pharmacopeia

Simethicone

Surfactant ActivityDigestive AlterationUS-FDASourced from openFDA
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Mechanism of action

Sourced from openFDA

Mechanism-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 openFDA

Directions 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 openFDA

If 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

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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.
  1. 1Chronic Kidney Disease1,15714%
  2. 2Nausea7018.7%
  3. 3Diarrhoea6498.0%
  4. 4Acute Kidney Injury6317.8%
  5. 5Fatigue6157.6%
  6. 6Renal Failure5827.2%
  7. 7Pain4095.1%
  8. 8Gastrooesophageal Reflux Disease4025.0%
  9. 9Vomiting3944.9%
  10. 10Dyspnoea3934.9%
  11. 11Headache3904.8%
  12. 12Drug Ineffective3664.5%
  13. 13Constipation3524.4%
  14. 14End Stage Renal Disease3384.2%
  15. 15Asthenia3294.1%

Literature

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Recent PubMed references pinned to Simethicone as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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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.

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.

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