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Stromectol

Last reviewed on RxList: 5/1/2019
Stromectol Side Effects Center

Last reviewed on RxList 5/1/2019

Stromectol (ivermectin) is an anthelmintic (anti-parasite) used to treat infections caused by certain parasites. Common side effects of Stromectol include:

  • headache,
  • dizziness,
  • muscle pain,
  • nausea,
  • diarrhea,
  • swelling of hands/ankles/feet,
  • swelling or tenderness of your lymph nodes,
  • itching,
  • skin rash, or
  • feeling something is in your eye(s).

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 or swollen lymph nodes, eye swelling/redness/pain, weakness, vision changes, itching, rash, and fever. Tell your doctor if you have rare but very serious side effects of Stromectol including:

  • neck or back pain,
  • swelling face/arms/hands/feet,
  • chest pain,
  • fast heartbeat,
  • confusion,
  • seizures, or
  • loss of consciousness.

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 breastfeeding.

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.

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Stromectol Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • eye pain or redness, puffy eyes, problems with your vision;
  • severe skin rash, itching, or rash with pus;
  • confusion, change in your mental status, balance problems, trouble walking;
  • fever, swollen glands, stomach pain, joint pain, swelling in your hands or feet;
  • fast heart rate, trouble breathing;
  • loss of bladder or bowel control;
  • neck or back pain, seizure (convulsions); or
  • a light-headed feeling, like you might pass out.

Common side effects may include:

  • headache, muscle aches;
  • dizziness;
  • nausea, diarrhea; or
  • mild skin rash.

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.

Read the entire detailed patient monograph for Stromectol (Ivermectin)

QUESTION

Bowel regularity means a bowel movement every day. See Answer
Stromectol Professional Information

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)

Related Resources for Stromectol

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Read the Stromectol User Reviews »

© Stromectol Patient Information is supplied by Cerner Multum, Inc. and Stromectol Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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