Aczone Gel

What Is Aczone Gel?

Aczone (dapsone) Gel, 5% is a sulfone drug indicated for the topical treatment of acne vulgaris. Aczone Gel 5% is available in generic form.

What Are Side Effects of Aczone Gel?

Common side effects of Aczone Gel, topical include:

• skin dryness,
• redness,
• oiliness, and
• peeling.

Dosage for Aczone Gel?

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%.

What Drugs, Substances, or Supplements Interact with Aczone Gel?

Aczone Gel 5% may interact with other topical medications, harsh or abrasive soaps, or cosmetics on the affected area. Tell your doctor all medications, supplements, and skin care products you use.

Aczone Gel During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Aczone Gel 5%; it is unknown if it will harm a fetus. Aczone Gel 5% passes into breast milk and may affect a nursing baby. Consult your doctor before breastfeeding.

Additional Information

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.

 

Aczone Gel Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Dapsone topical may cause methemoglobinemia (met-HEEM-oh glo-bin-EE-mee-a), a serious condition in which the amount of oxygen in your blood stream becomes dangerously low. Stop using this medicine and call your doctor at once if you notice a blue or gray appearance of your lips, fingernails, or the inside of your mouth.

Call your doctor at once if you have:

• severe sore throat;
• unusual thoughts or behavior;
• a red blood cell disorder--back pain, pale or yellowed skin, dark colored urine, fever, confusion or weakness;
• pancreas problems--severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate; or
• severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

• dry or peeling skin;
• oily skin; or
• redness where the medicine was applied.

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.

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

 

Aczone Gel Professional Information

SIDE EFFECTS

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.

A total of 2161 subjects were treated with ACZONE Gel, 7.5%, for 12 weeks in 2 controlled clinical trials. The population ranged in age from 12 to 63 years, was 56% female, and 58% Caucasian. Adverse drug reactions that were reported in at least 0.9% of subjects treated with ACZONE Gel, 7.5% appear in Table 1 below.

Table 1. Adverse Reactions Occurring in at Least 0.9% of Subjects with Acne Vulgaris in 12-week Controlled Clinical Trials

	ACZONE Gel, 7.5% (N=2161)	Vehicle (N=2175)
Application Site Dryness	24 (1.1%)	21 (1.0%)
Application Site Pruritus	20 (0.9%)	11 (0.5%)

Experience With Oral Use Of Dapsone

Although not observed in the clinical trials with 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

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.

The following adverse reactions have been identified during post-approval use of topical dapsone: methemoglobinemia, rash (including erythematous rash, application site rash) and swelling of face (including lip swelling, eye swelling).

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