Ivermectin
/api/v1/drug/ivermectinMechanism of action
Sourced from openFDAMechanism-of-action class: Chloride Channel Interactions.
Indications
Sourced from openFDA- Ivermectin is indicated for the treatment of the following infections: Strongyloidiasis of the intestinal tract Ivermectin is indicated for the treatment of intestinal (i.e., nondisseminated) strongyloidiasis due to the nematode parasite Strongyloides stercoralis . This indication is based on clinical studies of both comparative and open-label designs, in which 64-100% of infected patients were cured following a single 200-mcg/kg dose of ivermectin (See CLINICAL PHARMACOLOGY, Clinical Studies ).
Contraindications
Sourced from openFDA- Ivermectin Tablets are contraindicated in patients who are hypersensitive to any component of this product.contraindicated
Dosage & administration
Sourced from openFDAStrongyloidiasis The recommended dosage of ivermectin Tablets for the treatment of strongyloidiasis is a single oral dose designed to provide approximately 200 mcg of ivermectin per kg of body weight. See Table 1 for dosage guidelines. Patients should take tablets on an empty stomach with water (See CLINICAL PHARMACOLOGY, Pharmacokinetics ). In general, additional doses are not necessary. However, follow-up stool examinations should be performed to verify eradication of infection (See CLINICAL PHARMACOLOGY, Clinical Studies ). Table 1: Dosage Guidelines for Ivermectin Tablets for Strongyloidiasis Body Weight (kg) Single Oral Dose Number of 3-mg Tablets 15-24 1 tablet 25-35 2 tablets 36-50 3 tablets 51-65 4 tablets 66-79 5 tablets ≥ 80 200 mcg/kg Onchocerciasis The recommended dosage of ivermectin Tablets for the treatment of onchocerciasis is a single oral dose designed to provide approximately 150 mcg of ivermectin per kg of body weight. See Table 2 for dosage guidelines. Patients should take tablets on an empty stomach with water (See CLINICAL PHARMACOLOGY, Pharmacokinetics ). In mass distribution campaigns in international treatment programs, the most commonly used dose interval is 12 months. For the treatment of individual patients, retreatment may be considered at intervals as short as 3 months. Table 2: Dosage Guidelines for Ivermectin Tablets for Onchocerciasis Body Weight (kg) Single Oral Dose Number of 3-mg Tablets 15-25 1 tablet 26-44 2 tablets 45-64 3 tablets 65-84 4 tablets ≥ 85 150 mcg/kg
Warnings & precautions
Sourced from openFDAHistorical data have shown that microfilaricidal drugs, such as diethylcarbamazine citrate (DEC-C), might cause cutaneous and/or systemic reactions of varying severity (the Mazzotti reaction) and ophthalmological reactions in patients with onchocerciasis. These reactions are probably due to allergic and inflammatory responses to the death of microfilariae. Patients treated with ivermectin for onchocerciasis may experience these reactions in addition to clinical adverse reactions possibly, probably, or definitely related to the drug itself (See ADVERSE REACTIONS, Onchocerciasis ). The treatment of severe Mazzotti reactions has not been subjected to controlled clinical trials. Oral hydration, recumbency, intravenous normal saline, and/or parenteral corticosteroids have been used to treat postural hypotension. Antihistamines and/or aspirin have been used for most mild to moderate cases. Neurotoxicity with the use of ivermectin, including alteration of consciousness of variable severity (e.g., somnolence/drowsiness, stupor, and coma), confusion, disorientation and death, has been reported in patients without onchocerciasis or in patients with onchocerciasis in the absence of Loa loa infection. These reactions have generally resolved with supportive care and the discontinuation of ivermectin.
Adverse reactions
Sourced from openFDAStrongyloidiasis In four clinical studies involving a total of 109 patients given either one or two doses of 170 to 200 mcg/kg of ivermectin, the following adverse reactions were reported as possibly, probably, or definitely related to ivermectin: Body as a Whole: asthenia/fatigue (0.9%), abdominal pain (0.9%) Gastrointestinal: anorexia (0.9%), constipation (0.9%), diarrhea (1.8%), nausea (1.8%), vomiting (0.9%) Nervous System/Psychiatric: dizziness (2.8%), somnolence (0.9%), vertigo (0.9%), tremor (0.9%) Skin: pruritus (2.8%), rash (0.9%), and urticaria (0.9%). In comparative trials, patients treated with ivermectin experienced more abdominal distention and chest discomfort than patients treated with albendazole. However, ivermectin was better tolerated than thiabendazole in comparative studies involving 37 patients treated with thiabendazole. The Mazzotti-type and ophthalmologic reactions associated with the treatment of onchocerciasis or the disease itself would not be expected to occur in strongyloidiasis patients treated with ivermectin (See ADVERSE REACTIONS, Onchocerciasis ). Laboratory Test Findings In clinical trials involving 109 patients given either one or two doses of 170 to 200 mcg/kg ivermectin, the following laboratory abnormalities were seen regardless of drug relationship: elevation in ALT and/or AST (2%), decrease in leukocyte count (3%). Leukopenia and anemia were seen in one patient.
Use in specific populations
Sourced from openFDAPregnancy, Teratogenic Effects Ivermectin has been shown to be teratogenic in mice, rats, and rabbits when given in repeated doses of 0.2, 8.1, and 4.5 times the maximum recommended human dose, respectively (on a mg/m2/day basis). Teratogenicity was characterized in the three species tested by cleft palate; clubbed forepaws were additionally observed in rabbits. These developmental effects were found only at or near doses that were maternotoxic to the pregnant female. Therefore, ivermectin does not appear to be selectively fetotoxic to the developing fetus. There are, however, no adequate and well-controlled studies in pregnant women. Ivermectin should not be used during pregnancy since safety in pregnancy has not been established.
Pharmacokinetics
Sourced from openFDA- Metabolism
- Following oral administration of ivermectin, plasma concentrations are approximately proportional to the dose. In two studies, after single 12-mg doses of ivermectin in fasting healthy volunteers (representing a mean dose of 165 mcg/kg), the mean peak plasma concentrations of the major component (H 2 B 1a ) were 46.6 (±21.9) (range: 16.4 to 101.1) and 30.6 (±15.6) (range: 13.9 to 68.4) ng/mL, respectively, at approximately 4 hours after dosing.
Overdosage
Sourced from openFDACases of neurotoxicity, including alteration of consciousness of variable severity (e.g., somnolence/drowsiness, stupor, and coma), confusion, disorientation and death have been reported with recommended dosage and overdosage of ivermectin (see WARNINGS ). Significant lethality was observed in mice and rats after single oral doses of 25 to 50 mg/kg and 40 to 50 mg/kg, respectively. No significant lethality was observed in dogs after single oral doses of up to 10 mg/kg. At these doses, the treatment-related signs that were observed in these animals include ataxia, bradypnea, tremors, ptosis, decreased activity, emesis, and mydriasis. In accidental intoxication with, or significant exposure to, unknown quantities of veterinary formulations of ivermectin in humans, either by ingestion, inhalation, injection, or exposure to body surfaces, the following adverse effects have been reported most frequently: rash, edema, headache, dizziness, asthenia, nausea, vomiting, and diarrhea. Other adverse effects that have been reported include: seizure, ataxia, dyspnea, abdominal pain, paresthesia, urticaria, and contact dermatitis.
Approval history
Sourced from openFDA- Nov 22, 1996NDANDA050742Merck Sharp Dohme
- Feb 7, 2012NDANDA202736Arbor Pharms Llc
- Oct 24, 2014ANDAANDA204154Edenbridge Pharms
- Dec 19, 2014NDANDA206255Galderma Labs Lp
- Sep 13, 2019ANDAANDA210019Teva Pharms Usa
- Apr 13, 2020ANDAANDA210225Padagis Israel
- May 6, 2020ANDAANDA210720Taro
- Aug 2, 2022ANDAANDA215210Zydus Lifesciences
FAERS reports
- 1Drug Ineffective73912%
- 2Headache64611%
- 3Asthenia5889.6%
- 4Off Label Use4847.9%
- 5Pyrexia4847.9%
- 6Product Use In Unapproved Indication4617.6%
- 7Pruritus3786.2%
- 8Diarrhoea2894.7%
- 9Ocular Hyperaemia2564.2%
- 10Coma2464.0%
- 11Erythema2383.9%
- 12Conjunctival Haemorrhage2373.9%
- 13Back Pain2283.7%
- 14Vertigo2173.6%
- 15Arthralgia2063.4%
Literature
Recent PubMed references pinned to Ivermectin as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.
- Avermectin disrupts blood-brain barrier integrity in zebrafish larvae via the Wnt/β-catenin signaling pathway.Pesticide biochemistry and physiology · 2026 · Wang WG, Du LJ, Ma HO, et al.PMID 42264772DOI 10.1016/j.pestbp.2026.107178
- Gut microbial dysbiosis is associated with detoxification impairment in parasitoid wasps exposed to Emamectin benzoate.Pesticide biochemistry and physiology · 2026 · Yu L, Pang L, Xu Z, et al.PMID 42264718DOI 10.1016/j.pestbp.2026.107166
- Childhood granulomatous periorificial dermatitis: Ivermectin as a novel therapeutic approach.Dermatology online journal · 2026 · Correia MP, Fernandes S, de Vasconcelos P, et al.PMID 42246357DOI 10.25251/1qr8wf61
- Integrated in vitro and in vivo evaluation of ivermectin hydrogel formulation for management of scabies with pharmacological assessment.Scientific reports · 2026 · Mohamed SA, Ahmad AA, Mustafa FEA, et al.PMID 42243269DOI 10.1038/s41598-026-53626-w
- Optimising treatment options in scabies.Drug and therapeutics bulletin · 2026PMID 42209017DOI 10.1136/dtb.2026.000021
- 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
- Life-threatening neurotoxicity following off-label ivermectin use in metastatic breast cancer: a case report.Postgraduate medicine · 2026 · Saperstein Y, Bou Sanayeh E, Boazak P, et al.PMID 42170801DOI 10.1080/00325481.2026.2672183
- A Modified QuEChERS Combined With HPLC-MS/MS for the Determination of Emamectin Benzoate, Spinetoram, and Their Major Metabolites in Eggplant Field Samples.Journal of separation science · 2026 · Pei T, Wang X, Hu J, et al.PMID 42153591DOI 10.1002/jssc.70448
Clinical trials
The 10 most recently updated of 234 ClinicalTrials.gov registrations naming Ivermectin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.
- Analysis of the Microbiome in RosaceaActive not recruiting · Early phase 1 · Interventional · 150 enrolled · Johns Hopkins UniversityNCT04108897updated 2026-06-08
- Ivermectin in Combination With Balstilimab or Pembrolizumab in Patients With Metastatic Triple Negative Breast CancerRecruiting · Phase 1 · Phase 2 · Interventional · 34 enrolled · Yuan YuanNCT05318469updated 2026-05-06
- COVID-OUT: Early Outpatient Treatment for SARS-CoV-2 Infection (COVID-19)Completed · Phase 3 · Interventional · 1,323 enrolled · University of MinnesotaNCT04510194updated 2026-04-24
- Rosacea and IvermectinCompleted · Phase 2 · Interventional · 30 enrolled · Wake Forest University Health SciencesNCT04275999updated 2026-03-27
- Ivermectin Therapy for Scabies Infection in Children Younger Than 5 Years of Age (ITCHY Study)Active not recruiting · Phase 2 · Interventional · 120 enrolled · Murdoch Childrens Research InstituteNCT05500326updated 2026-03-23
- Ivermectin Combined With Immune Checkpoint Inhibition in Cancer (ICONIC)Not yet recruiting · Phase 2 · Interventional · 80 enrolled · University of FloridaNCT07487805updated 2026-03-23
- HEALTH Trial - Healthy Adult Evaluation of Ivermectin Bioequivalence: Infant Versus Standard FormulationSuspended · Phase 1 · Interventional · 52 enrolled · Murdoch Childrens Research InstituteNCT06918665updated 2026-03-20
- 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 AlbendazoleCompleted · Phase 3 · Interventional · 12,979 enrolled · Medicines Development for Global HealthNCT04311671updated 2026-03-03
- Finding Treatments for COVID-19: A Trial of Antiviral Pharmacodynamics in Early Symptomatic COVID-19 (PLATCOV)Recruiting · Phase 2 · Interventional · 3,800 enrolled · University of OxfordNCT05041907updated 2026-02-19
- the Efficacy of Ivermectin Alone or With Microneedling in Treatment of Cutaneous Warts.Not yet recruiting · Early phase 1 · Interventional · 88 enrolled · Assiut UniversityNCT07396714updated 2026-02-09
Frequently asked questions
- How does Ivermectin work?
- Mechanism-of-action class: Chloride Channel Interactions.
- What is Ivermectin used for?
- According to FDA labeling, Ivermectin carries indications including: Ivermectin is indicated for the treatment of the following infections: Strongyloidiasis of the intestinal tract Ivermectin is indicated for the treatment of intestinal (i.e., nondisseminated) strongyloidiasis due to the nematode parasite Strongyloides stercoralis . This indication is based on clinical studies of both comparative and open-label designs, in which 64-100% of infected patients were cured following a single 200-mcg/kg dose of ivermectin (See CLINICAL PHARMACOLOGY, Clinical Studies ).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
- What class of drug is Ivermectin?
- Ivermectin is classified as Avermectines, Other dermatologicals, Antiparasitic, Pediculicide, Chloride Channel Interactions, Nervous System Activity Alteration.
- What are the brand names for Ivermectin?
- Ivermectin is marketed under brand names including Agrimectin, Bimectin, Bimectin Plus, DuraMectin, Equimax, Heartgard Plus, Iverhart, Iverhart Plus.
- What are the contraindications for Ivermectin?
- Ivermectin labeling lists contraindications including: Ivermectin Tablets are contraindicated in patients who are hypersensitive to any component of this product.. Always consult the full prescribing information and a clinician.
ivermectin is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.