TABLE 5.
ADR 20 most frequent types among serious cases, n = 3,843 a .
| Adverse reaction type | n (%) |
|---|---|
| Hemorrhage | 1,529 (40) |
| Renal failure | 324 (8) |
| Hemorrhage (biological) b | 224 (6) |
| Pharmacokinetic interaction c | 193 (5) |
| Arrhythmia | 144 (4) |
| Fall | 123 (3) |
| Hematologic disorder | 120 (3) |
| Anticholinergic syndrome | 117 (3) |
| Hyperkaliemia | 105 (3) |
| Central nervous system depression | 99 (3) |
| Digestive system disorder | 97 (3) |
| Neurological disorder | 96 (3) |
| Hydroelectrolytic disorders | 96 (3) |
| Drug ineffective | 82 (2) |
| Seizure | 78 (2) |
| Weaning | 56 (1) |
| Rhabdomyolysis | 56 (1) |
| Hepatitis | 43 (1) |
| Death and cardiac arrest | 41 (1) |
| Neuroleptic malignant syndrome | 37 (1) |
a
Some cases contained ADRs belonging to different types.
b
ADRs corresponding to MedDRA SMQ: "Hemorrhage laboratory terms" (a change in INR, PTT, or clotting factors). The list of corresponding PTs can be viewed at: http://bioportal.bioontology.org/ontologies/MEDDRA?p=classes&conceptid=20000040
c
Increase or decrease in plasma concentration.