FDA label 81df1551-86d2-4792-8c7e-d9f71ca109f4

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
f6ba6f49-0055-4285-9e04-67001d4554fd
SPL ID
81df1551-86d2-4792-8c7e-d9f71ca109f4
Version
5
Effective date
2016-10-20
Source export date
2026-09-28
Source partition
11
Source file
https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:20:17

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 2 matching rows.

adverse reactions

6 ADVERSE REACTIONS Common adverse reactions occurring in ≥1% in subjects treated with KERYDIN included application site exfoliation, ingrown toenail, application site erythema, and application site dermatitis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Anacor Pharmaceuticals at 1-844-4ANACOR [1-844-426-2267] or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In two clinical trials, 791 subjects were treated with KERYDIN. The most commonly reported adverse reactions are listed below ( Table 1 ). Table 1: Adverse Reactions Occurring in ≥1% of KERYDIN Topical Solution, 5%-Treated Subjects and at a Greater Frequency than Observed with Vehicle Preferred Term KERYDIN N=791 n(%) Vehicle N=395 n(%) Application site exfoliation 21 (2.7%) 1 (0.3%) Ingrown toenail 20 (2.5%) 1 (0.3%) Application site erythema 13 (1.6%) 0 (0%) Application site dermatitis 10 (1.3%) 0 (0%) A cumulative irritancy study revealed the potential for KERYDIN to cause skin irritation. There was no evidence that KERYDIN causes contact sensitization.

adverse reactions table

<table ID="t1" width="100%"> <caption>Table 1: Adverse Reactions Occurring in &#x2265;1% of KERYDIN Topical Solution, 5%-Treated Subjects and at a Greater Frequency than Observed with Vehicle</caption> <col width="54.900%" align="left"/> <col width="22.167%" align="left"/> <col width="22.933%" align="left"/> <tbody> <tr> <td align="left" valign="bottom" styleCode="Toprule Botrule Lrule Rrule"> <content styleCode="bold">Preferred Term</content> </td> <td align="center" valign="bottom" styleCode="Toprule Botrule Rrule"> <content styleCode="bold">KERYDIN N=791</content> <content styleCode="bold">n(%)</content> </td> <td align="center" valign="bottom" styleCode="Toprule Botrule Rrule"> <content styleCode="bold">Vehicle N=395</content> <content styleCode="bold">n(%)</content> </td> </tr> <tr> <td align="left" valign="top" styleCode="Botrule Lrule Rrule">Application site exfoliation</td> <td align="center" valign="top" styleCode="Botrule Rrule">21 (2.7%)</td> <td align="center" valign="top" styleCode="Botrule Rrule">1 (0.3%)</td> </tr> <tr> <td align="left" valign="top" styleCode="Botrule Lrule Rrule">Ingrown toenail</td> <td align="center" valign="top" styleCode="Botrule Rrule">20 (2.5%)</td> <td align="center" valign="top" styleCode="Botrule Rrule">1 (0.3%)</td> </tr> <tr> <td align="left" valign="top" styleCode="Botrule Lrule Rrule">Application site erythema</td> <td align="center" valign="top" styleCode="Botrule Rrule">13 (1.6%)</td> <td align="center" valign="top" styleCode="Botrule Rrule">0 (0%)</td> </tr> <tr> <td align="left" valign="top" styleCode="Botrule Lrule Rrule">Application site dermatitis</td> <td align="center" valign="top" styleCode="Botrule Rrule">10 (1.3%)</td> <td align="center" valign="top" styleCode="Botrule Rrule">0 (0%)</td> </tr> </tbody> </table>

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.