Derma-Smoothe Side Effects

A few of the common side effects of Derma-Smoothe that may occur in adults include skin burning, irritation, and dryness. Although only vague information is available about the possible reactions that may occur in adults, extensive clinical trials have been done to document the side effects that may occur in children. In these studies, some of the problems included acne, skin reactions, and ear infections.

An Introduction to Derma-Smoothe Side Effects

Just like any medicine, Derma-Smoothe/FS® (fluocinolone oil) can cause side effects. However, not everyone who uses this product will have problems. In fact, most people tolerate it quite well. If side effects do occur, in most cases, they are minor and either require no treatment or are treated easily by you or your healthcare provider.
 
(This article covers many, but not all, of the possible side effects with Derma-Smoothe. Your healthcare provider can discuss a more complete list with you.)
 

Common Side Effects of Derma-Smoothe

For many medications, the prescribing information carefully explains the exact percentage of side effects that were reported in clinical trials. However, the prescribing information for Derma-Smoothe includes only vague information on possible side effects in adults.
 
Based on this information, the most commonly reported side effects in adults include:
 
  • Burning
  • Itching
  • Irritation
  • Dryness
  • Infection or irritation of the hair follicles
  • Acne
  • Lightening of skin color
  • Rash around the mouth
  • Allergic skin reaction
  • Skin infections
  • Thinning of the skin
  • Stretch marks
  • A sweat rash.
 
In addition, Derma-Smoothe has been studied extensively in clinical trials for children. In these studies, the side effects that occurred in children using Derma-Smoothe were carefully documented. As a result, it was possible to see what side effects occurred and how often they appeared.
 
In these studies, the most commonly observed side effects in children age 2 to 12 included:
 
  • The appearance of small blood vessels through the skin ("spider veins") -- in up to 9 percent of children
  • Itching -- up to 5.2 percent
  • Irritation -- up to 5.2 percent
  • Burning -- up to 5.2 percent
  • Redness -- up to 5.2 percent
  • Lightening of the skin -- up to 4 percent
  • Shiny skin -- up to 2 percent
  • Atopic dermatitis flares -- up to 2 percent
  • Bumps, blisters or pimples on the skin -- up to 2 percent
  • Irritation or infection of hair follicles -- up to 2 percent
  • Cold sores -- up to 2 percent
  • Ear infection -- up to 2 percent.
 
The most commonly observed side effects that occurred in children age 3 months to 2 years old included:
 
  • Cough -- in up to 20 percent of children
  • Runny or stuffy nose -- up to 13 percent
  • Fever -- up to 10 percent
  • Lightening of skin color -- up to 7 percent
  • Diarrhea -- up to 3 percent
  • Vomiting -- up to 3 percent
  • Nodules, bumps, blisters, or pimples -- up to 3 percent
  • Upper respiratory tract infections -- up to 3 percent
  • Ear infection -- up to 3 percent
  • Atopic dermatitis flare -- up to 3 percent
  • Skin rash -- up to 3 percent
  • Darkening of skin color -- up to 3 percent.
 

Derma-Smoothe Oil Information

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