ISOCONAZOLE: 34 Adverse Event Reports & Safety Profile
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34
Total FAERS Reports
15 (44.1%)
Deaths Reported
16
Hospitalizations
34
As Primary/Secondary Suspect
1
Life-Threatening
1
Disabilities
Active Ingredient: ISOCONAZOLE NITRATE ·
First Report: 2011 · Latest Report: 20190822
What Are the Most Common ISOCONAZOLE Side Effects?
#1 Most Reported
Death neonatal
13 reports (38.2%)
#2 Most Reported
Exposure during pregnancy
10 reports (29.4%)
#3 Most Reported
Pemphigoid
6 reports (17.6%)
All ISOCONAZOLE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Death neonatal | 13 | 38.2% | 13 | 0 |
| Exposure during pregnancy | 10 | 29.4% | 8 | 2 |
| Foetal exposure during pregnancy | 6 | 17.7% | 6 | 0 |
| Pemphigoid | 6 | 17.7% | 0 | 6 |
| Adverse reaction | 5 | 14.7% | 0 | 5 |
| Dermatitis contact | 5 | 14.7% | 0 | 4 |
| Hypersensitivity | 5 | 14.7% | 0 | 4 |
Who Reports ISOCONAZOLE Side Effects? Age & Gender Data
Gender: 84.6% female, 15.4% male. Average age: 31.4 years. Most reports from: CA. View detailed demographics →
Is ISOCONAZOLE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2011 | 1 | 0 | 0 |
| 2016 | 1 | 0 | 0 |
| 2019 | 8 | 0 | 8 |
What Is ISOCONAZOLE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 9 |
| Foetal exposure during pregnancy | 7 |
Official FDA Label for ISOCONAZOLE
Official prescribing information from the FDA-approved drug label.