What are the side effects of Dapsone (Diaminodiphenyl Sulfone)?

From the Guidelines

Dapsone's most concerning side effects include methemoglobinemia, hemolytic anemia, and agranulocytosis, which can lead to severe health complications, and therefore, patients should be closely monitored for these adverse effects, especially during the initial treatment phase. The side effects of Dapsone (Diaminodiphenyl Sulfone) can be severe and impact the patient's quality of life. According to the most recent study 1, Dapsone can cause methemoglobinemia, a condition where the blood carries less oxygen, leading to symptoms like cyanosis, headache, fatigue, and shortness of breath. Other significant side effects include:

• Hemolytic anemia, particularly in patients with G6PD deficiency, which can lead to decreased red blood cell counts and jaundice
• Agranulocytosis, reducing white blood cell counts and increasing infection risk
• Dermatological reactions ranging from mild rashes to severe conditions like Stevens-Johnson syndrome
• Peripheral neuropathy, which may develop with long-term use, causing numbness and weakness in extremities
• Gastrointestinal issues like nausea, vomiting, and abdominal pain
• Hepatotoxicity, presenting as elevated liver enzymes or jaundice As noted in the study 1, patients with G6PD deficiency are particularly at risk, and all patients at risk for G6PD deficiency should be screened before being treated. Additionally, patients should be monitored for the potential development of methemoglobin; in one trial, 5.7% reported having developed methemoglobinuria 1. In contrast to the older study 1, which reported dose-related hemolysis as the most common adverse effect, the more recent study 1 highlights the importance of monitoring for methemoglobinemia and hemolytic anemia, especially in patients with G6PD deficiency. Therefore, regular blood monitoring is crucial for patients on Dapsone, especially during the first few months of treatment, to detect any abnormalities early and prevent severe health complications.

From the FDA Drug Label

WARNINGS The patient should be warned to respond to the presence of clinical signs such as sore throat, fever, pallor, purpura or jaundice. Deaths associated with the administration of Dapsone have been reported from agranulocytosis, aplastic anemia and other blood dyscrasias. ADVERSE REACTIONS 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 1-2g of hemoglobin, an increase in the reticulocytes (2-12%), a shortened red cell life span and a rise in methemoglobin. 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.

The side effects of Dapsone include:

• Hematologic effects:
  • Dose-related hemolysis
  • Agranulocytosis
  • Aplastic anemia
  • Loss of 1-2g of hemoglobin
  • Increase in reticulocytes
  • Shortened red cell life span
  • Rise in methemoglobin
• Nervous system effects:
  • Peripheral neuropathy
  • Motor loss
  • Muscle weakness
• Body as a whole:
  • 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
  • An infectious mononucleosis-like syndrome
  • Cutaneous reactions, including bullous, exfoliative dermatitis, toxic erythema, erythema multiforme, toxic epidermal necrolysis, morbilliform and scarlatiniform reactions, urticaria and erythema nodosum 2, 2

From the Research

Side Effects of Dapsone

The side effects of Dapsone (Diaminodiphenyl Sulfone) include:

• Hemolytic anemia 3, 4, 5
• Methemoglobinemia 3, 4, 6, 7, 5
• Agranulocytosis 3
• Dyspnea 6, 7
• Cyanosis 6, 7
• Hypoxemia 4, 7

Factors Influencing Side Effects

The occurrence and severity of these side effects can be influenced by:

• Dose of Dapsone 3
• Presence of comorbidities such as anemia, chronic heart failure, and right pleural effusion 6
• Concurrent events such as pneumonia 5
• Level of methemoglobinemia 6, 5

Management of Side Effects

Management of Dapsone-induced methemoglobinemia typically involves:

• Discontinuation of Dapsone 4, 6, 7
• Administration of methylene blue 7, 5
• Monitoring of methemoglobin levels and clinical symptoms 5