What the label lists and what reports show
Podofilox side effects
Podofilox's FDA label: “The most common systemic adverse event reported during the clinical studies was headache (7%).” FAERS holds 109 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is pain (17 reports).
- Generic listed
- A presentation discontinued
Check it at the source: the podofilox FDA label on DailyMed (effective January 29, 2024, Allergan, Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common systemic adverse event reported during the clinical studies was headache (7%).
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
| Adverse Reaction | Mild | Moderate | Severe |
|---|---|---|---|
| Inflammation | 32.2% | 30.4% | 9.3% |
| Burning | 37.1% | 25.9% | 11.5% |
| Erosion | 27.0% | 20.8% | 8.9% |
| Pain | 23.7% | 20.4% | 11.5% |
| Itching | 32.2% | 16.0% | 7.8% |
| Bleeding | 19.2% | 3.0% | 0.7% |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedIn clinical trials with Condylox Gel 0.5%, the following local adverse reactions were reported during the treatment of anogenital warts. The severity of local adverse reactions were predominantly mild or moderate and did not increase during the treatment period. Severe reactions were most frequent within the first 2 weeks of treatment. Adverse Reaction Mild Moderate Severe Inflammation 32.2% 30.4% 9.3% Burning 37.1% 25.9% 11.5% Erosion 27.0% 20.8% 8.9% Pain 23.7% 20.4% 11.5% Itching 32.2% 16.0% 7.8% Bleeding 19.2% 3.0% 0.7% Other local adverse reactions reported included stinging (7%), and erythema (5%); less commonly reported local adverse events included desquamation, scabbing, discoloration, tenderness, dryness, crusting, fissures, soreness, ulceration, swelling/edema, tingling, rash, and blisters. The most common systemic adverse event reported during the clinical studies was headache (7%).
Source: FDA drug label, Allergan, Inc., effective January 29, 2024 (SPL set 032e4bcb-b1ed-4029-b2a6-e92f3bf5cc37), via openFDA; the full label on DailyMed
What do FAERS reports show?
109 reports list podofilox among the medicines taken, each a report of something that happened, not proof the medicine caused it; 2 are coded as a death and 24 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 22 reactions below, 1 is named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Podofilox: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions