Albendazole

Albendazole is a synthetic, antihelminthic drug of the class benzimidazole [see Clinical Pharmacology (12.4) ] .

• Albendazole is an anthelmintic drug indicated for: Treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, Taenia solium . ( 1.1 ) Treatment of cystic hydatid disease of the liver, lung, and peritoneum, caused by the larval form of the dog tapeworm, Echinococcus granulosus .

• Albendazole is contraindicated in patients with known hypersensitivity to the benzimidazole class of compounds or any components of albendazole. Patients with known hypersensitivity to the benzimidazole class of compounds or any components of albendazole.contraindicated

Patients weighing 60 kg or greater, 400 mg twice daily; less than 60 kg, 15 mg/kg/day in divided doses twice daily (maximum total daily dose 800 mg). Albendazole tablets should be taken with food. ( 2 ) Hydatid disease: 28-day cycle followed by 14-day albendazole-free interval for a total of 3 cycles. ( 2 ) Neurocysticercosis: 8 to 30 days. ( 2 ) See additional important information in the Full Prescribing Information. ( 2 ) 2.1 Dosage Dosing of albendazole will vary depending upon the indication. Albendazole tablets may be crushed or chewed and swallowed with a drink of water. Albendazole tablets should be taken with food [see Clinical Pharmacology (12.3) ] . Table 1: Albendazole Dosage Indication Patient Weight Dose Duration Hydatid Disease 60 kg or greater 400 mg twice daily, with meals 28-day cycle followed by a 14-day albendazole-free interval, for a total of 3 cycles Less than 60 kg 15 mg/kg/day given in divided doses twice daily with meals (maximum total daily dose 800 mg) Neurocysticercosis 60 kg or greater 400 mg twice daily, with meals 8 to 30 days Less than 60 kg 15 mg/kg/day given in divided doses twice daily with meals (maximum total daily dose 800 mg) 2.2 Concomitant Medication to Avoid Adverse Reactions Patients being treated for neurocysticercosis should receive appropriate steroid and anticonvulsant therapy as required. Oral or intravenous corticosteroids should be considered to prevent cerebral hypertensive episodes during the first week of treatment [see Warnings and Precautions (5.3) ] .

Bone Marrow Suppression: Fatalities have been reported due to bone marrow suppression; monitor blood counts in all patients at the beginning of each 28-day cycle of therapy, and every 2 weeks while on therapy. Discontinue albendazole if clinically significant changes in blood counts occur. ( 5.1 , 5.4 ) Embryo-fetal Toxicity: Obtain pregnancy test in women of reproductive potential prior to therapy and avoid usage in pregnant women except in clinical circumstances where no alternative management is appropriate. Discontinue therapy if pregnancy occurs and apprise patient of potential hazard to the fetus. ( 5.2 ) Risk of Neurologic Symptoms: Neurocysticercosis patients may experience cerebral hypertensive episodes, seizures or focal neurologic deficits after initiation of therapy; begin appropriate steroid and anticonvulsant therapy. ( 5.3 ) Risk of Retinal Damage in Retinal Cysticercosis: Cases of retinal involvement have been reported; examine the patient for the presence of retinal lesions before initiating therapy for neurocysticercosis. ( 5.4 ) Hepatic Effects. Elevations of liver enzymes may occur. Monitor liver enzymes before the start of each treatment cycle and at least every 2 weeks while on albendazole therapy and discontinue if clinically significant elevations occur. ( 5.5 ) 5.1 Bone Marrow Suppression Fatalities associated with the use of albendazole have been reported due to granulocytopenia or pancytopenia. Albendazole may cause bone marrow suppression, aplastic anemia, and agranulocytosis.

Adverse reactions 1% or greater in hydatid disease: abnormal liver function tests, abdominal pain, nausea/vomiting, reversible alopecia, headache, dizziness/vertigo, fever. ( 6.1 ) Adverse reactions 1% or greater in neurocysticercosis: headache, nausea/vomiting, raised intracranial pressure, meningeal signs. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 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. The adverse reaction profile of albendazole differs between hydatid disease and neurocysticercosis. Adverse reactions occurring with a frequency of 1% or greater in either disease are described in Table 2 below. These symptoms were usually mild and resolved without treatment. Treatment discontinuations were predominantly due to leukopenia (0.7%) or hepatic abnormalities (3.8% in hydatid disease). The following incidence reflects adverse reactions that were reported to be at least possibly or probably related to albendazole.

8.1 Pregnancy Risk Summary There are limited data on use of albendazole in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. In published studies, single-dose albendazole exposure during pregnancy did not show evidence of an increased risk of adverse maternal or fetal outcomes; however, this finding cannot be extrapolated to multiple-dose exposures ( see Data ). In animal reproductive studies, oral administration of albendazole during gestation caused embryotoxicity and skeletal malformations in pregnant rats (at oral doses of 0.10 times and 0.32 times the recommended human dose based on body surface area in mg/m 2 ) and pregnant rabbits (at oral doses of 0.60 times the recommended human dose based on body surface area in mg/m 2 ). Albendazole was also associated with maternal toxicity in rabbits (at doses of 0.60 times the recommended human dose based on body surface area in mg/m 2 ) ( see Data ). Albendazole should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Albendazole should not be used in pregnant women except in clinical circumstances where no alternative management is appropriate. If a patient becomes pregnant while taking this drug, albendazole should be discontinued immediately.

Metabolism

Absorption Albendazole is poorly absorbed from the gastrointestinal tract due to its low aqueous solubility. Albendazole concentrations are negligible or undetectable in plasma as it is rapidly converted to the sulfoxide metabolite prior to reaching the systemic circulation.

In case of overdosage, symptomatic therapy and general supportive measures are recommended.

• Jun 11, 1996NDANDA020666Impax Labs Inc
• May 14, 2019ANDAANDA211117Edenbridge Pharms
• May 20, 2019ANDAANDA208094Actavis Elizabeth
• Jan 22, 2021ANDAANDA213435Msn
• Jan 26, 2021ANDAANDA211034Dr Reddys
• Sep 4, 2024ANDAANDA215652Alembic

1. 1Drug Ineffective37420%
2. 2Off Label Use29216%
3. 3Pyrexia23813%
4. 4Product Use In Unapproved Indication22712%
5. 5Headache22412%
6. 6Condition Aggravated21512%
7. 7Fatigue1709.1%
8. 8Weight Decreased1689.0%
9. 9Pain1668.9%
10. 10Rash1668.9%
11. 11Somnolence1618.7%
12. 12Haematochezia1588.5%
13. 13Rectal Haemorrhage1518.1%
14. 14Colitis Ulcerative1508.1%
15. 15Stress1498.0%

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

• Albendazole Therapy in Postoperative Spinal Cystic Echinococcosis: Evaluating Recurrence and Survival Outcomes Between Short and Long-Term Protocols.
  La Tunisie medicale · 2026 · Gader G, Gharbi MA, Chaabouni M, et al.
  PMID 42223438DOI 10.62438/tunismed.v104i01.5749
• First ever programmatic implementation of triple drug therapy in the prevention of lymphatic filariasis in Haiti: lessons learned in improving the quality and coverage of locally led programming in lymphatic filariasis-persistent and conflict-affected endemic communes.
  International health · 2026 · Sommers K, Philippe WJ, Decastro GC, et al.
  PMID 42101814DOI 10.1093/inthealth/ihag042
• Community-wide deworming strategies to reduce high hookworm burden in endemic communities: Results from a cluster randomized trial in Southern India.
  PLoS neglected tropical diseases · 2026 · Ramesh RM, Sarkar R, Velusamy V, et al.
  PMID 41990097DOI 10.1371/journal.pntd.0013440
• Additive larvicidal activity of albendazole combined with a hydroxyethylamine-derived compound against Toxocara canis larvae: An in vitro and in silico study.
  Acta tropica · 2026 · Panassolo VP, Faria AM, da Cunha CNO, et al.
  PMID 41974317DOI 10.1016/j.actatropica.2026.108092
• Topology-engineered dopamine-mediated flower-like gold nanoparticle adjuvants: Boosting immune responses and enabling sensitive immunoassays for albendazole residue detection.
  Analytica chimica acta · 2026 · Yin J, Hu J, Chen J, et al.
  PMID 41965297DOI 10.1016/j.aca.2026.345410
• Therapeutic effects of IL-33/ST-2 pathway inhibition combined with albendazole on hepatic fibrosis and immune regulation in alveolar echinococcosis: in vivo and in vitro evidence.
  Parasites & vectors · 2026 · Cheng SL, Ma XM, Wu BJ, et al.
  PMID 41933369DOI 10.1186/s13071-026-07355-8
• An Outbreak of Neuroangiostrongyliasis (Rat Lungworm Disease) in Hawai'i: Evidence Supporting the Early Use of Albendazole-Corticosteroid Co-Therapy.
  The American journal of tropical medicine and hygiene · 2026 · Ansdell V, Jacob J, Gosnell WL, et al.
  PMID 41916270DOI 10.4269/ajtmh.25-0689
• Albendazole-loaded chitosan nanoparticle conjugated with hyaluronic acid for the treatment of psoriasis.
  Drug development and industrial pharmacy · 2026 · Nair S, Singh P
  PMID 41891658DOI 10.1080/03639045.2026.2651296

The 10 most recently updated of 151 ClinicalTrials.gov registrations naming Albendazole as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Efficacy and Safety of a Single Dose of Emodepside Compared to a Single Dose of Albendazole in Adolescents and Adults Infected With Trichuris Incognita
  Not yet recruiting · Phase 2 · Interventional · 100 enrolled · Jennifer Keiser
  NCT07258173updated 2026-05-08
• Oxfendazole in Mild Parenchymal Brain Cysticercosis
  Not yet recruiting · Phase 2 · Phase 3 · Interventional · 544 enrolled · Universidad Peruana Cayetano Heredia
  NCT06565507updated 2026-05-01
• Efficacy of Na-GST-1/Alhydrogel Hookworm Vaccine Assessed by Controlled Challenge Infection
  Completed · Phase 2 · Interventional · 39 enrolled · Baylor College of Medicine
  NCT03172975updated 2026-03-12
• Safety of a Single Dose of Moxidectin Compared With Ivermectin in Individuals Living in Onchocerciasis Endemic Areas and in Individuals Living in Onchocerciasis Endemic Areas With High Levels of Lymphatic Filariasis Co-endemicity Receiving Concomitant Albendazole
  Completed · Phase 3 · Interventional · 12,979 enrolled · Medicines Development for Global Health
  NCT04311671updated 2026-03-03
• Improving Cognition and Gestational Duration With Targeted Nutrition
  Active not recruiting · Interventional · 1,660 enrolled · Washington University School of Medicine
  NCT05949190updated 2026-03-02
• Comparative Evaluation of Post Obturation Pain After Root Canal Treatment Using Tricalcium Silicate vs Resin-Based Sealers
  Not yet recruiting · Interventional · 118 enrolled · Armed Forces Institute of Dentistry, Pakistan
  NCT07388368updated 2026-02-05
• Moxidectin for LF, Cote d'Ivoire (DOLF)
  Completed · Phase 3 · Interventional · 164 enrolled · Washington University School of Medicine
  NCT04410406updated 2026-01-29
• Field Studies on the Feasibility of Interrupting the Transmission of Soil-transmitted Helminths (STH)
  Completed · Phase 3 · Interventional · 357,716 enrolled · University of Washington
  NCT03014167updated 2026-01-22
• Tuberculosis - Learning the Impact of Nutrition
  Completed · Interventional · 786 enrolled · Boston Medical Center
  NCT03598842updated 2026-01-12
• Comparative Evaluation of Clinical and Radiographic Treatment Outcomes of Garlic Gel and Calcium Hydroxide as an Intracanal Medicament in Nonsurgical Root Canal Treatment of Permanent Teeth.
  Not yet recruiting · Phase 3 · Interventional · 96 enrolled · University of Health Sciences Lahore
  NCT07289971updated 2026-01-06

Frequently asked questions

How does Albendazole work?

Albendazole is a synthetic, antihelminthic drug of the class benzimidazole [see Clinical Pharmacology (12.4) ] .

What is Albendazole used for?

According to FDA labeling, Albendazole carries indications including: Albendazole is an anthelmintic drug indicated for: Treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, Taenia solium . ( 1.1 ) Treatment of cystic hydatid disease of the liver, lung, and peritoneum, caused by the larval form of the dog tapeworm, Echinococcus granulosus .. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Albendazole?

Albendazole is classified as Benzimidazole derivatives, Anthelmintic, beta Tubulin Interactions, Cytochrome P450 1A Inducers, Decreased Cytoskeleton Integrity, Decreased Glucose Transport into Cells, Decreased Metabolic Rate, Digestive Alteration.

What are the brand names for Albendazole?

Albendazole is marketed under brand names including Albendamax, Albenza, Valbazen.

What are the contraindications for Albendazole?

Albendazole labeling lists contraindications including: Albendazole is contraindicated in patients with known hypersensitivity to the benzimidazole class of compounds or any components of albendazole. Patients with known hypersensitivity to the benzimidazole class of compounds or any components of albendazole.. Always consult the full prescribing information and a clinician.