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Derma-Smoothe Scalp FS

Last reviewed on RxList: 12/21/2016
Derma-Smoothe Scalp FS Side Effects Center

Last reviewed on RxList 12/9/2016

Derma-Smoothe Scalp FS (fluocinolone acetonide) Oil is a topical (for the skin) steroid used to treat atopic dermatitis (a form of eczema), and is also used to treat scalp psoriasis. Derma-Smoothe Scalp FS Oil is available in generic form. Common side effects of Derma-Smoothe Scalp FS Oil include:

  • application site reactions (stinging, burning, irritation, dryness, itching, or redness),
  • temporary hair loss,
  • acne,
  • excessive hair growth,
  • "hair bumps" (folliculitis),
  • skin thinning,
  • stretch marks,
  • blisters 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).

Tell your doctor if you have serious side effects of Derma-Smoothe Scalp FS including:

  • blurred vision,
  • headache,
  • easy bruising,
  • mood changes,
  • weight gain,
  • puffiness in your face,
  • muscle weakness, or
  • feeling tired.

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.

Derma-Smoothe Scalp FS Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult 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.

Common 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. Call your doctor for medical advice about side effects. 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)

Derma-Smoothe Scalp FS Professional 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)

Related Resources for Derma-Smoothe Scalp FS

Read the Derma-Smoothe Scalp FS User Reviews »

© Derma-Smoothe Scalp FS Patient Information is supplied by Cerner Multum, Inc. and Derma-Smoothe Scalp FS Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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