PODOFILOX

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)

Brand name
PODOFILOX
Generic name
PODOFILOX
Manufacturer
Padagis US LLC
Product type
HUMAN PRESCRIPTION DRUG
SPL set ID
6af07697-5203-43e0-ba35-83683af851c3
SPL ID
e75d3f9f-dd11-4c3e-9e6e-3d9af2cd76da
Version
9
Effective date
2023-02-28
Source export date
2026-09-28
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:24:03
Harmonized routes table
Harmonized routes
TOPICAL

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS Correct diagnosis of the lesions to be treated is essential. See the " Diagnosis " subsection of the INDICATIONS AND USAGE statement. Podofilox Topical Solution 0.5% is intended for cutaneous use only. Avoid contact with the eye. If eye contact occurs, patient should immediately flush the eye with copious quantities of water and seek medical advice.

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

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

adverse reactions

ADVERSE REACTIONS In clinical trials, the following local adverse reactions were reported at some point during treatment. Adverse Experience Males Females Burning 64% 78% Pain 50% 72% Inflammation 71% 63% Erosion 67% 67% Itching 50% 65% Reports of burning and pain were more frequent and of greater severity in women than in men. Adverse effects reported in less than 5% of the patients included pain with intercourse, insomnia, tingling, bleeding, tenderness, chafing, malodor, dizziness, scarring, vesicle formation, crusting edema, dryness/peeling, foreskin irretraction, hematuria, vomiting and ulceration.

adverse reactions table

<table width="100%"><col width="10%"/><col width="24%"/><col width="33%"/><col width="33%"/><thead><tr><th align="left" colspan="2" styleCode="Botrule Toprule " valign="top"><content styleCode="bold">Adverse Experience</content></th><th align="left" styleCode="Botrule Toprule " valign="top"><content styleCode="bold">Males</content></th><th align="left" styleCode="Botrule Toprule " valign="top"><content styleCode="bold">Females</content></th></tr></thead><tbody><tr><td styleCode="Toprule " valign="top"/><td styleCode="Toprule " valign="top"><paragraph>Burning</paragraph></td><td styleCode="Toprule " valign="top"><paragraph>64%</paragraph></td><td styleCode="Toprule " valign="top"><paragraph>78%</paragraph></td></tr><tr><td valign="top"/><td valign="top"><paragraph>Pain</paragraph></td><td valign="top"><paragraph>50%</paragraph></td><td valign="top"><paragraph>72%</paragraph></td></tr><tr><td valign="top"/><td valign="top"><paragraph>Inflammation</paragraph></td><td valign="top"><paragraph>71%</paragraph></td><td valign="top"><paragraph>63%</paragraph></td></tr><tr><td valign="top"/><td valign="top"><paragraph>Erosion</paragraph></td><td valign="top"><paragraph>67%</paragraph></td><td valign="top"><paragraph>67%</paragraph></td></tr><tr><td styleCode="Botrule " valign="top"/><td styleCode="Botrule " valign="top"><paragraph>Itching</paragraph></td><td styleCode="Botrule " valign="top"><paragraph>50%</paragraph></td><td styleCode="Botrule " valign="top"><paragraph>65%</paragraph></td></tr></tbody></table>

Reported adverse events (FAERS/openFDA)#

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