Mebendazole

Mebendazole, a benzimidazole, is an anthelmintic [see Microbiology (12.4) ] .

• VERMOX™ CHEWABLE is indicated for the treatment of patients one year of age and older with gastrointestinal infections caused by Ascaris lumbricoides (roundworm) and Trichuris trichiura (whipworm). VERMOX™ CHEWABLE is an anthelmintic indicated for the treatment of patients one year of age and older with gastrointestinal infections caused by: Ascaris lumbricoides (roundworm) and Trichuris trichiura (whipworm) ( 1 ).

• VERMOX™ CHEWABLE is contraindicated in persons with a known hypersensitivity to the drug or its excipients.contraindicated

The recommended dosage in patients one year of age and older is one VERMOX™ CHEWABLE 500 mg tablet taken as a single dose. Chew VERMOX™ CHEWABLE 500 mg tablet completely before swallowing. Do not swallow the tablet whole. For patients who have difficulty chewing the tablet, approximately 2 mL to 3 mL of drinking water can be added to a suitably sized spoon and the VERMOX™ CHEWABLE 500 mg tablet placed into the water. Within 2 minutes, the tablet absorbs the water and turns into a soft mass with semi-solid consistency, which can then be swallowed. VERMOX™ CHEWABLE 500 mg tablet can be taken without regard to food intake [see Clinical Pharmacology (12.3) ]. The recommended dosage in patients one year of age and older is one single tablet of VERMOX™ CHEWABLE 500 mg taken as a single dose, chewed completely before swallowing ( 2 ). See Full Prescribing Information for administration instructions for patients who have difficulty chewing the tablets ( 2 )

Risk of Convulsions: Convulsions in infants below the age of 1 year have been reported ( 5.1 ) Hematologic Effects: Neutropenia and agranulocytosis have been reported in patients receiving mebendazole at higher doses and for prolonged duration. Monitor blood counts in these patients ( 5.2 ) Metronidazole and Serious Skin Reactions: Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) have been reported with the concomitant use of mebendazole and metronidazole. Avoid concomitant use of mebendazole and metronidazole ( 5.3 ) 5.1 Risk of Convulsions Convulsions have been reported in infants below the age of 1 year during post-marketing experience with mebendazole [see Adverse Reactions (6.2) ] . 5.2 Hematologic Effects Agranulocytosis and neutropenia have been reported with mebendazole use at higher doses and for more prolonged durations than is recommended for the treatment of soil-transmitted helminth infections. Monitor blood counts if VERMOX™ CHEWABLE is used at higher doses or for prolonged duration. 5.3 Metronidazole Drug Interaction and Serious Skin Reactions Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) have been reported with the concomitant use of mebendazole and metronidazole. Avoid concomitant use of mebendazole and metronidazole.

Adverse reactions reported in clinical trials were anorexia, abdominal pain, diarrhea, flatulence, nausea, vomiting and rash. ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Janssen Pharmaceuticals, Inc. at 1-800-JANSSEN (1-800-526-7736) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies 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. The safety of mebendazole was evaluated in 6276 adult and pediatric subjects one year of age and older who participated in 39 clinical trials for treatment of single or mixed parasitic infections of the gastrointestinal tract. In these trials, the formulations, dosages and duration of mebendazole treatment varied. Adverse reactions reported in mebendazole-treated subjects from the 39 clinical trials are shown in Table 1 below. Table 1: Adverse Reactions Reported in Mebendazole-Treated Subjects from 39 Clinical Trials Includes mebendazole formulations, dosages and treatment duration other than VERMOX™ CHEWABLE 500 mg tablet Adverse Reaction(s) Gastrointestinal Disorders Anorexia Abdominal Pain Diarrhea Flatulence Nausea Vomiting Skin and Subcutaneous Tissue Disorders Rash Clinical Studies with Mebendazole Chewable 500 mg Tablet The safety profile of mebendazole chewable 500 mg tablets administered as a single dose was evaluated in 677 pediatric subjects aged 1 to 16 years and in 34 adults.

8.1 Pregnancy Risk Summary The available published literature on mebendazole use in pregnant women has not reported a clear association between mebendazole and a potential risk of major birth defects or miscarriages [see Data ]. There are risks to the mother and fetus associated with untreated helminthic infection during pregnancy [see Clinical Considerations ] . In animal reproduction studies, adverse developmental effects (i.e., skeletal malformations, soft tissue malformations, decreased pup weight, embryolethality) were observed when mebendazole was administered to pregnant rats during the period of organogenesis at single oral doses as low as 10 mg/kg (approximately 0.2-fold the maximum recommended human dose (MRHD)). Maternal toxicity was present at the highest of these doses [see Data ]. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively.

Metabolism

Absorption Following oral administration of VERMOX™ CHEWABLE 500 mg tablet, the majority of the dose remains in the gastrointestinal tract where it exerts an anthelmintic effect locally. Dosing the VERMOX™ CHEWABLE 500 mg tablet with a high fat meal increases the bioavailability of mebendazole.

In patients treated at dosages substantially higher than recommended or for prolonged periods of time, the following adverse reactions have been reported: alopecia, reversible transaminase elevations, hepatitis, agranulocytosis, neutropenia, and glomerulonephritis. Symptoms and signs In the event of accidental overdose, gastrointestinal signs/symptoms may occur. Treatment There is no specific antidote.

• Oct 19, 2016NDANDA208398Janssen Pharms

1. 1Foetal Exposure During Pregnancy577.4%
2. 2Nausea496.3%
3. 3Vomiting445.7%
4. 4Abdominal Pain435.6%
5. 5Drug Ineffective425.4%
6. 6Off Label Use425.4%
7. 7Dizziness374.8%
8. 8Fatigue334.3%
9. 9Diarrhoea314.0%
10. 10Drug Exposure During Pregnancy303.9%
11. 11Asthenia293.8%
12. 12Headache293.8%
13. 13Pyrexia293.8%
14. 14Pruritus243.1%
15. 15Exposure During Pregnancy222.8%

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

• Real-world Clinical Outcomes of Ivermectin and Mebendazole in Cancer Patients: Results from a Prospective Observational Cohort.
  Anticancer research · 2026 · Hulscher N, Victory K, Thorp JA, et al.
  PMID 42203321DOI 10.21873/anticanres.18194
• Mebendazole Attenuates Cellular Invasion in a 3D Culture Model of Meningioma by Disrupting Rho-GTPase-Mediated Microtubule Function.
  Oncology research · 2026 · James MM, Clara Elena LV, Agadha W, et al.
  PMID 42065056DOI 10.32604/or.2026.074958
• Thermal and Kinetic Analysis of Benzimidazole Derivatives: Fenbendazole, Mebendazole, and Flubendazole.
  Molecules (Basel, Switzerland) · 2026 · Ledeți A, Pârvănescu RD, Ridichie A, et al.
  PMID 41900104DOI 10.3390/molecules31061005
• Rapid ultrasensitive detection of levamisole and mebendazole residues in meat products based on an intelligent nanozyme-imprinted fluorescence microfluidic sensor.
  Analytical methods : advancing methods and applications · 2026 · Wu Q, Liao Z, Ouyang Y, et al.
  PMID 41891191DOI 10.1039/d6ay00111d
• Repurposing mebendazole to reprogram oncogenic and tumor-suppressor networks: Multi-cancer insights from ENOX2, MMP2, RASSF1A, WFDC10A and METTL7A.
  PloS one · 2026 · Aqel RS, Ismail AS, El-Tanani M, et al.
  PMID 41886499DOI 10.1371/journal.pone.0345701
• Mebendazole impairs the expression and function of enzymes in nucleotide metabolism pathways, leading to Selective Cytotoxicity, Cell Cycle Arrest, and Damage to Cell Morphology in Gastric Cancer.
  Chemico-biological interactions · 2026 · da Silva EL, Pantoja Mesquita F, da Rocha Lima PV, et al.
  PMID 41720422DOI 10.1016/j.cbi.2026.111973
• Concurrent therapeutic and behavioral interventions are associated with a reduced number of emerging Dracunculus medinensis worms in dogs in Chad.
  PLoS neglected tropical diseases · 2026 · Dupper AC, Cleveland CA, Haynes EK, et al.
  PMID 41628272DOI 10.1371/journal.pntd.0012896
• Girdin silencing enhances mebendazole-mediated anticancer activity: a combinatorial therapeutic strategy for ovarian cancer.
  Medical oncology (Northwood, London, England) · 2025 · Gupta R, Begum Y, Ghosh D, et al.
  PMID 41460544DOI 10.1007/s12032-025-03210-5

The 10 most recently updated of 48 ClinicalTrials.gov registrations naming Mebendazole as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Efficacy and Safety of Emodepside in Participants With Soil-transmitted Helminth Infections
  Not yet recruiting · Phase 3 · Interventional · 315 enrolled · Swiss Tropical & Public Health Institute
  NCT06800248updated 2026-06-11
• Avapritinib for the Treatment of CKIT or PDGFRA Mutation-Positive Locally Advanced or Metastatic Malignant Solid Tumors
  Recruiting · Phase 2 · Interventional · 50 enrolled · M.D. Anderson Cancer Center
  NCT04771520updated 2026-06-11
• Efficacy and Safety of Emodepside in Participants With Soil-transmitted Helminth Infections
  Enrolling by invitation · Phase 3 · Interventional · 315 enrolled · Swiss Tropical & Public Health Institute
  NCT06736691updated 2026-05-14
• Treatment and Prevention of Severe Anemia in Pregnant Zanzibari Women
  Completed · Phase 3 · Interventional · 2,500 enrolled · Cornell University
  NCT00148629updated 2026-02-13
• Possible Efficacy and Safety of Mebendazole in Patients With Ulcerative Colitis Treated With Mesalamine
  Recruiting · Interventional · 46 enrolled · Tanta University
  NCT06335160updated 2026-02-06
• Curcumin, Resveratrol, and Stinging Nettle as Treatments for GWI
  Active not recruiting · Interventional · 390 enrolled · University of Alabama at Birmingham
  NCT05377242updated 2025-11-26
• Effectiveness Study During the First 1,000 Days in Kenya
  Completed · Interventional · 1,199 enrolled · Fabian Rohner
  NCT03558464updated 2025-11-20
• Efficacy and Safety of Oxantel Pamoate in Children Infected With Trichuris Trichiura
  Completed · Phase 2 · Interventional · 163 enrolled · Jennifer Keiser
  NCT06720259updated 2025-06-08
• Nutrition and Inflammation in Pregnancy: Impacts on Early Human Brain Development in Ethiopia
  Completed · Observational · 463 enrolled · Brown University
  NCT06296238updated 2025-03-26
• Community-based, Controlled, Open-label, Cluster-randomized Trial for the Reduction of Chronic Malnutrition in Children Under Two Years of Age, With Three Intervention Arms Grouped by Clusters, in Two Provinces in Southern Angola, Huíla and Cunene.
  Active not recruiting · Interventional · 1,423 enrolled · Hospital Universitari Vall d'Hebron Research Institute
  NCT05571280updated 2024-12-13

Frequently asked questions

How does Mebendazole work?

Mebendazole, a benzimidazole, is an anthelmintic [see Microbiology (12.4) ] .

What is Mebendazole used for?

According to FDA labeling, Mebendazole carries indications including: VERMOX™ CHEWABLE is indicated for the treatment of patients one year of age and older with gastrointestinal infections caused by Ascaris lumbricoides (roundworm) and Trichuris trichiura (whipworm). VERMOX™ CHEWABLE is an anthelmintic indicated for the treatment of patients one year of age and older with gastrointestinal infections caused by: Ascaris lumbricoides (roundworm) and Trichuris trichiura (whipworm) ( 1 ).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Mebendazole?

Mebendazole is classified as Benzimidazole derivatives, Anthelmintic, Receptor Interactions, Tubulin Interactions, Decreased Glucose Transport into Cells.

What are the brand names for Mebendazole?

Mebendazole is marketed under brand names including Emverm, Vermox.

What are the contraindications for Mebendazole?

Mebendazole labeling lists contraindications including: VERMOX™ CHEWABLE is contraindicated in persons with a known hypersensitivity to the drug or its excipients.. Always consult the full prescribing information and a clinician.