SIMETHICONE

N/A

Manufactured by Haleon US Holdings LLC

10,965 FDA adverse event reports analyzed

Last updated: 2026-04-15

About SIMETHICONE

SIMETHICONE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Haleon US Holdings LLC. The most commonly reported adverse reactions for SIMETHICONE include NAUSEA, DIARRHOEA, FATIGUE, PAIN, FLATULENCE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for SIMETHICONE.

Top Adverse Reactions

NAUSEA468 reports
DIARRHOEA433 reports
FATIGUE414 reports
PAIN261 reports
FLATULENCE248 reports
CONSTIPATION247 reports
VOMITING244 reports
DYSPNOEA239 reports
DRUG INEFFECTIVE238 reports
HEADACHE237 reports
ABDOMINAL DISTENSION211 reports
DIZZINESS207 reports
ASTHENIA206 reports
WEIGHT DECREASED188 reports
ABDOMINAL PAIN187 reports
ABDOMINAL PAIN UPPER184 reports
OFF LABEL USE177 reports
FALL161 reports
MALAISE160 reports
DECREASED APPETITE154 reports
PNEUMONIA154 reports
ARTHRALGIA146 reports
ABDOMINAL DISCOMFORT145 reports
DEATH144 reports
PYREXIA135 reports
COUGH134 reports
INSOMNIA130 reports
ANXIETY129 reports
RASH129 reports
URINARY TRACT INFECTION129 reports
PAIN IN EXTREMITY121 reports
BACK PAIN120 reports
PRURITUS116 reports
ANAEMIA109 reports
DYSPEPSIA109 reports
DEHYDRATION108 reports
HYPOTENSION102 reports
FEELING ABNORMAL101 reports
MUSCLE SPASMS100 reports
CONDITION AGGRAVATED96 reports
HYPERTENSION96 reports
WEIGHT INCREASED96 reports
DEPRESSION92 reports
CHEST PAIN86 reports
GASTROOESOPHAGEAL REFLUX DISEASE86 reports
PRODUCT DOSE OMISSION ISSUE82 reports
MYALGIA78 reports
OEDEMA PERIPHERAL77 reports
PERIPHERAL SWELLING77 reports
GAIT DISTURBANCE75 reports
SOMNOLENCE75 reports
CONFUSIONAL STATE73 reports
BLOOD PRESSURE INCREASED72 reports
SINUSITIS72 reports
PARAESTHESIA69 reports
GASTROINTESTINAL DISORDER68 reports
VISION BLURRED68 reports
NASOPHARYNGITIS67 reports
TREMOR67 reports
HYPOAESTHESIA66 reports
PRODUCT USE ISSUE65 reports
HAEMOGLOBIN DECREASED64 reports
RENAL FAILURE64 reports
WHITE BLOOD CELL COUNT DECREASED64 reports
ALOPECIA62 reports
CHILLS62 reports
SEPSIS62 reports
DYSPHAGIA61 reports
ATRIAL FIBRILLATION58 reports
INJECTION SITE PAIN57 reports
CONTUSION56 reports
HYPERSENSITIVITY56 reports
CEREBROVASCULAR ACCIDENT55 reports
PULMONARY EMBOLISM55 reports
DRUG HYPERSENSITIVITY54 reports
DRY MOUTH54 reports
DISEASE PROGRESSION53 reports
ERYTHEMA53 reports
PLATELET COUNT DECREASED53 reports
NEUROPATHY PERIPHERAL52 reports
HEART RATE INCREASED51 reports
PRODUCT USE IN UNAPPROVED INDICATION51 reports
COVID 1950 reports
HOSPITALISATION50 reports
OROPHARYNGEAL PAIN50 reports
PLEURAL EFFUSION50 reports
ARTHRITIS48 reports
INFECTION48 reports
ERUCTATION47 reports
HOT FLUSH47 reports
INFLUENZA46 reports
INJURY46 reports
MIGRAINE46 reports
MUSCULAR WEAKNESS46 reports
BRONCHITIS45 reports
RENAL FAILURE ACUTE45 reports
DYSGEUSIA44 reports
DYSPHONIA44 reports
INCORRECT DOSE ADMINISTERED44 reports
SWELLING44 reports

Report Outcomes

Out of 4,445 classified reports for SIMETHICONE:

Serious 63.9%Non-Serious 36.1%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female2,746 (65.3%)
Male1,452 (34.5%)
Unknown6 (0.1%)

Reports by Age

Age 6080 reports
Age 6778 reports
Age 6577 reports
Age 6375 reports
Age 7775 reports
Age 6673 reports
Age 7371 reports
Age 7070 reports
Age 6268 reports
Age 7268 reports
Age 6465 reports
Age 7465 reports
Age 7965 reports
Age 7562 reports
Age 5560 reports
Age 6160 reports
Age 6957 reports
Age 5956 reports
Age 6856 reports
Age 7156 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with SIMETHICONE?

This profile reflects 10,965 FDA FAERS reports that mention SIMETHICONE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for SIMETHICONE?

Frequently reported terms in FAERS include NAUSEA, DIARRHOEA, FATIGUE, PAIN, FLATULENCE, CONSTIPATION. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures SIMETHICONE?

Labeling and FAERS entries often list Haleon US Holdings LLC in connection with SIMETHICONE. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.