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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

PYRANTEL: 39 Adverse Event Reports & Safety Profile

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39
Total FAERS Reports
3 (7.7%)
Deaths Reported
2
Hospitalizations
39
As Primary/Secondary Suspect
OPMX LLC
Manufacturer

Active Ingredient: PYRANTEL PAMOATE · Route: ORAL · Manufacturer: OPMX LLC · HUMAN OTC DRUG · FDA Label: Available

First Report: 201411 · Latest Report: 20240407

What Are the Most Common PYRANTEL Side Effects?

#1 Most Reported
Adverse event
17 reports (43.6%)
#2 Most Reported
Drug ineffective
4 reports (10.3%)
#3 Most Reported
Nausea
3 reports (7.7%)

All PYRANTEL Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Adverse event 17 43.6% 2 0

Who Reports PYRANTEL Side Effects? Age & Gender Data

Gender: 64.7% female, 35.3% male. Average age: 38.6 years. Most reports from: US. View detailed demographics →

Is PYRANTEL Getting Safer? Reports by Year

YearReportsDeathsHosp.
2014 2 0 1
2015 1 0 0
2016 1 0 1
2018 1 0 0
2019 5 0 0
2023 1 0 0
2024 1 0 0

View full timeline →

What Is PYRANTEL Used For?

IndicationReports
Enterobiasis 8

Official FDA Label for PYRANTEL

Official prescribing information from the FDA-approved drug label.

FDA Approved Uses (Indications)

Directions Take Heating Patch out ofpackaging.Use immediatelyafter package is opened. Remove paper from theadhesive backing. Place on pain area againsunderwear/clothing, not against skin.

Dosage & Administration

Directions Shake well before use. Adults, children 12 years of age and over, and children 2 years to under 12 years of age: Oral dosage is a single dose of 5 milligrams of pyrantel base per pound, or 11 milligrams per kilogram, of body weight. Do not exceed 1 gram (1000 mg).

Weight

Dosage (Taken as a single dose)

Under

25 lbs or 2 yrs. Don't use unless directed by a doctor 25-37 lbs ½ teaspoonful 38-62 lbs 1 teaspoonful 63-87 lbs 1 ½ teaspoonful 88-112 lbs 2 teaspoonful 113-137 lbs 2 ½ teaspoonful 138-162 lbs 3 teaspoonful 163-187lbs 3 ½ teaspoonful over 188 lbs 4 teaspoonful * Read package insert carefully before taking this medication. Take only according to directions and do not exceed the recommended dosage unless directed by a doctor. Medication should only be taken one time as a single dose; do not repeat treatment unless directed by a doctor. When one individual in a household has pinworms, the entire household should be treated unless otherwise advised.

See

Warnings . If any worms other than pinworms are present before or after treatment consult a doctor. If any symptoms or pinworms are still present after treatment, consult a doctor. *This product can be taken any time of day, with or without meals, it may be taken alone or with milk or fruit juice. Use of a laxative is not necessary prior to, during or after medication.

Warnings

Warnings Ask a doctor before use if you have liver disease are pregnant Stop use and ask a doctor if any symptoms or pinworms are still present after treatment any worms other than pinworms are present before or after treatment any of these symptoms that sometimes occur after taking the product persist: abdominal cramps nausea vomiting diarrhea headache dizziness Keep out of reach of children. In case of an accidental overdose get medical help or contact a Poison Control Center right away.

Active Ingredient

Active ingredient & Purpose Active ingredient (in each tablet)

Purpose

Pyrantel pamoate 180 (equivalent to 62.5mg of pyrantel base)......... Pinworm treatment

Inactive Ingredients

Inactive ingredients banana flavor, citric acid, gylcerin, lecithin, magnesium aluminum silicate, methylcellulose, methylparaben, povidone, propylene glycol, propylparaben, purified water, simethicone, sodium benzoate, sodium citrate, sodium saccharin and sorbitol.