Derma-Smoothe Scalp FS Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Derma-Smoothe Scalp FS (fluocinolone acetonide) Oil 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 dose for the treatment of scalp psoriasis is to wet or dampen hair and scalp thoroughly, and apply a thin film of Derma-Smoothe FS on the scalp, massage well and cover scalp with the supplied shower cap. Leave on overnight or for a minimum of 4 hours before washing off. Wash hair with regular shampoo and rinse thoroughly. It is not likely other drugs you take orally or inject will have an effect on topically applied Derma-Smoothe Scalp FS Oil. But many drugs can interact with each other. Tell your doctor all medications and supplements you use. During pregnancy, Derma-Smoothe Scalp 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 Scalp FS (fluocinolone acetonide) Oil 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.
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 Scalp FS (Fluocinolone Acetonide) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
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 Scalp FS (Fluocinolone Acetonide)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Derma-Smoothe Scalp FS FDA Prescribing Information: Side Effects
The following local adverse reactions have been reported infrequently with topical corticosteroids. They may occur more frequently with the use of occlusive dressings, especially with higher potency corticosteroids. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria. One peanut sensitive child experienced a flare of his atopic dermatitis after 5 days of twice daily treatment with Derma-Smoothe/FS®.
A post marketing (open-label) safety study was conducted in 58 children to evaluate the local safety of Derma-Smoothe/FS® when applied twice daily for 4 weeks to the face in children (2 to 12 years) with moderate to severe atopic dermatitis (see Table of Incidence of Adverse Events).
Incidence of Adverse Events (%) N=58
|Adverse Event (AE)*||# of patients (%)||Day 14||Day 28†||Day 56‡|
|AnyAE||15 (25.9)||6 (10.3)||7 (12.1)||7 (12.1)|
|Telangiectasia||5 (8.6)||3 (5.2)||4 (6.9)||2 (3.5)|
|Erythema||3 (5.2)||3 (5.2)|
|Itching||3 (5.2)||3 (5.2)|
|Irritation||3 (5.2)||3 (5.2)|
|Burning||3 (5.2)||3 (5.2)|
|Hypopigmentation||2 (3.5)||2 (3.5)|
|Shiny Skin||1 (1.7)||1 (1.7)|
|Secondary atopic dermatitis||1 (1.7)||1 (1.7)|
|Papules and pustules||1 (1.7)||1 (1.7)|
|Keratosis pilaris||1 (1.7)||1 (1.7)|
|Folliculitis||1 (1.7)||1 (1.7)|
|Facial herpes simplex||1 (1.7)||1 (1.7)|
|Acneiform eruption||1 (1.7)||1 (1.7)|
|Ear infection||1 (1.7)||1 (1.7)|
| *The number of individual adverse events reported does not
necessarily reflect the number of individual subjects, since one subject
could have multiple reporting of an adverse event
†End of Treatment
‡Four Weeks Post Treatment
Read the entire FDA prescribing information for Derma-Smoothe Scalp FS (Fluocinolone Acetonide) »
Additional Derma-Smoothe Scalp/FS Information
Derma-Smoothe Scalp/FS - User Reviews
Derma-Smoothe Scalp/FS User Reviews
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