DAPSONE

N/A

Manufactured by Allergan, Inc.

19,006 FDA adverse event reports analyzed

Last updated: 2026-04-14

About DAPSONE

DAPSONE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Allergan, Inc.. The most commonly reported adverse reactions for DAPSONE include OFF LABEL USE, DRUG INEFFECTIVE, NAUSEA, PYREXIA, FATIGUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DAPSONE.

Top Adverse Reactions

OFF LABEL USE1,146 reports
DRUG INEFFECTIVE1,094 reports
NAUSEA468 reports
PYREXIA455 reports
FATIGUE451 reports
METHAEMOGLOBINAEMIA422 reports
DIARRHOEA413 reports
RASH383 reports
PNEUMONIA378 reports
DYSPNOEA375 reports
PAIN364 reports
ANAEMIA346 reports
DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS343 reports
CONDITION AGGRAVATED342 reports
TREATMENT FAILURE323 reports
PRODUCT USE IN UNAPPROVED INDICATION312 reports
HEADACHE293 reports
VOMITING284 reports
ASTHENIA274 reports
ACUTE KIDNEY INJURY234 reports
PRURITUS230 reports
RENAL FAILURE227 reports
SEPSIS223 reports
DEATH220 reports
DIZZINESS217 reports
ANXIETY204 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION202 reports
THROMBOCYTOPENIA193 reports
ERYTHEMA186 reports
HYPERTENSION186 reports
DRUG INTERACTION182 reports
MALAISE182 reports
WEIGHT DECREASED174 reports
ABDOMINAL PAIN171 reports
HYPOTENSION171 reports
NEUTROPENIA168 reports
COUGH167 reports
ARTHRALGIA164 reports
PANCYTOPENIA162 reports
DEPRESSION154 reports
HAEMOLYTIC ANAEMIA154 reports
URTICARIA154 reports
DRUG HYPERSENSITIVITY151 reports
PRODUCT DOSE OMISSION ISSUE145 reports
WEIGHT INCREASED145 reports
CHRONIC KIDNEY DISEASE140 reports
EMOTIONAL DISTRESS136 reports
DECREASED APPETITE132 reports
FALL130 reports
HYPOXIA130 reports
CONSTIPATION129 reports
HAEMOGLOBIN DECREASED128 reports
PLATELET COUNT DECREASED128 reports
WHITE BLOOD CELL COUNT DECREASED123 reports
BLOOD CREATININE INCREASED121 reports
FEBRILE NEUTROPENIA121 reports
NEUROPATHY PERIPHERAL121 reports
DISEASE PROGRESSION120 reports
RESPIRATORY FAILURE119 reports
INTENTIONAL PRODUCT USE ISSUE118 reports
OEDEMA PERIPHERAL118 reports
RENAL IMPAIRMENT118 reports
INFECTION116 reports
SKIN EXFOLIATION116 reports
BACK PAIN114 reports
THERAPY NON RESPONDER113 reports
DEHYDRATION112 reports
CHEST PAIN110 reports
CONFUSIONAL STATE109 reports
CHILLS108 reports
DRUG INTOLERANCE107 reports
OXYGEN SATURATION DECREASED107 reports
ANHEDONIA106 reports
INSOMNIA106 reports
NO ADVERSE EVENT106 reports
BLOOD PRESSURE INCREASED103 reports
FEELING ABNORMAL103 reports
ACNE101 reports
PRODUCT USE ISSUE100 reports
DRUG INDUCED LIVER INJURY99 reports
MUSCLE SPASMS99 reports
LEUKOPENIA98 reports
PAIN IN EXTREMITY94 reports
PULMONARY EMBOLISM94 reports
MYALGIA92 reports
URINARY TRACT INFECTION92 reports
OSTEOPOROSIS88 reports
HYPERSENSITIVITY87 reports
PERIPHERAL SWELLING86 reports
DEEP VEIN THROMBOSIS85 reports
GAIT DISTURBANCE85 reports
BLISTER84 reports
COVID 1982 reports
TOXICITY TO VARIOUS AGENTS80 reports
TREMOR80 reports
DISEASE RECURRENCE79 reports
SKIN LESION76 reports
ADVERSE DRUG REACTION75 reports
DRY SKIN75 reports
RENAL FAILURE ACUTE75 reports

Report Outcomes

Out of 10,166 classified reports for DAPSONE:

Serious 75.7%Non-Serious 24.3%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female4,924 (54.1%)
Male4,164 (45.8%)
Unknown9 (0.1%)

Reports by Age

Age 54162 reports
Age 58156 reports
Age 55154 reports
Age 65152 reports
Age 57146 reports
Age 66144 reports
Age 50136 reports
Age 60136 reports
Age 44134 reports
Age 49132 reports
Age 62128 reports
Age 67125 reports
Age 72125 reports
Age 69119 reports
Age 35118 reports
Age 64118 reports
Age 70118 reports
Age 41117 reports
Age 63117 reports
Age 59116 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with DAPSONE?

This profile reflects 19,006 FDA FAERS reports that mention DAPSONE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for DAPSONE?

Frequently reported terms in FAERS include OFF LABEL USE, DRUG INEFFECTIVE, NAUSEA, PYREXIA, FATIGUE, METHAEMOGLOBINAEMIA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures DAPSONE?

Labeling and FAERS entries often list Allergan, Inc. in connection with DAPSONE. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.