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Coughing (3)
Feeling Sick (3)
Anemia (2)
Blurred Visison (2)
Constipation (2)
Haemolytic Anaemia, Kidney And Liver Abnormality (2)
Haemolytic Anaemia (1)
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Dapsone Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Showing 1-25 of 105 

Hypoxia, Methaemoglobinaemia, Cyanosis (7785650-7)
on Sep 29, 2011 Male from UNITED STATES , 65 years of age, weighting 160.5 lb, was diagnosed with
  • localised infection
  • arthropod bite
and was treated with Dapsone. Directly after, patient experienced the unwanted or unexpected Dapsone side effects: hypoxia, methaemoglobinaemia, cyanosis. Dapsone dosage: 100 Mg. Patient was hospitalized.

Hypotension, Renal Failure Acute (7728741-9)
Patient was taking Dapsone. Patient felt the following Dapsone side effects: hypotension, renal failure acute on Aug 31, 2011 from UNITED STATES Additional patient health information: Male , 66 years of age, weighting 213.4 lb, . Dapsone dosage: 50 Mg Bid Po.
Multiple prescriptions taken:
  • Sulfamethoxazole And Trimethoprim (1 Tab Bid Po)
Patient was hospitalized.

Deep Vein Thrombosis, Pain In Extremity (7698770-2)
Adverse event was reported on Aug 17, 2011 by a Female taking Dapsone (Dosage: 100 Mg, Unk) . Location: UNITED KINGDOM , 56 years of age, weighting 198.4 lb, After Dapsone was administered, patient encountered several Dapsone side effects: deep vein thrombosis, pain in extremity.
Multiple concurrent drugs taken:
  • Prednisolone (9 Mg, Unk)
  • Omeprazole (20 Mg, Unk)
  • Romiplostim (500 A?g, Unk)
  • Folic Acid (5 Mg, Unk)
Patient was hospitalized.

Glomerulonephritis Acute, Haematuria, Hypertension, Proteinuria, Oedema Peripheral, Renal Impairment, Pulmonary Oedema, Type 2 Lepra Reaction, Ascites (7683574-7)
on Jul 31, 2011 Male from AUSTRALIA , child 10 years of age, was diagnosed with
  • leprosy
  • borderline leprosy
and was treated with Dapsone. Directly after, patient experienced the unwanted or unexpected Dapsone side effects: glomerulonephritis acute, haematuria, hypertension, proteinuria, oedema peripheral, renal impairment, pulmonary oedema, type 2 lepra reaction, ascites. Dapsone dosage: N/A.
Associated medications used:
  • Aminosalicylic Acid
  • Moxifloxacin
  • Ethambutol Hydrochloride (Unk)
  • Rifampicin
  • Penicillin
  • Cycloserine
  • Amikacin (Unk)
  • Isoniazid
Patient was hospitalized.


Product Measured Potency Issue, Product Packaging Issue (7647424-7)
on Jul 29, 2011 Male from UNITED STATES , weighting 165.3 lb, was treated with Dapsone. Patient felt the following Dapsone side effects: product measured potency issue, product packaging issue. Dapsone dosage: 100mg Daily Oral.

Rash Erythematous, Skin Exfoliation, Rash Maculo-papular, Pruritus, Prurigo, Activities Of Daily Living Impaired (7611197-4)
Patient was taking Dapsone. After Dapsone was administered, patient encountered several Dapsone side effects: rash erythematous, skin exfoliation, rash maculo-papular, pruritus, prurigo, activities of daily living impaired on Jun 22, 2011 from UNITED STATES Additional patient health information: Female , 77 years of age, weighting 145.5 lb, was diagnosed with
  • antifungal prophylaxis
and. Dapsone dosage: 100 Mg Daily, Oral Ctd.
Multiple concurrent drugs taken:
  • Rituximab (375 Mg/m2, Q 28 Days, Iv)
  • Treanda (90 Mg/m2, Q 28 Days, Iv)
  • Acyclovir (400 Mg, Twicfe Daily, Oral)


Muscular Weakness, Areflexia (7609934-8)
Adverse event was reported on Jul 07, 2011 by a Female taking Dapsone (Dosage: N/A) . Location: UNITED STATES , weighting 167.0 lb, Directly after, patient experienced the unwanted or unexpected Dapsone side effects: muscular weakness, areflexia.
Associated medications used:
  • Simvastatin
  • Rituxan (375 Mg/m2, 1/week)
  • Synthroid (0.225 Mg, Unk)
  • Labetalol Hcl


Abdominal Pain, Hepatic Enzyme Increased, Renal Failure Acute, Liver Disorder, Alanine Aminotransferase Increased, Blood Bilirubin Increased, Blood Urea Increased, Aspartate Aminotransferase Increased, Blood Alkaline Phosphatase Increased (7534722-0)
on Apr 19, 2011 Male from UNITED STATES , weighting 150.0 lb, was treated with Dapsone. Patient felt the following Dapsone side effects: abdominal pain, hepatic enzyme increased, renal failure acute, liver disorder, alanine aminotransferase increased, blood bilirubin increased, blood urea increased, aspartate aminotransferase increased, blood alkaline phosphatase increased. Dapsone dosage: N/A.
Multiple prescriptions taken:
  • Lasix
  • Exjade
  • Zofran
  • Tacrolimus
  • Magnesium Sulfate
  • Mucinex
  • Exjade (2000 Mg, Qd)
  • Valtrex
Patient was hospitalized.

Methaemoglobinaemia, Acute Respiratory Failure (7524721-7)
on Jun 02, 2011 Female from UNITED STATES , weighting 154.3 lb, was diagnosed with
  • cellulitis
and was treated with Dapsone. After Dapsone was administered, patient encountered several Dapsone side effects: methaemoglobinaemia, acute respiratory failure. Dapsone dosage: Po. Patient was hospitalized.

Rash Maculo-papular, Skin Exfoliation, Rash Erythematous, Rash Pruritic, Activities Of Daily Living Impaired (7516761-9)
Patient was taking Dapsone. Directly after, patient experienced the unwanted or unexpected Dapsone side effects: rash maculo-papular, skin exfoliation, rash erythematous, rash pruritic, activities of daily living impaired on May 10, 2011 from UNITED STATES Additional patient health information: Female , 77 years of age, weighting 145.5 lb, . Dapsone dosage: 100mg, Daily, Oral Ctd.
Associated medications used:
  • Rituximab (suspect Product) (375 Mg/m2, Q 28 Days, Iv)
  • Treanda (90 Mg/m2, Q 28 Days, Iv, Now Off)
  • Acyclovir (400mg, Twice Daily, Oral)


Bronchitis, Agranulocytosis, Upper Respiratory Tract Infection, Oral Candidiasis, Oropharyngeal Pain, Febrile Neutropenia (7513015-1)
Adverse event was reported on May 25, 2011 by a Male taking Dapsone (Dosage: 100 Mg Daily Po) was diagnosed with
  • psoriatic arthropathy
  • pyoderma
and. Location: UNITED STATES , weighting 238.1 lb, Patient felt the following Dapsone side effects: bronchitis, agranulocytosis, upper respiratory tract infection, oral candidiasis, oropharyngeal pain, febrile neutropenia. Patient was hospitalized.

Metabolic Acidosis, Anaemia (7488699-7)
on May 10, 2011 Male from MALAYSIA , 35 years of age, was treated with Dapsone. After Dapsone was administered, patient encountered several Dapsone side effects: metabolic acidosis, anaemia. Dapsone dosage: N/A.
Multiple concurrent drugs taken:
  • Efavirenz
  • Combivir (2unit Per Day)


Haematuria, Anaemia, Petechiae, Melaena, Thrombocytopenia (7479008-8)
on Apr 25, 2011 Male from UNITED STATES , 35 years of age, was treated with Dapsone. Directly after, patient experienced the unwanted or unexpected Dapsone side effects: haematuria, anaemia, petechiae, melaena, thrombocytopenia. Dapsone dosage: N/A.
Associated medications used:
  • Truvade (emtricitabine-tenofovir)
  • Clarithromycin
  • Levetiracetam
  • Rifabutin
  • Sertraline Hydrochloride
  • Clonazepam
  • Ritonavir
  • Atazanavir


Anaemia, Neutropenia, Skin Reaction, Leukopenia (7474549-1)
Patient was taking Dapsone. Patient felt the following Dapsone side effects: anaemia, neutropenia, skin reaction, leukopenia on Apr 19, 2011 from FRANCE Additional patient health information: Male , 54 years of age, was diagnosed with
  • prophylaxis
and. Dapsone dosage: 100 Mg/daily, Po.
Multiple prescriptions taken:
  • Acyclovir
  • Isentress (800 Mg/daily, Po)
  • Azithromycin
  • Sulfamethoxazole Trimethoprim
  • Rifampin (600 Mg/daily, Po)
  • Leucovorin Calcium
  • Ivermectin
  • Pyrazinamide


Febrile Neutropenia, Nausea, Hypophagia, Vomiting (7436247-X)
Adverse event was reported on Apr 19, 2011 by a Male taking Dapsone (Dosage: 2 Tabs=50mg) . Location: UNITED STATES , 69 years of age, After Dapsone was administered, patient encountered several Dapsone side effects: febrile neutropenia, nausea, hypophagia, vomiting.
Multiple concurrent drugs taken:
  • Omeprazole (1 Cap=20mg Empty Stomach)
  • Ciprofloxacin
  • Magnesium Sulfate (1000ml/day)
  • Potassium Chloride
  • Etoposide
  • Ceftazidime (Ivpb)
  • Fluconazole (1 Tab=200mg)
  • Ursodiol (1 Cap (df) =300mg)
Patient was hospitalized.

Pancytopenia, Pyrexia, Syncope, Aplasia Pure Red Cell, Anaemia Of Chronic Disease, Gastritis Erosive, Gastric Antral Vascular Ectasia, Fall, Oesophageal Varices Haemorrhage (7406364-9)
on Mar 31, 2011 Male from UNITED STATES , 74 years of age, weighting 133.4 lb, was treated with Dapsone. Directly after, patient experienced the unwanted or unexpected Dapsone side effects: pancytopenia, pyrexia, syncope, aplasia pure red cell, anaemia of chronic disease, gastritis erosive, gastric antral vascular ectasia, fall, oesophageal varices haemorrhage. Dapsone dosage: N/A.
Associated medications used:
  • Engerix-b
  • Magnesium Gluconate
  • Epogen (20000 Iu, 3 Times/wk)
  • Neomycin Sulfate
  • Epogen (10000 Iu, 3 Times/wk)
  • Cyclosporine (75 Mg, Bid)
  • Prilosec
  • Ursodiol
Patient was hospitalized.

Oesophageal Candidiasis (7313191-X)
on Feb 15, 2011 Female from CANADA , weighting 171.3 lb, was treated with Dapsone. Patient felt the following Dapsone side effects: oesophageal candidiasis. Dapsone dosage: N/A.
Multiple prescriptions taken:
  • Solu-cortef
  • Coumadin
  • Benadryl
  • Reactine
  • Flovent
  • Pradaxa
  • Remicade
  • Imuran


Toxic Epidermal Necrolysis (7290697-3)
Patient was taking Dapsone. After Dapsone was administered, patient encountered several Dapsone side effects: toxic epidermal necrolysis on Feb 10, 2011 from UNITED STATES Additional patient health information: Male , 58 years of age, weighting 183.0 lb, . Dapsone dosage: N/A. Patient was hospitalized.

Dialysis, Nephropathy Toxic, Renal Failure Acute (7274312-0)
Adverse event was reported on Jan 31, 2011 by a Male taking Dapsone (Dosage: N/A) . Location: UNITED STATES , weighting 156.0 lb, Directly after, patient experienced the unwanted or unexpected Dapsone side effects: dialysis, nephropathy toxic, renal failure acute.
Associated medications used:
  • Azithro
  • Viagra
  • Depakote
  • Fluconazole
  • Tenofovir Disoproxil Fumarate (300 Mg Po Daily)
  • Atripla
  • Loperamide


Aspartate Aminotransferase Increased, Liver Injury, Alanine Aminotransferase Increased, Nausea, Blood Alkaline Phosphatase Increased (7248710-5)
on Jan 21, 2011 Female from UNITED STATES , 35 years of age, was treated with Dapsone. Patient felt the following Dapsone side effects: aspartate aminotransferase increased, liver injury, alanine aminotransferase increased, nausea, blood alkaline phosphatase increased. Dapsone dosage: N/A.
Multiple prescriptions taken:
  • Cyclophosphamide


Thrombocytopenia, Haemoglobin Decreased, Blood Alkaline Phosphatase Increased, Platelet Count Decreased, Blood Bilirubin Increased, Poikilocytosis, Polychromasia, Blood Albumin Decreased, Pancytopenia (7241430-2)
on Jan 10, 2011 Male from UNITED STATES , 35 years of age, was treated with Dapsone. After Dapsone was administered, patient encountered several Dapsone side effects: thrombocytopenia, haemoglobin decreased, blood alkaline phosphatase increased, platelet count decreased, blood bilirubin increased, poikilocytosis, polychromasia, blood albumin decreased, pancytopenia. Dapsone dosage: Unk.
Multiple concurrent drugs taken:
  • Clarithromycin (Unk)
  • Ritonavir (Unk)
  • Sertraline (Unk)
  • Levetiracetam (500 Mg, Bid)
  • Truvada (Unk)
  • Levetiracetam (1500 Mg, Bid)
  • Clonazepam (Unk)
  • Rifabutin (Unk)


Neuropathy Peripheral (7225407-9)
Patient was taking Dapsone. Directly after, patient experienced the unwanted or unexpected Dapsone side effects: neuropathy peripheral on Jan 07, 2011 from UNITED STATES Additional patient health information: Male , weighting 225.0 lb, was diagnosed with
  • hiv infection
and. Dapsone dosage: 10mg Daily.
Associated medications used:
  • Zerit (Per Label Daily)


Blister, Chills, Erythema, Oedema Peripheral, Pain Of Skin, Skin Exfoliation (7173668-7)
Adverse event was reported on Dec 15, 2010 by a Male taking Dapsone (Dosage: 25 Mg 2x Day 30 Days (oct 5 - 26th Approx)) was diagnosed with
  • infection
and. Location: UNITED STATES , weighting 212.0 lb, Patient felt the following Dapsone side effects: blister, chills, erythema, oedema peripheral, pain of skin, skin exfoliation.

Haemolytic Anaemia (7115311-9)
on Nov 16, 2010 Male from UNITED STATES , 69 years of age, weighting 169.8 lb, was diagnosed with
  • antifungal prophylaxis
and was treated with Dapsone. After Dapsone was administered, patient encountered several Dapsone side effects: haemolytic anaemia. Dapsone dosage: 100 Mg Every Day Po. Patient was hospitalized.

Chills, Dysuria, Odynophagia, Pyrexia, Stevens-johnson Syndrome, Toxic Epidermal Necrolysis (7095963-2)
on Nov 09, 2010 Male from UNITED STATES , 58 years of age, weighting 197.0 lb, was treated with Dapsone. Directly after, patient experienced the unwanted or unexpected Dapsone side effects: chills, dysuria, odynophagia, pyrexia, stevens-johnson syndrome, toxic epidermal necrolysis. Dapsone dosage: 100mg Daily Po. Patient was hospitalized.

Showing 1-25 of 105 

Dapsone Health Episodes

How Can Dapsone Affect You?

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It is very important to keep track of all side effects and discuss them with your doctor. If you think you may have a medical emergency, call your doctor or 911 immediately.

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

Dapsone Information

Alternative DAPSONE Names:ACZONE

Active Ingredient: DAPSONE

More About Dapsone

Side Effects reported to FDA: 105. View Dapsone Adverse Reports

Dapsone safety alerts: No

Reported deaths: 4

Reported hospitalizations: 56

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