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Derma-Smoothe/FS

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

Last reviewed on RxList 02/14/2017

Derma-Smoothe FS (fluocinolone acetonide) 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 FS is available in generic form. Common side effects of Derma-Smoothe FS include:

  • application site reactions (stinging, burning, irritation, dryness, itching, or redness),
  • acne,
  • excessive hair growth,
  • "hair bumps" (folliculitis),
  • skin thinning,
  • skin discoloration,
  • stretch marks,
  • temporary hair loss,
  • blisters,
  • pimples,
  • crusting 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 severe irritation of any treated skin, or if you show signs of absorbing Derma-Smoothe FS topical oil through your skin, such as:

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

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.

Derma-Smoothe 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 FS (Fluocinolone Acetonide)

Derma-Smoothe FS Professional 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 (%)
N=58

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 (%)
N=30*

Adverse Reaction # of subjects (%)
Diarrhea 1 (3)
Vomiting 1 (3)
Pyrexia 3 (10)
Abscess 1 (3)
Molluscum 1 (3)
Nasopharyngitis 2 (7)
URI 1 (3)
Otitis media 1 (3)
Cough 6 (20)
Rhinorrhea 4 (13)
Atopic dermatitis 1 (3)
Eczema 1 (3)
Hyperpigmentation 1 (3)
Hypopigmentation 2 (7)
Rash 1 (3)
*Includes one subject who withdrew at Week 2

Read the entire FDA prescribing information for Derma-Smoothe FS (Fluocinolone Acetonide)

Related Resources for Derma-Smoothe FS

Read the Derma-Smoothe FS User Reviews »

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

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