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.
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:
Seek medical attention right away if any of these SEVERE side effects occur 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.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
TopAczone Side Effects - for the Professional
Aczone
Clinical Studies Experience
Because clinical trials are conducted under prescribed conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Serious adverse reactions 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
In the clinical trials, a total of 12 out of 4032 patients were reported to have depression (3 of 1660 treated with vehicle and 9 of 2372 treated with Aczone® Gel, 5%). Psychosis was reported in 2 of 2372 patients treated with Aczone® Gel, 5%, and in 0 of 1660 patients treated with vehicle.
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 1 below.
| Aczone® (N=1819) |
Vehicle (N=1660) |
|||||
| Application Site Event | Mild | Moderate | Severe | Mild | Moderate | Severe |
| Erythema | 9% | 5% | <1% | 9% | 6% | <1% |
| Dryness | 14% | 3% | <1% | 14% | 4% | <1% |
| Oiliness/Peeling | 13% | 6% | <1% | 15% | 6% | <1% |
The adverse reactions occurring in at least 1% of patients in either arm in the four vehicle controlled studies are presented in Table 2.
|
NOS = Not otherwise specified |
||
| Aczone® N=1819 |
Vehicle N=1660 |
|
| Application Site Reaction NOS | 18% | 20% |
| Application Site Dryness | 16% | 17% |
| Application Site Erythema | 13% | 14% |
| Application Site Burning | 1% | 2% |
| Application Site Pruritus | 1% | 1% |
| Pyrexia | 1% | 1% |
| Nasopharyngitis | 5% | 6% |
| Upper Respiratory Tract Inf. NOS | 3% | 3% |
| Sinusitis NOS | 2% | 1% |
| Influenza | 1% | 1% |
| Pharyngitis | 2% | 2% |
| Cough | 2% | 2% |
| Joint Sprain | 1% | 1% |
| Headache NOS | 4% | 4% |
One patient treated with Aczone® Gel 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.
Experience with Oral Use of Dapsone
Although not observed in the clinical trials with Aczone® Gel (topical dapsone) serious adverse reactions have been reported with oral use of dapsone, including agranulocytosis, hemolytic anemia, peripheral neuropathy (motor loss and muscle weakness), and skin reactions (toxic epidermal necrolysis, erythema multiforme, morbilliform and scarlatiniform reactions, bullous and exfoliative dermatitis, erythema nodosum, and urticaria).
TopSide Effects by Body System - for Healthcare Professionals
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.
TopMore Aczone resources
- Aczone Prescribing Information (FDA)
- Aczone topical Monograph (AHFS DI)
- Aczone Topical Advanced Consumer (Micromedex) - Includes Dosage Information
- Aczone Gel MedFacts Consumer Leaflet (Wolters Kluwer)
- Aczone Consumer Overview
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