Table 3 A positive signal not recorded in the drug information leaflets.
Clotrimazole | Adverse event | N | ROR |
---|---|---|---|
0–18 | Tinea infection* | 3 | 525.95 (1920.37, 144.04) |
0–18 | Granuloma* | 4 | 236.64 (683.44, 81.94) |
19–39 | Laryngotracheal oedema* | 4 | 2282.44 (10, 236.93, 508.9) |
19–39 | Post viral fatigue syndrome* | 7 | 604.47 (1439.02, 253.91) |
19–39 | Pubic pain* | 3 | 465.48 (1675.92, 129.29) |
19–39 | Eye infection toxoplasmal* | 3 | 365.73 (1278.45, 104.63) |
19–39 | Hypervigilance* | 6 | 224.59 (529.38, 95.28) |
19–39 | Plantar fasciitis* | 6 | 210.84 (495.49, 89.72) |
40–59 | Angiodermatitis* | 4 | 5087.07 (27, 849.93, 929.2) |
40–59 | Endocrine ophthalmopathy* | 6 | 464.68 (1114.93, 193.67) |
40–59 | Toxic shock syndrome* | 6 | 326.26 (767.28, 138.73) |
40–59 | Chemical burn of skin* | 3 | 262.49 (865.03, 79.65) |
40–59 | Mean cell haemoglobin increased* | 6 | 189.31 (436.25, 82.15) |
≥ 60 | Bladder transitional cell carcinoma* | 8 | 291.66 (613.67, 138.62) |
Econazole | Adverse event | N | ROR |
---|---|---|---|
19–39 | Muscle necrosis* | 4 | 2764.73 (8382.12, 911.91) |
19–39 | Myositis* | 4 | 338.44 (961.27, 119.15) |
40–59 | Vulvovaginal candidiasis* | 7 | 2261.48 (5305.21, 964.01) |
≥ 60 | Hypothalamic pituitary adrenal axis suppression* | 8 | 4128.62 (9704.05, 1756.54) |
≥ 60 | Nail toxicity* | 4 | 3423.23 (11, 025.99, 1062.81) |
≥ 60 | Adrenal insufficiency* | 10 | 166.33 (316.97, 87.28) |
Miconazole | Adverse event | N | ROR |
---|---|---|---|
19–39 | Cortisol increased* | 8 | 625.29 (1388.52, 281.58) |
40–59 | Endocrine ophthalmopathy* | 6 | 446.35 (1070.71, 186.07) |
40–59 | Toxic shock syndrome* | 6 | 313.39 (736.85, 133.29) |
40–59 | Cortisol increased* | 3 | 261.21 (862.4, 79.12) |
40–59 | Mean cell haemoglobin increased* | 6 | 181.84 (418.94, 78.92) |
≥ 60 | Xanthelasma* | 5 | 1785.05 (5863.64, 543.42) |
≥ 60 | Hypothalamic pituitary adrenal axis suppression* | 8 | 1012.69 (2354.84, 435.5) |
≥ 60 | Aspergillus test positive* | 7 | 752.02 (1784.59, 316.9) |
≥ 60 | Antiphospholipid antibodies positive* | 5 | 428.41 (1122.53, 163.5) |
Ketoconazole | Adverse event | N | ROR |
---|---|---|---|
≥ 60 | Jarisch–Herxheimer reaction* | 3 | 543.61 (1912.59, 154.51) |