DIMETHICONE: 607 Adverse Event Reports & Safety Profile
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Drug Class: Skin Barrier Activity [PE] · Route: TOPICAL · Manufacturer: Lidl US, LLC · HUMAN OTC DRUG · FDA Label: Available
First Report: 1981 · Latest Report: 20250910
What Are the Most Common DIMETHICONE Side Effects?
All DIMETHICONE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug ineffective | 78 | 12.9% | 2 | 18 |
| Off label use | 40 | 6.6% | 6 | 26 |
| Rash | 39 | 6.4% | 2 | 21 |
| Diarrhoea | 37 | 6.1% | 1 | 12 |
| Abdominal discomfort | 35 | 5.8% | 2 | 23 |
| Cerebrovascular accident | 35 | 5.8% | 0 | 30 |
| Nausea | 35 | 5.8% | 4 | 12 |
| Flatulence | 34 | 5.6% | 3 | 7 |
| Decreased appetite | 33 | 5.4% | 1 | 21 |
| Malaise | 31 | 5.1% | 2 | 18 |
| Pyrexia | 27 | 4.5% | 1 | 21 |
| Confusional state | 26 | 4.3% | 1 | 25 |
| Condition aggravated | 25 | 4.1% | 2 | 6 |
| Constipation | 25 | 4.1% | 1 | 7 |
| Fall | 25 | 4.1% | 1 | 19 |
| Vomiting | 25 | 4.1% | 5 | 11 |
| Abdominal pain | 24 | 4.0% | 3 | 14 |
| Lower respiratory tract infection | 24 | 4.0% | 0 | 17 |
| Abdominal distension | 23 | 3.8% | 2 | 8 |
| Fatigue | 23 | 3.8% | 3 | 11 |
Who Reports DIMETHICONE Side Effects? Age & Gender Data
Gender: 68.1% female, 31.9% male. Average age: 55.9 years. Most reports from: US. View detailed demographics →
Is DIMETHICONE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2000 | 1 | 0 | 1 |
| 2001 | 1 | 1 | 0 |
| 2004 | 2 | 0 | 1 |
| 2007 | 2 | 0 | 0 |
| 2009 | 2 | 0 | 0 |
| 2010 | 2 | 0 | 1 |
| 2011 | 1 | 0 | 0 |
| 2012 | 7 | 0 | 7 |
| 2013 | 6 | 0 | 4 |
| 2014 | 27 | 1 | 5 |
| 2015 | 39 | 1 | 9 |
| 2016 | 35 | 0 | 10 |
| 2017 | 20 | 2 | 6 |
| 2018 | 17 | 1 | 6 |
| 2019 | 25 | 2 | 8 |
| 2020 | 44 | 2 | 27 |
| 2021 | 16 | 0 | 3 |
| 2022 | 13 | 2 | 4 |
| 2023 | 23 | 1 | 7 |
| 2024 | 8 | 0 | 3 |
| 2025 | 12 | 0 | 0 |
What Is DIMETHICONE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 211 |
| Flatulence | 118 |
| Abdominal distension | 57 |
| Diarrhoea | 20 |
| Dry skin | 12 |
| Dry skin prophylaxis | 11 |
| Abdominal discomfort | 10 |
| Abdominal pain upper | 8 |
| Dyspepsia | 8 |
| Gastrooesophageal reflux disease | 8 |
DIMETHICONE vs Alternatives: Which Is Safer?
Official FDA Label for DIMETHICONE
Official prescribing information from the FDA-approved drug label.
FDA Approved Uses (Indications)
Uses Uses temporaily protects and helps relieve chafed, chapped or cracked skin helps protect from the drying effects of whine and cold weather helps treat and prevent diaper rash protects minor skin irritation associated with diaper rash and helps seal out wetness
Dosage & Administration
Directions
- drink plenty of clear fluids to help prevent dehydration caused by diarrhea
- take only on an empty stomach (1 hour before or 2 hours after a meal)
- take with a full (8 oz.) glass of water
- find right dose on chart below. If possible, use weight to dose; otherwise, use age. adults and children 12 years and over 2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours children 9-11 years (60-95 lbs) 1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours children 6-8 years (48-59 lbs) 1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours children 2-5 years (34 to 47 lbs) ask a doctor children under 2 years (upto 33 lbs) do not use Other information
- calcium: contains 142 mg/caplet
- store between 20-25° C (68-77° F). Protect from light.
- TAMPER EVIDENT: THIS PRODUCT PROTECTED WITH SEALED BLISTER UNITS. DO NOT USE IF ANY ARE TORN OR BROKEN.
Known Adverse Reactions
ADVERSE REACTION DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202 FOR MORE PRODUCT INFORMATION, SCAN UPC USING YOUR KROGER APP OR CALL 800-632-6900 Our brands.
Our
Guarantee. Love It or Your Money Back. www.kroger.com *Aveeno ® is a registered trademark of Johnson & Johnson Consumer Product Company, New Brunswick, New Jersey 08933. Johnson & Johnson Consumer Product Company is not affiliated with The Kroger Co. or this product. PLEASE RECYCLE
Warnings
WARNINGS Allergry alert: Do not user if you have ever had a rash or other allergic reaction to loperamide hydrochloride HEART ALERT Taking more than directed can cause serious heart problems or death. DO NOT USE
- if you have bloody or black stool
- if you have difficulty swallowing 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.
- you have difficulty swallowing the tablet If pregnant or breast-feeding , ask a health professional before use. 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)
Heart Alert
Taking more than directed can cause serious heart problems or death.
Active Ingredient
Active Ingredient Dimethicone 1%..............................Skin Protectant Petrolatum 30%..............................Skin Protectant
Inactive Ingredients
Inactive ingredients Pineapple Coconut: ozokerite, petrolatum, mineral oil, octyldodecanol, ethylhexyl palmitate, polyglyceryl-6 octastearate, cetearyl alcohol, flavor, polyglyceryl-6 polyricinoleate, sea water, VP/eicosene copolymer, ammonium glycyrrhizate, ananas sativus (pineapple) fruit extract, butylene glycol, carthamus tinctorius (safflower) seed oil, cetearyl glucoside, cocos nucifera (coconut) extract, ethylhexylglycerin, hyaluronic acid, limnanthes alba (meadowfoam) seed oil, menthol, nannochloropsis oculata extract, pentylene glycol, phenoxyethanol, phytosteryl/octyldodecyl lauroyl glutamate, porphyra umbilicalis extract, silanetriol, silybum marianum seed oil, tetrahexyldecyl ascorbate [vitamin C], tocopheryl acetate [vitamin E]
Peach
Mango: ozokerite, petrolatum, mineral oil, octyldodecanol, ethylhexyl palmitate, polyglyceryl-6 octastearate, cetearyl alcohol, flavor, polyglyceryl-6 polyricinoleate, sea water, VP/eicosene copolymer, ammonium glycyrrhizate, butylene glycol, carthamus tinctorius (safflower) seed oil, cetearyl glucoside, ethylhexylglycerin, hyaluronic acid, limnanthes alba (meadowfoam) seed oil, mangifera indica (mango) fruit extract, menthol, nannochloropsis oculata extract, pentylene glycol, phenoxyethanol, phytosteryl/octyldodecyl lauroyl glutamate, porphyra umbilicalis extract, prunus persica (peach) fruit extract, silanetriol, silybum marianum seed oil, tetrahexyldecyl ascorbate [vitamin C], tocopheryl acetate [vitamin E]
Strawberry
Kiwi: ozokerite, petrolatum, mineral oil, octyldodecanol, ethylhexyl palmitate, polyglyceryl-6 octastearate, cetearyl alcohol, flavor, polyglyceryl-6 polyricinoleate, sea water, VP/eicosene copolymer, actinidia chinesis (kiwi) fruit extract, ammonium glycyrrhizate, butylene glycol, carthamus tinctorius (safflower) seed oil, cetearyl glucoside, ethylhexylglycerin, fragaria vesca (strawberry) fruit extract, hyaluronic acid, limnanthes alba (meadowfoam) seed oil, menthol, nannochloropsis oculata extract, pentylene glycol, phenoxyethanol, phytosteryl/octyldodecyl lauroyl glutamate, porphyra umbilicalis extract, silanetriol, silybum marianum seed oil, tetrahexyldecyl ascorbate [vitamin C], tocopheryl acetate [vitamin E] Questions? 1-877-636-2677 MON-FRI 9 AM to 5 PM (EST) softlips.com