Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: • HPA axis suppression [see Warnings and Precautions (5.1), Use in Specific Populations (8.4)] • Ophthalmic Adverse Reactions [see Warnings and Precautions (
2)] • Skin infections [see Warnings and Precautions (5.3)] • Allergic contact dermatitis [see Warnings and Precautions (5.4)] The most common adverse reactions (> 1%) are application site reactions.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact The J.
Molner Company LLC at 1-800-552-8750 and/or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 11/2023 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of the drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety data described below reflect Hydrocortisone Butyrate Lotion applied topically twice daily for up to 4 weeks in vehicle-controlled clinical trials of 284 pediatric subjects 3 months to 18 years of age and 301 adult subjects with mild to moderate atopic dermatitis [see Clinical Studies (14)].
The incidence of selected adverse reactions reported by ≥1% of subjects during the studies is presented in Table 1 and Table 2 .
Frequency of adverse reactions in pediatric subjects with mild to moderate atopic dermatitis Hydrocortisone Butyrate 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
Frequency of adverse reactions in adult subjects with mild to moderate atopic dermatitis Hydrocortisone Butyrate Lotion (n=151) n (%) Vehicle (n=150) n (%) Application site reactions, including application site burning, dermatitis, eczema, erythema, or pruritus 5 (3) 7 (5) 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of topical corticosteroids, including Hydrocortisone Butyrate Lotion.
5 WARNINGS AND PRECAUTIONS • Endocrine System Adverse Reactions: o Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression may occur, with the potential for glucocorticosteroid insufficiency.
Consider periodic evaluations for HPA axis suppression if Hydrocortisone Butyrate Lotion is applied to large surface areas or used under occlusion.
If HPA axis suppression is noted, reduce the application frequency, discontinue use, or switch to a lower potency corticosteroid.
(5.1, 8.4) o Systemic effects of topical corticosteroids may also include manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria.
(5.1, 8.4) o Pediatric patients may be more susceptible to systemic toxicity due to their larger skin-surface-to-body-mass ratios.
Like all medications, Hydrocortisone Butyrate can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: