Stromectol Side Effects

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

Side Effects of Stromectol - for the Consumer

Stromectol

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Stromectol:

Diarrhea; dizziness; nausea.

Seek medical attention right away if any of these SEVERE side effects occur when using Stromectol:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); eye pain, swelling, or redness; fainting; fast heartbeat; fever; joint pain; red, swollen, blistered, or peeling skin; seizures; severe dizziness or lightheadedness; swelling of the skin, arms, legs, ankles, or feet; tender or swollen lymph glands (eg, in the neck, groin, underarms); vision changes; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Stromectol Side Effects - for the Professional

Stromectol

Strongyloidiasis

In four clinical studies involving a total of 109 patients given either one or two doses of 170 to 200 mcg/kg of Stromectol, the following adverse reactions were reported as possibly, probably, or definitely related to Stromectol:

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 Stromectol experienced more abdominal distention and chest discomfort than patients treated with albendazole. However, Stromectol 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 Stromectol.

Laboratory Test Findings

In clinical trials involving 109 patients given either one or two doses of 170 to 200 mcg/kg Stromectol, 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.

Onchocerciasis

In clinical trials involving 963 adult patients treated with 100 to 200 mcg/kg Stromectol, worsening of the following Mazzotti reactions during the first 4 days post-treatment were reported: arthralgia/synovitis (9.3%), axillary lymph node enlargement and tenderness (11.0% and 4.4%, respectively), cervical lymph node enlargement and tenderness (5.3% and 1.2%, respectively), inguinal lymph node enlargement and tenderness (12.6% and 13.9%, respectively), other lymph node enlargement and tenderness (3.0% and 1.9%, respectively), pruritus (27.5%), skin involvement including edema, papular and pustular or frank urticarial rash (22.7%), and fever (22.6%).

In clinical trials, ophthalmological conditions were examined in 963 adult patients before treatment, at day 3, and months 3 and 6 after treatment with 100 to 200 mcg/kg Stromectol. Changes observed were primarily deterioration from baseline 3 days post-treatment. Most changes either returned to baseline condition or improved over baseline severity at the month 3 and 6 visits. The percentages of patients with worsening of the following conditions at day 3, month 3 and 6, respectively, were: limbitis: 5.5%, 4.8%, and 3.5% and punctate opacity: 1.8%, 1.8%, and 1.4%. The corresponding percentages for patients treated with placebo were: limbitis: 6.2%, 9.9%, and 9.4% and punctate opacity: 2.0%, 6.4%, and 7.2%.

In clinical trials involving 963 adult patients who received 100 to 200 mcg/kg Stromectol, the following clinical adverse reactions were reported as possibly, probably, or definitely related to the drug in ≥1% of the patients: facial edema (1.2%), peripheral edema (3.2%), orthostatic hypotension (1.1%), and tachycardia (3.5%). Drug-related headache and myalgia occurred in <1% of patients (0.2% and 0.4%, respectively). However, these were the most common adverse experiences reported overall during these trials regardless of causality (22.3% and 19.7%, respectively).

A similar safety profile was observed in an open study in pediatric patients ages 6 to 13.

The following ophthalmological side effects do occur due to the disease itself but have also been reported after treatment with Stromectol: abnormal sensation in the eyes, eyelid edema, anterior uveitis, conjunctivitis, limbitis, keratitis, and chorioretinitis or choroiditis. These have rarely been severe or associated with loss of vision and have generally resolved without corticosteroid treatment.

Laboratory Test Findings

In controlled clinical trials, the following laboratory adverse experiences were reported as possibly, probably, or definitely related to the drug in ≥1% of the patients: eosinophilia (3%) and hemoglobin increase (1%).

Post-Marketing Experience

The following adverse reactions have been reported since the drug was registered overseas:

Onchocerciasis

Conjunctival hemorrhage

All Indications

Hypotension (mainly orthostatic hypotension), worsening of bronchial asthma, toxic epidermal necrolysis, Stevens-Johnson syndrome, seizures, hepatitis, elevation of liver enzymes, and elevation of bilirubin.

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Side Effects by Body System - for Healthcare Professionals

General

Ivermectin 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. 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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