Table 3 A positive signal not recorded in the drug information leaflets.

From: Possible adverse events of imidazole antifungal drugs during treatment of vulvovaginal candidiasis: analysis of the FDA Adverse Event Reporting System

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)