Table 1.
Characteristics of patients and ADRs due to NSAIDs from 2015 to 2019 (N=32,857)
| Characteristics | N | (%) | ||
| Sex | ||||
| Male | 11,679 | (35.5) | ||
| Female | 21,126 | (64.3) | ||
| NA | 52 | (0.2) | ||
| Age (years) | ||||
| 0–9 | 1,719 | (5.2) | ||
| 10–19 | 2,397 | (7.3) | ||
| 20–39 | 9,113 | (27.7) | ||
| 40–59 | 10,056 | (30.6) | ||
| ≥ 60 | 4,418 | (13.5) | ||
| NA | 5,154 | (15.7) | ||
| History of drug allergy | ||||
| No | 16,365 | (49.8) | ||
| Yes | 6,740 | (20.5) | ||
| NA | 9,752 | (29.7) | ||
| Underlying disease | ||||
| No | 15,196 | (46.3) | ||
| Yes | 3,751 | (11.4) | ||
| NA | 13,910 | (42.3) | ||
| Seriousness of ADR | ||||
| Seriousa | 6,801 | (20.7) | ||
| Non-serious | 23,827 | (72.5) | ||
| NA | 2,229 | (6.8) | ||
| Causality assessment | ||||
| Certain | 1,453 | (4.4) | ||
| Probable | 21,807 | (66.4) | ||
| Possible | 9,597 | (29.2) | ||
| Sender source | ||||
| Hospital/clinic | 32,776 | (99.8) | ||
| Pharmacy | 51 | (0.2) | ||
| Pharmaceutical company | 27 | (0.0) | ||
| Otherb | 3 | (0.0) | ||
| Sender region | ||||
| Bangkok | 5,495 | (16.8) | ||
| Province | 27,351 | (83.2) | ||
| NA | 11 | (0.0) | ||
| Period of having ADR (days)c | ||||
| Median (IQR) | 3.5 | (13.8) | ||
| Outcomed | ||||
| Recovered without sequelae | 20,593 | (62.7) | ||
| Recovered with sequelae | 1,887 | (5.7) | ||
| Recovering | 3,109 | (9.5) | ||
| Not recovered | 5,420 | (16.5) | ||
| Died | 20 | (0.1) | ||
| Possibly related to the event | 8 | |||
| Unrelated to the event | 12 | |||
| Unknown | 1,828 | (5.6) | ||
ADR: adverse drug reaction
NA: not available
IQR: interquartile range
aSerious means life-threatening, requiring hospitalization or extension of hospital stay, resulting in death or persistent or significant disability.
bOther includes Thai Food and Drug Administration and governmental public health offices.
c7,962 reports were included.
dOutcome of the event at the last observation.