Miconazole Nitrate

Common brands: Antifungal, Miconazole, Monistat 7 Combination Pack 7-Day Pre-Filled Applicators, Monistat 3 Combination Pack 3 Ovule Inserts, Monistat 1 Combination Pack

Top reporter: H E B

Azole Antifungal [EPC]Nonsteroidal Anti-inflammatory Drug [EPC]Corticosteroid [EPC]Proton Pump Inhibitor [EPC]Benzodiazepine [EPC]
8,286
Total Reports
2,940
Serious Reports
429
Death Reports
30
Reported Reactions
Death Report Ratio: High (5.18%)

Patient Demographics

Male
1,429
Female
6,113

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Miconazole Nitrate.

# Reaction Reports % of Total
1 VULVOVAGINAL BURNING SENSATION 1,673
17.0%
2 DRUG INEFFECTIVE 1,131
11.5%
3 VULVOVAGINAL PAIN 949
9.6%
4 VULVOVAGINAL PRURITUS 569
5.8%
5 CONDITION AGGRAVATED 526
5.3%
6 VAGINAL HAEMORRHAGE 467
4.7%
7 VULVOVAGINAL DISCOMFORT 422
4.3%
8 VULVOVAGINAL SWELLING 304
3.1%
9 DRUG INTERACTION 298
3.0%
10 PAIN 266
2.7%
11 OFF LABEL USE 245
2.5%
12 DIARRHOEA 226
2.3%
13 NAUSEA 212
2.2%
14 PRURITUS 195
2.0%
15 DYSPNOEA 180
1.8%
16 INTERNATIONAL NORMALISED RATIO INCREASED 178
1.8%
17 ABDOMINAL PAIN 176
1.8%
18 RASH 175
1.8%
19 BURNING SENSATION 174
1.8%
20 HYPERSENSITIVITY 167
1.7%
21 FATIGUE 155
1.6%
22 DIZZINESS 145
1.5%
23 URINARY TRACT INFECTION 140
1.4%
24 APPLICATION SITE PAIN 136
1.4%
25 VAGINAL DISCHARGE 135
1.4%
26 PYREXIA 134
1.4%
27 HEADACHE 129
1.3%
28 VOMITING 127
1.3%
29 ASTHENIA 114
1.2%
30 ACUTE KIDNEY INJURY 103
1.0%

Important Disclaimer

FDA adverse event reports are submitted voluntarily and do not prove causation. A reported reaction does not mean the drug caused it. Drugs with more users naturally have more reports. Always consult your doctor or pharmacist before making medication decisions.