Journal of Rheumatic Diseases

Table. 4.

Adverse events and adverse drug reactions reported in the MG study

Event No. patients or events (%)
AEs ADRs
Patients with AE or ADR (n=104 patients) 31 (29.8) 21 (20.2)
AEs considered potentially related to tacrolimus* (n=44 AEs) 25 (56.8) NR
AEs leading to discontinuation of tacrolimus (n=44 AEs) 14 (31.8) NR
Severity (n=44 AEs)
Mild 30 (68.2) NR
Moderate 11 (25.0) NR
Severe 3 (6.8) NR
All AEs (n=104 patients)
Blood and lymphatic system disorders
Anemia 1 (1.0) 0
Cardiac disorders
Cardiac arrest 1 (1.0) 1 (1.0)
Eye disorders
Retinopathy 1 (1.0) 0
Gastrointestinal disorders
Diarrhea 6 (5.8) 6 (5.8)
Heartburn 2 (1.9) 1 (1.0)
Dyspepsia 2 (1.9) 2 (1.9)
Epigastric discomfort 1 (1.0) 1 (1.0)
Dysphagia 1 (1.0) 0
Nausea 1 (1.0) 1 (1.0)
Bowel motility disorder 1 (1.0) 1 (1.0)
General disorders and administration site conditions
Chest pain 1 (1.0) 0
Leg pain 1 (1.0) 0
Lumbar pain 1 (1.0) 0
Infections and infestations
Herpes zoster 2 (1.9) 2 (1.9)
Cytomegalovirus infection 1 (1.0) 1 (1.0)
Metabolism and nutrition disorders
Hypercholesterolemia 1 (1.0) 0
Hyperglycemia 1 (1.0) 1 (1.0)
Diabetes mellitus 1 (1.0) 1 (1.0)
Weight decrease 1 (1.0) 0
Musculoskeletal and connective tissue disorders
Myalgia 1 (1.0) 0
Neoplasms
Uterine leiomyoma 1 (1.0) 0
Nervous system disorders
Headache 2 (1.9) 2 (1.9)
Hoarseness 1 (1.0) 0
Renal and urinary disorders
Urinary tract infection 1 (1.0) 0
Urinary incontinence 1 (1.0) 0
Respiratory, thoracic and mediastinal disorders
Common cold 1 (1.0) 0
Dyspnea 1 (1.0) 0
Skin and subcutaneous tissue disorders
Alopecia 5 (4.8) 5 (4.8)
Increased sweating 1 (1.0) 0
Hairiness 1 (1.0) 0
SAEs (n=104 patients) 9 (8.7) 4 (3.9)
Cardiac disorders
Cardiac arrest 1 (1.0) 1 (1.0)
Gastrointestinal disorders
Dysphagia 1 (1.0) 0
General disorders and administration site conditions
Chest pain 1 (1.0) 0
Leg pain 1 (1.0) 0
Lumbar pain 1 (1.0) 0
Infections and infestations
Cytomegalovirus infection 1 (1.0) 1 (1.0)
Metabolism and nutrition disorders
Hyperglycemia 1 (1.0) 1 (1.0)
Diabetes mellitus 1 (1.0) 1 (1.0)
Neoplasms
Uterine leiomyoma 1 (1.0) 0

ADR: adverse drug reaction, AE: adverse event, MG: myasthenia gravis, NR: not reported, SAE: serious adverse event. *Includes AEs classified as certainly, probably/likely, or possibly related to tacrolimus, or those recorded as conditional/unclassified or not assessable/unclassifiable. AEs leading to discontinuation were: diarrhea, heartburn, dyspepsia, nausea, alopecia, hyperglycemia, herpes zoster, headache, and cardiac arrest. All AEs reported are shown. 44 AEs were reported in 31 patients.

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