Halobetasol Propionate
Generic: HALOBETASOL PROPIONATE
Basic Information
Manufacturer
Coral Way Pharma, LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
TOPICAL
FDA Set ID
4cb1f7b3-c412-6fc7-e063-6394a90a63c9
Indications & Usage
1 INDICATIONS AND USAGE Halobetasol Propionate Lotion 0.05% is indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older.
Halobetasol Propionate Lotion 0.05% is a corticosteroid indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older.
( 1 )
Halobetasol Propionate Lotion 0.05% is a corticosteroid indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older.
( 1 )
Adverse Reactions
6 ADVERSE REACTIONS - The most commonly reported adverse reactions (≥1%) are telangiectasia, application site atrophy, and headache.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Coral Way Pharma, LLC at 1-888-403-8874 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
See 17 for PATIENT CONSELING INFORMATION Revised: 03/2026 6.1 Clinical Trials Experience 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.
During randomized, controlled, blinded clinical trials 277 adults with plaque psoriasis were treated with Halobetasole Propionate Lotion 0.05% twice daily for up to two weeks (up to approximately 50 grams/week).
Table 1 presents adverse reactions that occured in at least 1% of subjects treated with Halobetasol Propionate Lotion 0,05% twice daily for up to two weeks, and more frequently than in vehicle-treated subjects.
Tale 1: Adverse Reactions Occurring in ≥ 1% of Subjects Treated with Halobetasol Propionate Lotion 0.05% for up to Two Weeks 0.05% Halobetasol Propionate Lotion 0.05% (N=277) Vehicle Lotion (N=259) Adverse Reaction % % Telangiectasia 1% 0% Application site atrophy 1% <1% Headache 1% <1% Less common dverse reactions (incidence less than 1% but greater than 0.1%) that occured in subjects treated with Halobetasol Propionate Lotion 0,05% included application site discoloration, herpes zoster, influenza, nasopharyngitis, otitis media acute, throat infection, wound, and increased blood pressure.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Coral Way Pharma, LLC at 1-888-403-8874 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
See 17 for PATIENT CONSELING INFORMATION Revised: 03/2026 6.1 Clinical Trials Experience 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.
During randomized, controlled, blinded clinical trials 277 adults with plaque psoriasis were treated with Halobetasole Propionate Lotion 0.05% twice daily for up to two weeks (up to approximately 50 grams/week).
Table 1 presents adverse reactions that occured in at least 1% of subjects treated with Halobetasol Propionate Lotion 0,05% twice daily for up to two weeks, and more frequently than in vehicle-treated subjects.
Tale 1: Adverse Reactions Occurring in ≥ 1% of Subjects Treated with Halobetasol Propionate Lotion 0.05% for up to Two Weeks 0.05% Halobetasol Propionate Lotion 0.05% (N=277) Vehicle Lotion (N=259) Adverse Reaction % % Telangiectasia 1% 0% Application site atrophy 1% <1% Headache 1% <1% Less common dverse reactions (incidence less than 1% but greater than 0.1%) that occured in subjects treated with Halobetasol Propionate Lotion 0,05% included application site discoloration, herpes zoster, influenza, nasopharyngitis, otitis media acute, throat infection, wound, and increased blood pressure.