OpenClaim

Dapsone Side Effects

The most commonly reported side effects of dapsone include off label use, fatigue, and nausea, based on 10,533 FDA adverse event reports from 2004 to 2025. 9.9% of reports found the drug to be ineffective.

Dapsone side effects

Percentages show how often each reaction appears relative to total reports for dapsone.

1
Off Label Use11.2%1,180
2
Drug Ineffective9.9%1,047
3
Fatigue3.8%395
4
Nausea3.7%385
5
Pyrexia3.6%380
6
Drug Reaction With Eosinophilia And Systemic Symptoms3.6%377
7
Methaemoglobinaemia3.6%375
8
Rash3.4%353
9
Diarrhoea3.3%344
10
Pain3.2%334
11
Pneumonia3.0%320
12
Treatment Failure3.0%319
13
Condition Aggravated3.0%317
14
Product Use In Unapproved Indication3.0%315
15
Dyspnoea3.0%312

These are voluntary reports and do not establish that dapsone caused these reactions.

Report severity

75.6%Serious7,961 reports
36.1%Hospitalizations3,799 reports
8.9%Fatal938 reports

Seriousness is determined by the reporter, not by OpenClaim.

Dapsone drug interactions

Other drugs that appear in adverse event reports alongside dapsone. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Mycophenolate8.5%899
2
Prednisone8.2%868
3
Rituximab6.6%696
4
Lenalidomide6.6%692
5
Methotrexate6.2%657
6
Cyclosporine5.8%610
7
Prednisolone4.9%520
8
Tacrolimus4.9%518
9
Azathioprine4.6%484
10
Hydroxychloroquine-sulfate4.0%426
11
Cyclophosphamide3.5%369
12
Tenofovir3.2%342
13
Adalimumab3.0%311
14
Emtricitabine2.5%267
15
Doxycycline2.4%256

Taken alongside

1
Acyclovir17.4%1,831
2
Prednisone15.1%1,591
3
Acetaminophen11.9%1,256
4
Aspirin9.8%1,035
5
Ergocalciferol9.7%1,020
6
Omeprazole8.8%924
7
Dexamethasone8.8%923
8
Ondansetron8.3%869
9
Pantoprazole-sodium8.0%838
10
Fluconazole7.7%816
11
Levothyroxine-sodium7.1%744
12
Furosemide6.6%699
13
Amlodipine6.5%688
14
Albuterol6.5%683
15
Metoprolol6.2%650

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports dapsone side effects

48.6% of dapsone adverse event reports involve female patients and 40.7% involve male patients. The largest age group is adult at 68%. These figures reflect who reports side effects, not underlying risk.

Sex

Female48.6%
Male40.7%
Unknown10.6%

Age group

< 20.9%
2–112.3%
12–174.1%
18–6467.8%
65+24.9%

What is dapsone used for

Conditions and purposes for which patients were taking dapsone when the adverse event was reported.

AcneAcne ConglobataAcne CysticAcne FulminansAcquired Epidermolysis BullosaAcquired Immunodeficiency SyndromeAcute Febrile Neutrophilic DermatosisAcute Lymphocytic LeukaemiaAcute Promyelocytic LeukaemiaAlopecia ScarringAnaesthesiaAnal FissureAnalgesic Intervention Supportive TherapyAngioedemaAngiolymphoid Hyperplasia With Eosinophilia

Showing 15 of 547 indications

Dapsone brand names and reporting trend

Dapsone is sold under the brand name Aczone.

Brand names

Aczone10,869

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking dapsone with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.