Aczone Side Effects

Please note - some side effects for Aczone may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Aczone - for the Consumer

Aczone Gel

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Aczone Gel:

Dryness, oiliness, peeling, or redness of the skin.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark urine; fever, chills, or persistent sore throat; mental or mood changes; numbness, tingling, or burning of the hands or feet; red, swollen, blistered, or peeling skin; severe stomach pain or vomiting; shortness of breath; sudden back pain; suicidal thoughts or attempts; unusual tiredness or weakness; yellow or pale skin.

Aczone Side Effects - for the Professional

Aczone

While clinical studies conducted with Aczone™ Gel, 5%, for acne vulgaris did not demonstrate evidence of clinically significant anemia, an increased reticulocyte count and a decreased hemoglobin level were found in a G6PD deficient patient who had a complete blood count performed.  Only 25 patients with low plasma glucose 6-phosphate dehydrogenase activity treated with Aczone™ Gel, 5%, were included in the clinical study program.

Serious adverse events reported in patients treated with Aczone™ Gel, 5%, during clinical trials included but were not limited to the following:

Nervous system/Psychiatric – Suicide attempt, tonic clonic movements.

Gastrointestinal – Abdominal pain, severe vomiting, pancreatitis.

Other – Severe pharyngitis

Combined contact sensitization/irritation studies with Aczone™ Gel, 5%, in 253 healthy subjects resulted in at least 3 subjects with moderate erythema.  Aczone™ Gel, 5%, did not induce phototoxicity or photoallergy in human dermal safety studies.

Aczone™ Gel, 5%, was evaluated for 12 weeks in four controlled studies for local cutaneous events in 1819 patients.  The most common events reported from these studies include oiliness/peeling, dryness, and erythema.  These data are shown by severity in Table 3 below.

There were no significant differences in the adverse event rates between Aczone™ Gel, 5%, and vehicle control treated patients.  The adverse events occurring in at least 1% of patients in either arm in the four vehicle controlled studies are presented in Table 4.

One patient treated with topical dapsone in the clinical trials had facial swelling which led to discontinuation of medication.

In addition, 486 patients were evaluated in a 12 month safety study.  The adverse event profile in this study was consistent with that observed in the vehicle-controlled studies.

Side Effects by Body System

Local

Local side effects for dapsone topical 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 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 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 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 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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