <1e-300 | 286.2 EB05 269.7 · IC025 +7.8 3/3 methods agree | Labeled (related wording) related wording | serious n=775 | no trial data cached |
| Complications of transplanted kidney | 349 | 333.1 297.6–373.0ROR 343.4 · χ² 96,984 / p <1e-300 | 276.3 EB05 252.8 · IC025 +7.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=349 | no trial data cached |
| Mastitis bacterial | 10 | 327.6 166.9–643.0ROR 327.8 · χ² 2,478 / p <1e-300 | 181.4 EB05 105.3 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Urinary fistula | 18 | 315.2 191.0–520.3ROR 315.7 · χ² 4,522 / p <1e-300 | 208.7 EB05 139.7 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
| Rhodococcus infection | 23 | 286.5 184.5–444.9ROR 287.1 · χ² 5,388 / p <1e-300 | 204.9 EB05 143.8 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=23 · 100% clinician | no trial data cached |
| Chronic allograft nephropathy | 108 | 285.1 232.9–349.1ROR 287.8 · χ² 26,090 / p <1e-300 | 235.5 EB05 200.5 · IC025 +6.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=108 · 91% clinician | no trial data cached |
| Parvovirus b19 infection | 119 | 280.3 231.2–339.8ROR 283.2 · χ² 28,346 / p <1e-300 | 233.0 EB05 200.0 · IC025 +6.6 3/3 methods agree | Not in label — unassessed | serious n=114 · 97% clinician | no trial data cached |
| Biloma | 19 | 277.7 171.3–450.4ROR 278.2 · χ² 4,292 / p <1e-300 | 193.7 EB05 131.1 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=19 | no trial data cached |
| Donor specific antibody present | 20 | 274.2 171.3–439.1ROR 274.7 · χ² 4,480 / p <1e-300 | 193.8 EB05 132.5 · IC025 +4.4 3/3 methods agree | Lab value / disease marker | serious n=20 | no trial data cached |
| Cerebral ventricle collapse | 10 | 272.1 139.9–529.4ROR 272.4 · χ² 2,112 / p <1e-300 | 163.2 EB05 94.7 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Pancreas transplant rejection | 26 | 262.8 174.1–396.6ROR 263.4 · χ² 5,678 / p <1e-300 | 196.1 EB05 140.6 · IC025 +4.8 3/3 methods agree | Labeled (related wording) related wording | serious n=26 | no trial data cached |
| Herpes simplex hepatitis | 30 | 261.4 178.2–383.4ROR 262.1 · χ² 6,555 / p <1e-300 | 199.1 EB05 146.2 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=30 · 93% clinician | no trial data cached |
| Ureaplasma infection | 51 | 259.2 193.3–347.6ROR 260.4 · χ² 11,218 / p <1e-300 | 208.6 EB05 164.8 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=50 · 100% clinician | no trial data cached |
| Cutaneous mucormycosis | 21 | 239.6 152.0–377.9ROR 240.1 · χ² 4,187 / p <1e-300 | 177.4 EB05 122.4 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=21 · 100% clinician | no trial data cached |
| Capillaritis | 30 | 225.8 154.5–330.1ROR 226.4 · χ² 5,756 / p <1e-300 | 177.8 EB05 130.6 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=30 | no trial data cached |
| Human ehrlichiosis | 22 | 221.1 142.0–344.3ROR 221.5 · χ² 4,091 / p <1e-300 | 168.2 EB05 117.1 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=22 · ♀ 0% (drug 37%) · 100% clinician | no trial data cached |
| Transplant rejection | 858 | 215.4 201.1–230.7ROR 232.4 · χ² 163,089 / p <1e-300 | 191.3 EB05 180.8 · IC025 +7.3 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 113.9 · 91% clinician | no trial data cached |
| Malacoplakia | 42 | 215.3 156.4–296.5ROR 216.1 · χ² 7,798 / p <1e-300 | 176.7 EB05 136.3 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=42 · 95% clinician | no trial data cached |
| Microsporidia infection | 37 | 208.4 148.3–292.9ROR 209.1 · χ² 6,649 / p <1e-300 | 170.3 EB05 129.0 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=37 · 97% clinician | no trial data cached |
| Lymphocele | 69 | 206.5 161.0–264.8ROR 207.7 · χ² 12,453 / p <1e-300 | 176.1 EB05 143.9 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious n=69 | no trial data cached |
| Viral vasculitis | 11 | 204.8 109.7–382.2ROR 205.0 · χ² 1,821 / p <1e-300 | 139.7 EB05 83.3 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Human herpesvirus 8 infection | 60 | 196.5 150.6–256.5ROR 197.5 · χ² 10,330 / p <1e-300 | 167.6 EB05 134.9 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=60 · 98% clinician | no trial data cached |
| Oedematous kidney | 25 | 186.6 123.6–281.6ROR 187.0 · χ² 4,008 / p <1e-300 | 149.8 EB05 106.7 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=25 | no trial data cached |
| Hepatic artery stenosis | 12 | 179.9 99.4–325.7ROR 180.1 · χ² 1,779 / p <1e-300 | 130.1 EB05 79.3 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Graft thrombosis | 24 | 179.1 117.8–272.5ROR 179.5 · χ² 3,700 / p <1e-300 | 144.3 EB05 102.0 · IC025 +4.6 3/3 methods agree | Labeled (related wording) related wording | serious n=24 · ♀ 59% (drug 37%) · 100% clinician | no trial data cached |
| Mycobacterium haemophilum infection | 23 | 178.4 116.3–273.9ROR 178.8 · χ² 3,527 / p <1e-300 | 143.1 EB05 100.5 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=23 · ♀ 0% (drug 37%) | 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) | 1,026 | 2.1 2.0–2.2ROR 2.2 · χ² 633 / p 6e-140 | 2.1 EB05 2.0 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious PRR 2.2 · 97% clinician | no trial data cached |
| Cytomegalovirus infection | 924 | 105.5 99.0–112.5ROR 114.5 · χ² 90,231 / p <1e-300 | 99.4 EB05 94.2 · IC025 +6.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 57.7 · 95% clinician | no trial data cached |
| Drug ineffective (drug did not work) | 903 | 1.2 1.2–1.3ROR 1.2 · χ² 41 / p 7e-11 | 1.2 EB05 1.2 · IC025 +0.2 | Reporting / coding artifact | serious PRR 2.0 · 96% clinician | no trial data cached |
| Transplant rejection | 858 | 215.4 201.1–230.7ROR 232.4 · χ² 163,089 / p <1e-300 | 191.3 EB05 180.8 · IC025 +7.3 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 113.9 · 91% clinician | no trial data cached |
| Kidney transplant rejection | 775 | 344.2 319.4–370.9ROR 368.5 · χ² 221,754 / p <1e-300 | 286.2 EB05 269.7 · IC025 +7.8 3/3 methods agree | Labeled (related wording) related wording | serious n=775 | no trial data cached |
| Pyrexia (fever) | 619 | 3.2 3.0–3.5ROR 3.3 · χ² 954 / p 9e-210 | 3.2 EB05 3.0 · IC025 +1.5 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 2.4 | no trial data cached |
| Product use in unapproved indication | 536 | 3.9 3.6–4.3ROR 4.1 · χ² 1,185 / p 6e-260 | 3.9 EB05 3.7 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 5.1 · 94% clinician | no trial data cached |
| Blood creatinine increased | 517 | 14.3 13.1–15.5ROR 14.9 · χ² 6,340 / p <1e-300 | 14.2 EB05 13.2 · IC025 +3.7 3/3 methods agree | Lab value / disease marker | serious PRR 9.6 | no trial data cached |
| Diarrhoea (diarrhea) | 513 | 1.4 1.3–1.6ROR 1.5 · χ² 68 / p 8e-17 | 1.4 EB05 1.3 · IC025 +0.4 | Labeled — boxed warning exact term | serious PRR 1.5 | no trial data cached |
| Renal impairment | 466 | 10.0 9.2–11.0ROR 10.4 · χ² 3,777 / p <1e-300 | 9.9 EB05 9.2 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 | no trial data cached |
| Anaemia (low red blood cells) | 453 | 4.3 3.9–4.7ROR 4.4 · χ² 1,137 / p 2e-249 | 4.2 EB05 3.9 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.7 · 91% clinician | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 449 | 5.3 4.8–5.8ROR 5.5 · χ² 1,569 / p <1e-300 | 5.3 EB05 4.9 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.1 · 95% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 435 | 28.4 25.9–31.2ROR 29.4 · χ² 11,301 / p <1e-300 | 27.9 EB05 25.8 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 16.5 · 97% clinician | no trial data cached |
| Thrombotic microangiopathy | 434 | 84.1 76.5–92.5ROR 87.3 · χ² 33,963 / p <1e-300 | 80.1 EB05 73.9 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious PRR 47.4 · 94% clinician | no trial data cached |
| Sepsis (blood infection) | 426 | 6.9 6.3–7.5ROR 7.1 · χ² 2,133 / p <1e-300 | 6.8 EB05 6.3 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.1 · 98% clinician | 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.
- Ventricular remodelling — n=28, PRR 1,125.6
- Delayed graft function — n=192, PRR 671.2
- Intracranial infection — n=26, PRR 484.1
- Polyomavirus-associated nephropathy — n=390, PRR 362.1
- Rhodococcus infection — n=23, PRR 286.5
- Parvovirus b19 infection — n=119, PRR 280.3
- Herpes simplex hepatitis — n=30, PRR 261.4
- Ureaplasma infection — n=51, PRR 259.2
- Cutaneous mucormycosis — n=21, PRR 239.6
- Capillaritis — n=30, PRR 225.8
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 Basiliximab?
In FDA FAERS, the most frequently co-reported reaction terms for Basiliximab are cytomegalovirus infection, transplant rejection, kidney transplant rejection, pyrexia, blood creatinine increased, diarrhoea. 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 Basiliximab have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: Only physicians experienced in immunosuppression therapy and management of organ transplantation patients should prescribe Simulect ® (basiliximab). The physician responsible for Simulect administration should have complete information requisite for the follow-up of the patient.
Do FAERS signals prove that Basiliximab 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 1af01887-b69d-444b-91ed-ebfe12784440, effective 20251212; matched on
openfda.generic_name.exact:"BASILIXIMAB") - 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, 1,057 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.