Adverse drug events in randomised controlled studies
| Formulations | AE total (%) | AE drugs (%) | AE withdrawal (%) | Nausea (%) | Vomiting (%) | Constipation (%) | Fatigue/somnolence (%) | Dizziness (%) | Drowsiness (%) | Reference |
|---|---|---|---|---|---|---|---|---|---|---|
| OTFC Nasal spray | 35 46 | 7 8 | 8 8 | 3 5 | 3 4 | 3 2 | 2 3 | 59 | ||
| FPNS Nasal spray | 60 | |||||||||
| SLF Placebo | 73 | 31 | 23 | 12 | 5 | 5 | 61 | |||
| SLF Placebo | 26 | 3 | 7 | 7 | 7 | 10 | 62 | |||
| SLF IRMS oral | 25 | 0 | 0 | 15 | 5 | 15 | 10 | 63 | ||
| SLF-E Placebo | 4 | 6 | 64 | |||||||
| OTFC IRMS oral | 13 | 13 | 10 | 15 | 7 | 7 | 65 | |||
| OTFC Mor IV | 8 4 | 19 13 | 66 | |||||||
| OTFC Placebo | 14 | 3 | 5 | 8 | 17 | 67 | ||||
| Buccal Placebo | 8 | 22 | 11 | 8 | 12 | 22 | 68 | |||
| Buccal Placebo | 66 | 13 | 6 | 6 | 8 | 11 | 69 | |||
| Buccal Placebo | 83 | 11 | 14 | 27 | 70 | |||||
| Buccal film Placebo | 50 | 5 (drug related) | 4 | 2 | 6 | 5 | 71 | |||
| Nasal spray Placebo | 20 | 5 | 5 | 72 | ||||||
| FPNS IRMS oral | 33 (400 µg dose) 16 | 3 1 | 5 4 | 5 2 | 5 1 | 3 0^ | 73 | |||
| FPNS Placebo | 51 | 9 | 11 | 4 | 8 | 75 |
AE, adverse event; FPNS, fentanyl pectin nasal spray; IRMS, immediate release morphine sulfate; IV, intravenous; Mor, morphine; Nasal, fentanyl nasal spray; OTFC oral transmucosal fentanyl citrate; SLF, sublingual fentanyl (Abstral); SLF-E, sublingual fentanyl ethypharm (Recivit).