Table 2.
Adverse drug reactions
| Adverse drug reactions, n (%) | N = 3359 |
|---|---|
| No. of patients with ADR | 626 (18.6) |
| Eye disorders | |
| Conjunctival hyperemiaa | 223 (6.6) |
| Blepharitisb | 189 (5.6) |
| Conjunctivitisc | 141 (4.2) |
| Eye pruritus | 44 (1.3) |
| Punctate keratitis | 25 (0.7) |
| Eye pain | 16 (0.5) |
| Vision blurred | 12 (0.4) |
| Corneal erosion | 9 (0.3) |
| Eye irritation | 9 (0.3) |
| Eyelid edema | 9 (0.3) |
| Dry eye | 8 (0.2) |
| Erythema of eyelid | 4 (0.1) |
| Eye discharge | 4 (0.1) |
| Corneal disorder | 4 (0.1) |
| Conjunctival follicles | 3 (0.1) |
| Lacrimation increased | 3 (0.1) |
| Eyelids pruritus | 3 (0.1) |
| Keratitisd | 3 (0.1) |
| Abnormal sensation in eye | 2 (0.1) |
| Eyelid ptosis | 2 (0.1) |
| Foreign body sensation in eyes | 2 (0.1) |
| Cataracte | 2 (0.1) |
| Otherf (incidence of each) | 1 (< 0.1) |
| Other ADRs | |
| Dermatitis contact | 6 (0.2) |
| Headache | 5 (0.2) |
| Dermatitis allergic | 3 (0.1) |
| Dizziness | 3 (0.1) |
| Intraocular pressure increased | 3 (0.1) |
| Somnolence | 2 (0.1) |
| Nausea | 2 (0.1) |
| Otherg (incidence of each) | 1 (< 0.1) |
ADR adverse drug reaction
a Including ocular hyperemia
b Including blepharitis allergic
c Including conjunctivitis allergic
d Including allergic keratitis
e Including nuclear cataract
f One patient each developed asthenopia, conjunctival erosion, conjunctival hemorrhage, conjunctival edema, corneal epithelium defect, corneal edema, eczema of the eyelids, macular edema, meibomianitis, scintillating scotoma, eyelid skin dryness, administration site dermatitis, hordeolum
g One patient each developed erythema, pruritus, urticaria, cerebral infarction, cough, dyspnea, epistaxis, malaise, dermatitis, bradycardia, palpitations, rhinitis, otitis externa, dysgeusia