Table 4.
Adverse and hypersensitivity reactions identified through voluntary reporting classified by culprit agents and route
| HSR reports (n=436) |
Side effect reaction reports (n=440) |
Total AR reports (n=876) |
p-value* | |
|---|---|---|---|---|
| Drug Culprit Agents | 352 (81) | 332 (75) | 684 (78) | |
| Antibiotics | 115 (26) | 25 (6) | 140 (16) | <0.001 |
| Penicillins | 16 (4) | 5 (1) | 21 (2) | 0.02 |
| Cephalosporins | 30 (7) | 3 (<1) | 33 (4) | <0.001 |
| Vancomycin | 36 (8) | 11 (3) | 47 (5) | <0.001 |
| Fluoroquinolones | 12 (3) | 2 (0.5) | 14 (2) | 0.007 |
| Sulfonamides | 8 (2) | 3 (0.7) | 11 (1) | 0.14 |
| Macrolides | 1 (<1) | 1 (0.2) | 2 (<1) | >0.99 |
| Other antibiotics | 21 (5) | 6 (1) | 27 (3) | 0.003 |
| Contrast agents | 106 (24) | 20 (5) | 126 (14) | <0.001 |
| Opioids | 25 (6) | 64 (15) | 89 (10) | <0.001 |
| Anticoagulants | 5 (1) | 75 (17) | 80 (9) | <0.001 |
| Cardiovascular agents † | 11 (3) | 31 (7) | 42 (5) | 0.002 |
| Chemotherapeutics ‡ | 29 (7) | 10 (2) | 39 (5) | 0.002 |
| General anesthetics | 12 (3) | 20 (5) | 32 (4) | 0.21 |
| Vasopressors § | 2 (<1) | 15 (3) | 17 (2) | 0.002 |
| Insulins | 0 (0) | 13 (3) | 13 (2) | <0.001 |
| Antipsychotics | 5 (1) | 8 (2) | 13 (2) | 0.58 |
| Immunosuppressants | 8 (2) | 4 (<1) | 12 (1) | 0.26 |
| Anxiolytics | 2 (<1) | 9 (2) | 11 (1) | 0.06 |
| Local anesthetics | 3 (<1) | 7 (2) | 10 (1) | 0.34 |
| Anticonvulsants | 1 (<1) | 9 (2) | 10 (1) | 0.02 |
| Antidotes or reversal agents ǁ | 2 (<1) | 7 (2) | 9 (1) | 0.18 |
| Hormones | 4 (1) | 4 (1) | 8 (1) | 0.99 |
| Antiemetics | 3 (<1) | 4 (1) | 7 (1) | >0.99 |
| Electrolyte supplements | 2 (<1) | 4 (1) | 6 (1) | 0.69 |
| Topical agents | 5 (1) | 1 (<1) | 6 (1) | 0.12 |
| Diuretics | 2 (<1) | 4 (1) | 6 (1) | 0.69 |
| Respiratory agents | 1 (<1) | 4 (1) | 5 (1) | 0.37 |
| Acetaminophen | 3 (1) | 2 (<1) | 5 (1) | 0.69 |
| Aspirin | 1 (<1) | 3 (1) | 4 (<1) | 0.62 |
| Non-steroidal anti-inflammatory drugs | 1 (<1) | 3 (1) | 4 (<1) | 0.62 |
| Vaccines | 1 (<1) | 3 (1) | 4 (<1) | 0.62 |
| Antihistamines | 0 (0) | 3 (1) | 3 (<1) | 0.25 |
| Antidepressants | 2 (<1) | 1 (<1) | 3 (<1) | 0.62 |
| Radioactive isotopes | 2 (<1) | 1 (<1) | 3 (<1) | 0.62 |
| Vitamins | 3 (1) | 0 (0) | 3 (<1) | 0.12 |
| Antivirals | 0 (0) | 2 (<1) | 2 (<1) | 0.50 |
| Corticosteroids | 0 (0) | 2 (<1) | 2 (<1) | 0.50 |
| Other anti-inflammatory drugs | 1 (<1) | 1 (<1) | 2 (<1) | 0.99 |
| Gastrointestinal agents | 2 (<1) | 0 (0) | 2 (<1) | 0.25 |
| Other drug agents ¶ | 8 (2) | 10 (2) | 18 (2) | 0.81 |
| Non-Drug Culprit Agents | 84 (19) | 108 (25) | 192 (22) | |
| Blood products | 35 (8) | 29 (7) | 64 (7) | 0.44 |
| Adhesives | 8 (2) | 20 (5) | 28 (3) | 0.03 |
| Devices | 11 (3) | 15 (3) | 26 (3) | 0.55 |
| Tubing, needles, or catheters | 2 (<1) | 17 (4) | 19 (2) | <0.001 |
| Fluid and electrolyte solutions | 4 (1) | 11 (3) | 15 (2) | 0.12 |
| Latex | 12 (3) | 3 (1) | 15 (2) | 0.02 |
| Other non-drug agents** | 4 (1) | 7 (2) | 11 (1) | 0.55 |
| Nutritional supplements | 3 (1) | 6 (1) | 9 (1) | 0.51 |
| Food | 5 (1) | 2 (<1) | 7 (1) | 0.29 |
| Route †† | ||||
| Intravenous | 326 (75) | 247 (56) | 573 (65) | <0.001 |
| Oral/nasogastric | 43 (10) | 58 (13) | 101 (12) | 0.14 |
| Intradermal | 1 (<1) | 28 (6) | 29 (3) | <0.001 |
| Epidural | 3 (1) | 5 (1) | 8 (1) | 0.73 |
| Intramuscular | 2 (<1) | 5 (1) | 7 (1) | 0.45 |
| Transdermal | 0 (0) | 3 (1) | 3 (<1) | 0.25 |
| Other | 5 (1) | 6 (1) | 11 (1) | >0.99 |
| Unknown | 4 (1) | 6 (1) | 10 (1) | 0.75 |
| Non-medication | 52 (12) | 82 (19) | 134 (15) | 0.006 |
Fisher’s exact test.
Includes adenosine, amiodarone, captopril, digoxin, diltiazem, doxazosin, hydralazine, labetalol, lisinopril, metoprolol, milrinone, nicardipine, nifedipine, nitroglycerin, verapamil, and valsartan. Three events were from an ACE-inhibitor.
Includes anastrazole, carboplatin, cetuximab, doxorubicin, erlotinib, etoposide, ifosfamide, mitomycin, ofatumumab, oxaliplatin, paclitaxel, panitumumab, rituximab, taxotere.
Includes dopamine, epinephrine, phenylephrine, norepinephrine, neosynephrine, vasopressin.
Includes acetylcysteine, aminocaproic acid, deferasirox.
Includes acarbose, anti-thymocyte globulin, carbidopa-levodopa, citrate, dexmedetomidine, dextran, edrophonium, EMD experimental medication, glyburide, mivacurium, pramipexole, probenecid, sildenafil, simvastatin, sitagliptin, and tizanidine.
Includes burn from electrophysiology lab, dressing materials, support bandage, support stockings, oxygen equipment, tourniquet, adhesive remover, warming system materials, and chlorine bleach.
Excludes food ARs, all of which were oral/nasogastric.