Table 4.
Adverse event manifestation by most commonly reported suspected drug classes.
| Adverse event manifestation | ED visits for ADEs | ED visits for ADEs resulting in hospitalization |
|---|---|---|
| No. of preferred terms N (%) |
No. of preferred terms N (row %) |
|
|
Anticoagulants + Antiplatelets N = 16,054 |
21,230 | 9749 |
| Haemorrhage | 10,719 (50.5) | 4,286 (40.0) |
| Epistaxis | 3,559 (16.76) | 346 (9.7) |
| Gastrointestinal | 3,083 (14.5) | 2,058 (67.0) |
| Genitourinary | 1,221 (5.7) | 429 (35.1) |
| Central nervous system | 1,142 (5.4) | 924 (80.9) |
| Dermatologic | 1,018 (4.8) | 407 (40.0) |
| Pulmonary | 365 (1.7) | 103 (28.2) |
| Ophthalmic | 331 (1.5) | 19 (5.7) |
| Altered international normalized ratio | 1,966 (9.3) | 524 (26.6) |
| Anaemia | 994 (4.7) | 880 (88.5) |
| Unintentional or intentional overdose | 280 (1.3) | 129 (46.1) |
|
Antibacterials N = 12,389 |
22,720 | 4,827 |
| Dermatologic reaction | 9,710 (42.7) | 1,546 (15.9) |
| Urticaria | 3,208 (14.1) | 441 (13.7) |
| Localized or general pruritus | 2,674 (11.8) | 442 (16.5) |
| Erythema | 2,001 (8.8) | 399 (19.9) |
| Rash | 1,827 (8.0) | 264 (14.4) |
| Localized or peripheral edema | 1,484 (6.5) | 324 (21.8) |
| Gastrointestinal disturbance | 2,296 (10.1) | 460 (20.0) |
| Nausea or vomiting | 1,064 (4.7) | 218 (20.5) |
| Abdominal pain | 644 (2.8) | 126 (19.6) |
| Diarrhoea | 588 (2.6) | 116 (19.7) |
| Unspecified hypersensitivity | 1,050 (4.6) | 203 (19.3) |
| Neurological effect | 1,029 (4.5) | 229 (22.2) |
| Respiratory reaction | 844 (3.7) | 233 (27.6) |
| Dyspnea | 684 (3.0) | 193 (28.2) |
| Throat tightness | 160 (0.7) | 40 (25.0) |
| Anaphylaxis | 163 (0.7) | 88 (54.0) |
|
Nonsteroidal anti-inflammatory drugs N = 6,617 |
12,157 | 3,269 |
| Dermatologic reaction | 3,391 (27.9) | 521 (15.4) |
| Urticaria | 1,348 (11.1) | 188 (13.9) |
| Localized or general pruritus | 961 (7.9) | 156 (16.2) |
| Erythema | 552 (4.5) | 97 (17.6) |
| Rash | 530 (4.3) | 80 (15.1) |
| Gastrointestinal disturbance | 1,757 (14.4) | 643 (36.6) |
| Abdominal pain | 813 (6.7) | 228 (28.0) |
| Nausea or vomiting | 500 (4.1) | 147 (29.4) |
| Melena | 181 (1.5) | 136 (75.1) |
| Gastritis | 140 (1.1) | 38 (27.1) |
| Hematemesis | 123 (1.0) | 94 (76.4) |
| Localized or peripheral edema | 1,366 (11.2) | 263 (19.2) |
| Unspecified hypersensitivity | 434 (3.6) | 73 (16.8) |
| Respiratory reaction | 324 (2.7) | 93 (28.7) |
| Abuse or self-harm | 157 (1.3) | 97 (61.8) |
|
Insulin + Oral diabetes agents N = 6,042 |
6,723 | 3,697 |
| Hypoglycaemia (from mild to severe) | 3,006 (44.7) | 1,560 (51.9) |
| Hypoglycaemia-related symptoms | 992 (14.7) | 634 (63.9) |
| Shock, loss of consciousness, or seizures | 514 (7.6) | 347 (67.5) |
| Altered mental status | 191 (2.8) | 124 (64.9) |
| Presyncope or syncope | 152 (2.3) | 74 (48.7) |
| Acidosis | 135 (2.0) | 89 (65.9) |
| Neurological effect | 708 (10.5) | 403 (56.9) |
| Drowsiness | 231 (3.4) | 154 (66.7) |
| Hyperhidrosis | 173 (2.6) | 90 (52.0) |
| Muscular weakness | 170 (2.5) | 84 (49.4) |
| Aphasia, dizziness, or tremor | 134 (2.0) | 75 (56.0) |
| Therapeutic error | 261 (3.9) | 136 (52.1) |
| Gastrointestinal disturbance | 192 (2.8) | 95 (49.5) |
|
Opioid + Non-opioid analgesics N = 5,321 |
11,237 | 3,001 |
| Neurological effect | 2,549 (22.7) | 568 (22.3) |
| Muscular weakness | 615 (5.5) | 111 (18.0) |
| Dizziness | 558 (5.0) | 81 (14.5) |
| Presyncope or syncope | 355 (3.2) | 92 (25.9) |
| Drowsiness | 224 (2.0) | 137 (61.2) |
| Hyperhidrosis | 199 (1.8) | 44 (22.1) |
| Altered mental status | 199 (1.8) | 77 (38.7) |
| Headache | 139 (1.2) | 26 (18.7) |
| Gastrointestinal disturbance | 2,437 (21.7) | 593 (24.3) |
| Nausea or vomiting | 1,730 (15.4) | 377 (21.8) |
| Abdominal pain | 707 (6.3) | 193 (27.3) |
| Constipation | 78 (0.7) | 26 (33.3) |
| Dermatologic reaction | 1,587 (14.1) | 229 (14.4) |
| Urticaria | 592 (5.3) | 72 (12.2) |
| Localized or general pruritus | 479 (4.3) | 75 (15.6) |
| Erythema | 300 (2.7) | 49 (16.3) |
| Rash | 216 (1.9) | 33 (15.3) |
| Localized or peripheral edema | 287 (2.5) | 60 (20.9) |
| Abuse or self-harm | 190 (1.7) | 111 (58.4) |
| Respiratory distress | 189 (1.7) | 52 (27.5) |
| Unspecified hypersensitivity | 154 (1.4) | 19 (12.3) |
|
Sedative or hypnotic agents N = 3,802 |
7,744 | 4,271 |
| Neurological effect | 2,553 (33.0) | 1,607 (62.9) |
| Drowsiness | 1,595 (20.6) | 994 (62.3) |
| Altered mental status or bradyphrenia | 501 (6.5) | 277 (55.3) |
| Loss of consciousness | 158 (2.0) | 110 (69.6) |
| Bradykinesia | 157 (2.0) | 112 (71.3) |
| Muscular weakness | 142 (1.8) | 48 (33.8) |
| Presyncope or syncope | 130 (1.7) | 66 (50.8) |
| Abuse or self-harm | 1,962 (25.3) | 1,273 (64.9) |