Stromectol Side Effects

Generic name: ivermectin

Note: This document contains side effect information about ivermectin. Some of the dosage forms listed on this page may not apply to the brand name Stromectol.

Some side effects of Stromectol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to ivermectin: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking ivermectin (the active ingredient contained in Stromectol) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• vision changes or problems with your vision;

• urinary or bowel problems;

• weakness, confusion, lack of coordination;

• eye redness, swelling, or pain; or

• seizure (convulsions).

Other less serious side effects may be more likely to occur, such as:

• nausea, diarrhea;

• dizziness;

• swelling of your hands, ankles, or feet;

• swelling or tenderness of your lymph nodes;

• itching or skin rash; or

• feeling that something is in your eye(s).

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

For Healthcare Professionals

Applies to ivermectin: compounding powder, oral tablet

General

Ivermectin (the active ingredient contained in Stromectol) is well tolerated compared to other microfilaricidal agents (i.e., thiabendazole, diethylcarbamazine). Adverse reactions (i.e., pruritus, fever, rash, myalgia, headache) occur commonly during the first 3 days after treatment and appear to be related to the extent of parasitic infection and systemic mobilization and killing of microfilariae. The majority of reactions can usually be treated with aspirin, acetaminophen and/or antihistamines. Adverse effects tend to occur with lesser frequency during periods of retreatment.

Ocular

Ocular side effects have included eyelid edema, anterior uveitis, blurred vision, conjunctivitis, limbitis, punctate opacity, keratitis, abnormal sensation in the eyes, and chorioretinitis/choroiditis; however, these effects are also associated with the disease onchocerciasis. Loss of vision has occurred rarely but usually resolved without corticosteroid treatment. Conjunctival hemorrhage has been reported during postmarketing experience in patients treated for onchocerciasis.

Other

Worsening of Mazzotti reactions, including arthralgia, synovitis, lymph node enlargement and tenderness, pruritus, skin involvement (including edema, papular and pustular or frank urticarial rash), and fever, has been reported during the first 4 days following treatment for onchocerciasis.

Nervous system

Nervous system side effects have included dizziness, headache, somnolence, vertigo, and tremor. Serious or fatal encephalopathy has been reported rarely in patients with onchocerciases, and heavily infected with Loa loa, either spontaneously or after treatment with ivermectin (the active ingredient contained in Stromectol) Seizures have been reported during postmarketing experience.

Gastrointestinal

Gastrointestinal side effects have included anorexia, constipation, diarrhea, nausea, vomiting, and abdominal distention.

Other

Other side effects have included asthenia, fatigue, abdominal pain, chest discomfort, facial edema, and peripheral edema.

Hematologic

Hematologic side effects have included decreased leukocyte count (3%), eosinophilia (3%), and increased hemoglobin (1%). Hematomatous swellings associated with prolonged prothrombin times have been reported, but the clinical significance is unknown. Leukopenia and anemia have been reported in at least one patient.

Hepatic

Hepatic side effects have included elevated ALT and/or AST. Elevated liver enzymes, elevated bilirubin, and hepatitis have been reported during postmarketing experience.

Cardiovascular

Cardiovascular side effects have included tachycardia and orthostatic hypotension. EKG changes, including prolonged PR interval, flattened T waves and peaked T waves, have been reported in single cases. Hypotension (primarily orthostatic hypotension) has been reported during postmarketing experience.

Dermatologic

Dermatologic side effects have included pruritus, rash, and urticaria. Toxic epidermal necrolysis and Stevens-Johnson syndrome have been reported during postmarketing experience.

Respiratory

Respiratory side effects have included worsening bronchial asthma, laryngeal edema, and dyspnea.

Musculoskeletal

Musculoskeletal side effects have included myalgia.

Renal

Renal side effects have included rare transient proteinuria.

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