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.
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%).
The following adverse reactions have been reported since the drug was registered
Hypotension (mainly orthostatic hypotension), worsening of bronchial asthma, toxic epidermal necrolysis, Stevens-Johnson syndrome, seizures, hepatitis, elevation of liver enzymes, and elevation of bilirubin.
Post-marketing reports of increased INR (International Normalized Ratio) have
been rarely reported when ivermectin was co-administered with warfarin.