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

Applies to dapsone topical: topical gel/jelly.

Serious side effects of Aczone

Along with its needed effects, dapsone topical (the active ingredient contained in Aczone) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking dapsone topical:

Incidence not known

• Bluish-colored lips, fingernails, or palms
• dark urine
• difficult breathing
• dizziness or lightheadedness
• fever
• headache
• pale skin
• rapid heart rate
• sore throat
• unusual bleeding or bruising
• unusual tiredness or weakness

Other side effects of Aczone

Some side effects of dapsone topical may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Dryness, redness, oiliness, or peeling at the application site

For Healthcare Professionals

Applies to dapsone topical: topical gel.

Local

Very common (10% or more): Local stinging/burning (up to 23.5%), application site reaction (not otherwise specified [NOS]; 18%), local dryness (up to 17.7%), application site dryness (up to 16%), application site erythema (up to 13%), application site oiliness/peeling (up to 13%), local scaling (up to 12.4%)

Common (1% to 10%): Local erythema, application site burning, application site pruritus

Uncommon (0.1% to 1%): Application site pain^[Ref]

Dermatologic

Postmarketing reports: Rash (including erythematous rash, application site rash), facial swelling (including lip swelling, eye swelling)

Oral Dapsone:

-Frequency not reported: Skin reactions (toxic epidermal necrolysis, erythema multiforme, morbilliform and scarlatiniform reactions, bullous and exfoliative dermatitis, erythema nodosum, urticaria)^[Ref]

Hematologic

Postmarketing reports: Methemoglobinemia

Oral Dapsone:

-Frequency not reported: Agranulocytosis, hemolytic anemia^[Ref]

Nervous system

Common (1% to 10%): Headache NOS

Frequency not reported: Tonic clonic movements

Oral Dapsone:

-Frequency not reported: Peripheral neuropathy (motor loss and muscle weakness)^[Ref]

Respiratory

Common (1% to 10%): Nasopharyngitis, upper respiratory tract infection NOS, sinusitis NOS, pharyngitis, cough, influenza

Frequency not reported: Severe pharyngitis^[Ref]

Other

Common (1% to 10%): Pyrexia^[Ref]

Musculoskeletal

Common (1% to 10%): Joint sprain^[Ref]

Psychiatric

Uncommon: Depression

Rare (0.01% to 0.1%): Psychosis

Frequency not reported: Suicide attempt^[Ref]

Gastrointestinal

Frequency not reported: Abdominal pain, severe vomiting, pancreatitis^[Ref]