Table 4.
Adverse effects in dental pain
| Adverse effects with active | Adverse effects with placebo | ||||||
| Number of trials | Drug and dose | Number | Percent | Number | Percent | Relative risk (95% CI) | NNH/NNTp (95% CI) |
| Any adverse event | |||||||
| 13 | Rofecoxib 50 mg | 459/1330 | 35 | 231/570 | 41 | 0.9 (0.8 to 1.0) | nc |
| 6 | Ibuprofen 400 mg | 102/303 | 34 | 122/298 | 41 | 0.8 (0.7 to 1.0) | nc |
| 1 | Diclofenac 50 mg* | 72/121 | 60 | 31/63 | 41 | 1.2 (0.9 to 1.6) | nc |
| 6 | Ibuprofen 400 mg | 102/303 | 34 | 122/298 | 41 | 0.8 (0.7 to 1.0) | nc |
| 2 | Naproxen 550 mg | 27/88 | 31 | 25/87 | 29 | 1.1 (0.7 to 1.7) | nc |
| 2 | Oxycodone 5 mg + paracetamol 325 mg | 116/180 | 64 | 29/61 | 48 | 1.4 (1.02 to 1.8) | 5.9 (3.2 to 39) |
| 2 | paracetamol 600 mg + codeine 60 mg | 146/360 | 41 | 24/61 | 39 | 1.0 (0.7 to 1.4) | nc |
| Post-extraction alveolitis | |||||||
| 13 | Rofecoxib 50 mg | 179/1330 | 13 | 52/570 | 9 | 1.5 (1.1 to 2.1) | 24 (14 to 80) |
| 6 | Ibuprofen 400 mg | 23/304 | 8 | 31/298 | 10 | 0.7 (0.4 to 1.2) | nc |
| 1 | Diclofenac 50 mg* | 9/180 | 5 | 3/63 | 5 | 1.0 (0.3 to 3.8) | nc |
| 6 | Ibuprofen 400 mg | 23/304 | 8 | 31/298 | 10 | 0.7 (0.4 to 1.2) | nc |
| 2 | Naproxen 550 mg | 13/88 | 15 | 8/87 | 10 | 1.6 (0.7 to 3.4) | nc |
| 2 | Oxycodone 5 mg + paracetamol 325 mg | 20/180 | 11 | 7/61 | 11 | 0.9 (0.4 to 2.2) | nc |
| 2 | Paracetamol 600 mg + codeine 60 mg | 27/360 | 8 | 3/61 | 6 | 1.3 (0.5 to 3.9) | nc |
| Dizziness | |||||||
| 13 | Rofecoxib 50 mg | 30/1330 | 2 | 25/570 | 5 | 0.5 (0.3 to 0.9) | 43 (24 to 253) |
| 6 | Ibuprofen 400 mg | 7/304 | 3 | 13/298 | 5 | 0.6 (0.3 to 1.4) | nc |
| 1 | Diclofenac 50 mg* | 9/180 | 8 | 5/63 | 8 | 0.6 (0.2 to 1.8) | nc |
| 6 | Ibuprofen 400 mg | 7/304 | 3 | 13/298 | 5 | 0.6 (0.3 to 1.4) | nc |
| 2 | Naproxen 550 mg | 1/88 | 2 | 1/87 | 1 | 0.9 (0.2 to 9.3) | nc |
| 2 | Oxycodone 5 mg + paracetamol 325 mg | 44/180 | 24 | 6/61 | 10 | 2.5 (1.1 to 5.6) | 6.9 (4.1 to 21) |
| 2 | Paracetamol 600 mg + codeine 60 mg | 19/360 | 1 | 1/61 | 2 | 3.3 (0.5 to 24) | nc |
| Drowsiness | |||||||
| 13 | Rofecoxib 50 mg | 8/1330 | 0.6 | 1/570 | 0.6 | 0.9 (0.3 to 3.1) | nc |
| 6 | Ibuprofen 400 mg | 1/304 | 0.7 | 0/298 | 0.5 | 1.3 (0.2 to 11) | nc |
| 1 | Diclofenac 50 mg* | 5/180 | 3 | 0/63 | 0 | 3.5 (0.2 to 64) | nc |
| 6 | Ibuprofen 400 mg | 1/304 | 0.7 | 0/298 | 0.5 | 1.3 (0.2 to 11) | nc |
| 2 | Naproxen 550 mg | 0/88 | 0 | 0/87 | 0 | 0.9 (0.0 to 16) | nc |
| 2 | Oxycodone 5 mg + paracetamol 325 mg | 6/180 | 4 | 1/61 | 2 | 2.2 (0.3 to 18) | nc |
| 2 | Paracetamol 600 mg + codeine 60 mg | 7/360 | 2 | 1/61 | 2 | 1.2 (0.2 to 9.2) | nc |
| Nausea | |||||||
| 13 | Rofecoxib 50 mg | 112/1330 | 8 | 80/570 | 14 | 0.6 (0.5 to 0.8) | 18 (11 to 41) |
| 6 | Ibuprofen 400 mg | 38/304 | 12 | 51/298 | 17 | 0.7 (0.5 to 1.08) | nc |
| 1 | Diclofenac 50 mg* | 21/180 | 12 | 10/63 | 16 | 0.7 (0.4 to 1.5) | nc |
| 6 | Ibuprofen 400 mg | 38/304 | 12 | 51/298 | 17 | 0.7 (0.5 to 1.08) | nc |
| 2 | Naproxen 550 mg | 4/88 | 5 | 3/87 | 3 | 1.3 (0.3 to 5.7) | nc |
| 2 | Oxycodone 5 mg + paracetamol 325 mg | 61/180 | 34 | 10/61 | 17 | 2.0 (1.1 to 3.5) | 6.0 (3.5 to 19) |
| 2 | Paracetamol 600 mg + codeine 60 mg | 70/360 | 19 | 6/61 | 10 | 2.0 (0.9 to 4.4) | 10 (5.5 to 92) |
| Vomiting | |||||||
| 13 | Rofecoxib 50 mg | 51/1330 | 4 | 51/570 | 9 | 0.4 (0.3 to 0.6) | 19 (13 to 38) |
| 6 | Ibuprofen 400 mg | 25/304 | 8 | 36/298 | 12 | 0.7 (0.4 to 1.1) | nc |
| 1 | Diclofenac 50 mg* | 6/180 | 3 | 7/63 | 11 | 0.3 (0.1 to 1.0) | nc |
| 2 | Naproxen 550 mg | 1/88 | 2 | 1/87 | 2 | 0.9 (0.1 to 9.3) | nc |
| 2 | Oxycodone 5 mg + paracetamol 325 mg | 35/180 | 19 | 3/61 | 6 | 3.4 (1.2 to 9.8) | 7.2 (4.6 to 18) |
| 2 | Paracetamol 600 mg + codeine 60 mg | 58/360 | 16 | 4/61 | 7 | 2.46 (0.9 to 6.5) | 10 (5.9 to 44) |
*NB: Diclofenac was taken every eight hours during the study. Naproxen was given as the sodium salt Bold type: NNTp to prevent one event (significantly fewer events occurred with rofecoxib 50 mg compared with placebo