Aczone Side Effects

Generic Name: dapsone topical

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

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

For the Consumer

Applies to dapsone topical: topical gel/jelly

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 as soon as possible if any of the following side effects occur while taking dapsone topical:

Incidence not known
  • Attempts at killing oneself
  • bloating
  • body aches or pain
  • chills
  • congestion
  • constipation
  • cough
  • darkened urine
  • dryness or soreness of throat
  • fast heartbeat
  • fever
  • hoarseness
  • indigestion
  • loss of appetite
  • nausea
  • pains in stomach, side, or abdomen, possibly radiating to the back
  • runny nose
  • stomach pain
  • tender, swollen glands in neck
  • tonic and clonic muscle movements
  • trouble swallowing
  • voice changes
  • vomiting, severe
Reported in clinical trials
  • Discouragement
  • feeling sad or empty
  • feeling that others are watching you or controlling your behavior
  • feeling that others can hear your thoughts
  • feeling, seeing, or hearing things that are not there
  • irritability
  • loss of interest or pleasure
  • severe mood or mental changes
  • tiredness
  • trouble concentrating
  • unusual behavior

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
  • flushing, redness of skin
  • oiliness/peeling
  • unusually warm skin
Less common
  • Burning
  • diarrhea
  • difficulty breathing
  • ear congestion
  • headache
  • itching skin
  • general feeling of discomfort or illness
  • headache
  • joint pain
  • joint sprain
  • muscle aches and pains
  • pain or tenderness around eyes and cheekbones
  • shivering
  • shortness of breath or trouble breathing
  • sneezing
  • sore throat
  • stuffy nose
  • sweating
  • tightness of chest or wheezing
  • trouble sleeping
  • unusual tiredness or weakness
Incidence not known
  • Facial swelling

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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