Ivermectin (ivermectin)

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

The manufacturer states that safety and efficacy of ivermectin in children weighing less than 15 kg have not been established.

Ivermectin is administered orally as tablets. The tablets should be taken on an empty stomach with water.

Ivermectin is principally metabolized by the cytochrome P450 (CYP) isoenzyme 3A4 and, to a lesser extent, CYP2D6 and 2E1. Ivermectin does not inhibit CYP isoenzymes 3A4, 2D6, 2C9, 1A2, and 2E1.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

There is no enhanced messaging for this drug.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

• Loiasis

There is no enhanced messaging for this drug.

Less Frequent

• Conjunctivitis
• Corneal limbitis
• Corneal opacity
• Eyelid edema

Rare or Very Rare

• Abnormal hepatic function tests
• Asthma exacerbation
• Conjunctival hemorrhage
• Eosinophilia
• Hepatitis
• Hyperbilirubinemia
• Hypotension
• Leukopenia
• Mazzotti reaction
• Seizure disorder
• Stevens-johnson syndrome
• Toxic epidermal necrolysis

More Frequent

• Arthralgia
• Fever
• Lymphadenopathy
• Pruritus of skin
• Skin rash
• Tachycardia

Less Frequent

• Diarrhea
• Dizziness
• Facial edema
• Headache disorder
• Nausea
• Peripheral edema

Rare or Very Rare

• Acute abdominal pain
• Acute cognitive impairment
• Anorexia
• Constipation
• Drowsy
• Fatigue
• Myalgia
• Orthostatic hypotension
• Tremor
• Urticaria
• Vertigo
• Vomiting

No enhanced messaging available.

No enhanced messaging available.

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. Developmental effects (e.g., cleft palate, clubbed forepaws) were observed only at or near doses that were maternotoxic to the pregnant female; thus, ivermectin does not appear to be selectively fetotoxic to the developing fetus.

There are no adequate and controlled studies to date in humans, and the manufacturer and the American Academy of Pediatrics (AAP) state that ivermectin should not be used during pregnancy since safety in pregnancy has not been established. Although ivermectin has been inadvertently administered to pregnant women during mass distribution campaigns for treatment of onchocerciasis or lymphatic filariasis, the drug has not been associated with adverse pregnancy outcomes, congenital malformations, or differences in developmental status or disease patterns in the offspring of such women.

Because limited human pregnancy experience to date has revealed no evidence of teratogenicity or other adverse outcomes, the World Health Organization (WHO) and other experts state that use of ivermectin after the first trimester probably is acceptable for onchocerciasis since there is a high risk of infection-associated blindness if untreated.

Ivermectin is distributed into milk in low concentrations. Ivermectin should be used in nursing women only when the risk of delayed treatment to the woman outweighs the possible risk to the nursing infant.

No enhanced messaging available.