Side effects of dapsone

Dapsone

SIDE EFFECTS

In addition to the warnings listed above, the following syndromes and serious reactions have been reported in patients on dapsone.

Hematologic Effects

Dose-related hemolysis is the most common adverse effect and is seen in patients with or without G6PD deficiency. Almost all patients demonstrate the inter-related changes of a loss of 1 to 2 g of hemoglobin, an increase in the reticulocytes (2 to 12%), a shortened red cell life span and a rise in methemoglobin. G6PD deficient patients have greater responses.

Nervous System Effects

Peripheral neuropathy is a definite but unusual complication of dapsone therapy in non-leprosy patients. Motor loss is predominant. If muscle weakness appears, dapsone should be withdrawn. Recovery on withdrawal is usually substantially complete. The mechanism of recovery is reported by axonal regeneration. Some recovered patients have tolerated retreatment at reduced dosage. In leprosy this complication may be difficult to distinguish from a leprosy reactional state.

Body As A Whole

In addition to the warnings and adverse effects reported above, additional adverse reactions include: nausea, vomiting, abdominal pains, pancreatitis, vertigo, blurred vision, tinnitus, insomnia, fever, headache, psychosis, phototoxicity, pulmonary eosinophilia, tachycardia, albuminuria, the nephrotic syndrome, hypoalbuminemia without proteinuria, renal papillary necrosis, male infertility, drug-induced Lupus erythematosus and an infectious mononucleosis-like syndrome. In general, with the exception of the complications of severe anoxia from overdosage (retinal and optic nerve damage, etc.) these adverse reactions have regressed off drug.

Read the entire FDA prescribing information for Dapsone (Dapsone)

Dapsone is a prescription antibiotic; topical dapsone is sold under the brand name Aczone (manufactured by Allergan) and is used to treat acne.

The oral form of the drug is used to treat leprosy (an infectious disease that causes skin lesions and nerve damage), certain lung and brain infections associated with HIV/AIDS, and skin infections.

The medicine works by reducing swelling and stopping the growth of bacteria.

The Food and Drug Administration (FDA) first approved dapsone in 1955.

Oral dapsone is manufactured by various pharmaceutical companies.

Dapsone Warnings

Before taking oral dapsone, tell your doctor if you have, or have ever had:

  • Anemia or another blood disorder
  • A glucose-6-phosphate dehydrogenase (G6PD) deficiency
  • Liver disease
  • Kidney or heart problems
  • HIV/AIDS
  • Problems with urination
  • Lung disease
  • Allergies to medications
  • Another infection at the same time as the one being treated

Oral dapsone may make your skin more sensitive to sunlight.

Avoid unnecessary or prolonged exposure to the sun, and wear protective clothing and sunscreen while outdoors.

Long-term or repeated use of oral dapsone may cause a second infection. Discuss this risk with your doctor.

Dapsone will only treat bacterial infections. It won’t work for the common cold, the flu, or other viral infections.

Oral dapsone should be used with extreme caution in newborn babies. Safety and effectiveness haven’t been confirmed in this age group.

Your doctor may want to perform frequent tests to check your body’s response to this drug. Keep all appointments with your doctor and laboratory.

Let your healthcare provider know if your symptoms don’t improve or worsen while using oral dapsone.

Before using topical Aczone, tell your doctor if you have, or have ever had:

  • Anemia or another blood disorder
  • Glucose-6-phosphate dehydrogenase (G6PD) deficiency (a genetic disorder)
  • Liver disease
  • Allergies to other medicines

Aczone should only be used on the skin. Avoid contact with the eyes, mouth, nose, or vagina.

Don’t use other skin products or medicines at the same time as Aczone without first checking with your doctor.

If Aczone is used along with benzoyl peroxide, it may cause a temporary yellow or orange discoloration of the skin and facial hair.

Let your doctor know if your symptoms don’t improve, or if they worsen, within 12 weeks of starting this medicine.

Aczone shouldn’t be used by children under age 12. Safety and effectiveness haven’t been confirmed in this age group.

Pregnancy and Dapsone

It’s not known whether dapsone may harm an unborn baby.

Talk to your doctor if you become pregnant while using dapsone. You’ll have to discuss the risks and benefits of taking the medicine during your pregnancy.

Certain antibiotics, possibly including dapsone, may interfere with oral contraceptives. Talk to your doctor if this is a concern.

Dapsone is found in breast milk and may harm a breastfeeding baby.

Don’t breastfeed while using dapsone without first talking to your doctor.

PMC

Dapsone (4,4′-diaminodiphenylsulfone) was synthesized a century ago (1908) and continues to be a powerful therapeutic tool in many skin diseases. It has an antibacterial spectrum and a similar mechanism of action as sulphonamide. It is the drug of choice in chemotherapy of leprosy. Other analogs owe their activity and toxicity to dapsone released from them. Dapsone is therefore the preferred sulfone being cheaper than and as effective as others. It is well absorbed by the oral route, preferably at lower doses and acetylated in the liver prior to elimination. It has been found that there are slow and fast acetylators among the patient population. This variability does not affect the clinical utilization of dapsone. The drug is also N-hydroxylated in the liver which product is responsible for the hemodynamic adverse effects. Its half life is long, 10-50 h and the time to reach plateau is at least 8 days. The drug has been used for other skin disorders also. It has been reported for use in acne but less effective than retinoic acid; for cutaneous manifestations of Behcet’s disease requiring further trials; for the treatment of bullous pemphygoid as an adjunct therapy; combined with trimethoprim it is as effective as co-trimoxazole in Pneumocystis carinii pneumonia; it is a useful suppressant in treating dermatitis herpetiformis and relapsing Polychondritis; for vesico bullous lesions of lupus erythematous, it has been recommended as first line systemic therapy; its use has been reported in pemphigus herpetiformis, pyoderma gangrenosum; dapsone reduces the local and systemic reactions to spider bite and found to be useful for urticarial vasculitis syndrome.

A variety of adverse effects have been recognized with dapsone therapy. The most frequent and well-documented adverse drug reactions (ADRs) being methemoglobinemia (caused by the hydroxylamine metabolite), agranulocytosis, hypersensitivity syndrome, psychosis and neuropathy. Some useful drug interactions have been documented with fluconazole which reduce the adverse reactions to dapsone by reducing the production of its toxic metabolite and with cimetidine which reduces methemoglobinemia due to dapsone. Of an adverse drug interaction, didanosine is known to cause increased peripheral neuropathy when given with dapsone. Dapsone-induced methemoglobinemia is treated with 1-2 mg/kg methylene blue by slow intravenous drip in emergency situation or orally 3-5 mg/kg every 4-6 h in non-emergency.

This study was initiated to understand the prescribing patterns of dapsone, its safety, efficacy, and to educate patients through information leaflets on the proper use of dapsone thereby emphasizing the primary responsibilities a clinical pharmacist could share with the health care team.

The Institutional Medical Ethics Committee permission was obtained before performing the study. Patients visiting the out-patient skin clinics of Sri Ramachandra Hospital were enrolled for this study. The dermatology department has provided special clinics every day; Monday-vitiligo, Tuesday-psoriasis, Wednesday-leprosy, Thursday-eczema, Friday-acne and autoimmune and bullous disorders every Saturday. Patients who attended the leprosy clinic on Wednesdays and autoimmune disorders on Saturdays and who were prescribed dapsone by the dermatologists were taken for the study. During the study period, 80 patients were reviewed. Of the 80, only 19 (7 leprosy and 12 non-leprosy) were newly recruited and the remaining 61 patients (47 leprosy and 14 non-leprosy) were on regular follow-up. A patient data collection form was prepared and the data on demographic details (name, age, sex), past medical history, social history, biochemical values such as hematological, liver function tests, renal function tests and relevant histopathological findings were procured and analyzed. Patients were counseled after their consultation with the dermatologists regarding the dose, dosing interval, side effects, adverse drug reactions and their follow-up schedule to the dermatology clinic. Patient information leaflets on dapsone were prepared in English (Appendix 1) and the vernacular language (not shown) and these were given to all patients after oral counseling. They were also educated to report to their physician/pharmacist, in case of any side effects experienced by them.

The patients were classified as leprosy (54) and non-leprosy (26) patients. The 54 leprosy patients (33 males, 21 females; mean age 40.48±14.67 years) were categorized by the dermatologists as shown in (Table 1). These patients were prescribed dapsone 100 mg orally O.D. for a period of 6 months. In addition to dapsone, 47 patients were administered rifampin 600 mg as a single dose once a month for 6 months, one patient with rifampin 450 mg and one patient with rifampin 300 mg single dose once a month for 6 months; 10 patients were prescribed with clofazimine 100 mg O.D. orally for 6 months, one patient with clofazimine 50 mg O.D. per oral for 6 months; 14 patients were prescribed with oral prednisolone as follows: 2 patients were given 5 mg, 3 patients 10 mg, 2 patients 20 mg, 3 patients 25 mg and 4 patients 30 mg O.D. for 6 months.

TABLE 1

CLASSIFICATION OF LEPROSY PATIENTS

Type of Leprosy No of Patients (n=54)
n %
Paucibacillary 41 75
Multibacillary 10 19
Neuritic 3 6

Majority of the patients had paucibacillary leprosy.

Twenty six non-leprosy patients (14 males and 12 females; mean age 38.15±15.20 years) were diagnosed by the dermatologists as having other dermatological conditions (explained in Appendix 2) as listed in (Table 2). These patients were prescribed dapsone 100 mg O.D. In addition to dapsone, 16 patients were prescribed oral prednisolone as shown: 4 patients- 5 mg O.D., 3 patients-10 mg O.D., 2 patients- 15 mg O.D., 4 patients-20 mg O.D. and 25 mg O.D. for 3 patients.

TABLE 2

CLASSIFICATION OF NON-LEPROSY PATIENTS

Type of Diseases No of Patients (n=26)
n %
Lichen planus 16 62
Bullous pemphygoid 2 7
Pemphigus vulgaris 2 7
Acne 1 4
Pemphigus erythematosus 1 4
Familial benign pemphigus 1 4
Dermatitis herpetiformis 1 4
Bullous lichen planus irritant dermatitis 1 4
Psoriasiform dermatitis 1 4

Skin conditions for which dapsone had been used in non-leprosy patients, of which, lichen planus was predominant.

Of the 54 leprosy patients, only one patient was a known diabetic and one known hypertensive. In 24 non-leprosy patients, one had hypertension, 2 had diabetes and 3 had dermatitis. The social history of all patients show that 3 were cigarette smokers, 2 on tobacco chewing and one was a heroin drug abuser. Biochemical parameters were normal for all the patients during the 6 month study period, but the past medical records of 47 patients who were on follow-up had an elevated eosinophil documented in 3 patients only. Adverse reaction events of the 80 patients were recorded in both groups of leprosy and non-leprosy patients. Peripheral neuropathy was the ADR of dapsone reported by majority of the leprosy patients (35%) and 18% of the non-leprosy patients. Gastrointestinal effects (abdominal pain and anorexia) were reported by 25% of leprosy group and 55% of non-leprosy group. Other nervous effects included insomnia; headache and vertigo were seen in 20% of the leprosy group and 27% of the non-leprosy group. Type I lepra reactions (delayed hypersensitivity reactions caused by increased recognition of Mycobacterium leprae antigens in skin and nerve sites in borderline tuberculosis patients) and other ADRs such as fever and tinnitus were reported by each 10% leprosy patients only (Table 3). All the patients were counseled orally at the time of their hospital visit and patient information leaflets on dapsone were provided to all patients at the time of counseling.

TABLE 3

ADVERSE DRUG REACTIONS IN STUDY POPULATION

ADRs Leprosy patients (n = 54) Non-leprosy patients (n=26)
N % n %
Lepra reactions-type I 2 10 0 0
Peripheral Neuropathy 7 35 2 18
Other nervous effects 4 20 3 27
Gastrointestinal effects 5 25 6 55
Other ADRs 2 10 0 0

Majority of the leprosy patients have reported of peripheral neuropathy where as gastrointestinal side effects were more common among the non-leprosy group.

Dapsone was one of the chemicals reviewed by the Royal Commission, which recommended evaluation of carcinogenicity of dapsone as it was used during the Vietnam conflict by the Australian forces for the treatment of falciparum malaria. The study did not reveal any evidence of cancer incidence with dapsone exposure.

Dapsone treatment has been found to be effective with no serious hematological complications in both leprosy and non-leprosy patients. No serious laboratory abnormalities were noted as only 3 patients have reported elevated eosinophil count. In this study, the adverse effects reported by the study group were not serious and were managed symptomatically. Dapsone was not withdrawn for any of the patients as none of them reported of any severe adverse side effects. None of the patients have reported dapsone hypersensitivity syndrome which is a rare hypersensitivity reaction to dapsone. Therefore dapsone is a beneficial, safe and inexpensive therapy in both leprosy and non leprosy patients.

Patient education provided to the patient improved patient compliance as all the patients were regular for their follow-up and reported the side effects, if any occurred to the physician /pharmacist during their follow-up visit. This helped the physician to be aware of the side effects experienced by the patients and to avoid the incidence of any serious ADR.

Dapsone is available as a topical gel in the US to be used only with the doctor’s prescription. It is used for the treatment of acne. The same precautions for dapsone tablets may be taken when dapsone is used as topical preparation. In this study, the clinical pharmacist had a leading role in addressing the use, effectiveness, adverse drug reactions, drug interactions commonly seen with dapsone. The fears arising out of adverse drug reactions of dapsone was allayed through effective counseling and distributing patient information leaflets to motivate patient compliance.

Dapsone Side Effects

Medically reviewed by Drugs.com. Last updated on Jan 20, 2019.

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For the Consumer

Applies to dapsone: oral tablet

Along with its needed effects, dapsone 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:

More common

  • Back, leg, or stomach pains
  • bluish fingernails, lips, or skin
  • difficult breathing
  • fever
  • loss of appetite
  • pale skin
  • skin rash
  • unusual tiredness or weakness

Rare

  • Itching, dryness, redness, scaling, or peeling of the skin, or loss of hair
  • mood or other mental changes
  • numbness, tingling, pain, burning, or weakness in hands or feet
  • sore throat
  • unusual bleeding or bruising
  • yellow eyes or skin

Some side effects of dapsone 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:

Rare

  • Headache
  • loss of appetite
  • nausea or vomiting
  • nervousness
  • trouble in sleeping

For Healthcare Professionals

Applies to dapsone: oral tablet

Hematologic

Hematologic side effects have been the most pronounced. These have included methemoglobinemia, aplastic anemia, leukopenia, agranulocytosis, eosinophilia, macrocytic anemia, and Heinz bodies. Dapsone may induce a dose-related hemolytic anemia, which is more likely with doses greater than 200 mg/day or in patients with glucose-6-phosphate dehydrogenase (G-6-PD) deficiency. Leukopenia, megaloblastic pancytopenia, and hemolysis have been reported. At least one case of pure red cell aplasia has also been reported, in addition to a case of exanthema with desquamation of the trunk and extremities.

Agranulocytosis usually occurs during the first few months of therapy and has been fatal. In one case report, filgrastim (G-CSF) was used to control the agranulocytosis.

Dapsone may induce methemoglobinemia, which may be important in patients with underlying respiratory insufficiency, anemia, or cardiovascular disease. Patients with methemoglobinemia may show normal oxygen saturation by pulse oximetry and by arterial blood gas (ABG). The diagnosis is based on cyanosis, dyspnea (usually only in patients with underlying respiratory insufficiency), elevated methemoglobin level from ABG sampling, and reversal of brown blood to red after addition of cyanide in vitro. Methemoglobin levels exceeding 10% may lead to peripheral cyanosis. Concentrations greater than 35% often produce symptoms of weakness, headache, or dyspnea, while those greater than 70% may result in fatality.

Recent data indicate vitamin E may be protective against dapsone-induced hemolytic anemia and methemoglobinemia, although more studies are needed.

Aplastic anemia due to dapsone has been reported occasionally. The onset of aplastic anemia has ranged from 2 to 12 weeks following initiation of therapy and has been fatal.

A 75-year-old male with granuloma annulare experienced pure red cell aplasia (PRCA) coincident with dapsone therapy. He was given dapsone 100 mg per day. Four weeks after the start of this therapy, the patient presented with asthenia. A diagnosis of PRCA was made based off of hematological counts. Dapsone was discontinued, and the patient received blood transfusions until his condition improved considerably. Hematological counts gradually returned to normal levels.

Nervous system

Peripheral neuropathy often affects the hands, resulting in thenar, hypothenar, and interosseous muscle atrophy. Rare cases of pure sensory loss associated with dapsone-induced peripheral neuropathy have been reported. In the treatment of leprosy, peripheral neuropathy may be difficult to distinguish from that of a leprosy reactional state. There has also been an isolated case of optic atrophy reported in a patient receiving dapsone 600 mg/day for 10 days.

Nervous system side effects have included peripheral neuropathy and manifested predominantly as motor deficits, but in up to 40% of cases, also included sensory loss. The peripheral neuropathy is reversible upon discontinuation of dapsone. Dizziness, vertigo, blurred vision, and headache have also been reported. At least one case of paresthesias has also been reported.

Gastrointestinal

Gastrointestinal side effects have included mild nausea, vomiting, and abdominal pains.

Hepatic

Hepatic side effects have frequently included elevations in liver function tests, which may occur as part of the dapsone syndrome. Rare cases of hepatitis and cholestatic jaundice have been reported. Hyperbilirubinemia has also been reported.

Hyperbilirubinemia may occur more often in patients with glucose-6-phosphate dehydrogenase (G-6-PD) deficiency.

Respiratory

Respiratory side effects including at least two cases of pulmonary eosinophilia have been reported. One patient received pyrimethamine and dapsone, and the other patient received just dapsone. Both patients recovered upon drug withdrawal.

Immunologic

Rare cases of dapsone-induced lupus erythematosus and exacerbations of existing lupus erythematosus have been reported.

Psychiatric

Psychiatric side effects have rarely included depression, psychosis, and hypomania.

Hypersensitivity

A 39-year-old female with paucibacillary leprosy experienced renal hypersensitivity vasculitis coincident with dapsone therapy. She was prescribed dapsone 100 mg per day and rifampicin 600 mg per month. After 23 days of treatment, she stopped treatment because of low fever, headache, dizziness, and weakness. On presentation, in addition to the symptoms described, the patient was toxic with fever, respiratory discomfort, dry cough, jaundice, hepatomegaly, and arterial hypotension. She developed edema and pruritus of the face, with a vesicopustular skin rash. The skin rash worsened to exfoliative erythroderma, associated with purpura of the lower extremities. Severe acute failure and oliguria were observed within 4 days after admission. On day 7, kidney histopathologic and immunohistochemical studies illustrated interstitial perivascular lymphocytic infiltrate affecting the media of arched and interlobular arteries, composed of T cells. The patient’s renal function and dermatological condition normalized 2 months after admission.

Hypersensitivity side effects have been commonly reported, especially in HIV-infected patients. Rash has been reported the most frequently. Stevens-Johnson syndrome, toxic erythema, erythema multiforme, toxic epidermal necrolysis, and morbilliform and scariatiniform reactions have been reported in a few patients treated with dapsone or other sulfone agents. Rare cases of dapsone-induced lupus erythematosus and exacerbations of existing lupus erythematosus have been reported. Sulfone syndrome has been reported. At least one case of renal hypersensitivity vasculitis has also been reported.

Renal

Renal side effects have rarely included nephritic syndrome and renal papillary necrosis.

Other

Other side effects including the “dapsone syndrome” have been reported. The “dapsone syndrome” is manifested by viral illness-like symptoms (fever, chills, myalgias, arthralgias, exanthema, lymphadenopathy, edema, lymphocytosis), hepatomegaly, elevated liver function tests, methemoglobinemia, and anemia. Some or all of these signs and symptoms may be present in less than 0.5% of patients. Dapsone syndrome usually occurs within the first 6 weeks of therapy and may be fatal. The dapsone syndrome is neither dose-related nor predictable. It is often confused with infectious mononucleosis.

“Leprosy reactional states” can commonly occur as a result of effective treatment for leprosy. They are generally classified into two types: reversal reactions (type 1) and erythema nodosum leprosum (ENL or type 2). Reversal reactions primarily occur in borderline or tuberculoid leprosy patients soon after the initiation of chemotherapy and consist of fever and swelling of existing skin and nerve lesions. Acute neuritis may develop. ENL occurs mostly in lepromatous patients (approximately 50% of treated patients within the first year) and a small number of borderline patients. Manifestations include fever and tender erythematous skin nodules sometimes associated with malaise, neuritis, orchitis, albuminuria, joint swelling, iritis, epistaxis or depression. In addition, skin lesions may become pustular and/or ulcerate. Histologically, there is vasculitis with an intense polymorphonuclear infiltrate. In general, antileprosy treatment is continued. Patients with severe reactions require hospitalization. Therapeutic management for reversal reactions may include administration of analgesics and/or corticosteroids and surgical decompression of swollen nerve trunks. Analgesics, corticosteroids, and other agents may be used for ENL reactions. For guidance concerning the management of reactional states, the Gillis W. Long Hansen’s Disease Center in Carville, Louisiana (tel: 800-642-2477) should be contacted.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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How does this medication work? What will it do for me?

Dapsone is an antibacterial in the sulfone family of antibiotics. It is used to treat leprosy and the skin condition known as dermatitis herpetiformis. When treating leprosy, this medication is used along with other medications for at least 6 months. In some cases the medication may need to be taken for many more months or years.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. As well, some forms of this medication may not be used for all of the conditions discussed here. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

Each round, scored tablet, debossed “100” above and “101” below the score and, on the other side, “Jacobus”, contains dapsone 100 mg. Nonmedicinal ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, and cornstarch.

How should I use this medication?

Leprosy: The recommended adult dose of dapsone when used for leprosy is 100 mg daily. For children, the dose should be adjusted according to body weight (1 mg to 2 mg per kilogram of body weight daily). Dapsone is used in combination with other medications.

Dermatitis herpetiformis: To treat dermatitis herpetiformis, the usual starting dose is from 50 mg once daily, to be increased until an effective dose is reached. In some cases, up to 300 mg daily may be required.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

The medication needs to be taken for several months after the symptoms have disappeared to prevent the condition from returning. It is important to take dapsone as directed for as long as it has been prescribed, even if you are feeling better.

The medication may be taken with food or on an empty stomach. Take it with food if stomach upset occurs.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Dapsone should not be taken by anyone who:

  • is allergic to dapsone or to any of the ingredients of the medication
  • has a kidney problem called advanced amyloidosis of the kidneys

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • blurred vision
  • dizziness
  • fast heartbeat
  • fatigue
  • headache
  • loss of appetite
  • nausea or vomiting
  • skin rash or itch
  • trouble sleeping

Although most of these side effects listed below don’t happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • easy bruising
  • itching, dryness, redness, scaling, or peeling of the skin
  • loss of hair
  • numbing or tingling sensation in the hands or feet
  • signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities)
  • signs of infections (e.g., fever or chills, sore throat)
  • signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
  • unusual tiredness or weakness

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • severe skin reaction (e.g., blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort)
  • signs of an allergic reaction (e.g., shortness of breath or difficulty breathing; hives; swelling of the eyes, mouth, lips, or throat)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Anemia: Dapsone is known to cause certain types of anemia (low levels of red blood cells). People with anemia should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. You will need to have your blood counts checked routinely while taking this medication.

Dizziness/reduced alertness: Dapsone can cause dizziness for people who take normal doses. Do not drive, use machinery, or do any activity that requires alertness until you are sure that you can do these activities safely.

Glucose-6-phosphate dehydrogenase deficiency: People who lack the enzyme glucose-6-phosphate dehydrogenase should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Heart disease: People with heart disease should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Kidney disease: People with kidney disease should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. You will probably need regular kidney tests while taking this medication to make sure that this medication is not harming your kidneys.

Liver disease: People with liver disease should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. You will probably need regular liver tests while taking this medication to make sure that this medication is not harming your liver.

Lung disease: People with lung disease should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: This medication passes into breast milk. If you are a breast-feeding mother and are taking dapsone, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: This medication should not be used for children less than 1 month old.

What other drugs could interact with this medication?

There may be an interaction between dapsone and any of the following:

  • azole antifungals (e.g., fluconazole, itraconazole, ketoconazole, voriconazole)
  • chloroquine
  • clarithromycin
  • didanosine
  • hydroxychloroquine
  • mefloquine
  • nicardipine
  • primaquine
  • probenecid
  • proguanil
  • protease inhibitors; anti-HIV medications (lopinavir, ritonavir, saquinavir)
  • quinine
  • rifabutin
  • rifampin
  • sulfisoxazole

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2020. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Dapsone

see the results.

ACZONE® (dapsone) GEL, 7.5% IMPORTANT INFORMATION
APPROVED USE

ACZONE® (dapsone) Gel, 7.5% is a prescription medicine used on the skin (topical) to treat acne in people 9 years and older.

IMPORTANT SAFETY INFORMATION

Tell your doctor about all of your medical conditions, including if you have glucose-6-phosphate dehydrogenase deficiency (G6PD) or higher than normal levels of methemoglobin in your blood (methemoglobinemia).

Talk to your doctor about any medications you’re using, including topical benzoyl peroxide (BPO). Use of BPO with ACZONE® Gel may cause your skin and facial hair to temporarily turn yellow or orange at the site of application.

ACZONE® Gel 7.5% may cause serious side effects, including:

  • A decrease of oxygen in your blood caused by a certain type of abnormal red blood cell (methemoglobinemia). If your lips, nail beds, or the inside of your mouth turns gray or blue, stop using ACZONE® Gel 7.5% and get medical help right away.
  • A breakdown of red blood cells (hemolytic anemia) for some people with G6PD deficiency using ACZONE® Gel 7.5%. Stop using ACZONE® Gel 7.5%, and call your doctor right away if you get any of the following signs and symptoms: back pain, breathlessness, tiredness/weakness, dark‑brown urine, fever, or yellow or pale skin.

The most common side effects of ACZONE® Gel are dryness and itching of the skin being treated.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088.

Please click here for the full Prescribing Information.

Reference:

1. ACZONE® 7.5% Prescribing Information.

Aczone is one of the lesser known acne treatment options. Based on an oral drug called dapsone it allowed for acne treatment in people 12 and older. Dapsone, first synthesized in 1908, is oral medications known for its use in the treatment in leprosy and one rare skin disorder (dermatitis herpetiform). The oral form of dapsone has a few notable side effects the more serious of the hemolysis. This is the most common adverse effect and is seen in patients with or without G6PD deficiency. Almost all patients demonstrate the inter-related changes of a loss of 1-2g of hemoglobin. G6PD deficient patients have greater responses.

Does Aczone gel (dapsone 7.5% gel) work for acne?

It is not clear how Aczone works on acne. It is believed that Aczone has an anti-inflammatory effect and also anti-bacterial effects. Clinical reports have shown that after 12 weeks of treatment Aczone reduced acne in 41% people as compared with to 33 % percent in the control group with no treatment. Results inferior to most other prescription and over the counter anti-acne medications. Due to these inferior results aczone if frequently prescribed together with oral anti-acne treatment such as spironolactone and oral antibiotics.

Who can use aczone for acne?

Aczone should not be used by people with G6PD deficiency higher than normal levels of methemoglobin in your blood (methemoglobinemia) and people under the age of 12. It cannot be used together with benzoyl peroxide. Combining the two may cause your skin and facial hair to temporarily turn yellow or orange at the site of application.

The company suggests users be aware of a possible decrease in blood oxygen by a certain type of abnormal red blood cell (methemoglobinemia). People on Aczone gel that feel that their If lips, nail beds, or the inside of their mouth turn gray or blue, need to stop the use of aczone gel and get medical help right away. A breakdown of red blood cells (hemolytic anemia) for some people with G6PD deficiency using aczone gel can lead to back pain, breathlessness, tiredness/weakness, dark‑brown urine, fever, or yellow or pale skin that require immediate physician attention.

How does aczone compare to micronized benzoyl peroxide?

Benzoyl peroxide is regarded as the best single anti-acne ingredient (updated acne treatment guidelines of the American Academy of Dermatology). With an outstanding safety profile, high efficacy it is clearly superior to aczone for any type of acne. A special form of benzoyl peroxide (micronized) significantly increases its efficacy and reduce skin dryness that can be caused in the initial phases of benzoyl peroxide treatment.

How does aczone compare to micronized Differin (adapalene) and Epiduo?

Differin and Epiduo contain adapalene a retinoid. Having some effect on blackheads and active acne their use is usually limited by significant skin irritation and sun sensitivity. Although aczone seems to be less irritating than Differin and Epiduo it seems that Differin and Epiduo have less potential systemic side than aczone.

The list price of a 60gr tube of aczone (aczone (dapsone) 7.5% gel, is around $600.

Can people with G6PD deficiency use Aczone for their acne?

A double-blinded study of 64 subjects, consisting mostly of African Americans, evaluated the risk of hemolysis in acne patients with glucose-6-phosphate dehydrogenase deficiency (G6PD) who were treated with dapsone 5% gel vs vehicle gel. The data showed a 0.32 g/dL decrease in hemoglobin levels after 2 weeks without other signs other laboratory parameters indicative of hemolysis. Thus, the authors concluded that the risk of hemolytic anemia with topical dapsone 5% gel is minimal in patients with G6PD deficiency.
More info on Dapsone tablets

Aczone for people with G6PD deficiency

Dapsone (Aczone) 5% Gel for the Treatment of Acne

SAFETY

Orally administered dapsone is known to cause hematologic reactions, including met-hemoglobinemia; hemolysis, especially in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency; and agranulocytosis. These reactions are less likely with topical treatment. Hemolytic anemia has been shown not to occur in patients with G6PD deficiency with acne who were treated with topical therapy.1,2 However, the manufacturer warns of an increased risk of hemolysis in patients who use a combination of topical dapsone and oral trimethoprim/sulfamethoxazole (Bactrim, Septra).3 Dapsone gel should not be used in patients who are taking oral dapsone or antimalarial medications because of the potential for hemolytic reactions. Dapsone gel is FDA pregnancy category C; safety has not been established in breastfeeding mothers.3

TOLERABILITY

Adverse effects of dapsone gel therapy occur mainly at the site of application. The most common are dryness (16 percent), erythema (13 percent), and oiliness/peeling (13 percent).3 These reactions are most likely caused by the gel vehicle. Application of dapsone gel followed by benzoyl peroxide causes a temporary local yellow or orange discoloration of the skin and facial hair; this reaction typically resolves in one to eight weeks.3

EFFECTIVENESS

Studies show that dapsone gel has modest effectiveness in the treatment of moderately severe inflammatory and noninflammatory acne. Two studies show a clinical success rate of 40.5 versus 32.8 percent with placebo over a 12-week period (number needed to treat = 13), as defined by global assessment and a statistically significant reduction in the percentage of lesions.4,5 Dapsone gel is more effective in reducing inflammatory lesions (i.e., papules, pustules, and nodules) than noninflammatory lesions (i.e., open and closed comedones), with up to 50 percent reduction by 12 weeks of use, compared with a 42 percent response with placebo.4 For comparison, large studies of patients with moderately severe acne show up to 90 percent clearing of lesions after six to eight weeks of retinoid plus benzoyl peroxide therapy.6 Although there may be a response to initial treatment with dapsone gel within one to two weeks, this rate is not faster than the response to a combination of a retinoid and benzoyl peroxide.

Dapsone gel has not been directly compared with more established therapies (e.g., topical retinoid monotherapy) or combination topical therapies (e.g., benzoyl peroxide plus either a topical antibiotic or a retinoid).

PRICE

SIMPLICITY

A pea-sized amount of dapsone gel should be applied in a thin layer to the acne-affected areas twice daily and rubbed in gently and completely.3 Although erythema and dryness are common adverse effects, they are generally mild and rarely require discontinuation of treatment. For more severe reactions, dapsone gel therapy should be discontinued and alternate topical medications substituted.

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