Podofilox

Treatment of anogenital warts with podofilox results in necrosis of visible wart tissue. The exact mechanism of action is unknown.

• Condylox Gel 0.5% is indicated for the topical treatment of anogenital warts (external genital warts and perianal warts). This product is not indicated in the treatment of mucous membrane warts (see PRECAUTIONS ).

• Condylox Gel 0.5% is contraindicated for patients who develop hypersensitivity or intolerance to any components of the formulation.contraindicated

The prescriber should ensure that the patient is fully aware of the correct method of therapy and identify which specific warts should be treated. Apply twice daily for 3 consecutive days, then discontinue for 4 consecutive days. This one-week cycle of treatment may be repeated until there is no visible wart tissue or for a maximum of four cycles. If there is incomplete response after four treatment cycles, discontinue treatment and consider alternative treatment. Safety and effectiveness of more than four treatment cycles has not been established. There is no evidence to suggest that more frequent application will increase efficacy, but additional applications would be expected to increase the rate of local adverse reactions and systemic absorption. Condylox Gel 0.5% should be applied to the warts with the applicator tip or finger. Application on the surrounding normal tissue should be minimized. Treatment should be limited to 10 cm 2 or less of wart tissue and to no more than 0.5 g ram of the gel per day. Care should be taken to allow the gel to dry before allowing the return of opposing skin surfaces to their normal positions. Patients should be instructed to wash their hands thoroughly before and after each application.

Correct diagnosis of the lesions to be treated is essential. See the Diagnosis subsection of the INDICATIONS AND USAGE section. Condylox Gel 0.5% is intended for cutaneous use only. Avoid contact with the eyes. If contact with the eyes occurs, patients should immediately flush the eyes with copious quantities of water and seek medical advice. Drug Product is Flammable. Keep Away f rom Open Flame.

In 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%).

Pregnancy 0.5% podofilox solution was not teratogenic in the rabbit following topical application of up to 0.21 mg/kg (2.85 mg/m 2 , approximately 2 times the maximum human dose) once daily for 13 days. The scientific literature contains references that podofilox is embryotoxic in rats when administered intraperitoneally at a dose of 5 mg/kg (29.5 mg/m 2 , approximately 19 times the recommended maximum human dose). 9 Teratogenicity and embryotoxicity have not been studied with intravaginal application. Many antimitotic drug products are known to be embryotoxic. There are no adequate and well-controlled studies in pregnant women. Condylox Gel 0.5% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Metabolism

In systemic absorption studies in 52 patients, topical application of 0.05 mL of an ethanolic solution containing 0.5% podofilox to external genitalia did not result in detectable serum levels. Applications of 0.1 to 1.5 mL resulted in peak serum levels of 1 to 17 ng/mL one to two hours after application.

Topically applied podofilox may be absorbed systemically (see CLINICAL PHARMACOLOGY section). Toxicity reported following systemic administration of podofilox in investigational use for cancer treatment included: nausea, vomiting, fever, diarrhea, bone marrow depression, and oral ulcers. Following 5 to 10 daily intravenous doses of 0.5 to 1 mg/kg/day, significant hematological toxicity occurred but was reversible. 10 Other toxicities occurred at lower doses. Toxicity reported following systemic administration of podophyllum resin included: nausea, vomiting, fever, diarrhea, peripheral neuropathy, altered mental status, lethargy, coma, tachypnea, respiratory failure, leukocytosis, pancytosis, hematuria, renal failure and seizures. 11 Treatment of topical overdosage should include washing the skin free of any remaining drug and symptomatic and supportive therapy.

• Mar 13, 1997NDANDA020529Allergan
• Jan 29, 2002ANDAANDA075600Padagis Us
• Nov 22, 2023ANDAANDA211871Padagis Us

Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

• Condylox , Topical Gel, 0.5% (NDC 0023-6118-03)To be discontinued
  Sponsor: AbbVie Inc.
  Updated Jan 28, 2026

1. 1Pain1716%
2. 2Anxiety1312%
3. 3Drug Ineffective1211%
4. 4Off Label Use1211%
5. 5Emotional Distress1110%
6. 6Anhedonia109.2%
7. 7Application Site Pain98.3%
8. 8Renal Failure98.3%
9. 9Chronic Kidney Disease87.3%
10. 10Dyspnoea87.3%
11. 11Acute Kidney Injury76.4%
12. 12Drug Interaction76.4%
13. 13Tremor76.4%
14. 14Asthenia65.5%
15. 15Depression65.5%

Recent PubMed references pinned to Podofilox as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• [Clinical Study and Economic Evaluation of High-Dose Etoposide Combined with Mecapegfilgrastim for Autologous Peripheral Blood Stem Cell Mobilization in Patients with Lymphoma].
  Zhongguo shi yan xue ye xue za zhi · 2026 · Zhang WJ, Feng YF, Wei XF, et al.
  PMID 42227428DOI 10.19746/j.cnki.issn1009-2137.2026.02.009
• Flexibility-driven design of etoposide derivatives targeting Daam1: a thermodynamics-guided strategy against breast cancer metastasis.
  Journal of computer-aided molecular design · 2026 · Zhu X, Shen Y, Cao P, et al.
  PMID 42213223DOI 10.1007/s10822-026-00841-2
• Optimal Duration of Adjuvant Platinum-Etoposide in High-Risk Merkel Cell Carcinoma.
  Medicina (Kaunas, Lithuania) · 2026 · Brenner R, Edri HTF, Rouvinov K, et al.
  PMID 42195135DOI 10.3390/medicina62050882
• Picropodophyllotoxin Mitigates Severe Inflammation Through HMGB1 Inhibition.
  Biomolecules · 2026 · Han G, Kim GE, Bae JS, et al.
  PMID 42193989DOI 10.3390/biom16050638
• An integrated multi-omics approach for deciphering podophyllotoxin-induced nephrotoxicity via the microbiome-gut-kidney (MGK) axis based on the toxicological evidence (TEC) concept.
  Journal of molecular histology · 2026 · Guo X, Wang Y, Wang L, et al.
  PMID 42185548DOI 10.1007/s10735-026-10832-0
• Total marrow and lymphoid irradiation in combination with cyclophosphamide and etoposide before haematopoietic cell transplantation for relapsed or refractory acute leukaemia: a single-centre, open-label, phase 2 trial.
  The Lancet. Haematology · 2026 · Stein A, Wang Y, Malki MMA, et al.
  PMID 42150590DOI 10.1016/S2352-3026(26)00014-1
• Regionally specific dysregulation of gut microbiota and host-metabolite interface in podophyllotoxin-induced enterotoxicity based on the toxicological evidence chain concept.
  Toxicology and applied pharmacology · 2026 · Jiang T, Sun J, Liu C, et al.
  PMID 42114568DOI 10.1016/j.taap.2026.117862
• Etoposide suppresses skin cutaneous melanoma growth by inducing ferroptosis through p53-mediated transcriptional inhibition of TSP50.
  Biochimica et biophysica acta. Molecular basis of disease · 2026 · Yang S, Gao D, Li M, et al.
  PMID 42061523DOI 10.1016/j.bbadis.2026.168277

The 10 most recently updated of 1,444 ClinicalTrials.gov registrations naming Podofilox as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Evaluating the Addition of the Immunotherapy Drug Atezolizumab to Standard Chemotherapy Treatment for Advanced or Metastatic Neuroendocrine Carcinomas That Originate Outside the Lung
  Recruiting · Phase 2 · Phase 3 · Interventional · 189 enrolled · National Cancer Institute (NCI)
  NCT05058651updated 2026-06-12
• Eflornithine (DFMO) for Ewing Sarcoma and Osteosarcoma
  Recruiting · Phase 2 · Interventional · 406 enrolled · Milton S. Hershey Medical Center
  NCT07321912updated 2026-06-12
• A Clinical Study of Gocatamig (MK-6070) and Infinatamab Deruxtecan (MK-2400) in People With Small Cell Lung Cancer (MK-6070-003)
  Recruiting · Phase 1 · Phase 2 · Interventional · 170 enrolled · Merck Sharp & Dohme LLC
  NCT07227597updated 2026-06-12
• A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity
  Recruiting · Phase 2 · Interventional · 60 enrolled · National Cancer Institute (NCI)
  NCT06406465updated 2026-06-12
• A Study Comparing Tarlatamab, Durvalumab, Carboplatin, and Etoposide Versus Durvalumab, Carboplatin, and Etoposide in First-line Extensive Stage Small-Cell Lung Cancer (ES-SCLC)
  Recruiting · Phase 3 · Interventional · 330 enrolled · Amgen
  NCT07005128updated 2026-06-12
• Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma
  Recruiting · Phase 3 · Interventional · 478 enrolled · National Cancer Institute (NCI)
  NCT06172296updated 2026-06-12
• A Study to Compare Standard Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab Vedotin and Nivolumab
  Recruiting · Phase 3 · Interventional · 1,875 enrolled · National Cancer Institute (NCI)
  NCT05675410updated 2026-06-12
• Olaparib and Durvalumab With Carboplatin, Etoposide, and/or Radiation Therapy for the Treatment of Extensive-Stage Small Cell Lung Cancer, PRIO Trial
  Active not recruiting · Phase 1 · Phase 2 · Interventional · 63 enrolled · M.D. Anderson Cancer Center
  NCT04728230updated 2026-06-11
• Polatuzumab Vedotin Plus Rituximab, Ifosfamide, Carboplatin and Etoposide (Pola-R-ICE) Versus R-ICE Alone in Second Line Treatment of Diffuse Large B-cell Lymphoma (DLBCL)
  Completed · Phase 3 · Interventional · 306 enrolled · GWT-TUD GmbH
  NCT04833114updated 2026-06-10
• A Study to Evaluate the Optimal Dose, Adverse Events and Change in Disease Activity of Intravenous ABBV-706 in Combination With Atezolizumab Versus Standard of Care as First-Line Treatment in Adult Participants With Previously Untreated Extensive Stage Small Cell Lung Cancer
  Recruiting · Phase 2 · Interventional · 180 enrolled · AbbVie
  NCT07155174updated 2026-06-09

Frequently asked questions

How does Podofilox work?

Treatment of anogenital warts with podofilox results in necrosis of visible wart tissue. The exact mechanism of action is unknown.

What is Podofilox used for?

According to FDA labeling, Podofilox carries indications including: Condylox Gel 0.5% is indicated for the topical treatment of anogenital warts (external genital warts and perianal warts). This product is not indicated in the treatment of mucous membrane warts (see PRECAUTIONS ).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Podofilox?

Podofilox is classified as Antivirals, Unknown Cellular or Molecular Interaction, Decreased Mitosis.

What are the brand names for Podofilox?

Podofilox is marketed under brand names including Condylox.

What are the contraindications for Podofilox?

Podofilox labeling lists contraindications including: Condylox Gel 0.5% is contraindicated for patients who develop hypersensitivity or intolerance to any components of the formulation.. Always consult the full prescribing information and a clinician.