BASILIXIMAB

N/A

Manufactured by Novartis Pharmaceuticals Corporation

23,408 FDA adverse event reports analyzed

Last updated: 2026-04-14

About BASILIXIMAB

BASILIXIMAB is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Novartis Pharmaceuticals Corporation. The most commonly reported adverse reactions for BASILIXIMAB include OFF LABEL USE, CYTOMEGALOVIRUS INFECTION, DRUG INEFFECTIVE, TRANSPLANT REJECTION, KIDNEY TRANSPLANT REJECTION. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for BASILIXIMAB.

Top Adverse Reactions

OFF LABEL USE937 reports
CYTOMEGALOVIRUS INFECTION888 reports
DRUG INEFFECTIVE863 reports
TRANSPLANT REJECTION835 reports
KIDNEY TRANSPLANT REJECTION768 reports
PYREXIA604 reports
PRODUCT USE IN UNAPPROVED INDICATION534 reports
BLOOD CREATININE INCREASED507 reports
DIARRHOEA488 reports
RENAL IMPAIRMENT456 reports
ANAEMIA424 reports
SEPSIS413 reports
ACUTE KIDNEY INJURY395 reports
THROMBOTIC MICROANGIOPATHY392 reports
PNEUMONIA387 reports
POLYOMAVIRUS ASSOCIATED NEPHROPATHY376 reports
MULTIPLE ORGAN DYSFUNCTION SYNDROME375 reports
URINARY TRACT INFECTION368 reports
LEUKOPENIA366 reports
NEUTROPENIA349 reports
COMPLICATIONS OF TRANSPLANTED KIDNEY348 reports
TOXICITY TO VARIOUS AGENTS329 reports
RESPIRATORY FAILURE317 reports
THROMBOCYTOPENIA291 reports
BK VIRUS INFECTION290 reports
CYTOMEGALOVIRUS VIRAEMIA284 reports
PANCYTOPENIA261 reports
RENAL TUBULAR NECROSIS260 reports
POST TRANSPLANT LYMPHOPROLIFERATIVE DISORDER246 reports
DRUG INTERACTION234 reports
SEPTIC SHOCK233 reports
RENAL FAILURE222 reports
ASPERGILLUS INFECTION218 reports
NEPHROPATHY TOXIC215 reports
TUBULOINTERSTITIAL NEPHRITIS210 reports
HYPERTENSION207 reports
ABDOMINAL PAIN198 reports
EPSTEIN BARR VIRUS INFECTION195 reports
VOMITING193 reports
COVID 19192 reports
HAEMOGLOBIN DECREASED192 reports
INFECTION190 reports
DELAYED GRAFT FUNCTION189 reports
GRAFT VERSUS HOST DISEASE187 reports
MUCORMYCOSIS185 reports
BRONCHOPULMONARY ASPERGILLOSIS180 reports
KAPOSI^S SARCOMA178 reports
DIABETES MELLITUS174 reports
NAUSEA172 reports
IMMUNOSUPPRESSANT DRUG LEVEL INCREASED169 reports
DYSPNOEA167 reports
HYPOTENSION165 reports
PLEURAL EFFUSION164 reports
DRUG RESISTANCE153 reports
ENTEROCOCCAL INFECTION148 reports
DEATH145 reports
PROTEINURIA145 reports
TRANSPLANT DYSFUNCTION145 reports
CANDIDA INFECTION141 reports
POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME141 reports
PSEUDOMONAS INFECTION139 reports
ACUTE RESPIRATORY DISTRESS SYNDROME133 reports
PNEUMOCYSTIS JIROVECII PNEUMONIA130 reports
LYMPHOCYTE COUNT DECREASED129 reports
CONDITION AGGRAVATED124 reports
BLOOD UREA INCREASED123 reports
FOCAL SEGMENTAL GLOMERULOSCLEROSIS122 reports
ESCHERICHIA INFECTION118 reports
LIVER TRANSPLANT REJECTION117 reports
MULTI ORGAN FAILURE117 reports
ASCITES116 reports
BLOOD GLUCOSE INCREASED116 reports
CARDIAC ARREST114 reports
DISSEMINATED INTRAVASCULAR COAGULATION114 reports
BACTERIAL INFECTION112 reports
PARVOVIRUS B19 INFECTION112 reports
CYTOMEGALOVIRUS INFECTION REACTIVATION111 reports
FUNGAL INFECTION111 reports
DISEASE RECURRENCE110 reports
HYDRONEPHROSIS110 reports
OEDEMA PERIPHERAL110 reports
HYPERKALAEMIA109 reports
KLEBSIELLA INFECTION108 reports
ANURIA107 reports
CHRONIC ALLOGRAFT NEPHROPATHY106 reports
HEADACHE106 reports
TRANSPLANT FAILURE106 reports
PLATELET COUNT DECREASED104 reports
PRODUCT USE ISSUE103 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION101 reports
URINE OUTPUT DECREASED101 reports
HEPATIC FAILURE100 reports
WHITE BLOOD CELL COUNT INCREASED98 reports
ASTHENIA97 reports
HAEMATURIA97 reports
KIDNEY FIBROSIS97 reports
STRONGYLOIDIASIS97 reports
MALAISE95 reports
NEUTROPHIL COUNT INCREASED95 reports
SHOCK95 reports

Report Outcomes

Out of 11,331 classified reports for BASILIXIMAB:

Serious 97.6%Non-Serious 2.4%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Male6,117 (62.4%)
Female3,596 (36.7%)
Unknown92 (0.9%)

Reports by Age

Age 63293 reports
Age 58229 reports
Age 65222 reports
Age 57219 reports
Age 56213 reports
Age 50204 reports
Age 53199 reports
Age 64196 reports
Age 55195 reports
Age 59194 reports
Age 61184 reports
Age 47180 reports
Age 60178 reports
Age 48177 reports
Age 51177 reports
Age 44173 reports
Age 52172 reports
Age 49163 reports
Age 62163 reports
Age 54160 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with BASILIXIMAB?

This profile reflects 23,408 FDA FAERS reports that mention BASILIXIMAB. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for BASILIXIMAB?

Frequently reported terms in FAERS include OFF LABEL USE, CYTOMEGALOVIRUS INFECTION, DRUG INEFFECTIVE, TRANSPLANT REJECTION, KIDNEY TRANSPLANT REJECTION, PYREXIA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures BASILIXIMAB?

Labeling and FAERS entries often list Novartis Pharmaceuticals Corporation in connection with BASILIXIMAB. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.