Table 3.
Ranking of the adverse drug reactions with the highest reporting odds ratio values
| ADR (PTName) | ROR | Number of reports | Lower limit ROR | Upper limit ROR | Described in SmPC |
|---|---|---|---|---|---|
| Nasal septum perforation | 463.23 | 14 | 186.65 | 1149.67 | Yes |
| Nasal mucosal disorder | 104.52 | 5 | 36.26 | 301.27 | Yes |
| Hyposmia | 90.77 | 11 | 45.09 | 182.72 | Yes |
| Nasal discomfort | 56.02 | 24 | 35.76 | 87.77 | Yes |
| Anosmia | 49.14 | 57 | 36.75 | 65.71 | Yes |
| Nasal disorder | 45.92 | 3 | 13.28 | 158.80 | Yes |
| Nasal crusting | 45.92 | 3 | 13.28 | 158.80 | Yes |
| Nasal pruritus | 38.26 | 3 | 11.26 | 130.06 | Yes |
| Chorioretinopathy | 38.26 | 3 | 11.26 | 130.06 | Yes |
| Rhinalgia | 31.31 | 3 | 9.36 | 104.73 | Yes |
| Epistaxis | 23.76 | 124 | 19.59 | 28.82 | Yes |
| Cushing's syndrome | 22.11 | 5 | 8.82 | 55.44 | Yes |
| Hypogeusia | 21.90 | 11 | 11.77 | 40.75 | Yes |
| Parosmia | 21.55 | 27 | 14.47 | 32.09 | Yes |
| Product odour abnormal | 18.75 | 4 | 6.76 | 52.05 | Not applicable |
| Abortion | 16.02 | 3 | 4.96 | 51.69 | No |
| Dry throat | 14.51 | 10 | 7.64 | 27.56 | Yes |
| Glaucoma | 14.26 | 7 | 6.63 | 30.66 | Yes |
| Cataract | 14.01 | 12 | 7.80 | 25.15 | Yes |
| Growth retardation | 13.68 | 5 | 5.54 | 33.79 | Yes |
| Nasal dryness | 13.68 | 5 | 5.54 | 33.79 | Yes |
ADR adverse drug reaction, PTname Preferred Term name of Medical Dictionary for Regulatory Activities [12], ROR reporting odds ratio, SmPC summary of product characteristics