Journal of Rheumatic Diseases

Table. 3.

Adverse events and adverse drug reactions reported in the LN study

Event No. patients or events (%)
AEs ADRs
Patients with AE or ADR (n=307 patients) 64 (20.9) 30 (9.8)
AEs considered potentially related to tacrolimus* (n=98 AEs) 37 (37.8) NR
AEs leading to discontinuation of tacrolimus (n=98 AEs) 29 (29.6) NR
Severity (n=98 AEs)
Mild 68 (69.4) NR
Moderate 21 (21.4) NR
Severe 9 (9.2) NR
AEs occurring in ≥0.5% of patients (n=307 patients)
Gastrointestinal disorders
Nausea 5 (1.6) 2 (0.7)
Diarrhea 4 (1.3) 1 (0.3)
Dyspepsia 4 (1.3) 1 (0.3)
Abdominal pain 2 (0.7) 1 (0.3)
General disorders and administration site conditions
Edema 2 (0.7) 0
Leg pain 2 (0.7) 0
Fever 2 (0.7) 1 (0.3)
Cellulitis 2 (0.7) 1 (0.3)
Infections and infestations
Herpes zoster 2 (0.7) 1 (0.3)
Metabolism and nutrition disorders
Hypercholesterolemia 3 (1.0) 0
Nervous system disorders
Headache 3 (1.0) 2 (0.7)
Seizure 2 (0.7) 1 (0.3)
Renal and urinary disorders
Albuminuria 3 (1.0) 2 (0.7)
Azotemia 3 (1.0) 2 (0.7)
Decreased creatinine clearance 3 (1.0) 3 (1.0)
Respiratory, thoracic and mediastinal disorders
Pharyngitis 7 (2.3) 4 (1.3)
Upper respiratory tract infection 2 (0.7) 0
Vascular disorders
Hypertension 2 (0.7) 2 (0.7)
SAEs (n=307 patients) 22 (7.2) 9 (2.9)
Blood and lymphatic system disorders
Thrombocytopenia 1 (0.3) 1 (0.3)
Gastrointestinal disorders
Abdominal pain 2 (0.7) 1 (0.3)
Diarrhea 1 (0.3) 0
Nausea 1 (0.3) 0
Gastroenteritis 1 (0.3) 0
Appendicitis 1 (0.3) 0
General disorders and administration site conditions
Leg pain 1 (0.3) 0
Edema 1 (0.3) 0
Fever 1 (0.3) 0
Pain 1 (0.3) 0
Cellulitis 1 (0.3) 1 (0.3)
Hepatobiliary disorders
Cholecystitis 1 (0.3) 0
Infections and infestations
Herpes zoster 2 (0.7) 1 (0.3)
Infection 1 (0.3) 1 (0.3)
Varicella 1 (0.3) 0
Metabolism and nutrition disorders
Hyperglycemia 1 (0.3) 1 (0.3)
Aggravated diabetes mellitus 1 (0.3) 0
Increased alkaline phosphatase 1 (0.3) 0
Musculoskeletal and connective tissue disorders
Aggravated SLE 1 (0.3) 0
Nervous system disorders
Seizure 1 (0.3) 0
Psychiatric disorders
Insomnia 1 (0.3) 0
Renal and urinary disorders
Azotemia 2 (0.7) 1 (0.3)
Cystitis 1 (0.3) 0
Albuminuria 1 (0.3) 1 (0.3)
Decreased creatinine clearance 1 (0.3) 1 (0.3)
Respiratory, thoracic and mediastinal disorders
Pneumonia 1 (0.3) 1 (0.3)

ADR: adverse drug reaction, AE: adverse event, LN: lupus nephritis, NR: not reported, SAE: serious adverse event, SLE: systemic lupus erythematosus.*Includes AEs classified as certainly, probably/likely, or possibly related to tacrolimus, or thoserecorded as conditional/unclassified or not assessable/unclassifiable. AEs leading to discontinuation were: nausea, diarrhea, abdominal pain, vomiting, albuminuria, azotemia, decreased creatinine clearance, hematuria, pneumonia, fever, pain, hyperglycemia, headache, dizziness, eczema, alopecia, unspecified infection, auto-antibody response, cellulitis, hypertension, and thrombocytopenia. 98 AEs were reported in 64 patients.

J Rheum Dis 2021;28:202~215 https://doi.org/10.4078/jrd.2021.28.4.202
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