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Stromectol

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Stromectol

Stromectol Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Stromectol (ivermectin) is used to treat infections caused by certain parasites. It is an anthelmintic (anti-parasite). Common side effects include headache, dizziness, muscle pain, nausea, or diarrhea. If you are being treated for "river blindness" (onchocerciasis), you may experience reactions to the dying parasites during the first 4 days of treatment, including joint pain, tender/swollen lymph nodes, eye swelling/redness/pain, weakness, vision changes, itching, rash, and fever.

The recommended dosage of Stromectol for the treatment of strongyloidiasis is a single oral dose that provides approximately 200 mcg per kg of body weight. The recommended dosage for the treatment of onchocerciasis is a single oral dose that provides approximately 150 mcg per kg of body weight. Patients should take tablets on an empty stomach with water. There may be other drugs that can affect Stromectol. Tell your doctor all prescription and over-the-counter medications and supplements you use. During pregnancy, Stromectol should be used only when prescribed. This medication passes into breast milk. Though there have been no reports of harm to nursing infants, consult your doctor before breast-feeding.

Our Stromectol (ivermectin) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Stromectol in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: 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. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Stromectol (Ivermectin) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Stromectol Overview - Patient Information: Side Effects

SIDE EFFECTS: Headache, dizziness, muscle pain, nausea, or diarrhea may occur. If you are being treated for "river blindness" (onchocerciasis), you may experience reactions to the dying parasites during the first 4 days of treatment, including joint pain, tender/swollen lymph nodes, eye swelling/redness/pain, weakness, vision changes, itching, rash, and fever. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To reduce dizziness upon standing, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these rare but very serious side effects occur: neck/back pain, swelling face/arms/hands/feet, chest pain, fast heartbeat, confusion, seizures, loss of consciousness.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Stromectol (Ivermectin)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Stromectol FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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 (ivermectin) , the following adverse reactions were reported as possibly, probably, or definitely related to STROMECTOL (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 STROMECTOL (ivermectin) experienced more abdominal distention and chest discomfort than patients treated with albendazole. However, STROMECTOL (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 STROMECTOL (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 STROMECTOL (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.

Onchocerciasis

In clinical trials involving 963 adult patients treated with 100 to 200 mcg/kg STROMECTOL (ivermectin) , 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%). (See WARNINGS.)

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 (ivermectin) . 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%. (See WARNINGS.)

In clinical trials involving 963 adult patients who received 100 to 200 mcg/kg STROMECTOL (ivermectin) , 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 (ivermectin) : 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.

Read the entire FDA prescribing information for Stromectol (Ivermectin) »

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Stromectol - User Reviews

Stromectol User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Stromectol sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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