ADEs a | No. of Cases (%) | No. of preventable Cases (%) | Most frequent drug classes (No. of Cases)b |
---|---|---|---|
Mild allergic reactionc | 214 (37.2) | 1 (1.4) | Antibiotics (116), anti-inflammatory/antirheumatic drugs (55) |
Moderate to severe allergic reactiond | 154 (26.8) | 6 (8.5) | Antibiotics (64), anti-inflammatory/antirheumatic drugs (52) |
Moderate to severe neurological effecte | 30 (5.2) | 12 (16.9) | Psycholeptics (12), antiepileptics (7) |
Mild neurological effectf | 29 (5.0) | 10 (14.1) | Psycholeptics (8), analgesics (6) |
Gastrointestinal disturbanceg | 27 (4.7) | 9 (12.7) | Anti-inflammatory/antirheumatic drugs (10), hRAS-acting agents (3), antibiotics (3), antineoplastic agents (3) |
Haemorrhage | 21 (3.7) | 4 (5.6) | Â |
- Major haemorrhage (i.e. gastrointestinal or pulmonary haemorrhage) | 4 (0.7) | 1 (1.4) | Antithrombotics (2), RAS-acting agents (1), antianemic preparations (1), beta-blocking agents (1), lipid modifying agents (1), anti-gout preparations (1) |
- Minor bleeding (e.g. epistaxis, gingival or conjunctival haemorrhage) | 17 (3.0) | 3 (4.2) | Antithrombotics (15), lipid modifying agents (1), anti-inflammatory/antirheumatic drugs (1) |
Rhythm disorder (e.g. bradycardia, tachycardia, palpitations, atrial fibrillation) | 16 (2.9) | 3 (4.2) | Cardiac therapy (8), RAS-acting agents (4) |
Blood pressure disorder (i.e. hypotension, hypertension) | 12 (2.1) | 3 (4.2) | Antibiotics (3), cardiac therapy (3), psycholeptics (2), antihypertensives (2), beta blocking agents (2) |
Suicide attempt | 12 (2.1) | 12 (16.9) | Psycholeptics (7), antiepileptics (3), psychoanaleptics (2) |
Respiratory distress (e.g. respiratory depression, dyspnoea, desaturation) | 7 (1.2) | 2 (2.8) | Psycholeptics (4), antibiotics (2) |
Hematologic disorder (e.g. anemia, leucopenia, thrombocytopenia) | 7 (1.2) | – | Antithrombotics (2), psychoanaleptics (2) |
Hyperglycemia | 7 (1.2) | 3 (4.2) | Anti-diabetes agents (3), corticosteroids for systemic use (2) |
Acute renal failure | 5 (0.9) | – | Diuretics (3), anti-diabetes agents (2) |
Behavioural psychiatric disorder (e.g. anxiety, stupor, aggression) | 4 (0.7) | 3 (4.2) | Anti-inflammatory/antirheumatic drugs (1), analgesics (1), psycholeptics (1), anti-Parkinson (1) |
Rhabdomyolysis | 4 (0.7) | – | Antiepileptics (2), RAS-acting agents (1), lipid modifying agents (1), psychoanaleptics (1) |
Subcutaneous abscess | 4 (0.7) | – | Antibiotics (4) |
Pancreatitis | 3 (0.5) | 1 (1.4) | Antiacid drugs (1), antibiotics (1), anti-inflammatory/antirheumatic drugs (1), calcium channel blockers (1), corticosteroids for systemic use (1), immunosuppressants (1), drugs for bone diseases (1) |
Hypoglycaemia | 3 (0.5) | 2 (2.8) | Anti-diabetes agents (3) |
Other effecti | 16 (2.9) | – | RAS-acting agents (4), psycholeptics (3), diuretics (2), anti-diabetes agents (2), psychoanaleptics (2) |