pharmacopeia

Mechanism of action

Sourced from openFDA

Mechanism-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 openFDA

Strongyloidiasis 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 openFDA

Historical 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 openFDA

Strongyloidiasis 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 openFDA

Pregnancy, 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 openFDA

Cases 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

View JSON
Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
6,095 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective73912%
  2. 2Headache64611%
  3. 3Asthenia5889.6%
  4. 4Off Label Use4847.9%
  5. 5Pyrexia4847.9%
  6. 6Product Use In Unapproved Indication4617.6%
  7. 7Pruritus3786.2%
  8. 8Diarrhoea2894.7%
  9. 9Ocular Hyperaemia2564.2%
  10. 10Coma2464.0%
  11. 11Erythema2383.9%
  12. 12Conjunctival Haemorrhage2373.9%
  13. 13Back Pain2283.7%
  14. 14Vertigo2173.6%
  15. 15Arthralgia2063.4%

Literature

View JSON

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

Clinical trials

View JSON

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.

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.
Note. Data for 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.

Search pharmacopeia

Search drugs, classes, and ingredients