Clinical Studies Experience
Because clinical trials are conducted under prescribed 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.
Serious adverse reactions reported in patients treated with ACZONE Gel (dapsone) , 5%, during clinical trials included but were not limited to the following:
- Nervous system/Psychiatric - Suicide attempt, tonic clonic movements.
- Gastrointestinal - Abdominal pain, severe vomiting, pancreatitis.
- Other - Severe pharyngitis
In the clinical trials, a total of 12 out of 4032 patients were reported to have depression (3 of 1660 treated with vehicle and 9 of 2372 treated with ACZONE Gel (dapsone) , 5%). Psychosis was reported in 2 of 2372 patients treated with ACZONE Gel (dapsone) , 5%, and in 0 of 1660 patients treated with vehicle.
Combined contact sensitization/irritation studies with ACZONE Gel (dapsone) , 5%, in 253 healthy subjects resulted in at least 3 subjects with moderate erythema. ACZONE Gel (dapsone) , 5%, did not induce phototoxicity or photoallergy in human dermal safety studies.
ACZONE Gel (dapsone) , 5%, was evaluated for 12 weeks in four controlled studies for local cutaneous events in 1819 patients. The most common events reported from these studies include oiliness/peeling, dryness, and erythema. These data are shown by severity in Table 1 below.
Table 1: Application Site Adverse Reactions by Maximum Severity
|Erythema||9%||5%||< 1%||9%||6%||< 1%|
|Dryness||14%||3%||< 1%||14%||4%||< 1%|
|Oiliness/ Peeling||13%||6%||< 1%||15%||6%||< 1%|
The adverse reactions occurring in at least 1% of patients in either arm in the four vehicle controlled studies are presented in Table 2.
Table 2 : Adverse Reactions Occurring in at least 1% of Patients
|Application Site Reaction NOS||18%||20%|
|Application Site Dryness||16%||17%|
|Application Site Erythema||13%||14%|
|Application Site Burning||1%||2%|
|Application Site Pruritus||1%||1%|
|Upper Respiratory Tract Inf. NOS||3%||3%|
|NOS = Not otherwise specified|
One patient treated with ACZONE Gel (dapsone) in the clinical trials had facial swelling which led to discontinuation of medication.
In addition, 486 patients were evaluated in a 12 month safety study. The adverse event profile in this study was consistent with that observed in the vehicle-controlled studies.
Experience with Oral Use of Dapsone
Although not observed in the clinical trials with ACZONE Gel (topical dapsone) serious adverse reactions have been reported with oral use of dapsone, including agranulocytosis, hemolytic anemia, peripheral neuropathy (motor loss and muscle weakness), and skin reactions (toxic epidermal necrolysis, erythema multiforme, morbilliform and scarlatiniform reactions, bullous and exfoliative dermatitis, erythema nodosum, and urticaria).
Read the Aczone Gel (dapsone) Side Effects Center for a complete guide to possible side effects
A drug-drug interaction study evaluated the effect of the use of ACZONE Gel (dapsone) , 5%, in combination with double strength (160 mg/800 mg) trimethoprim-sulfamethoxazole (TMP/SMX). During co-administration, systemic levels of TMP and SMX were essentially unchanged. However, levels of dapsone and its metabolites increased in the presence of TMP/SMX. Systemic exposure (AUC0-12) of dapsone and N-acetyl-dapsone (NAD) were increased by about 40% and 20% respectively in presence of TMP/SMX. Notably, systemic exposure (AUC0-12) of dapsone hydroxylamine (DHA) was more than doubled in the presence of TMP/SMX. Exposure from the proposed topical dose is about 1% of that from the 100 mg oral dose, even when co-administered with TMP/SMX.
Topical Benzoyl Peroxide
Topical application of ACZONE Gel (dapsone) followed by benzoyl peroxide in subjects with acne vulgaris resulted in a temporary local yellow or orange discoloration of the skin and facial hair (reported by 7 out of 95 subjects in a clinical study) with resolution in 4 to 57 days.
Drug Interactions with Oral Dapsone
Certain concomitant medications (such as rifampin, anticonvulsants, St. John's wort) may increase the formation of dapsone hydroxylamine, a metabolite of dapsone associated with hemolysis. With oral dapsone treatment, folic acid antagonists such as pyrimethamine have been noted to possibly increase the likelihood of hematologic reactions.
Last reviewed on RxList: 3/28/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Aczone Gel Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.