Journal of Rheumatic Diseases

Table. 2.

Adverse events and adverse drug reactions reported in the RA study

Event No. patients or events (%)
AEs ADRs
Patients with AE or ADR (n=740 patients) 94 (12.7) 62 (8.4)
AEs potentially related to tacrolimus* (n=123 AEs) 79 (64.2) NR
AEs leading to discontinuation of tacrolimus (n=123 AEs) 60 (48.8) NR
Severity (n=123 AEs)
Mild 76 (61.8) NR
Moderate 40 (32.5) NR
Severe 7 (5.7) NR
AE or ADR occurring in ≥0.5% of patients (n=740 patients)
Gastrointestinal disorders
Abdominal pain 8 (1.1) 7 (1.0)
Dyspepsia 5 (0.7) 5 (0.7)
Nausea 5 (0.7) 5 (0.7)
Diarrhea 4 (0.5) 4 (0.5)
General disorders and administration site conditions
ESR increased 6 (0.8) 2 (0.3)
Hepatobiliary disorders
SGPT increased 4 (0.5) 3 (0.4)
Investigations
CRP increased 5 (0.7) 3 (0.4)
Renal and urinary disorders
Face edema 4 (0.5) 2 (0.3)
Skin and subcutaneous tissue disorders
Rash 4 (0.5) 4 (0.5)
SAEs (n=740 patients) 5 (0.7) 1 (0.1)
Cardiac disorders
Myocardial infarction 1 (0.1) 0
Gastrointestinal disorders
Gastric ulcer 1 (0.1) 0
General disorders and administration site conditions
Deterioration in physical condition 1 (0.1) 0
Asthenia 1 (0.1) 0
Musculoskeletal and connective tissue disorders
Worsening RA 1 (0.1) 1 (0.1)
Neoplasms
Cervical carcinoma 1 (0.1) 0
Skin and subcutaneous tissue disorders
Pruritus 1 (0.1) 0
Surgical and medical procedures
Surgical intervention 1 (0.1) 0

ADR: adverse drug reaction, AE: adverse event, CRP: C-reactive protein, ESR: erythrocyte sedimentation rate, NR: not reported, RA: rheumatoid arthritis, SAE: serious adverse event, SGPT: serum glutamic-pyruvic transaminase. *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 abdominal pain, indigestion, diarrhea, nausea, constipation, unspecified gastrointestinal disorder, gastroenterocolitis, xerostomia, vomiting, gastric ulcer, elevated erythrocyte sedimentation rate, peripheral edema, asthenia, edema, deterioration in physical condition, pharyngitis, cough, hepatosis, cholelithiasis, elevated C-reactive protein, dizziness, hypoesthesia, headache, muscle pain, infectious arthritis, arthralgia, rash, itchiness, dermatitis, facial edema, panhematopenia, palpitation, high pulse rate, loss of appetite, hyperglycemia, dazzled vision, vaginitis, vaginal bleeding, and residual urine. 123 AEs were reported in 94 patients.

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