What the label lists and what reports show
Dapsone side effects
Dapsone's FDA label: “Hematologic Effects: Dose-related hemolysis is the most common adverse effect and is seen in patients with or without G6PD deficiency.” FAERS holds 10,643 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is nausea (487 reports).
- Generic listed
- A presentation discontinued
Check it at the source: the dapsone FDA label on DailyMed (effective July 20, 2026, Macleods Pharmaceuticals Limited); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of ACZONE Gel, 7.5%?ACZONE Gel, 7.5% may cause serious side effects, including: Decrease of oxygen in your blood caused by a certain type of abnormal red blood cell (methemoglobinemia). Stop using ACZONE Gel, 7.5% and get medical help right away if your lips, nail beds, or the inside of your mouth turns grey or blue. Breakdown of red blood cells (hemolytic anemia). Some people with G6PD deficiency using ACZONE Gel, 7.5% may develop mild hemolytic anemia. Stop using ACZONE Gel, 7.5% and tell your doctor right away if you get any of the following signs and symptoms: back pain dark brown urine shortness of breath fever tiredness or weakness yellow or pale skin The most common side effects of ACZONE Gel, 7.5% include dryness and itching of the skin being treated. These are not all of the possible side effects of ACZONE Gel, 7.5%. Call your doctor for medical advice about side effects. […]
Source: FDA drug label (Aczone), Almirall, LLC, effective October 23, 2025 (SPL set 22058b7d-a578-4eaa-a476-ac982337f02a), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsHematologic Effects: Dose-related hemolysis is the most common adverse effect and is seen in patients with or without G6PD deficiency.
Table 2 – Adverse Reactions Occurring in at Least 1% of Subjects
This table is printed in the DAPSONE label published by Alembic Pharmaceuticals Inc. of July 9, 2026; the label quoted above does not print one.
| Reaction | Dapsone Gel, 5% 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% |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedIn 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 2g 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. Falsely Reduced HbA1c: Falsely reduced HbA1c measurements have been reported with dapsone use. Alternate measures of glycemic control (e.g., fructosamine and/or more frequent blood glucose monitoring) are recommended when a discordance between HbA1c and blood glucose concentrations are observed or suspected. Falsely reduced HbA1c may occur without overt evidence of hemolysis or anemia.
Source: FDA drug label, Macleods Pharmaceuticals Limited, effective July 20, 2026 (SPL set 839d7440-ba0e-4c56-b648-d374b155cf03), via openFDA; the full label on DailyMed
What do FAERS reports show?
10,643 reports list dapsone among the medicines taken, each a report of something that happened, not proof the medicine caused it; 934 are coded as a death and 3,831 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 19 reactions below, 7 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Dapsone: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions