LOCOID LOTION SIDE EFFECTS
- Generic Name: hydrocortisone butyrate lotion
- Brand Name: Locoid Lotion
- Drug Class: Corticosteroids, Topical
SIDE EFFECTS
The following adverse reactions are discussed in greater detail in other sections of the labeling:
- HPA axis suppression. This has been observed in pediatric subjects using Locoid® Lotion
- Concomitant skin infections
- Allergic contact dermatitis
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in clinical practice.
The safety data derived from Locoid® Lotion clinical trials reflect exposure to Locoid® Lotion twice daily for up to four weeks in separate clinical trials involving pediatric subjects 3 months to 18 years of age and adult subjects 18 years of age and older with mild to moderate atopic dermatitis.
Adverse reactions shown in the tables below include those for which there is some basis to believe there is a causal relationship to Locoid® Lotion. Although the rates of application site reactions in the vehicle group were greater than those in the Locoid® group in both studies, these rates are included in the tables (Table 1 and Table 2) because skin irritation is a known adverse reaction of topical corticosteroids.
TABLE 1: Frequency of adverse reactions in pediatric subjects with mild to moderate atopic dermatitis
| Locoid® Lotion (n=139) n (%) |
Vehicle (n=145) n (%) |
|
| Application site reactions, including application site burning, pruritus, dermatitis, erythema, eczema, inflammation, or irritation | 2 (1) | 20 (14) |
| Infantile acne | 1 (1) | 0 (0) |
| Skin depigmentation | 1 (1) | 0 (0) |
TABLE 2: Frequency of adverse reactions in adult subjects with mild to moderate atopic dermatitis
| Locoid® Lotion (n=151) n (%) |
Vehicle (n=150) n (%) |
|
| Application site reactions, including application site burning, dermatitis, eczema, erythema, or pruritus | 5 (3) | 7 (5) |
Postmarketing Experience
Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The following additional local adverse reactions have been reported infrequently with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings and higher potency corticosteroids. These reactions included: irritation, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, miliaria and telangiectasia.
SRC: NLM .