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Basiliximab Side Effects

The most commonly reported side effects of basiliximab include off label use, transplant rejection, and cytomegalovirus infection, based on 11,424 FDA adverse event reports from 2004 to 2025. 7.3% of reports found the drug to be ineffective.

Basiliximab side effects

Percentages show how often each reaction appears relative to total reports for basiliximab.

1
Off Label Use8.1%930
2
Drug Ineffective7.3%836
3
Transplant Rejection6.7%771
4
Cytomegalovirus Infection6.7%771
5
Kidney Transplant Rejection5.2%596
6
Product Use In Unapproved Indication4.7%534
7
Pyrexia3.7%428
8
Diarrhoea3.6%414
9
Acute Kidney Injury3.5%395
10
Renal Impairment3.3%382
11
Multiple Organ Dysfunction Syndrome3.3%375
12
Anaemia3.3%373
13
Thrombotic Microangiopathy3.2%362
14
Polyomavirus-associated Nephropathy3.2%361
15
Blood Creatinine Increased3.1%354

These are voluntary reports and do not establish that basiliximab caused these reactions.

Report severity

97.6%Serious11,154 reports
41.7%Hospitalizations4,762 reports
21.2%Fatal2,425 reports

Seriousness is determined by the reporter, not by OpenClaim.

Basiliximab drug interactions

Other drugs that appear in adverse event reports alongside basiliximab. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Tacrolimus63.3%7,236
2
Mycophenolate57.1%6,524
3
Methylprednisolone26.9%3,073
4
Prednisone23.1%2,640
5
Prednisolone17.0%1,946
6
Cyclosporine16.1%1,838
7
Rituximab7.3%839
8
Ganciclovir5.9%670
9
Everolimus4.9%555
10
Azathioprine3.7%421
11
Sirolimus3.1%349
12
Cyclophosphamide2.7%313
13
Methotrexate2.4%275
14
Sulfamethoxazole1.7%191
15
Belatacept1.6%182

Taken alongside

1
Mycophenolate15.8%1,810
2
Methylprednisolone14.1%1,612
3
Tacrolimus12.7%1,455
4
Ganciclovir11.0%1,255
5
Prednisone8.4%958
6
Prednisolone6.6%756
7
Sulfamethoxazole6.6%749
8
Trimethoprim4.5%519
9
Cyclosporine4.2%481
10
Furosemide3.9%443
11
Amlodipine3.3%380
12
Insulin3.3%379
13
Aspirin2.9%329
14
Fluconazole2.9%329
15
Amoxicillin2.8%320

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports basiliximab side effects

31.7% of basiliximab adverse event reports involve female patients and 54.0% involve male patients. The largest age group is adult at 73%. These figures reflect who reports side effects, not underlying risk.

Sex

Female31.7%
Male54.0%
Unknown14.2%

Age group

< 22.0%
2–117.0%
12–174.8%
18–6472.5%
65+13.7%

What is basiliximab used for

Conditions and purposes for which patients were taking basiliximab when the adverse event was reported.

Abo IncompatibilityAcquired Immunodeficiency SyndromeAcute Graft Versus Host DiseaseAcute Graft Versus Host Disease In IntestineAcute Graft Versus Host Disease In SkinAcute Myeloid LeukaemiaAllogenic Stem Cell TransplantationAntiviral ProphylaxisAntiviral TreatmentAutoimmune DisorderAcute Graft Versus Host DiseaseAcute Graft Versus Host Disease In IntestineAcute Graft Versus Host Disease In LiverAcute Graft Versus Host Disease In SkinAcute Kidney Injury

Showing 15 of 212 indications

Basiliximab brand names and reporting trend

Basiliximab is sold under the brand name Simulect.

Brand names

Simulect11,293

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking basiliximab with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.