Table 1 ADRs of glucocorticoids and synthetic DMARDs in patients with JIA, JSLE and JDM
Medications | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Â | GCs | MTX | LEF | HCQ/CQ | CSA | MMF | AZA | CPA | TOTAL |
Patients on MED | 339 | 398 | 86 | 271 | 92 | 29 | 115 | 75 | 1405 |
Patients on MED with ADR | 151 | 252 | 18 | 30 | 31 | 5 | 17 | 34 | 538 |
Patients on MED with ADR(%) | (44.5) | (63.3) | (20.9) | (11.1) | (33.7) | (17.2) | (14.8) | (45.3) | (38,3) |
Infections | 9 | 20 | – | 2 | 3 | 2 | 5 | 2 | 43 |
Blood and lymphatic system disorders: | |||||||||
 - Persistent anemia | – | 1 | – | – | – | – | – | – | 1 |
 - Leukopenia/Lymphopenia | – | – | – | – | – | – | 6 | 4 | 10 |
 - Pancytopenia/Neutropenia | – | – | – | – | – | – | 1 | – | 1 |
Immune system disorders: | |||||||||
 - MAS | – | – | 1 | – | – | – | – | – | 1 |
Endocrine disorders: | |||||||||
 - Cushing syndrome | 122 | – | – | – | – | – | – | – | 122 |
 - Obesity | 3 | – | – | – | – | – | – | – | 3 |
Metabolism and nutrition disorders: | |||||||||
 -Osteoporosis*/ Low bone mineral density | 51 | 9 | – | – | – | – | – | – | 60 |
Nervous system disorders: | |||||||||
 - Chronic headache/dizziness/discomfort | 8 | 32 | 0 | 1 | – | 2 | – | 4 | 47 |
 - Pseudotumor cerebri | 2 | – | – | – | – | – | – | – | 2 |
 -↓ convulsive threshold | – | – | 1 | – | – | – | – | – | 1 |
Eye disorders: | |||||||||
 - Glaucoma | 2 | – | – | – | – | – | – | – | 2 |
 - Cataract | 19 | – | – | – | – | – | – | – | 19 |
 - Maculopathy | – | – | – | 16 | – | – | – | – | 16 |
 - Blurred vision | – | 1 | – | – | – |  | – | – | 1 |
Cardiovascular disorders: | |||||||||
 - Arterial hypertension | 42 | – | – | – | 3 | – | – | – | 45 |
 - Arrhythmia | – | – | – | 1 | – | – | 1 | – | 2 |
 - Edema | 4 | – | – | – | – | – | – | – | 4 |
Gastrointestinal disorders: | |||||||||
 - Nausea/vomiting | 10 | 199 | 4 | 6 | 17 | – | 2 | 28 | 266 |
 - Epigastric/abdominal pain | 7 | 73 | 2 | 2 | 6 | – | 2 | 1 | 93 |
 - Diarrhea | – | 8 | – | 1 | – | 2 | – | – | 11 |
 - Hyporexia | – | 7 | – | – | 1 | – | – | – | 8 |
 - Constipation | – | 1 | – | – | – | – | – | 1 | 2 |
Hepatobiliary disorders: | |||||||||
 - ↑ liver enzymes | 2 | 68 | 7 | 1 | 1 | – | 5 | 1 | 85 |
 - Hepatic steatosis | 1 | – | – | – | – | – | – | – | 1 |
 - Jaundice | – | – | 1 | 1 | – | – | – | – | 2 |
Oral disorders: | Â | Â | Â | Â | Â | Â | Â | Â | Â |
 - Mouth ulcers | – | 3 | 1 | – | – | – | – | – | 4 |
 - Mucositis | – | 3 | – | – | – | – | – | – | 3 |
 - Gingival hyperplasia | – | – | – | – | 2 | – | – | – | 2 |
Skin and subcutaneous tissue disorders: | |||||||||
 - Striae | 3 | – | – | – | – | – | – | – | 3 |
 - Atopic dermatitis | – | – | – | 1 | – | – | – | – | 1 |
 - Alopecia | – | 5 | 4 | – | – | – | 1 | 10 | 20 |
 - Hypertrichosis | – | – | – | – | 7 | – | – | – | 7 |
 - Urticaria | 4 | 5 | 1 | 2 | 2 | – | – | – | 14 |
Musculoskeletal and connective tissue disorders: | |||||||||
 -↑ muscle enzymes | – | – | – | 1 | – | – | – | – | 1 |
 - Myositis | – | – | – | 1 | – | – | – | – | 1 |
 - Myalgia | 3 | – | – | – | – | – | – | – | 3 |
Renal and urinary disorders: | |||||||||
 -↑ urea | – | – | – | – | 1 | – | – | – | 1 |
General disorders and administration site conditions: | |||||||||
 - Infusion reactions and pain | 3 | 4 | – | – | – | – | – | – | 7 |
Total number of ADRs | 295 | 439 | 22 | 36 | 43 | 6 | 23 | 51 | 915 |