July 23, 2016
Recommended Topic Related To:

Aczone Gel

"The U.S. Food and Drug Administration today approved Differin Gel 0.1% (adapalene), a once-daily topical gel for the over-the-counter (OTC) treatment of acne. Differin Gel 0.1% is approved for use in people 12 years of age and older.



Aczone Gel

Aczone Gel Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 8/11/2015

Aczone (dapsone) Gel, 5% is a sulfone drug indicated for the topical treatment of acne vulgaris. Aczone Gel 5% is available in generic form. Common side effects of Aczone Gel, topical include skin dryness, redness, oiliness, and peeling.

For topical use only. Not for oral, ophthalmic, or intravaginal use. After the skin is gently washed and patted dry, apply approximately a pea-sized amount of Aczone Gel 5%, in a thin layer to the acne affected areas twice daily. Rub in Aczone Gel 5% gently and completely. Wash hands after application of Aczone Gel 5%. Aczone Gel 5% use with trimethoprim-Sulfomethoxazole, topical Benzoyl Peroxide, and Oral Dapsone may cause adverse reactions. There are no adequate Aczone studies in pregnant women. Aczone Gel 5% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Because of the potential for oral dapsone to cause adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue Aczone Gel 5%.

Our Aczone (dapsone) Gel, 5% Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Aczone Gel in Detail - Patient Information: Side Effects

The most common side effects of dapsone topical are dryness, redness, oiliness and peeling of the skin being treated. Call your doctor if you have excessive tiredness or any side effects that do not go away or bother you.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Aczone Gel (Dapsone)

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Aczone Gel FDA Prescribing Information: Side Effects
(Adverse Reactions)


Clinical Studies 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.

Serious adverse reactions reported in patients treated with ACZONE® Gel, 5%, during clinical trials included but were not limited to the following:

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, 5%). Psychosis was reported in 2 of 2372 patients treated with ACZONE® Gel, 5%, and in 0 of 1660 patients treated with vehicle.

Combined contact sensitization/irritation studies with ACZONE® Gel, 5%, in 253 healthy subjects resulted in at least 3 subjects with moderate erythema. ACZONE® Gel, 5%, did not induce phototoxicity or photoallergy in human dermal safety studies.

ACZONE® Gel, 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

Application Site Event ACZONE®
Mild Moderate Severe Mild Moderate Severe
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%
Pyrexia 1% 1%
Nasopharyngitis 5% 6%
Upper Respiratory Tract Inf. NOS 3% 3%
Sinusitis NOS 2% 1%
Influenza 1% 1%
Pharyngitis 2% 2%
Cough 2% 2%
Joint Sprain 1% 1%
Headache NOS 4% 4%
NOS = Not otherwise specified

One patient treated with ACZONE® Gel 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).

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of ACZONE® Gel, 5%. Because these 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.

Methemoglobinemia has been identified during postmarketing use of ACZONE® Gel, 5% [see WARNINGS AND PRECAUTIONS].

Read the entire FDA prescribing information for Aczone Gel (Dapsone)

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.

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