Aczone Side Effects

Generic name: dapsone topical

Note: This document contains side effect information about dapsone topical. Some of the dosage forms listed on this page may not apply to the brand name Aczone.

Some side effects of Aczone may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to dapsone topical: topical gel

The most common side effects of dapsone topical (the active ingredient contained in Aczone) 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.

For Healthcare Professionals

Applies to dapsone topical: topical gel

Local

Local side effects for dapsone topical (the active ingredient contained in Aczone) in relation to the vehicle alone have frequently included dryness (16% vs. 17%), erythema (13% vs. 14%), burning (1% vs. 2%), and pruritus (1% vs. 1%) at the site of application.

Respiratory

Respiratory side effects for dapsone topical (the active ingredient contained in Aczone) in relation to the vehicle alone have included nasopharyngitis (5% vs. 6%), upper respiratory tract infection (3% vs. 3%), sinusitis (2% vs. 1%), pharyngitis (2% vs. 2%), and cough (2% vs. 2%).

Other

Other side effects for dapsone topical (the active ingredient contained in Aczone) in relation to the vehicle alone have included pyrexia (1% vs. 1%), influenza (1% vs. 1%), and headache (4% vs. 4%). Facial swelling (1 case) resulting in discontinuation of treatment has been reported.

Musculoskeletal

Musculoskeletal side effects for dapsone topical (the active ingredient contained in Aczone) in relation to the vehicle alone have included joint sprain (1% vs. 1%).

Nervous system

Nervous system side effects have included tonic clonic movements.

Psychiatric

Clinical trials (n=2372) reported 9 and 2 patients treated with dapsone topical (the active ingredient contained in Aczone) to have depression and psychosis, respectively.

Psychiatric side effects have included suicide attempt, depression, and psychosis.

Gastrointestinal

Gastrointestinal side effects have included abdominal pain, severe vomiting, and pancreatitis.

Hematologic

Hematologic side effects have included increased reticulocyte count and decreased hemoglobin level in a single patient with G6PD deficiency who had a complete blood count performed prior to initiation of treatment.

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