Options: Hide MedDRA Preferred Terms
| MedDRA Preferred Term | Side effect | Data for drug | Placebo | Labels | 
|---|---|---|---|---|
| 1 | ||||
| Pain | Pain | 7.09% - 8.31% | x | |
| Aphthous stomatitis | Aphthous stomatitis | 1.22% - 6.19% | x | |
| Stomatitis | Mouth ulceration | 1.22% - 6.19% | x | |
| Mouth ulceration | Mouth ulceration | 1.22% - 6.19% | x | |
| Headache | Headache | 0% - 1.47% | x | |
| Paraesthesia | Paraesthesia | 0.733% - 1.33% | x | |
| Oropharyngeal discomfort | Throat sore | 0.244% - 1.03% | x | |
| Oropharyngeal pain | Throat sore | 0.244% - 1.03% | x | |
| Nausea | Nausea | 0% - 1.66% | x | |
| Liver function test abnormal | Liver function test abnormal | 0.489% | x | |
| Gastrointestinal disorder | Gastrointestinal disorder | x | ||
| Nervous system disorder | Nervous system disorder | x | ||
Information about indications was extracted from the indications and usage sections of the labels.
| Indication | Labels | |||
|---|---|---|---|---|
| Aphthous stomatitis | x | |||
standard – alternative
| 100% | ||
| 75% | ||
| 50% | ||
| 10% | ||
| frequent (1% to 100%) | ||
| infrequent (0.1% to 1%) | ||
| rare (<0.1%) | ||
| postmarketing | ||
| 0% | ||
| no frequency information | ||
| not found on label |