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 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 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 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: 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 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 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 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 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 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 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 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 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 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 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
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
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