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Dapsone (Dapsone) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Dapsone and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (70)
Death (14)
Life Threatening Events (10)
Disability (3)

Reports by Reaction Type

Methaemoglobinaemia (14)Pancytopenia (14)Zygomycosis (13)Toxicity To Various Agents (12)Haemolytic Anaemia (10)Pyrexia (9)Ophthalmoplegia (7)Blindness Unilateral (6)Haemodynamic Instability (5)Herpes Zoster (5)Eyelid Ptosis (5)Exophthalmos (5)

Below are a few examples of reports where side effects / adverse reactions may be related to Dapsone. For a complete list or a specific selection of reports, please use the links above.

Possible Dapsone side effects in 74 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-20

Patient: 74 year old male, weighing 77.6 kg (170.6 pounds)

Reactions: Methaemoglobinaemia

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Dapsone



Possible Dapsone side effects in

Reported by a consumer/non-health professional from France on 2012-07-30

Patient:

Reactions: Drug Eruption, Death, Aspartate Aminotransferase Increased, Anaemia, Neutropenia, Leukopenia

Adverse event resulted in: death

Drug(s) suspected as cause:
Viread
    Dosage: 300 mg, qd
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2010-05-30

Rifampin
    Dosage: 600 mg, qd
    Administration route: Oral
    Indication: Tuberculosis
    Start date: 2010-05-22
    End date: 2010-08-10

Isentress
    Dosage: 800 mg, qd
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2010-05-30
    End date: 2010-08-31

Isoniazid
    Dosage: 400 mg, qd
    Administration route: Oral
    Indication: Tuberculosis
    Start date: 2010-05-22
    End date: 2010-08-10

Dapsone
    Dosage: 100 mg, qd
    Indication: Prophylaxis
    Start date: 2011-01-15

Pyrazinamide
    Dosage: 2 g, qd
    Administration route: Oral
    Indication: Tuberculosis
    Start date: 2010-05-22
    End date: 2010-07-26

Epivir
    Dosage: 300 mg, qd
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2010-06-30

Kaletra
    Dosage: 20
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2010-11-22

Other drugs received by patient: Bactrim; Leucovorin Calcium; Leucovorin Calcium; Ivermectin; Acyclovir; Ciproflaxacin; Azithromycin; Pyridoxine HCL; Omeprazole



Possible Dapsone side effects in 50 year old male

Reported by a pharmacist from United States on 2012-07-30

Patient: 50 year old male, weighing 66.4 kg (146.1 pounds)

Reactions: Haemolytic Anaemia

Drug(s) suspected as cause:
Dapsone



Possible Dapsone side effects in male

Reported by a health professional (non-physician/pharmacist) from Philippines on 2012-07-25

Patient: male

Reactions: Blood Creatinine Increased

Drug(s) suspected as cause:
Dapsone
    Administration route: Oral
    Indication: Leprosy
    Start date: 2011-10-01
    End date: 2012-07-01

Rifampicin
    Administration route: Oral
    Indication: Leprosy
    Start date: 2011-10-01
    End date: 2012-07-01

Clofazimine
    Administration route: Oral
    Indication: Leprosy
    Start date: 2011-10-01
    End date: 2012-07-01

Other drugs received by patient: Metformin Hydrochloride



Possible Dapsone side effects in male

Reported by a health professional (non-physician/pharmacist) from Philippines on 2012-07-23

Patient: male

Reactions: Blood Creatinine Increased

Drug(s) suspected as cause:
Clofazimine
    Administration route: Oral
    Indication: Leprosy
    Start date: 2011-10-01
    End date: 2012-07-01

Rifampicin
    Administration route: Oral
    Indication: Leprosy
    Start date: 2011-10-01
    End date: 2012-07-01

Dapsone
    Administration route: Oral
    Indication: Leprosy
    Start date: 2011-10-01
    End date: 2012-07-01

Other drugs received by patient: Metformin Hydrochloride



Possible Dapsone side effects in 75 year old male

Reported by a physician from Argentina on 2012-07-20

Patient: 75 year old male

Reactions: Hyperaesthesia, Skin Lesion, Neuritis

Drug(s) suspected as cause:
Rifampicin
    Dosage: 600 mg, the first day of each month
    Administration route: Oral
    Indication: Skin Lesion

Clofazimine
    Dosage: 300 mg, the first day of each month
    Administration route: Oral
    Indication: Skin Lesion

Dapsone
    Dosage: 100 mg, every other day for twelve months
    Administration route: Oral

Dapsone
    Dosage: 100 mg, the first day of each month
    Administration route: Oral
    Indication: Skin Lesion

Clofazimine
    Dosage: 50 mg, every other day for twelve months
    Administration route: Oral



Possible Dapsone side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-19

Patient:

Reactions: Haemolytic Anaemia

Drug(s) suspected as cause:
Yervoy

Dapsone



Possible Dapsone side effects in female

Reported by a individual with unspecified qualification from United States on 2012-07-13

Patient: female

Reactions: Aphagia, White Blood Cell Count Decreased, Fluid Intake Reduced

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Dapsone

Other drugs received by patient: Spiriva; Aldactone; Calritin; Albuterol; Pravachol; Lisinopril; Lopressor; Cymbacprt Inhaler; Prozac; Lasix; Actapres; Loratadine; Proventil Gentlehaler



Possible Dapsone side effects in 41 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-28

Patient: 41 year old female

Reactions: Localised Infection, International Normalised Ratio Increased, International Normalised Ratio Decreased, Drug Interaction, Herpes Zoster

Drug(s) suspected as cause:
Dapsone
    Dosage: 100 mg
    Indication: Infection

Warfarin Sodium
    Dosage: 22.5 mg;qw
    Indication: Deep Vein Thrombosis
    Start date: 2009-07-01

Warfarin Sodium
    Dosage: 22.5 mg;qw
    Indication: Pulmonary Embolism
    Start date: 2009-07-01

Other drugs received by patient: Multi-Vitamin; Tramadol Hydrochloride and Acetaminophen; Ducosate Sodium; Omeprazole; Acyclovir; Hydroxychloroquine Sulfate; Clindamycin; Oxycodone / Acetaminophen; Trospium XR; Nifedipine; Solifenacin Succinate; Calcium-Vitamin D; Ferrous Sulfate TAB; Gabapentin; Folic Acid; Prednisone



Possible Dapsone side effects in 65 year old female

Reported by a pharmacist from United States on 2012-06-25

Patient: 65 year old female

Reactions: Malaise, Fatigue, Pancytopenia, Asthenia

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Cyclophosphamide
    Dosage: 1 tablet twice daily po
    Administration route: Oral
    Indication: Idiopathic Pulmonary Fibrosis

Dapsone
    Dosage: 1 tablet daily po
    Administration route: Oral
    Indication: Rheumatoid Arthritis



Possible Dapsone side effects in 60 year old female

Reported by a consumer/non-health professional from United States on 2012-06-21

Patient: 60 year old female, weighing 75.8 kg (166.7 pounds)

Reactions: Vomiting, Pain in Extremity, Nail Discolouration, Urticaria, Cystitis, Pyrexia, Renal Failure, Dysstasia, Skin Discolouration, Visual Impairment, Ocular Icterus, Decreased Appetite

Drug(s) suspected as cause:
Dapsone



Possible Dapsone side effects in male

Reported by a physician from United States on 2012-06-19

Patient: male

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Sulfamethoxazole
    Dosage: unk

Trimethoprim
    Dosage: unk

Dapsone
    Dosage: unk



Possible Dapsone side effects in 54 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-14

Patient: 54 year old male, weighing 76.2 kg (167.6 pounds)

Reactions: Abdominal Pain, Viral Rash, Impaired Work Ability, Pyrexia, Headache, Erythema, Neck Pain, Tongue Disorder, Liver Function Test Abnormal, Blister, Nausea, Skin Graft, Anaemia, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Dapsone

Other drugs received by patient: Atrovent; Cholesterol Lowering Drug; Singulair; Albuterol; Spironolactone; Steroids; Vitamin D



Possible Dapsone side effects in 66 year old male

Reported by a physician from United Kingdom on 2012-06-14

Patient: 66 year old male

Reactions: Haemolytic Anaemia

Drug(s) suspected as cause:
Dapsone



Possible Dapsone side effects in 21 year old male

Reported by a health professional (non-physician/pharmacist) from Austria on 2012-05-31

Patient: 21 year old male

Reactions: Methaemoglobinaemia, Pancytopenia, Pyrexia, Herpes Zoster, Bacteraemia, Brain Abscess, Cerebral Thrombosis, Thrombocytopenia, Candidiasis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Dexamethasone

Infliximab
    Dosage: 5 mg/kg body weight
    Indication: Hidradenitis

Fosfomycin

Etanercept
    Dosage: 50 mg/week
    Indication: Hidradenitis

Cefotaxime

Moxifloxacin
    Administration route: Oral
    Indication: Bacterial Infection

Dapsone
    Administration route: Oral
    Indication: Hidradenitis

Linezolid

Clindamycin
    Indication: Bacterial Infection

Ampicillin

Doripenem
    Indication: Bacteraemia



Possible Dapsone side effects in 21 year old male

Reported by a health professional (non-physician/pharmacist) from Austria on 2012-05-24

Patient: 21 year old male

Reactions: Methaemoglobinaemia, Pancytopenia, Pyrexia, Herpes Zoster, Bacteraemia, Brain Abscess, Cerebral Thrombosis, Thrombocytopenia, Candidiasis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Etanercept
    Dosage: 50 mg/week
    Indication: Hidradenitis

Dapsone
    Administration route: Oral
    Indication: Hidradenitis

Ampicillin

Clindamycin
    Indication: Bacterial Infection

Dexamethasone

Doripenem
    Indication: Bacteraemia

Infliximab
    Dosage: 5 mg/kg body weight
    Indication: Hidradenitis

Moxifloxacin
    Administration route: Oral
    Indication: Bacterial Infection

Fosfomycin

Linezolid

Cefotaxime



Possible Dapsone side effects in 21 year old male

Reported by a health professional (non-physician/pharmacist) from Austria on 2012-05-24

Patient: 21 year old male

Reactions: Bacteraemia, Brain Abscess, Methaemoglobinaemia, Cerebral Thrombosis, Herpes Zoster

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Etanercept
    Indication: Hidradenitis

Dapsone
    Dosage: daily, duration 730 days
    Indication: Skin Disorder

Infliximab, Recombinant
    Indication: Hidradenitis



Possible Dapsone side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-22

Patient: female, weighing 76.2 kg (167.6 pounds)

Reactions: Dyspnoea, Chills, Tinea Capitis, Vertigo, Cough, Feeling Cold, Muscle Spasms

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Dapsone



Possible Dapsone side effects in 66 year old female

Reported by a individual with unspecified qualification from United States on 2012-04-26

Patient: 66 year old female, weighing 56.7 kg (124.7 pounds)

Reactions: Dysphagia, Enterococcal Infection, Rectal Haemorrhage, Anaemia, Ataxia, Cystitis, Oedema Peripheral, Dizziness, Platelet Count Decreased, Oedema, Gastrooesophageal Reflux Disease, Oesophageal Ulcer

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Temodar
    Dosage: 75 mg/m[2]/daily/po
    Administration route: Oral
    Indication: Glioblastoma Multiforme
    Start date: 2012-03-12
    End date: 2012-04-09

CAP Vorinostat UNK
    Dosage: 300 mg/5xw/po
    Administration route: Oral
    Indication: Glioblastoma Multiforme
    Start date: 2012-03-12
    End date: 2012-04-09

Dapsone
    Indication: Product Used FOR Unknown Indication

Decadron
    Dosage: po
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication



Possible Dapsone side effects in male

Reported by a health professional (non-physician/pharmacist) from Australia on 2012-04-26

Patient: male, weighing 118.0 kg (259.6 pounds)

Reactions: Pulmonary Embolism

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Pantoprazole Sodium
    Indication: Product Used FOR Unknown Indication

Mycophenolate Mofetil (Cellcept)
    Indication: Product Used FOR Unknown Indication

Calcium Carbonate
    Indication: Product Used FOR Unknown Indication

Prednisolone
    Indication: Product Used FOR Unknown Indication

Flebogamma
    Indication: Product Used FOR Unknown Indication

Dapsone
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Folic Acid
    Indication: Product Used FOR Unknown Indication

Vitamin D
    Indication: Product Used FOR Unknown Indication



Possible Dapsone side effects in 21 year old male

Reported by a health professional (non-physician/pharmacist) from Austria on 2012-04-23

Patient: 21 year old male

Reactions: Bacteraemia, Methaemoglobinaemia, Brain Abscess, Cerebral Thrombosis, Herpes Zoster

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Etanercept
    Indication: Hidradenitis

Infliximab, Recombinant
    Indication: Hidradenitis

Dapsone
    Dosage: daily, duration 730 days
    Indication: Skin Disorder



Possible Dapsone side effects in 27 year old female

Reported by a physician from United States on 2012-04-16

Patient: 27 year old female

Reactions: Liver Injury, Aspartate Aminotransferase Increased, Alanine Aminotransferase Increased, Rash

Drug(s) suspected as cause:
Amoxicillin and Clavulanate Potassium
    Start date: 2011-01-08
    End date: 2011-01-14

Dapsone
    Start date: 2010-12-02
    End date: 2011-02-04



Possible Dapsone side effects in 15 year old female

Reported by a physician from Australia on 2012-04-11

Patient: 15 year old female

Reactions: Intentional Overdose, Methaemoglobinaemia, Lactic Acidosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Azathioprine
    Dosage: small quantity
    Administration route: Oral
    Indication: Intentional Self-Injury

Prednisolone
    Dosage: small quantity
    Administration route: Oral
    Indication: Intentional Self-Injury

Methotrexate
    Dosage: small quantity
    Administration route: Oral
    Indication: Intentional Self-Injury

Dapsone
    Dosage: 7.2 g, single
    Administration route: Oral
    Indication: Intentional Overdose

Methylprednisolone
    Dosage: small quantity
    Administration route: Oral
    Indication: Intentional Self-Injury



Possible Dapsone side effects in female

Reported by a physician from Korea, Republic of on 2012-04-05

Patient: female, weighing 55.0 kg (121.0 pounds)

Reactions: Rash Pustular, Scab, Drug Hypersensitivity, Toxicity To Various Agents, Neurodermatitis, Pyrexia, Skin Lesion, Haemolytic Anaemia, Papule

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Imatinib Mesylate
    Dosage: 400 mg, daily
    Administration route: Oral
    Start date: 2008-03-01
    End date: 2008-03-14

Dapsone
    Dosage: 100 mg, unk
    Administration route: Oral
    Start date: 2008-03-05
    End date: 2008-03-05

Imatinib Mesylate
    Dosage: 400 mg, daily
    Administration route: Oral
    Indication: Gastrointestinal Stromal Tumour
    Start date: 2007-04-04
    End date: 2008-02-15

Dapsone
    Dosage: 100 mg, unk
    Administration route: Oral
    Start date: 2008-01-29



Possible Dapsone side effects in 57 year old female

Reported by a physician from United States on 2012-03-29

Patient: 57 year old female, weighing 63.5 kg (139.7 pounds)

Reactions: Gastrointestinal Haemorrhage, Anaemia, Pulmonary Embolism, Occult Blood Positive, Small Intestinal Perforation, Hypoxia, Enteritis Infectious, Abscess, Diverticular Perforation, Lymphocyte Count Decreased

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Vorinostat
    Dosage: 4500 mg; po
    Administration route: Oral
    Indication: Glioblastoma Multiforme
    End date: 2012-02-24

Temozolomide
    Dosage: 2160 mg
    Indication: Glioblastoma Multiforme
    Start date: 2012-02-06
    End date: 2012-02-23

Dexamethasone TAB

Dapsone



Possible Dapsone side effects in 21 year old male

Reported by a health professional (non-physician/pharmacist) from Austria on 2012-03-29

Patient: 21 year old male

Reactions: Bacteraemia, Brain Abscess, Methaemoglobinaemia

Drug(s) suspected as cause:
Etanercept
    Dosage: 50 mg/week
    Indication: Product Used FOR Unknown Indication

Dapsone
    Dosage: 50 mg, daily
    Indication: Skin Disorder

Infliximab
    Dosage: 5 mg/kg body weight
    Indication: Hidradenitis



Possible Dapsone side effects in 57 year old female

Reported by a consumer/non-health professional from United States on 2012-03-28

Patient: 57 year old female, weighing 63.0 kg (138.7 pounds)

Reactions: Gastrointestinal Infection, Gastrointestinal Haemorrhage, Small Intestinal Perforation, Diverticulitis, Abscess, Lymphocyte Count Decreased

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Decadron
    Dosage: po
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

CAP Vorinostat UNK
    Dosage: 300 mg/5xw/po
    Administration route: Oral
    Indication: Glioblastoma Multiforme
    Start date: 2012-02-06
    End date: 2012-02-24

Temozolomide
    Dosage: 75 mg/m [2]/daily/po
    Administration route: Oral
    Indication: Glioblastoma Multiforme
    Start date: 2012-02-06
    End date: 2012-02-23

Dapsone
    Indication: Product Used FOR Unknown Indication



Possible Dapsone side effects in male

Reported by a physician from United States on 2012-03-28

Patient: male

Reactions: Pancreatitis, Hepatic Failure, Haemolytic Anaemia

Drug(s) suspected as cause:
Dapsone

Claravis

Other drugs received by patient: Insulin; Lorazepam; Cetirizine Hydrochloride; Ranitidine HCL



Possible Dapsone side effects in female

Reported by a physician from United States on 2012-03-23

Patient: female

Reactions: Dapsone Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Dapsone
    Dosage: 25 milligram
    Start date: 2011-11-30
    End date: 2011-12-26

Thalomid
    Dosage: 100 milligram
    Administration route: Oral
    Indication: Lepromatous Leprosy
    Start date: 2011-11-30
    End date: 2011-12-26

Other drugs received by patient: Prednisone; Clofazimine; Minocin; Rifampin



Possible Dapsone side effects in 72 year old male

Reported by a pharmacist from United States on 2012-03-23

Patient: 72 year old male

Reactions: Skin Exfoliation, Rash Pruritic

Drug(s) suspected as cause:
Revlimid
    Dosage: 10 mg, daily for 21 days, po
    Administration route: Oral
    Indication: Multiple Myeloma
    Start date: 2011-02-17
    End date: 2011-03-10

Revlimid
    Dosage: 10 mg, daily for 21 days, po
    Administration route: Oral
    Indication: Multiple Myeloma
    Start date: 2011-05-03

Dapsone
    Indication: Product Used FOR Unknown Indication

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