Simethicone
GET
/api/v1/drug/simethiconeMechanism of action
Sourced from openFDAMechanism-of-action class: Surfactant Activity.
Indications
Sourced from openFDA- Uses For the relief of pressure and bloating commonly referred to as gas
Dosage & administration
Sourced from openFDADirections adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime do not exceed 2 softgels in 24 hours except under the advice and supervision of a physician
Warnings & precautions
Sourced from openFDAIf pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.
Approval history
Sourced from openFDA- Sep 6, 2006ANDAANDA077500Sun Pharm Inds Ltd
- Sep 5, 2018ANDAANDA209837Perrigo R And D
- Dec 14, 2020ANDAANDA211059Aurobindo Pharma Ltd
- May 27, 2021ANDAANDA214541Guardian Drug
- Jun 17, 2021ANDAANDA211438Hetero Labs Ltd V
- Sep 10, 2021ANDAANDA213484Bionpharma
- Aug 29, 2022ANDAANDA215981Granules
FAERS reports
Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
8,083 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
- 1Chronic Kidney Disease1,15714%
- 2Nausea7018.7%
- 3Diarrhoea6498.0%
- 4Acute Kidney Injury6317.8%
- 5Fatigue6157.6%
- 6Renal Failure5827.2%
- 7Pain4095.1%
- 8Gastrooesophageal Reflux Disease4025.0%
- 9Vomiting3944.9%
- 10Dyspnoea3934.9%
- 11Headache3904.8%
- 12Drug Ineffective3664.5%
- 13Constipation3524.4%
- 14End Stage Renal Disease3384.2%
- 15Asthenia3294.1%
Literature
Recent PubMed references pinned to Simethicone as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.
- Efficacy and Safety of Pre-Endoscopy Regimens for Mucosal Visualization During Sedated Esophagogastro-duodenoscopy: A Randomized Controlled Trial.Acta medica Indonesiana · 2026 · Yusuf F, Abubakar A, Maghfirah D, et al.PMID 41978298
- Impact of Timing of Premedication on Mucosal Visibility During Endoscopy: A Randomized Controlled Trial.Journal of gastroenterology and hepatology · 2026 · Nabi Z, Dasireddy PS, Sayyed M, et al.PMID 41960652DOI 10.1111/jgh.70392
- Pre-endoscopy drink of small doses of simethicone and pronase solution improves visualization in upper gastrointestinal endoscopy: Randomised double-blind experiment.Medicine · 2025 · Li Y, Jiang J, Sheng J, et al.PMID 41327659DOI 10.1097/MD.0000000000046271
- Simethicone dosages with minimal normal saline solution volume to enhance mucosal visualization in upper endoscopy: a multicenter, randomized, double-blind, placebo-controlled trial.Scientific reports · 2025 · Saeung S, Morasert T, Wannawong P, et al.PMID 41318875DOI 10.1038/s41598-025-30192-1
- Efficacy and Safety of Bowel Cleansing with Mini S-Oral Sulfate Tablet versus the Conventional Oral Sulfate Tablet: A Prospective, Randomized, Investigator-Blinded, Multicenter, Noninferior, Phase 3 Trial.Gut and liver · 2026 · Park SK, Jeon SR, Yang DH, et al.PMID 41306094DOI 10.5009/gnl250291
- Efficacy of a mixture of simethicone and tyndallized bacillus coagulans in infant colic: a pilot study on behalf of Italian Society of Pediatrics (SIP).Italian journal of pediatrics · 2025 · Saviano M, Russo M, Buono P, et al.PMID 41225617DOI 10.1186/s13052-025-02140-2
- Comparative efficacy of 200 mg versus 1200 mg of simethicone with 3 L polyethylene glycol electrolyte solution for afternoon colonoscopy: a randomized controlled trial.BMC gastroenterology · 2025 · Cai X, Xue P, Li Y, et al.PMID 41073931DOI 10.1186/s12876-025-04215-0
- The efficacy and safety of simethicone for gastrointestinal preparation prior to pediatric endoscopy: a systematic review and meta-analysis.European journal of pediatrics · 2025 · Li S, Geng T, Li Z, et al.PMID 40906278DOI 10.1007/s00431-025-06438-5
Clinical trials
The 10 most recently updated of 111 ClinicalTrials.gov registrations naming Simethicone as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.
- Famotidine and Antacids for Treatment of DyspepsiaRecruiting · Phase 4 · Interventional · 80 enrolled · Stony Brook UniversityNCT06241183updated 2026-06-02
- Effects of Pre-procedure and Intra-procedure Simethicone and Dicyclomine Administration in Improving Quality of Endoscopic Reterograde Cholangipancreaticography (ERCP)Completed · Phase 4 · Interventional · 90 enrolled · CMH Lahore Medical College and Institute of DentistryNCT07461389updated 2026-04-13
- Effect of Intraluminal Administration of Menthol Solution During Colonoscopy on Colonic Spasm and Adenoma Detection RateNot yet recruiting · Interventional · 440 enrolled · The First Affiliated Hospital of Zhengzhou UniversityNCT07501962updated 2026-03-30
- Effect of a Novel Colonoscopic Lavage Solution on Colonoscopy QualityNot yet recruiting · Interventional · 498 enrolled · The First Affiliated Hospital of Zhengzhou UniversityNCT07501975updated 2026-03-30
- Robot-controlled Magnet-Assisted Capsule EndoscopyCompleted · Interventional · 15 enrolled · Sheffield Children's NHS Foundation TrustNCT06030518updated 2026-03-10
- 4-L Split-dose Polyethylene Glycol and Bisacodyl and Docusate Sodium Regimen Versus 2-L Split-dose Polyethylene Glycol Plus Oral Simethicone Regimen for Bowel Preparation Before ColonoscopyRecruiting · Interventional · 450 enrolled · Tanta UniversityNCT07328880updated 2026-01-09
- Effect of Simethicone on Helicobacter Pylori Detection in Routine EndoscopyNot yet recruiting · Interventional · 100 enrolled · Asian Institute of Gastroenterology, IndiaNCT07293234updated 2026-01-02
- Effect of Non-invasive Neuromodulation on the Quality of Intestinal CleansingNot yet recruiting · Interventional · 270 enrolled · Shanghai East HospitalNCT07290816updated 2025-12-18
- Hot Water Foot Bath for Pain and Gas Relief After Laparoscopic CholecystectomyNot yet recruiting · Interventional · 62 enrolled · Cansu MertNCT07126223updated 2025-12-05
- Double-blind, Randomized, Placebo-controlled Trial of Ganaxolone in CDKL5 Deficiency Patients 6 Months to Less Than 2 Years OldNot yet recruiting · Phase 3 · Interventional · 20 enrolled · Immedica Pharma ABNCT05249556updated 2025-11-28
Frequently asked questions
- How does Simethicone work?
- Mechanism-of-action class: Surfactant Activity.
- What is Simethicone used for?
- According to FDA labeling, Simethicone carries indications including: Uses For the relief of pressure and bloating commonly referred to as gas. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
- What class of drug is Simethicone?
- Simethicone is classified as Surfactant Activity, Digestive Alteration.
- What are the brand names for Simethicone?
- Simethicone is marketed under brand names including Almacone, Bicarsim, Comfort Gel, E-Z-Gas II, Gas Aide, Gas-X, Gas-X Total Relief, Gas-X with Maalox.
Note. Data for
simethicone 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.