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Derma-Smoothe FS Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Derma-Smoothe FS (fluocinolone acetonide) is used to treat atopic dermatitis (a form of eczema), and is also used to treat scalp psoriasis. It is a topical (for the skin) steroid. This medication is available in generic form. Common side effects include stinging, burning, irritation, dryness, or redness at the application site. Acne, excessive hair growth, "hair bumps" (folliculitis), skin thinning/discoloration, or stretch marks may also occur.
The recommended adult dose of Derma-Smoothe FS is to apply as a thin film to the affected areas three times daily. For pediatric patients, moisten skin and apply Derma-Smoothe FS as a thin film to the affected areas twice daily for up to four weeks. It is not likely other drugs you take orally or inject will have an effect on topically applied Derma-Smoothe FS. But many drugs can interact with each other. Tell your doctor all medications and supplements you use. During pregnancy, Derma-Smoothe FS should be used only when prescribed. It is unknown if this drug passes into breast milk when applied to the skin. Similar medications pass into breast milk when taken by mouth. Consult your doctor before breastfeeding.
Our Derma-Smoothe FS (fluocinolone acetonide) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Derma-Smoothe FS in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using this medication and call your doctor at once if you have severe irritation of any treated skin, or if you show signs of absorbing fluocinolone topical oil through your skin, such as:
- blurred vision, headache;
- thinning skin, easy bruising;
- mood changes;
- weight gain, puffiness in your face; or
- muscle weakness, feeling tired.
Less serious side effects may include:
- mild skin itching, burning, dryness, or other irritation;
- temporary hair loss;
- swollen hair follicles;
- blisters, pimples, or crusting of treated skin;
- changes in color of treated skin;
- skin rash or irritation around your mouth;
- fever, cough, sore throat, runny or stuffy nose; or
- red spots or the appearance of tiny veins (especially around your nose, cheeks, or chin).
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Derma-Smoothe FS (Fluocinolone Acetonide) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Derma-Smoothe FS Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Rarely, it is possible this medication will be absorbed from the skin into the bloodstream. This can lead to side effects of too much corticosteroid. These side effects are more likely in children, and in people who use this medication for a long time or over large areas of the skin. Tell your doctor right away if any of the following side effects occur: unusual/extreme tiredness, weight loss, headache, swelling ankles/feet, increased thirst/urination, vision problems.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Derma-Smoothe FS (Fluocinolone Acetonide)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Derma-Smoothe FS FDA Prescribing Information: Side Effects
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Clinical Studies Experience: Evaluation of Facial Use in Pediatric Subjects
An, open-label, study was conducted in 58 children with moderate to severe atopic dermatitis (2 to 12 years old) to evaluate the safety of Derma-Smoothe/FS® (fluocinolone acetonide) when applied to the face twice daily for 4 weeks. The following adverse reactions were reported:
Incidence of Adverse Reactions (%)
|Adverse Reaction (AR)*|| # of subjects
|Day 14||Day 28**||Day 56***|
|Any AE||15 (26)||6 (10)||7 (12)||7 (12)|
|Telangiectasia||5 (9)||3 (5)||4 (7)||2 (4)|
|Erythema||3 (5)||3 (5)|
|Itching||3 (5)||3 (5)|
|Irritation||3 (5)||3 (5)|
|Burning||3 (5)||3 (5)|
|Hypopigmentation||2 (4)||2 (4)|
|Shiny skin||1 (2)||1 (2)|
|Secondary atopic dermatitis||1 (2)||1 (2)|
|Papules and pustules||1 (2)||1 (2)|
|Keratosis pilaris||1 (2)||1 (2)|
|Folliculitis||1 (2)||1 (2)|
|Facial herpes simplex||1 (2)||1 (2)|
|Acneiform eruption||1 (2)||1 (2)|
|Ear infection||1 (2)||1 (2)|
| *The number of individual adverse reactions reported does
not necessarily reflect the number of individual subjects, since one subject
could have multiple reporting of an adverse reaction.
**End of Treatment
***Four Weeks Post Treatment
Clinical Studies Experience: Evaluation in Pediatric Subjects 3 months to 2 years old
An open-label safety study was conducted in 29 children to assess the HPA axis by ACTH stimulation testing following use of Derma-Smoothe/FS (fluocinolone acetonide) twice daily for 4 weeks. The following adverse reactions were reported in the study [See Use in Specific Populations]:
Adverse Reactions (%)
|Adverse Reaction||# of subjects (%)|
|Otitis media||1 (3)|
|Atopic dermatitis||1 (3)|
|*Includes one subject who withdrew at Week 2|
Read the entire FDA prescribing information for Derma-Smoothe FS (Fluocinolone Acetonide) »
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