Loperamide
/api/v1/drug/loperamideMechanism of action
Sourced from openFDAMechanism-of-action class: Opioid Agonists.
Indications
Sourced from openFDA- Use controls symptoms of diarrhea, including Travelers’ Diarrhea
Dosage & administration
Sourced from openFDADirections • drink plenty of clear fluids to help prevent dehydration caused by diarrhea • find right dose on chart. If possible, use weight to dose; otherwise use age. • shake well before using • use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device. • mL = milliliter adults and children 12 years and over 30 mL after the first loose stool; 15 mL after each subsequent loose stool; but no more than 60 mL in 24 hours children 9-11 years (60-95 lbs) 15 mL after the first loose stool; 7.5 mL after each subsequent loose stool; but no more than 45 mL in 24 hours children 6-8 years (48-59 lbs) 15 mL after the first loose stool; 7.5 mL after each subsequent loose stool; but no more than 30 mL in 24 hours children 2-5 years (34 to 47 lbs) ask a doctor children under 2 years (up to 33 lbs) do not use
Warnings & precautions
Sourced from openFDAAllergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide HCl Heart alert: Taking more than directed can cause serious heart problems or death Do not use if you have bloody or black stool Ask a doctor before use if you have • fever • mucus in the stool • a history of liver disease • a history of abnormal heart rhythm Ask a doctor or pharmacist before use if you are taking a prescription drug. Loperamide may interact with certain prescription drugs. When using this product tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery. Stop use and ask a doctor if • symptoms get worse • diarrhea lasts for more than 2 days • you get abdominal swelling or bulging. These may be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Approval history
Sourced from openFDA- Mar 1, 1988NDANDA019487Kenvue Brands
- Sep 18, 1991ANDAANDA072741Mylan
- Apr 30, 1992ANDAANDA073192Teva
- Dec 10, 1992ANDAANDA074091Ohm Labs
- Jan 6, 2000ANDAANDA075232L Perrigo Co
- Nov 30, 2000NDANDA021140Kenvue Brands
- Jun 10, 2003ANDAANDA076497Lnk
- Aug 4, 2005NDANDA021855Bionpharma
FAERS reports
- 1Diarrhoea9,27218%
- 2Drug Ineffective5,33010%
- 3Nausea4,4628.7%
- 4Fatigue3,9907.7%
- 5Off Label Use3,5616.9%
- 6Vomiting2,9595.7%
- 7Constipation2,6445.1%
- 8Incorrect Dose Administered2,2014.3%
- 9Weight Decreased2,1554.2%
- 10Dyspnoea2,0854.0%
- 11Headache2,0494.0%
- 12Abdominal Pain1,8943.7%
- 13Asthenia1,8933.7%
- 14Decreased Appetite1,8323.6%
- 15Dizziness1,7993.5%
Literature
Recent PubMed references pinned to Loperamide as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.
- L-β-Galactoglucan alleviates loperamide-induced constipation in mice and regulates gut microbiota and metabolism.International journal of biological macromolecules · 2026 · Liu S, Yang Q, Du L, et al.PMID 41887441DOI 10.1016/j.ijbiomac.2026.151532
- Toxicity profile of supratherapeutic loperamide: a systematic review and dose-response analysis.Clinical toxicology (Philadelphia, Pa.) · 2026 · Bekka E, Martinez-De la Torre A, Haschke M, et al.PMID 41817965DOI 10.1080/15563650.2026.2634757
- L-Arabinose attenuates loperamide-induced constipation through the regulation of gut microbiota in mice.Food & function · 2026 · Zheng S, Zheng H, Huang Y, et al.PMID 41699997DOI 10.1039/d4fo03554b
- Ameliorative effects of Atractylodes macrocephala insoluble dietary fiber on loperamide-induced functional constipation in rats.Food research international (Ottawa, Ont.) · 2026 · Wang S, Feng W, Tu S, et al.PMID 41652675DOI 10.1016/j.foodres.2025.118256
- Smart CaCO(3)-coated probiotics relieve constipation by enhancing intestinal motility and modulating microbial enzymes in a loperamide-induced rat model.Scientific reports · 2026 · Jeong SN, Kim MJPMID 41634370DOI 10.1038/s41598-026-37864-6
- Managing Drug-Drug Interactions Involving the Non-Prescription Opioid Loperamide Through Physiologically Based Pharmacokinetic Modeling.CPT: pharmacometrics & systems pharmacology · 2026 · Zhou Z, Ainslie GR, Li M, et al.PMID 41563903DOI 10.1002/psp4.70148
- Effect of honey-aloe paste on alleviating loperamide-induced constipation, in relation to regulation on gastrointestinal function and intestinal microenvironment.Food research international (Ottawa, Ont.) · 2025 · Chang D, Wu F, Yang Y, et al.PMID 40922156DOI 10.1016/j.foodres.2025.117006
- Comparative evaluation of two herbal formulas for gastrointestinal function and gut microbiota modulation in rats with loperamide-induced dyspepsia.Scientific reports · 2025 · Khakisahneh S, Wang JH, Zhang XY, et al.PMID 40854940DOI 10.1038/s41598-025-15574-9
Clinical trials
The 10 most recently updated of 115 ClinicalTrials.gov registrations naming Loperamide as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.
- Efficacy of Pregabalin for Patients With Irritable Bowel SyndromeRecruiting · Interventional · 258 enrolled · Beijing Tiantan HospitalNCT07635394updated 2026-06-09
- Dalpiciclib, Anti-HER2 Therapy, and Endocrine Therapy for Hormone-Receptor-Positive, HER2-Positive Metastatic Breast CancerRecruiting · Phase 2 · Interventional · 57 enrolled · Sun Yat-sen UniversityNCT07610720updated 2026-05-28
- BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid TumorsRecruiting · Phase 1 · Interventional · 399 enrolled · BeOne MedicinesNCT06120283updated 2026-05-27
- Probiotics for Abemaciclib-Induced Abdominal Discomfort.Recruiting · Phase 2 · Interventional · 80 enrolled · Leeuwenhoek Laboratories Co. Ltd.NCT07605728updated 2026-05-26
- Improving Functional Outcomes and Quality of Life in Patients With Rectal Cancer After Surgery With Intensified Follow-up & SurveillanceRecruiting · Phase 3 · Interventional · 140 enrolled · University Hospital, Basel, SwitzerlandNCT06936774updated 2026-05-06
- A Bowel Management Program (Retrograde Rectal Enema) for the Treatment of Low Anterior Resection Syndrome in Rectal Cancer PatientsRecruiting · Interventional · 80 enrolled · Ohio State University Comprehensive Cancer CenterNCT06424522updated 2026-04-21
- Multi-System Analysis of Opioid Receptor BindingActive not recruiting · Phase 1 · Interventional · 25 enrolled · University of PennsylvaniaNCT05528848updated 2026-03-30
- Fecal Microbiota Transplantation in Treating Immune-Checkpoint Inhibitor Induced-Diarrhea or Colitis in Genitourinary Cancer PatientsRecruiting · Phase 1 · Interventional · 40 enrolled · M.D. Anderson Cancer CenterNCT04038619updated 2026-03-20
- Concentrated Complex Plant Dietary Elements for Chemotherapy-Induced DiarrheaCompleted · Phase 2 · Interventional · 30 enrolled · Tianjin Medical University Cancer Institute and HospitalNCT07460596updated 2026-03-10
- E7 TCR T Cells for Human Papillomavirus-Associated CancersCompleted · Phase 1 · Phase 2 · Interventional · 224 enrolled · National Cancer Institute (NCI)NCT02858310updated 2026-03-09
Frequently asked questions
- How does Loperamide work?
- Mechanism-of-action class: Opioid Agonists.
- What is Loperamide used for?
- According to FDA labeling, Loperamide carries indications including: Use controls symptoms of diarrhea, including Travelers’ Diarrhea. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
- What class of drug is Loperamide?
- Loperamide is classified as Antipropulsives, Opioid Agonist, Opioid Agonists, Decreased GI Motility, Stimulation Large Intestine Fluid/Electrolyte Absorption, Stimulation Small Intestine Fluid/Electrolyte Absorption.
- What are the brand names for Loperamide?
- Loperamide is marketed under brand names including Diamode, Imodium, Imodium Advanced, Imodium Multi-Symptom Relief.
loperamide is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.