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Dapsone topical Side Effects

For the Consumer

Applies to dapsone topical: topical gel/jelly

In addition to its needed effects, some unwanted effects may be caused by dapsone topical. In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when 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

Minor Side Effects

Some of the side effects that can occur with dapsone topical may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common:
  • Dryness, redness, oiliness, or peeling at the application site

For Healthcare Professionals

Applies to dapsone topical: topical gel

General

The most commonly reported side effects were application site reaction not otherwise specified, application site dryness, application site erythema, and oiliness/peeling.[Ref]

Hematologic

Frequency not reported: Agranulocytosis, hemolytic anemia
Postmarketing reports: Methemoglobinemia[Ref]

Dermatologic

Frequency not reported: Toxic epidermal necrolysis, erythema multiforme, morbilliform and scarlatiniform reactions, bullous and exfoliative dermatitis, erythema nodosum, urticaria[Ref]

Local

Very common (10% or more): Application site reaction not otherwise specified (18%), application site dryness (16%), application site erythema (13%), oiliness/peeling (up to 13%)
Common (1% to 10%): Application site pruritus[Ref]

Respiratory

Common (1% to 10%): Nasopharyngitis, upper respiratory tract infection not otherwise specified, sinusitis not otherwise specified, influenza, pharyngitis, cough[Ref]

Other

Common (1% to 10%): Pyrexia
Very rare (less than 0.01%): Facial swelling[Ref]

Musculoskeletal

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

Nervous system

Common (1% to 10%): Headache not otherwise specified
Frequency not reported: Tonic clonic movements, peripheral neuropathy (motor loss and muscle weakness)[Ref]

Psychiatric

Very rare (less than 0.01%): Depression, psychosis
Frequency not reported: Suicide attempt[Ref]

Gastrointestinal

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

References

1. "Product Information. Aczone (dapsone topical)." QLT USA, Inc, Fort Collins, CO.

Not all side effects for dapsone topical may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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