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Dapsone Adverse Events Reported to the FDA Over Time

How are Dapsone adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Dapsone, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Dapsone is flagged as the suspect drug causing the adverse event.

Most Common Dapsone Adverse Events Reported to the FDA

What are the most common Dapsone adverse events reported to the FDA?

Methaemoglobinaemia
61 (2.9%)
Pyrexia
39 (1.85%)
Haemolytic Anaemia
36 (1.71%)
Anaemia
28 (1.33%)
Dyspnoea
19 (.9%)
Nausea
19 (.9%)
Pancytopenia
19 (.9%)
Cyanosis
18 (.86%)
Erythema
18 (.86%)
Oedema Peripheral
18 (.86%)
Drug Exposure During Pregnancy
17 (.81%)
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Drug Ineffective
17 (.81%)
Asthenia
16 (.76%)
Drug Rash With Eosinophilia And Sys...
16 (.76%)
Fatigue
16 (.76%)
Oxygen Saturation Decreased
16 (.76%)
Drug Hypersensitivity
15 (.71%)
Neutropenia
15 (.71%)
Rash
15 (.71%)
Confusional State
13 (.62%)
Headache
13 (.62%)
Hydrocephalus
13 (.62%)
Zygomycosis
13 (.62%)
Skin Exfoliation
12 (.57%)
Chills
11 (.52%)
Leukopenia
11 (.52%)
Neuropathy Peripheral
11 (.52%)
Rash Erythematous
11 (.52%)
Rash Generalised
11 (.52%)
Skin Lesion
11 (.52%)
Blister
10 (.48%)
Loss Of Consciousness
10 (.48%)
Malaise
10 (.48%)
Abdominal Pain Upper
9 (.43%)
Aspartate Aminotransferase Increase...
9 (.43%)
Condition Aggravated
9 (.43%)
Renal Tubular Necrosis
9 (.43%)
Tachycardia
9 (.43%)
Thrombocytopenia
9 (.43%)
Abdominal Pain
8 (.38%)
Bone Marrow Failure
8 (.38%)
Dizziness
8 (.38%)
Drug Interaction
8 (.38%)
Drug Intolerance
8 (.38%)
Haemoglobin Decreased
8 (.38%)
Insomnia
8 (.38%)
Pallor
8 (.38%)
Paraesthesia
8 (.38%)
Rash Maculo-papular
8 (.38%)
Scab
8 (.38%)
Stevens-johnson Syndrome
8 (.38%)
Agranulocytosis
7 (.33%)
Aplasia Pure Red Cell
7 (.33%)
Arthralgia
7 (.33%)
Cardiac Arrest
7 (.33%)
Chest Pain
7 (.33%)
Diarrhoea
7 (.33%)
General Physical Health Deteriorati...
7 (.33%)
Granuloma
7 (.33%)
Haemolysis
7 (.33%)
Herpes Zoster
7 (.33%)
Hyperkalaemia
7 (.33%)
Hypoxia
7 (.33%)
Neurodermatitis
7 (.33%)
Ophthalmoplegia
7 (.33%)
Pain In Extremity
7 (.33%)
Pseudomonas Infection
7 (.33%)
Rash Pustular
7 (.33%)
Renal Failure Acute
7 (.33%)
Sepsis
7 (.33%)
Staphylococcal Infection
7 (.33%)
Vomiting
7 (.33%)
Alanine Aminotransferase Increased
6 (.29%)
Bacteraemia
6 (.29%)
Blindness Unilateral
6 (.29%)
Cholestasis
6 (.29%)
Coagulopathy
6 (.29%)
Corneal Perforation
6 (.29%)
Dermatitis Exfoliative
6 (.29%)
Discomfort
6 (.29%)
Haematuria
6 (.29%)
Hepatic Failure
6 (.29%)
Hypertension
6 (.29%)
Jaundice
6 (.29%)
Pain
6 (.29%)
Polyglandular Disorder
6 (.29%)
Pregnancy
6 (.29%)
Pruritus
6 (.29%)
Toxic Epidermal Necrolysis
6 (.29%)
Tuberculoid Leprosy
6 (.29%)
Blood Alkaline Phosphatase Decrease...
5 (.24%)
Blood Bilirubin Abnormal
5 (.24%)
Blood Glucose Decreased
5 (.24%)
Blood Methaemoglobin Present
5 (.24%)
Brain Abscess
5 (.24%)
Congenital Hydrocephalus
5 (.24%)
Convulsion
5 (.24%)
Dapsone Syndrome
5 (.24%)
Dysphagia
5 (.24%)
Exophthalmos
5 (.24%)
Eyelid Ptosis
5 (.24%)

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This graph shows the top adverse events submitted to the FDA for Dapsone, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Dapsone is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Dapsone

What are the most common Dapsone adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Dapsone, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Dapsone is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Dapsone According to Those Reporting Adverse Events

Why are people taking Dapsone, according to those reporting adverse events to the FDA?

Antifungal Prophylaxis
121
Prophylaxis
112
Drug Use For Unknown Indication
100
Product Used For Unknown Indication
56
Infection Prophylaxis
55
Antibiotic Prophylaxis
49
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Pneumocystis Jiroveci Pneumonia
44
Leprosy
30
Acne
24
Hiv Infection
19
Dermatitis Herpetiformis
17
Pemphigus
16
Conjunctivitis
13
Pruritus
11
Drug Exposure During Pregnancy
11
Dermatitis
9
Skin Disorder
8
Behcets Syndrome
8
Pemphigoid
7
Idiopathic Thrombocytopenic Purpura
7
Tuberculoid Leprosy
7
Lepromatous Leprosy
7
Pyoderma Gangrenosum
6
Ill-defined Disorder
6
Systemic Lupus Erythematosus
6
Infection
6
Immunosuppression
5
Arthropod Bite
5
Vasculitis
5
Prophylaxis Against Hiv Infection
5
Pneumonia
5
Hiv Test Positive
5
Pathogen Resistance
5
Insomnia
4
Lupus-like Syndrome
4
Leukocytoclastic Vasculitis
4
Coeliac Disease
4
Intentional Overdose
4
Rash
4
Neurodermatitis
4
Acquired Immunodeficiency Syndrome
3
Skin Lesion
3
Rheumatoid Arthritis
3
Localised Infection
3
Crohns Disease
3
Antiviral Treatment
3
Granuloma Annulare
3
Drug Hypersensitivity
3
Hidradenitis
3
Pneumocystis Jiroveci Infection
3
Opportunistic Infection
3

Drug Labels

LabelLabelerEffective
DapsonePhysicians Total Care, Inc.15-JUN-10
DapsoneREMEDYREPACK INC. 18-NOV-10
DapsoneJacobus Pharmaceutical Company, Inc.11-JUL-11
AczoneAllergan, Inc.28-MAR-13

Dapsone Case Reports

What Dapsone safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Dapsone. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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